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Nipah, Hendra, and other henipaviruses

Nipah and Hendra viruses are two related zoonotic pathogens that have emerged in the Asia-Pacific region. Both are RNA viruses belonging to the Paramyxoviridae family and grouped under the genus Henipavirus, since they share antigenic, serological, and ultrastructural characteristics and differ from

Triprolidine and pseudoephedrine: Pediatric drug information

CloseTriprolidine and pseudoephedrine: Pediatric drug informationTriprolidine and pseudoephedrine: Pediatric drug information(For additional information see "Triprolidine and pseudoephedrine: Drug information" and see "Triprolidine and pseudoephedrine: Patient drug information")For abbreviations, symbols, and age group definitions used in Lexicomp (show table)Brand Names: USAprodine [OTC];Ed A-Hist PSE [OTC] [DSC]Therapeutic CategoryAntihistamine/Decongestant Combination;SympathomimeticDosing: PediatricNote: Multiple products with varying strengths exist; pay close attention to the product and strength when ordering or administering.Cold, allergy symptomsCold, allergy symptoms:Liquid:Triprolidine 1.25 mg and pseudoephedrine 30 mg per 5 mL (eg, Maxi-Tuss TR):Children 6 to <12 years: Oral: 5 mL every 4 to 6 hours as needed; maximum daily dose: 4 doses (20 mL) per 24 hours.Children ≥12 years and Adolescents: Oral: 10 mL every 4 to 6 hours as needed; maximum daily dose: 4 doses (40 mL) per 24 hours.Tablet:Triprolidine 1.25 mg and pseudoephedrine 30 mg (eg, Maxifed TR):Children 6 to <12 years: Oral: 1 tablet every 4 to 6 hours as needed; maximum daily dose: 4 doses (4 tablets) per 24 hours.Children ≥12 years and Adolescents: Oral: 2 tablets every 4 to 6 hours as needed; maximum daily dose: 4 doses (8 tablets) per 24 hours.Triprolidine 2.5 mg and pseudoephedrine 60 mg (eg, Aprodine):Children 6 to <12 years: Oral: 1/2 tablet every 4 to 6 hours as needed; maximum daily dose: 4 doses (2 tablets) per 24 hours.Children ≥12 years and Adolescents: Oral: 1 tablet every 4 to 6 hours as needed; maximum daily dose: 4 doses (4 tablets) per 24 hours.Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.Dosing: Kidney Impairment: PediatricThere are no dosage adjustments provided in the manufacturer's labeling.Dosing: Hepatic Impairment: PediatricThere are no dosage adjustments provided in the manufacturer's labeling.Dosing: Adult(For additional information see "Triprolidine and pseudoephedrine: Drug information")Cold, allergy symptomsCold, allergy symptoms: Oral:Liquid: Triprolidine 1.25 mg and pseudoephedrine 30 mg per 5 mL: 10 mL every 4 to 6 hours (maximum: 4 doses [40 mL] per 24 hours).Tablet:Triprolidine 1.25 mg and pseudoephedrine 30 mg: 2 tablets every 4 to 6 hours (maximum: 8 tablets per 24 hours).Triprolidine 2.5 mg and pseudoephedrine 60 mg: 1 tablet every 4 to 6 hours (maximum: 4 tablets per 24 hours).Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.Dosing: Kidney Impairment: AdultThere are no dosage adjustments provided in the manufacturer’s labeling.Dosing: Hepatic Impairment: AdultThere are no dosage adjustments provided in the manufacturer’s labeling.Dosage Forms: USExcipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued productLiquid, oral:Generic: Triprolidine hydrochloride 1.25 mg and pseudoephedrine hydrochoride 30 mg per 5 mLTablet, oral:Aprodine: Triprolidine hydrochloride 2.5 mg and pseudoephedrine hydrochloride 60 mg (24s, 100s)Ed A-Hist PSE: Triprolidine hydrochloride 2.5 mg and pseudoephedrine hydrochloride 60 mg (100s [DSC])Generic: Triprolidine hydrochloride 1.25 mg and pseudoephedrine hydrochloride 30 mg, Triprolidine hydrochloride 2.5 mg and pseudoephedrine hydrochloride 60 mgGeneric Equivalent Available: USYesAdministration: PediatricOral: Administer liquid formulations with an accurate measuring device; do not use a household teaspoon (overdosage may occur).Administration: AdultOral: Administer liquid formulations with an accurate measuring device; do not use a household teaspoon (overdosage may occur).Storage/StabilityStore at room temperature. Protect from light and freezing.UseTemporary relief of nasal congestion, running nose, sneezing, itching of nose or throat and itchy, watery eyes due to common cold, hay fever, or other upper respiratory allergies (OTC product: FDA approved in ages ≥6 years and adults). Note: Approved ages and uses may vary by product; consult product-specific labeling for details.Medication Safety IssuesOlder Adult: High-Risk Medication:Beers Criteria: Triprolidine, a first-generation antihistamine, is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its potent anticholinergic properties resulting in increased risk of confusion, dry mouth, constipation, and other anticholinergic effects or toxicity; use should also be avoided due to reduced clearance with advanced age and tolerance associated with use as a hypnotic (Beers Criteria [AGS 2019]).Pharmacy Quality Alliance (PQA): Triprolidine, as a single agent or as part of a combination (excludes OTC products), is identified as a high-risk medication in patients 65 years and older on the PQA’s, Use of High-Risk Medications in the Elderly (HRM) performance measure, a safety measure used by the Centers for Medicare and Medicaid Services (CMS) for Medicare plans (PQA 2017).Adverse ReactionsThe following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.Frequency not defined.Cardiovascular: TachycardiaCentral nervous system: Dizziness, drowsiness, excitement (transient), fatigue, headache, insomnia, nervousnessDermatologic: DiaphoresisEndocrine & metabolic: Weight gainGastrointestinal: Abdominal pain, diarrhea, increased appetite, nausea, xerostomiaGenitourinary: DysuriaNeuromuscular & skeletal: Arthralgia, weaknessRespiratory: Pharyngitis, thickening of bronchial secretionsContraindicationsOTC labeling: When used for self-medication, in combination with or within 14 days of stopping a monoamine oxidase inhibitor; are taking sedatives or tranquilizers (without first consulting physician); >7 days or if symptoms accompanied by fever.Warnings/PrecautionsConcerns related to adverse effects:• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).Disease-related concerns:• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).• Diabetes: Use with caution in patients with diabetes mellitus.• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or glaucoma.• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.• Respiratory disease: Use caution in patients with asthma, emphysema, or chronic bronchitis.• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.Dosage form specific issues:• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP 1997; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).Other warnings/precautions:• Self-medication (OTC use): When used for self medication (OTC), do not exceed recommended doses; discontinue use and contact health care provider if symptoms do not improve within 7 days or are accompanied by fever; if nervousness, dizziness or sleeplessness occur; or if new symptoms occur.Warnings: Additional Pediatric ConsiderationsSafety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported (in some cases, high blood concentrations of pseudoephedrine were found). Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).Metabolism/Transport EffectsNone known.Drug InteractionsNote: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed).For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions programAcetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapyAclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationAlcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl).Risk C: Monitor therapyAlizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyAlkalinizing Agents: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapyAlpha1-Blockers: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapyAmantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapyAmezinium: Antihistamines may enhance the stimulatory effect of Amezinium.Risk C: Monitor therapyAnticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapyAtomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapyAzelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationBenzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine.Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modificationBenzylpenicilloyl Polylysine: Alpha-/Beta-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine.Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider therapy modificationBetahistine: May diminish the therapeutic effect of Antihistamines. Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapyBlonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin.Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider therapy modificationBotulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapyBrexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone.Risk C: Monitor therapyBrimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyBromocriptine: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider therapy modificationBromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyBromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationBuprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine.Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider therapy modificationCannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapyCannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products.Risk C: Monitor therapyCannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products.Risk C: Monitor therapyCarbonic Anhydrase Inhibitors: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapyChloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapyChlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modificationChloroprocaine (Systemic): May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapyChlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapyCimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium.Risk X: Avoid combinationCloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine.Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modificationCNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapyCocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modificationDaridorexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modificationDexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect of DexmedeTOMIDine.Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider therapy modificationDifelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyDimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyDoxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline.Risk C: Monitor therapyDoxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants isnot recommended. Risk C: Monitor therapyDroperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider therapy modificationEluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline.Risk X: Avoid combinationErgot Derivatives (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Risk X: Avoid combinationEsketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyFlunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine.Risk X: Avoid combinationFlunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam.Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider therapy modificationGastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic).Risk C: Monitor therapyGlucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased.Risk C: Monitor therapyGlycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation).Risk X: Avoid combinationGlycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationGuanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapyHyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase.Risk C: Monitor therapyHydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider therapy modificationIobenguane Radiopharmaceutical Products: Alpha-/Beta-Agonists (Indirect-Acting) may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products.Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combinationIpratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationItopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride.Risk C: Monitor therapyKava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyKratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationKratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combinationLemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider therapy modificationLevosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride.Risk X: Avoid combinationLinezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid.Specific dose adjustment recommendations are not presently available. Risk D: Consider therapy modificationLisuride: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk X: Avoid combinationLofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyMagnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyMethotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants.Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider therapy modificationMetoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyMetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE.Risk C: Monitor therapyMianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapyMinocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyMirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron.Risk C: Monitor therapyMonoamine Oxidase Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors.Refer to linezolid specific monographs for details. Risk X: Avoid combinationNitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption.Risk C: Monitor therapyOlopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationOpioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists.Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modificationOrphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine.Risk X: Avoid combinationOxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationOxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationOxybate Salt Products: CNS Depressants may enhance the CNS depressant effect of Oxybate Salt Products.Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider therapy modificationOxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE.Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modificationOzanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapyParaldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde.Risk X: Avoid combinationPerampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyPergolide: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapyPiribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil.Risk C: Monitor therapyPitolisant: Antihistamines may diminish the therapeutic effect of Pitolisant.Risk X: Avoid combinationPotassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride.Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combinationPotassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate.Risk X: Avoid combinationPramipexole: CNS Depressants may enhance the sedative effect of Pramipexole.Risk C: Monitor therapyPramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combinationProcarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyRamosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron.Risk C: Monitor therapyReserpine: May diminish the therapeutic effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapyRevefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin.Risk X: Avoid combinationRopeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased.Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modificationROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole.Risk C: Monitor therapyRotigotine: CNS Depressants may enhance the sedative effect of Rotigotine.Risk C: Monitor therapyRufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapySecretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin.Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modificationSerotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Management: If possible, avoid coadministration of direct-acting alpha-/beta-agonists and serotonin/norepinephrine reuptake inhibitors. If coadministered, monitor for increased sympathomimetic effects (eg, increased blood pressure, chest pain, headache). Risk D: Consider therapy modificationSolriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol.Risk C: Monitor therapySpironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapySuvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant.Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary.Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modificationSympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapyTedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapyThalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide.Risk X: Avoid combinationThiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics.Risk C: Monitor therapyTiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium.Risk X: Avoid combinationTopiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate.Risk C: Monitor therapyTricyclic Antidepressants: May enhance the vasopressor effect of Alpha-/Beta-Agonists. Management: Avoid, if possible, the use of alpha-/beta-agonists in patients receiving tricyclic antidepressants. If combined, monitor for evidence of increased pressor effects and consider reductions in initial dosages of the alpha-/beta-agonist. Risk D: Consider therapy modificationTrimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyUmeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationUrinary Acidifying Agents: May decrease the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapyValerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyZolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem.Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg formen who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modificationPregnancy ConsiderationsRefer to individual monographs.Mechanism of ActionRefer to Pseudoephedrine (Systemic) monograph.Triprolidine is a member of the propylamine (alkylamine) chemical class of H1-antagonist antihistamines. As such, it is considered to be relatively less sedating than traditional antihistamines of the ethanolamine, phenothiazine, and ethylenediamine classes of antihistamines. Triprolidine has a shorter half-life and duration of action than most of the other alkylamine antihistamines. Like all H1-antagonist antihistamines, the mechanism of action of triprolidine is believed to involve competitive blockade of H1-receptor sites resulting in the inability of histamine to combine with its receptor sites and exert its usual effects on target cells. Antihistamines do not interrupt any effects of histamine which have already occurred. Therefore, these agents are used more successfully in the prevention rather than the treatment of histamine-induced reactions.Pharmaco*kinetics (Adult data unless noted)Also see Pseudoephedrine (Systemic) monograph.Metabolism: Triprolidine: Extensively hepatic (Simons, 1986)Half-life elimination: Triprolidine: ~2 hours (Simons, 1986)Time to peak, serum: Triprolidine: ~2 hours (Simons, 1986)Excretion: Triprolidine: Urine (~1% as unchanged triprolidine) (Simons, 1986)Pricing: USTablets (Aprodine Oral)2.5-60 mg (per each): $0.06Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursem*nt or purchasing functions or considered to be an exact price for a single product and/or manufacturer.Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions.In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data.Pricing data is updated monthly.Brand Names: InternationalActifed (AE, AU, BB, BF, BH, BJ, BM, BS, BZ, CI, CY, EE, EG, ET, GH, GM, GN, GY, ID, IE, IQ, IR, JM, JO, KE, KR, KW, LR, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NL, OM, PE, PY, QA, SA, SC, SD, SG, SL, SN, SR, SY, TN, TT, TZ, UG, VE, YE, ZA, ZM);Actifed Cold Syrup (ZW);Actifedrin (AR, BR, CL);Actimin (MY);Afidil (VN);Beatafed (MY);Becanden (TW);Colfed (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM);Consudine (TH);Eugen (TW);Fedac (HK, MY, SG);Flu-Care (QA);Green Nose (KR);Hiscifed (TH);Histafed (IL);Histamine-Care (IL);Lapifed (ID);Nasafed (ID);Peace (MY, TW);Rinofed (AE, QA);Sedofan (AE, BH, KW, LB, QA, SA);Tamin (EG);Tosumin (TW);Trifed (AE, CY, ID, IQ, IR, JO, KW, LY, OM, QA, SA, SY, YE);Triphed (EG);Tripofed (QA);Unifed (AE, BH, CY, IQ, IR, JO, KW, LY, OM, QA, SA, SY, YE);Valved (ID);Zentra (ID)For country code abbreviations (show table)2019 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2019 updated AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019;67(4):674-694. doi: 10.1111/jgs.15767. [PubMed 30693946]Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. doi:10.1067/mpd.2001.116281 [PubMed 11487763]American Academy of Pediatrics (AAP). Cough and cold medicines should not be prescribed, recommended or used for respiratory illnesses in young children. Updated June 12, 2018. Available at http://www.choosingwisely.org/clinician-lists/american-academy-pediatrics-cough-and-cold-medicines-for-children-under-four/American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. doi:10.1542/peds.99.2.268 [PubMed 9024461]Aprodine tablets (triprolidine hydrochloride/pseudoephedrine hydrochloride) [prescribing information]. Livonia, MI: Major Pharmaceuticals; November 2019.Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications--two states, 2005. MMWR Morb Mortal Wkly Rep. 2007;56(1):1-4. [PubMed 17218934]Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol--United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. [PubMed 6810084]Ed A-Hist PSE tablets (triprolidine hydrochloride/pseudoephedrine hydrochloride) [prescribing information]. Ripley, MS: Edwards Pharmaceuticals; November 2011.Food and Drug Administration (FDA). Most young children with a cough or cold don't need medicines. July 18, 2017. Available at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm422465.htm. Last accessed November 2, 2018.Food and Drug Administration (FDA). Use caution when giving cough and cold products to kids. Updated February 8, 2018. Available at https://www.fda.gov/drugs/resourcesforyou/specialfeatures/ucm263948.htm. Last accessed November 2, 2018.Maxifed TR (triprolidine/pseudoephedrine) [prescribing information]. Brooksville, FL: MCR American Pharmaceuticals Inc; May 2020.Maxi-Tuss TR (triprolidine/pseudoephedrine) [prescribing information]. Brooksville, FL: MCR American Pharmaceuticals Inc; May 2020.Pharmacy Quality Alliance. Use of high-risk medications in the elderly (2017 update) (HRM-2017). https://www.pqaalliance.org/medication-safety. Published 2017. Accessed March 21, 2019.Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]Simons KJ, Singh M, Gillespie CA, et al, "An Investigation of the H1-Receptor Antagonist Triprolidine: Pharmaco*kinetics and Antihistaminic Effects," J Allergy Clin Immunol, 1986, 77(2):326-30. [PubMed 3944383]Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219. doi:10.1111/j.1525-139X.2007.00280.x [PubMed 17555487]Topic 12866 Version 239.0

Triprolidine and pseudoephedrine: Drug information

CloseTriprolidine and pseudoephedrine: Drug informationTriprolidine and pseudoephedrine: Drug information(For additional information see "Triprolidine and pseudoephedrine: Patient drug information" and see "Triprolidine and pseudoephedrine: Pediatric drug information")For abbreviations, symbols, and age group definitions used in Lexicomp (show table)Brand Names: USAprodine [OTC];Ed A-Hist PSE [OTC] [DSC]Pharmacologic CategoryAlkylamine Derivative;Alpha-/Beta- Agonist;Decongestant;Histamine H1 Antagonist;Histamine H1 Antagonist, First GenerationDosing: AdultCold, allergy symptomsCold, allergy symptoms: Oral:Liquid: Triprolidine 1.25 mg and pseudoephedrine 30 mg per 5 mL: 10 mL every 4 to 6 hours (maximum: 4 doses [40 mL] per 24 hours).Tablet:Triprolidine 1.25 mg and pseudoephedrine 30 mg: 2 tablets every 4 to 6 hours (maximum: 8 tablets per 24 hours).Triprolidine 2.5 mg and pseudoephedrine 60 mg: 1 tablet every 4 to 6 hours (maximum: 4 tablets per 24 hours).Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.Dosing: Kidney Impairment: AdultThere are no dosage adjustments provided in the manufacturer’s labeling.Dosing: Hepatic Impairment: AdultThere are no dosage adjustments provided in the manufacturer’s labeling.Dosing: Pediatric(For additional information see "Triprolidine and pseudoephedrine: Pediatric drug information")Note: Multiple products with varying strengths exist; pay close attention to the product and strength when ordering or administering.Cold, allergy symptomsCold, allergy symptoms:Liquid:Triprolidine 1.25 mg and pseudoephedrine 30 mg per 5 mL (eg, Maxi-Tuss TR):Children 6 to <12 years: Oral: 5 mL every 4 to 6 hours as needed; maximum daily dose: 4 doses (20 mL) per 24 hours.Children ≥12 years and Adolescents: Oral: 10 mL every 4 to 6 hours as needed; maximum daily dose: 4 doses (40 mL) per 24 hours.Tablet:Triprolidine 1.25 mg and pseudoephedrine 30 mg (eg, Maxifed TR):Children 6 to <12 years: Oral: 1 tablet every 4 to 6 hours as needed; maximum daily dose: 4 doses (4 tablets) per 24 hours.Children ≥12 years and Adolescents: Oral: 2 tablets every 4 to 6 hours as needed; maximum daily dose: 4 doses (8 tablets) per 24 hours.Triprolidine 2.5 mg and pseudoephedrine 60 mg (eg, Aprodine):Children 6 to <12 years: Oral: 1/2 tablet every 4 to 6 hours as needed; maximum daily dose: 4 doses (2 tablets) per 24 hours.Children ≥12 years and Adolescents: Oral: 1 tablet every 4 to 6 hours as needed; maximum daily dose: 4 doses (4 tablets) per 24 hours.Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.Dosing: Kidney Impairment: PediatricThere are no dosage adjustments provided in the manufacturer's labeling.Dosing: Hepatic Impairment: PediatricThere are no dosage adjustments provided in the manufacturer's labeling.Dosing: Older AdultAvoid use (Beers Criteria [AGS 2019]).Dosage Forms: USExcipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued productLiquid, oral:Generic: Triprolidine hydrochloride 1.25 mg and pseudoephedrine hydrochoride 30 mg per 5 mLTablet, oral:Aprodine: Triprolidine hydrochloride 2.5 mg and pseudoephedrine hydrochloride 60 mg (24s, 100s)Ed A-Hist PSE: Triprolidine hydrochloride 2.5 mg and pseudoephedrine hydrochloride 60 mg (100s [DSC])Generic: Triprolidine hydrochloride 1.25 mg and pseudoephedrine hydrochloride 30 mg, Triprolidine hydrochloride 2.5 mg and pseudoephedrine hydrochloride 60 mgGeneric Equivalent Available: USYesAdministration: AdultOral: Administer liquid formulations with an accurate measuring device; do not use a household teaspoon (overdosage may occur).Administration: PediatricOral: Administer liquid formulations with an accurate measuring device; do not use a household teaspoon (overdosage may occur).Use: Labeled IndicationsCold, allergy symptoms: Temporary relief of symptoms (runny nose, nasal congestion, sneezing, itchy nose or throat, itchy/watery eyes, nasal passages swelling) associated with common cold, hay fever (allergic rhinitis), or other upper respiratory allergies.Medication Safety IssuesOlder Adult: High-Risk Medication:Beers Criteria: Triprolidine, a first-generation antihistamine, is identified in the Beers Criteria as a potentially inappropriate medication to be avoided in patients 65 years and older (independent of diagnosis or condition) due to its potent anticholinergic properties resulting in increased risk of confusion, dry mouth, constipation, and other anticholinergic effects or toxicity; use should also be avoided due to reduced clearance with advanced age and tolerance associated with use as a hypnotic (Beers Criteria [AGS 2019]).Pharmacy Quality Alliance (PQA): Triprolidine, as a single agent or as part of a combination (excludes OTC products), is identified as a high-risk medication in patients 65 years and older on the PQA’s, Use of High-Risk Medications in the Elderly (HRM) performance measure, a safety measure used by the Centers for Medicare and Medicaid Services (CMS) for Medicare plans (PQA 2017).Adverse ReactionsThe following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.Frequency not defined.Cardiovascular: TachycardiaCentral nervous system: Dizziness, drowsiness, excitement (transient), fatigue, headache, insomnia, nervousnessDermatologic: DiaphoresisEndocrine & metabolic: Weight gainGastrointestinal: Abdominal pain, diarrhea, increased appetite, nausea, xerostomiaGenitourinary: DysuriaNeuromuscular & skeletal: Arthralgia, weaknessRespiratory: Pharyngitis, thickening of bronchial secretionsContraindicationsOTC labeling: When used for self-medication, in combination with or within 14 days of stopping a monoamine oxidase inhibitor; are taking sedatives or tranquilizers (without first consulting physician); >7 days or if symptoms accompanied by fever.Warnings/PrecautionsConcerns related to adverse effects:• CNS depression: May cause CNS depression, which may impair physical or mental abilities; patients must be cautioned about performing tasks that require mental alertness (eg, operating machinery, driving).Disease-related concerns:• Cardiovascular disease: Use with caution in patients with cardiovascular disease (including hypertension and ischemic heart disease).• Diabetes: Use with caution in patients with diabetes mellitus.• Increased intraocular pressure/glaucoma: Use with caution in patients with increased intraocular pressure or glaucoma.• Prostatic hyperplasia/urinary obstruction: Use with caution in patients with prostatic hyperplasia and/or GU obstruction.• Respiratory disease: Use caution in patients with asthma, emphysema, or chronic bronchitis.• Thyroid dysfunction: Use with caution in patients with thyroid dysfunction.Dosage form specific issues:• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity ("gasping syndrome") in neonates; the "gasping syndrome" consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension, and cardiovascular collapse (AAP 1997; CDC 1982); some data suggest that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Zar 2007).Other warnings/precautions:• Self-medication (OTC use): When used for self medication (OTC), do not exceed recommended doses; discontinue use and contact health care provider if symptoms do not improve within 7 days or are accompanied by fever; if nervousness, dizziness or sleeplessness occur; or if new symptoms occur.Warnings: Additional Pediatric ConsiderationsSafety and efficacy for the use of cough and cold products in pediatric patients <4 years of age is limited; the AAP warns against the use of these products for respiratory illnesses in young children. Serious adverse effects including death have been reported (in some cases, high blood concentrations of pseudoephedrine were found). Many of these products contain multiple active ingredients, increasing the risk of accidental overdose when used with other products. The FDA does not recommend OTC uses for these products in pediatric patients <2 years of age and recommends to use with caution in pediatric patients ≥2 years of age. Health care providers are reminded to ask caregivers about the use of OTC cough and cold products in order to avoid exposure to multiple medications containing the same ingredient (AAP 2018; CDC 2007; FDA 2017; FDA 2018).Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).Metabolism/Transport EffectsNone known.Drug InteractionsNote: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed).For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.Acetylcholinesterase Inhibitors: May diminish the therapeutic effect of Anticholinergic Agents. Anticholinergic Agents may diminish the therapeutic effect of Acetylcholinesterase Inhibitors. Risk C: Monitor therapyAclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationAlcohol (Ethyl): CNS Depressants may enhance the CNS depressant effect of Alcohol (Ethyl).Risk C: Monitor therapyAlizapride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyAlkalinizing Agents: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapyAlpha1-Blockers: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Similarly, Alpha-/Beta-Agonists may antagonize Alpha1-Blocker vasodilation. Risk C: Monitor therapyAmantadine: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapyAmezinium: Antihistamines may enhance the stimulatory effect of Amezinium.Risk C: Monitor therapyAnticholinergic Agents: May enhance the adverse/toxic effect of other Anticholinergic Agents. Risk C: Monitor therapyAtomoxetine: May enhance the hypertensive effect of Sympathomimetics. Atomoxetine may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapyAzelastine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationBenzylpenicilloyl Polylysine: Antihistamines may diminish the diagnostic effect of Benzylpenicilloyl Polylysine.Management: Suspend systemic H1 antagonists for benzylpenicilloyl-polylysine skin testing and delay testing until systemic antihistaminic effects have dissipated. A histamine skin test may be used to assess persistent antihistaminic effects. Risk D: Consider therapy modificationBenzylpenicilloyl Polylysine: Alpha-/Beta-Agonists may diminish the diagnostic effect of Benzylpenicilloyl Polylysine.Management: Consider use of a histamine skin test as a positive control to assess a patient's ability to mount a wheal and flare response. Risk D: Consider therapy modificationBetahistine: May diminish the therapeutic effect of Antihistamines. Antihistamines may diminish the therapeutic effect of Betahistine. Risk C: Monitor therapyBlonanserin: CNS Depressants may enhance the CNS depressant effect of Blonanserin.Management: Use caution if coadministering blonanserin and CNS depressants; dose reduction of the other CNS depressant may be required. Strong CNS depressants should not be coadministered with blonanserin. Risk D: Consider therapy modificationBotulinum Toxin-Containing Products: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapyBrexanolone: CNS Depressants may enhance the CNS depressant effect of Brexanolone.Risk C: Monitor therapyBrimonidine (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyBromocriptine: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Management: Consider alternatives to this combination when possible. If combined, monitor for hypertension and tachycardia, and do not coadminister these agents for more than 10 days. Risk D: Consider therapy modificationBromopride: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyBromperidol: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationBuprenorphine: CNS Depressants may enhance the CNS depressant effect of Buprenorphine.Management: Consider reduced doses of other CNS depressants, and avoiding such drugs in patients at high risk of buprenorphine overuse/self-injection. Initiate buprenorphine at lower doses in patients already receiving CNS depressants. Risk D: Consider therapy modificationCannabinoid-Containing Products: May enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapyCannabinoid-Containing Products: Anticholinergic Agents may enhance the tachycardic effect of Cannabinoid-Containing Products.Risk C: Monitor therapyCannabinoid-Containing Products: CNS Depressants may enhance the CNS depressant effect of Cannabinoid-Containing Products.Risk C: Monitor therapyCarbonic Anhydrase Inhibitors: May increase the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapyChloral Betaine: May enhance the adverse/toxic effect of Anticholinergic Agents. Risk C: Monitor therapyChlormethiazole: May enhance the CNS depressant effect of CNS Depressants. Management: Monitor closely for evidence of excessive CNS depression. The chlormethiazole labeling states that an appropriately reduced dose should be used if such a combination must be used. Risk D: Consider therapy modificationChloroprocaine (Systemic): May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapyChlorphenesin Carbamate: May enhance the adverse/toxic effect of CNS Depressants. Risk C: Monitor therapyCimetropium: Anticholinergic Agents may enhance the anticholinergic effect of Cimetropium.Risk X: Avoid combinationCloZAPine: Anticholinergic Agents may enhance the constipating effect of CloZAPine.Management: Consider alternatives to this combination whenever possible. If combined, monitor closely for signs and symptoms of gastrointestinal hypomotility and consider prophylactic laxative treatment. Risk D: Consider therapy modificationCNS Depressants: May enhance the adverse/toxic effect of other CNS Depressants. Risk C: Monitor therapyCocaine (Topical): May enhance the hypertensive effect of Sympathomimetics. Management: Consider alternatives to use of this combination when possible. Monitor closely for substantially increased blood pressure or heart rate and for any evidence of myocardial ischemia with concurrent use. Risk D: Consider therapy modificationDaridorexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dose reduction of daridorexant and/or any other CNS depressant may be necessary. Use of daridorexant with alcohol is not recommended, and the use of daridorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modificationDexmedeTOMIDine: CNS Depressants may enhance the CNS depressant effect of DexmedeTOMIDine.Management: Monitor for increased CNS depression during coadministration of dexmedetomidine and CNS depressants, and consider dose reductions of either agent to avoid excessive CNS depression. Risk D: Consider therapy modificationDifelikefalin: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyDimethindene (Topical): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyDoxofylline: Sympathomimetics may enhance the adverse/toxic effect of Doxofylline.Risk C: Monitor therapyDoxylamine: May enhance the CNS depressant effect of CNS Depressants. Management: The manufacturer of Diclegis (doxylamine/pyridoxine), intended for use in pregnancy, specifically states that use with other CNS depressants isnot recommended. Risk C: Monitor therapyDroperidol: May enhance the CNS depressant effect of CNS Depressants. Management: Consider dose reductions of droperidol or of other CNS agents (eg, opioids, barbiturates) with concomitant use. Risk D: Consider therapy modificationEluxadoline: Anticholinergic Agents may enhance the constipating effect of Eluxadoline.Risk X: Avoid combinationErgot Derivatives (Vasoconstrictive CYP3A4 Substrates): May enhance the vasoconstricting effect of Alpha-/Beta-Agonists. Risk X: Avoid combinationEsketamine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyFlunarizine: CNS Depressants may enhance the CNS depressant effect of Flunarizine.Risk X: Avoid combinationFlunitrazepam: CNS Depressants may enhance the CNS depressant effect of Flunitrazepam.Management: Reduce the dose of CNS depressants when combined with flunitrazepam and monitor patients for evidence of CNS depression (eg, sedation, respiratory depression). Use non-CNS depressant alternatives when available. Risk D: Consider therapy modificationGastrointestinal Agents (Prokinetic): Anticholinergic Agents may diminish the therapeutic effect of Gastrointestinal Agents (Prokinetic).Risk C: Monitor therapyGlucagon: Anticholinergic Agents may enhance the adverse/toxic effect of Glucagon. Specifically, the risk of gastrointestinal adverse effects may be increased.Risk C: Monitor therapyGlycopyrrolate (Oral Inhalation): Anticholinergic Agents may enhance the anticholinergic effect of Glycopyrrolate (Oral Inhalation).Risk X: Avoid combinationGlycopyrronium (Topical): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationGuanethidine: May enhance the arrhythmogenic effect of Sympathomimetics. Guanethidine may enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapyHyaluronidase: Antihistamines may diminish the therapeutic effect of Hyaluronidase.Risk C: Monitor therapyHydrOXYzine: May enhance the CNS depressant effect of CNS Depressants. Management: Consider a decrease in the CNS depressant dose, as appropriate, when used together with hydroxyzine. Increase monitoring of signs/symptoms of CNS depression in any patient receiving hydroxyzine together with another CNS depressant. Risk D: Consider therapy modificationIobenguane Radiopharmaceutical Products: Alpha-/Beta-Agonists (Indirect-Acting) may diminish the therapeutic effect of Iobenguane Radiopharmaceutical Products.Management: Discontinue all drugs that may inhibit or interfere with catecholamine transport or uptake for at least 5 biological half-lives before iobenguane administration. Do not administer these drugs until at least 7 days after each iobenguane dose. Risk X: Avoid combinationIpratropium (Oral Inhalation): May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationItopride: Anticholinergic Agents may diminish the therapeutic effect of Itopride.Risk C: Monitor therapyKava Kava: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyKratom: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationKratom: May enhance the adverse/toxic effect of Sympathomimetics. Risk X: Avoid combinationLemborexant: May enhance the CNS depressant effect of CNS Depressants. Management: Dosage adjustments of lemborexant and of concomitant CNS depressants may be necessary when administered together because of potentially additive CNS depressant effects. Close monitoring for CNS depressant effects is necessary. Risk D: Consider therapy modificationLevosulpiride: Anticholinergic Agents may diminish the therapeutic effect of Levosulpiride.Risk X: Avoid combinationLinezolid: May enhance the hypertensive effect of Sympathomimetics. Management: Reduce initial doses of sympathomimetic agents, and closely monitor for enhanced pressor response, in patients receiving linezolid.Specific dose adjustment recommendations are not presently available. Risk D: Consider therapy modificationLisuride: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk X: Avoid combinationLofexidine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyMagnesium Sulfate: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyMethotrimeprazine: CNS Depressants may enhance the CNS depressant effect of Methotrimeprazine. Methotrimeprazine may enhance the CNS depressant effect of CNS Depressants.Management: Reduce the usual dose of CNS depressants by 50% if starting methotrimeprazine until the dose of methotrimeprazine is stable. Monitor patient closely for evidence of CNS depression. Risk D: Consider therapy modificationMetoclopramide: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyMetyroSINE: CNS Depressants may enhance the sedative effect of MetyroSINE.Risk C: Monitor therapyMianserin: May enhance the anticholinergic effect of Anticholinergic Agents. Risk C: Monitor therapyMinocycline (Systemic): May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyMirabegron: Anticholinergic Agents may enhance the adverse/toxic effect of Mirabegron.Risk C: Monitor therapyMonoamine Oxidase Inhibitors: May enhance the hypertensive effect of Alpha-/Beta-Agonists (Indirect-Acting). While linezolid is expected to interact via this mechanism, management recommendations differ from other monoamine oxidase inhibitors.Refer to linezolid specific monographs for details. Risk X: Avoid combinationNitroglycerin: Anticholinergic Agents may decrease the absorption of Nitroglycerin. Specifically, anticholinergic agents may decrease the dissolution of sublingual nitroglycerin tablets, possibly impairing or slowing nitroglycerin absorption.Risk C: Monitor therapyOlopatadine (Nasal): May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationOpioid Agonists: CNS Depressants may enhance the CNS depressant effect of Opioid Agonists.Management: Avoid concomitant use of opioid agonists and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modificationOrphenadrine: CNS Depressants may enhance the CNS depressant effect of Orphenadrine.Risk X: Avoid combinationOxatomide: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationOxomemazine: May enhance the CNS depressant effect of CNS Depressants. Risk X: Avoid combinationOxybate Salt Products: CNS Depressants may enhance the CNS depressant effect of Oxybate Salt Products.Management: Consider alternatives to this combination when possible. If combined, dose reduction or discontinuation of one or more CNS depressants (including the oxybate salt product) should be considered. Interrupt oxybate salt treatment during short-term opioid use Risk D: Consider therapy modificationOxyCODONE: CNS Depressants may enhance the CNS depressant effect of OxyCODONE.Management: Avoid concomitant use of oxycodone and benzodiazepines or other CNS depressants when possible. These agents should only be combined if alternative treatment options are inadequate. If combined, limit the dosages and duration of each drug. Risk D: Consider therapy modificationOzanimod: May enhance the hypertensive effect of Sympathomimetics. Risk C: Monitor therapyParaldehyde: CNS Depressants may enhance the CNS depressant effect of Paraldehyde.Risk X: Avoid combinationPerampanel: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyPergolide: May enhance the hypertensive effect of Alpha-/Beta-Agonists. Risk C: Monitor therapyPiribedil: CNS Depressants may enhance the CNS depressant effect of Piribedil.Risk C: Monitor therapyPitolisant: Antihistamines may diminish the therapeutic effect of Pitolisant.Risk X: Avoid combinationPotassium Chloride: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Chloride.Management: Patients on drugs with substantial anticholinergic effects should avoid using any solid oral dosage form of potassium chloride. Risk X: Avoid combinationPotassium Citrate: Anticholinergic Agents may enhance the ulcerogenic effect of Potassium Citrate.Risk X: Avoid combinationPramipexole: CNS Depressants may enhance the sedative effect of Pramipexole.Risk C: Monitor therapyPramlintide: May enhance the anticholinergic effect of Anticholinergic Agents. These effects are specific to the GI tract. Risk X: Avoid combinationProcarbazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyRamosetron: Anticholinergic Agents may enhance the constipating effect of Ramosetron.Risk C: Monitor therapyReserpine: May diminish the therapeutic effect of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapyRevefenacin: Anticholinergic Agents may enhance the anticholinergic effect of Revefenacin.Risk X: Avoid combinationRopeginterferon Alfa-2b: CNS Depressants may enhance the adverse/toxic effect of Ropeginterferon Alfa-2b. Specifically, the risk of neuropsychiatric adverse effects may be increased.Management: Avoid coadministration of ropeginterferon alfa-2b and other CNS depressants. If this combination cannot be avoided, monitor patients for neuropsychiatric adverse effects (eg, depression, suicidal ideation, aggression, mania). Risk D: Consider therapy modificationROPINIRole: CNS Depressants may enhance the sedative effect of ROPINIRole.Risk C: Monitor therapyRotigotine: CNS Depressants may enhance the sedative effect of Rotigotine.Risk C: Monitor therapyRufinamide: May enhance the adverse/toxic effect of CNS Depressants. Specifically, sleepiness and dizziness may be enhanced. Risk C: Monitor therapySecretin: Anticholinergic Agents may diminish the therapeutic effect of Secretin.Management: Avoid concomitant use of anticholinergic agents and secretin. Discontinue anticholinergic agents at least 5 half-lives prior to administration of secretin. Risk D: Consider therapy modificationSerotonin/Norepinephrine Reuptake Inhibitors: May enhance the tachycardic effect of Alpha-/Beta-Agonists. Serotonin/Norepinephrine Reuptake Inhibitors may enhance the vasopressor effect of Alpha-/Beta-Agonists. Management: If possible, avoid coadministration of direct-acting alpha-/beta-agonists and serotonin/norepinephrine reuptake inhibitors. If coadministered, monitor for increased sympathomimetic effects (eg, increased blood pressure, chest pain, headache). Risk D: Consider therapy modificationSolriamfetol: Sympathomimetics may enhance the hypertensive effect of Solriamfetol. Sympathomimetics may enhance the tachycardic effect of Solriamfetol.Risk C: Monitor therapySpironolactone: May diminish the vasoconstricting effect of Alpha-/Beta-Agonists. Risk C: Monitor therapySuvorexant: CNS Depressants may enhance the CNS depressant effect of Suvorexant.Management: Dose reduction of suvorexant and/or any other CNS depressant may be necessary.Use of suvorexant with alcohol is not recommended, and the use of suvorexant with any other drug to treat insomnia is not recommended. Risk D: Consider therapy modificationSympathomimetics: May enhance the adverse/toxic effect of other Sympathomimetics. Risk C: Monitor therapyTedizolid: May enhance the hypertensive effect of Sympathomimetics. Tedizolid may enhance the tachycardic effect of Sympathomimetics. Risk C: Monitor therapyThalidomide: CNS Depressants may enhance the CNS depressant effect of Thalidomide.Risk X: Avoid combinationThiazide and Thiazide-Like Diuretics: Anticholinergic Agents may increase the serum concentration of Thiazide and Thiazide-Like Diuretics.Risk C: Monitor therapyTiotropium: Anticholinergic Agents may enhance the anticholinergic effect of Tiotropium.Risk X: Avoid combinationTopiramate: Anticholinergic Agents may enhance the adverse/toxic effect of Topiramate.Risk C: Monitor therapyTricyclic Antidepressants: May enhance the vasopressor effect of Alpha-/Beta-Agonists. Management: Avoid, if possible, the use of alpha-/beta-agonists in patients receiving tricyclic antidepressants. If combined, monitor for evidence of increased pressor effects and consider reductions in initial dosages of the alpha-/beta-agonist. Risk D: Consider therapy modificationTrimeprazine: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyUmeclidinium: May enhance the anticholinergic effect of Anticholinergic Agents. Risk X: Avoid combinationUrinary Acidifying Agents: May decrease the serum concentration of Alpha-/Beta-Agonists (Indirect-Acting). Risk C: Monitor therapyValerian: May enhance the CNS depressant effect of CNS Depressants. Risk C: Monitor therapyZolpidem: CNS Depressants may enhance the CNS depressant effect of Zolpidem.Management: Reduce the Intermezzo brand sublingual zolpidem adult dose to 1.75 mg formen who are also receiving other CNS depressants. No such dose change is recommended for women. Avoid use with other CNS depressants at bedtime; avoid use with alcohol. Risk D: Consider therapy modificationPregnancy ConsiderationsRefer to individual monographs.Breastfeeding ConsiderationsRefer to individual monographs.Mechanism of ActionRefer to Pseudoephedrine (Systemic) monograph.Triprolidine is a member of the propylamine (alkylamine) chemical class of H1-antagonist antihistamines. As such, it is considered to be relatively less sedating than traditional antihistamines of the ethanolamine, phenothiazine, and ethylenediamine classes of antihistamines. Triprolidine has a shorter half-life and duration of action than most of the other alkylamine antihistamines. Like all H1-antagonist antihistamines, the mechanism of action of triprolidine is believed to involve competitive blockade of H1-receptor sites resulting in the inability of histamine to combine with its receptor sites and exert its usual effects on target cells. Antihistamines do not interrupt any effects of histamine which have already occurred. Therefore, these agents are used more successfully in the prevention rather than the treatment of histamine-induced reactions.Pharmaco*kineticsAlso see Pseudoephedrine (Systemic) monograph.Metabolism: Triprolidine: Extensively hepatic (Simons, 1986)Half-life elimination: Triprolidine: ~2 hours (Simons, 1986)Time to peak, serum: Triprolidine: ~2 hours (Simons, 1986)Excretion: Triprolidine: Urine (~1% as unchanged triprolidine) (Simons, 1986)Pricing: USTablets (Aprodine Oral)2.5-60 mg (per each): $0.06Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursem*nt or purchasing functions or considered to be an exact price for a single product and/or manufacturer.Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions.In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data.Pricing data is updated monthly.Brand Names: InternationalActifed (AE, AU, BB, BF, BH, BJ, BM, BS, BZ, CI, CY, EE, EG, ET, GH, GM, GN, GY, ID, IE, IQ, IR, JM, JO, KE, KR, KW, LR, LY, MA, ML, MR, MT, MU, MW, MX, MY, NE, NG, NL, OM, PE, PY, QA, SA, SC, SD, SG, SL, SN, SR, SY, TN, TT, TZ, UG, VE, YE, ZA, ZM);Actifed Cold Syrup (ZW);Actifedrin (AR, BR, CL);Actimin (MY);Afidil (VN);Beatafed (MY);Becanden (TW);Colfed (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZA, ZM);Consudine (TH);Eugen (TW);Fedac (HK, MY, SG);Flu-Care (QA);Green Nose (KR);Hiscifed (TH);Histafed (IL);Histamine-Care (IL);Lapifed (ID);Nasafed (ID);Peace (MY, TW);Rinofed (AE, QA);Sedofan (AE, BH, KW, LB, QA, SA);Tamin (EG);Tosumin (TW);Trifed (AE, CY, ID, IQ, IR, JO, KW, LY, OM, QA, SA, SY, YE);Triphed (EG);Tripofed (QA);Unifed (AE, BH, CY, IQ, IR, JO, KW, LY, OM, QA, SA, SY, YE);Valved (ID);Zentra (ID)For country code abbreviations (show table)2019 American Geriatrics Society Beers Criteria Update Expert Panel. American Geriatrics Society 2019 updated AGS Beers Criteria for Potentially Inappropriate Medication Use in Older Adults. J Am Geriatr Soc. 2019;67(4):674-694. doi: 10.1111/jgs.15767. [PubMed 30693946]Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. doi:10.1067/mpd.2001.116281 [PubMed 11487763]American Academy of Pediatrics (AAP). Cough and cold medicines should not be prescribed, recommended or used for respiratory illnesses in young children. Updated June 12, 2018. Available at http://www.choosingwisely.org/clinician-lists/american-academy-pediatrics-cough-and-cold-medicines-for-children-under-four/American Academy of Pediatrics Committee on Drugs. "Inactive" ingredients in pharmaceutical products: update (subject review). Pediatrics. 1997;99(2):268-278. doi:10.1542/peds.99.2.268 [PubMed 9024461]Aprodine tablets (triprolidine hydrochloride/pseudoephedrine hydrochloride) [prescribing information]. Livonia, MI: Major Pharmaceuticals; November 2019.Centers for Disease Control and Prevention (CDC). Infant deaths associated with cough and cold medications--two states, 2005. MMWR Morb Mortal Wkly Rep. 2007;56(1):1-4. [PubMed 17218934]Centers for Disease Control (CDC). Neonatal deaths associated with use of benzyl alcohol--United States. MMWR Morb Mortal Wkly Rep. 1982;31(22):290-291. [PubMed 6810084]Ed A-Hist PSE tablets (triprolidine hydrochloride/pseudoephedrine hydrochloride) [prescribing information]. Ripley, MS: Edwards Pharmaceuticals; November 2011.Food and Drug Administration (FDA). Most young children with a cough or cold don't need medicines. July 18, 2017. Available at https://www.fda.gov/ForConsumers/ConsumerUpdates/ucm422465.htm. Last accessed November 2, 2018.Food and Drug Administration (FDA). Use caution when giving cough and cold products to kids. Updated February 8, 2018. Available at https://www.fda.gov/drugs/resourcesforyou/specialfeatures/ucm263948.htm. Last accessed November 2, 2018.Maxifed TR (triprolidine/pseudoephedrine) [prescribing information]. Brooksville, FL: MCR American Pharmaceuticals Inc; May 2020.Maxi-Tuss TR (triprolidine/pseudoephedrine) [prescribing information]. Brooksville, FL: MCR American Pharmaceuticals Inc; May 2020.Pharmacy Quality Alliance. Use of high-risk medications in the elderly (2017 update) (HRM-2017). https://www.pqaalliance.org/medication-safety. Published 2017. Accessed March 21, 2019.Shehab N, Lewis CL, Streetman DD, Donn SM. Exposure to the pharmaceutical excipients benzyl alcohol and propylene glycol among critically ill neonates. Pediatr Crit Care Med. 2009;10(2):256-259. [PubMed 19188870]Simons KJ, Singh M, Gillespie CA, et al, "An Investigation of the H1-Receptor Antagonist Triprolidine: Pharmaco*kinetics and Antihistaminic Effects," J Allergy Clin Immunol, 1986, 77(2):326-30. [PubMed 3944383]Zar T, Graeber C, Perazella MA. Recognition, treatment, and prevention of propylene glycol toxicity. Semin Dial. 2007;20(3):217-219. doi:10.1111/j.1525-139X.2007.00280.x [PubMed 17555487]Topic 10304 Version 254.0

Middle East respiratory syndrome coronavirus: Virology, pathogenesis, and epidemiology

In September 2012, a case of novel coronavirus infection was reported involving a man in Saudi Arabia who was admitted to a hospital with pneumonia and acute kidney injury in June 2012 [1]. Only a few days later, a separate report appeared of an almost identical virus detected in a second patient wi

Acetaminophen (paracetamol): Drug information

CloseAcetaminophen (paracetamol): Drug informationAcetaminophen (paracetamol): Drug information(For additional information see "Acetaminophen (paracetamol): Patient drug information" and see "Acetaminophen (paracetamol): Pediatric drug information")For abbreviations, symbols, and age group definitions used in Lexicomp (show table)ALERT: US Boxed WarningRisk of medication errors and hepatotoxicity (injection):Take care when prescribing, preparing, and administering acetaminophen injection to avoid dosing errors that could result in accidental overdose and death. In particular, be careful to ensure the following: the dose in milligrams and milliliters is not confused; the dosing is based on weight for patients less than 50 kg; infusion pumps are properly programmed; and the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than 1 acetaminophen-containing product.Brand Names: US7T Gummy ES [DSC];8 Hour Pain Reliever [OTC];Acetaminophen 8 Hour [OTC];Acetaminophen Extra Strength [OTC];Aminofen [OTC] [DSC];Apra [OTC];Arthritis Pain Relief [OTC];Aurophen Childrens [OTC] [DSC];BetaTemp Childrens [OTC];Childrens Acetaminophen [OTC];Childrens APAP [OTC];Childrens Non-Aspirin [OTC];Childrens Silapap [OTC];Childrens Tactinal [OTC] [DSC];Ed-APAP [OTC];ElixSure Fever/Pain [OTC];FeverAll Adults [OTC];FeverAll Childrens [OTC];FeverAll Infants [OTC];FeverAll Junior Strength [OTC];GoodSense Pain & Fever Child [OTC];GoodSense Pain & Fever Infants [OTC];GoodSense Pain Relief Extra St [OTC];GoodSense Pain Relief [OTC] [DSC];Healthy Mama Shake That Ache [OTC];Liquid Pain Relief [OTC];M-PAP [OTC];Mapap Acetaminophen Extra Str [OTC];Mapap Arthritis Pain [OTC];Mapap Childrens [OTC];Mapap [OTC];Non-Aspirin Extra Strength [OTC];Non-Aspirin Pain Reliever [OTC] [DSC];Non-Aspirin [OTC];Nortemp Infants [OTC] [DSC];Nortemp [OTC] [DSC];Ofirmev [DSC];Pain & Fever Childrens [OTC] [DSC];Pain & Fever Extra Strength [OTC] [DSC];Pain & Fever Infants [OTC] [DSC];Pain & Fever [OTC] [DSC];Pain Relief Childrens [OTC];Pain Relief Extra Strength [OTC];Pain Relief Regular Strength [OTC];Pain Relief [OTC];Panadol Childrens [OTC];Panadol Extra Strength [OTC];Panadol Infants [OTC];Pharbetol Extra Strength [OTC];Pharbetol [OTC];Tactinal Extra Strength [OTC] [DSC];Tactinal [OTC] [DSC];Triaminic Fever Reducer [OTC];Tylenol 8 Hour Arthritis Pain [OTC];Tylenol 8 Hour [OTC];Tylenol Childrens Chewables [OTC];Tylenol Childrens Pain + Fever [OTC];Tylenol Childrens [OTC];Tylenol Dissolve Packs [OTC];Tylenol Extra Strength [OTC];Tylenol for Children + Adults [OTC];Tylenol Infants Pain+Fever [OTC];Tylenol [OTC]Pharmacologic CategoryAnalgesic, NonopioidDosing: AdultNote: Safety: Acetaminophen-induced hepatotoxicity, which can be life threatening, has been associated with doses >4 g/day. Although doses up to 4 g/day are generally well tolerated (Ref), hepatotoxicity has been reported rarely at this dose limit (Ref). Due to this risk, some experts recommend a lower maximum dose of 3 g/day in adults with normal liver function, particularly when used for longer durations (eg, >7 days) for pain (Ref). Heavy alcohol use, malnutrition, fasting, low body weight, advanced age, febrile illness, select liver disease, and use of drugs that interact with acetaminophen metabolism may increase risk of hepatotoxicity; a lower total daily dose (eg, 2 g/day) or avoidance may be preferred (Ref). When calculating total daily dose, confirm that all sources (eg, prescription, OTCs, combinations) are included.Pain and/or feverPain (mild to moderate) and/or fever (monotherapy or as an adjunct): Oral: 325 to 650 mg every 4 to 6 hours as needed or 1 g every 6 hours as needed; maximum dose: 4 g/day (Ref). See "Note: Safety" above regarding maximum dose.OTC labeling (patient-guided therapy): Note: Dosage recommendations, including maximum doses, vary among OTC manufacturers.Immediate release:Regular strength (325 mg/tablet): 2 tablets (650 mg) every 4 to 6 hours as needed; maximum daily dose: 10 tablets/day (3.25 g/day).Extra strength (500 mg/tablet): 2 tablets (1 g) every 6 hours as needed; maximum daily dose: 6 tablets/day (3 g/day).Extended release (650 mg/tablet): 2 tablets (1.3 g) every 8 hours as needed; maximum daily dose: 6 tablets/day (3.9 g/day).IV:≥50 kg: 650 mg every 4 hours or 1 g every 6 hours; maximum single dose: 1 g/dose; maximum daily dose: 4 g/day.<50 kg: 12.5 mg/kg every 4 hours or 15 mg/kg every 6 hours; maximum single dose: 15 mg/kg/dose (≤750 mg/dose); maximum daily dose: 75 mg/kg/day (≤3.75 g/day). Note: Some experts recommend this reduced dosing if used in patients with chronic alcoholism, malnutrition, or dehydration regardless of weight (Ref).Rectal: 325 to 650 mg every 4 to 6 hours as needed (Ref); maximum daily dose: 3.9 g/day. Note: Absorption is irregular; bioavailability may be reduced by ~10% to 20% relative to oral administration (Ref).Dosing: Kidney Impairment: AdultThe renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.IV, Oral, Rectal:Mild to severe impairment: No dosage adjustment likely to be necessary. The manufacturer's labeling for IV acetaminophen states that longer dosing intervals and a reduced total daily dose may be warranted in patients with severe kidney impairment (CrCl ≤30 mL/minute); however, acetaminophen concentrations and half-life are increased but similar to those in patients with normal renal function (Ref). Glucuronide and sulfate conjugate metabolites accumulate in renal impairment, but the clinical effects are unknown (Ref).Hemodialysis, intermittent (thrice weekly): Acetaminophen and its conjugates are readily dialyzable (Ref): No dosage adjustment necessary (Ref).Peritoneal dialysis: Not dialyzed (Ref): No dosage adjustment necessary (Ref).CRRT: Dialyzed (Ref): No dosage adjustment necessary (Ref).PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).Dosing: Hepatic Impairment: AdultOral: Use with caution and consider dosage adjustment or avoiding use, depending on degree of hepatic impairment and other patient-specific factors. Although limited data exist, low-dose therapy (maximum: ≤2 to 3 g/day) is usually well tolerated in patients with chronic liver disease or cirrhosis, provided patients are not actively drinking alcohol; however, the presence of other factors increasing the risk of acetaminophen-induced hepatoxicity (eg, malnutrition, fasting, low body weight, advanced age, febrile illness, concurrent use of drugs that interact with acetaminophen metabolism) must also be taken into consideration (Ref). Some experts would limit the maximum dose to ≤2 g/day in any patient with advanced chronic liver disease or cirrhosis (provided the patient is not actively drinking alcohol) and would avoid use in any patient with severe alcoholic hepatitis or acute liver injury. Avoiding use is also recommended by some experts in patients with advanced chronic liver disease or cirrhosis who are actively drinking alcohol, malnourished, not eating, or receiving a concomitant interacting medication. For short-term or one-time use, a maximum of ≤4 g/day may be considered in lower risk patients with chronic liver disease or early-stage compensated cirrhosis who are not actively drinking alcohol (Ref).IV:Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling. Use with caution; a reduced total daily dosage may be warranted.Severe impairment: Use is contraindicated.Dosing: Pediatric(For additional information see "Acetaminophen (paracetamol): Pediatric drug information")Note: Oral liquids are available in multiple concentrations (eg, 160 mg/5 mL, 500 mg/5 mL, 500 mg/15 mL); precautions should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented as "mg."Pain or feverPain (mild to moderate) or fever: Note: All sources of acetaminophen (eg, prescription, OTC, combination products) should be considered when evaluating a patient's maximum daily dose. To lower the risk for hepatotoxicity, limit daily dose to ≤75 mg/kg/day (maximum of 5 daily doses), not to exceed 4,000 mg/day; while recommended doses are generally considered safe, hepatotoxicity has been reported (rarely) even with doses below recommendations (Ref).Oral:Weight-directed dosing: Infants, Children, and Adolescents: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Ref); do not exceed 5 doses in 24 hours; maximum daily dose: 75 mg/kg/day not to exceed 4,000 mg/day.Fixed dosing:Oral suspension, chewable tablets: Infants and Children <12 years: Consult specific product formulations for appropriate age groups. See table; use of weight to select dose is preferred; if weight is not available, then use age; doses may be repeated every 4 hours; maximum: 5 doses/day.Acetaminophen Dosing (Oral)Weight (preferred)AAgeDosage(mg)kglbsAManufacturer’s recommendations are based on weight in pounds (OTC labeling); weight in kg listed here is derived from pounds and rounded; kg weight listed also is adjusted to allow for continuous weight ranges in kg. OTC labeling instructs consumer to consult with physician for dosing instructions in infants and children under 2 years of age.2.7 to 5.36 to 110 to 3 mo405.4 to 8.112 to 174 to 11 mo808.2 to 10.818 to 231 to 2 y12010.9 to 16.324 to 352 to 3 y16016.4 to 21.736 to 474 to 5 y24021.8 to 27.248 to 596 to 8 y320 to 32527.3 to 32.660 to 719 to 10 y325 to 40032.7 to 43.272 to 9511 y480 to 500Immediate-release solid dosage formulations: Note: Actual OTC dosing recommendations may vary by product and/or manufacturer:Children 6 to 11 years: 325 mg every 4 to 6 hours; maximum daily dose: 1,625 mg/day; Note: Do not use more than 5 days unless directed by a physician.Children ≥12 years and Adolescents:Regular strength: 650 mg every 4 to 6 hours; maximum daily dose: 3,250 mg/day unless directed by a physician; under physician supervision daily doses ≤4,000 mg may be used.Extra strength: 1,000 mg every 6 hours; maximum daily dose: 3,000 mg/day unless directed by a physician; under physician supervision daily doses ≤4,000 mg may be used.Extended release: Children ≥12 years and Adolescents: 1,300 mg every 8 hours; maximum daily dose: 3,900 mg/day.IV:Infants and Children <2 years:Manufacturer’s labeling: Fever: 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day.Alternate dosing: Limited data available: Pain and fever: 7.5 to 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day (Ref).Children ≥2 years (Ref):<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day.≥50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 1,000 mg; maximum daily dose: 75 mg/kg/day not to exceed 4,000 mg/day.Adolescents:<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day.≥50 kg: 1,000 mg every 6 hours or 650 mg every 4 hours; maximum single dose: 1,000 mg; maximum daily dose: 4,000 mg/day.Rectal:Weight-directed dosing: Limited data available: Infants and Children <12 years: 10 to 20 mg/kg/dose every 4 to 6 hours as needed; do not exceed 5 doses in 24 hours (Ref); maximum daily dose: 75 mg/kg/day not to exceed 1,625 mg/day.Fixed dosing:Infants 6 to 11 months: 80 mg every 6 hours; maximum daily dose: 320 mg/day.Infants and Children 12 to 36 months: 80 mg every 4 to 6 hours; maximum daily dose: 400 mg/day.Children >3 to 6 years: 120 mg every 4 to 6 hours; maximum daily dose: 600 mg/day.Children >6 up to 12 years: 325 mg every 4 to 6 hours; maximum daily dose: 1,625 mg/day.Children ≥12 years and Adolescents: 650 mg every 4 to 6 hours; maximum daily dose: 3,900 mg/day.Pain; peri-/postoperative management; adjunct to opioid therapyPain; peri-/postoperative management; adjunct to opioid therapy: IV:Infants and Children <2 years: Limited data available: 7.5 to 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day (Ref).Children ≥2 years (Ref):<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day.≥50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 1,000 mg; maximum daily dose: 75 mg/kg/day not to exceed 4,000 mg/day.Adolescents:<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day.≥50 kg: 1,000 mg every 6 hours or 650 mg every 4 hours; maximum single dose: 1,000 mg; maximum daily dose: 4,000 mg/day.Rectal: Limited data available: Children:Loading dose: 40 mg/kg for 1 dose, in most trials, the dose was administered postoperatively (Ref); a maximum dose of 1,000 mg was most frequently reported. However, in one trial evaluating 24 older pediatric patients (all patients ≥25 kg; mean age: ~13 years), the data suggested that a dose of 1,000 mg does not produce therapeutic serum concentrations (target for study: >10 mcg/mL) compared to a 40 mg/kg dose (up to ~2,000 mg); the resultant Cmax was: 7.8 mcg/mL (1,000 mg dose group) vs 15.9 mcg/mL (40 mg/kg dose group). Note: Therapeutic serum concentrations for analgesia have not been well-established (Ref).Maintenance dose: 20 to 25 mg/kg/dose every 6 hours as needed for 2 to 3 days has been suggested if further pain control is needed postoperatively; maximum daily dose: 100 mg/kg/day not to exceed 4,000 mg/day; therapy longer than 5 days has not been evaluated (Ref).Note: In the majority of trials, suppositories were not divided due to unequal distribution of drug within suppository; doses were rounded to the nearest mg amount using 1 or 2 suppositories of available product strengths.Dosing: Kidney Impairment: PediatricAltered kidney function: Infants, Children, and Adolescents:Oral, rectal: Mild to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; based on adult pharmaco*kinetic studies, dosage adjustment may not be necessary for short courses. In adult pharmaco*kinetic studies, plasma concentrations of acetaminophen did not differ in renal impairment patients when compared to healthy patients for short courses of treatment (ie, 3 days); however, accumulation of the glucuronide and sulfate conjugate metabolites in renal impairment has been described following a single dose of acetaminophen up to repeat dosing for 10 days; the clinical significance of this finding is unknown (Ref).IV:Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.Severe impairment (CrCl <30 mL/minute): The manufacturer's labeling for IV acetaminophen states that longer dosing intervals and a reduced total daily dose may be warranted in patients with severe kidney impairment; use with caution.Hemodialysis, intermittent: Acetaminophen and its conjugates are readily dialyzable (Ref): No dosage adjustment necessary when used for mild to moderate pain (Ref).Peritoneal dialysis: Not dialyzed (Ref): No dosage adjustment necessary when used for mild to moderate pain (Ref).Dosing: Hepatic Impairment: PediatricUse with caution. Limited, low-dose therapy is usually well-tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4,000 mg/day have been reported. Avoid chronic use in hepatic impairment.Dosing: Older AdultPain (acute) or fever: Oral, IV: Refer to adult dosing.Persistent pain (off-label): Adults ≥75 years: Oral:Initial: 325 to 500 mg every 4 hours or 500 to 1,000 mg every 6 hoursMaximum: ≤4,000 mg/day. In older adults with hepatic impairment or history of alcohol abuse being treated for persistent pain, do not exceed a maximum of 2,000 to 3,000 mg/day (Ref).Dosage Forms: USExcipient information presented when available (limited, particularly for generics); consult specific product labeling.[DSC] = Discontinued productCapsule, Oral: Mapap: 500 mg [aspirin free; contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]Tylenol: 325 mg [aspirin free; contains fd&c red #40 (allura red ac dye), soybeans (glycine soja)]Elixir, Oral: Apra: 160 mg/5 mL (120 mL, 240 mL, 480 mL, 3840 mL) [contains alcohol, usp]Pain Relief Childrens: 160 mg/5 mL (118 mL, 237 mL, 473 mL) [alcohol free, aspirin free; contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), saccharin sodium, sodium benzoate, sorbitol]Generic: 160 mg/5 mL (473 mL [DSC])Gel, Oral: ElixSure Fever/Pain: 160 mg/5 mL (120 mL) [alcohol free, aspirin free; contains butylparaben, carbomer 934p, polyethylene glycol (macrogol); bubble-gum flavor]ElixSure Fever/Pain: 160 mg/5 mL (120 mL) [alcohol free, aspirin free; contains butylparaben, carbomer 934p, polyethylene glycol (macrogol); cherry flavor]ElixSure Fever/Pain: 160 mg/5 mL (120 mL) [alcohol free, aspirin free; contains butylparaben, carbomer 934p, polyethylene glycol (macrogol); grape flavor]Liquid, Oral: Acetaminophen Extra Strength: 500 mg/15 mL (237 mL [DSC]) [alcohol free, aspirin free; contains fd&c blue #1 (brilliant blue), polyethylene glycol (macrogol), quinoline yellow (d&c yellow #10), saccharin sodium, sodium benzoate]Childrens Silapap: 160 mg/5 mL (118 mL, 237 mL, 473 mL) [alcohol free, sugar free; contains fd&c red #40 (allura red ac dye), methylparaben, propylene glycol, saccharin sodium, sodium benzoate; cherry flavor]Ed-APAP: 160 mg/5 mL (236 mL) [alcohol free; contains fd&c red #40 (allura red ac dye), saccharin sodium, sodium benzoate; cherry flavor]Liquid Pain Relief: 160 mg/5 mL (473 mL [DSC]) [contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), saccharin sodium, sodium benzoate; cherry flavor]Liquid Pain Relief: 160 mg/5 mL (473 mL) [alcohol free, aspirin free; contains fd&c red #40 (allura red ac dye), methylparaben, polyethylene glycol (macrogol), propylene glycol, propylparaben]M-PAP: 160 mg/5 mL (120 mL, 473 mL) [alcohol free, aspirin free, sugar free; contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), saccharin sodium, sodium benzoate; cherry flavor]Mapap: 160 mg/5 mL (118 mL [DSC], 473 mL [DSC]) [alcohol free, aspirin free; contains benzoic acid, fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, sodium benzoate]Mapap Acetaminophen Extra Str: 500 mg/15 mL (237 mL) [contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, saccharin sodium, sodium benzoate; cherry flavor]Pain Relief: 500 mg/15 mL (237 mL) [alcohol free, aspirin free; contains fd&c red #40 (allura red ac dye), methylparaben, polyethylene glycol (macrogol), propylene glycol, propylparaben]Generic: 160 mg/5 mL (118 mL, 473 mL)Packet, Oral: Tylenol Childrens Pain + Fever: 160 mg (18 ea, 30 ea) [aspirin free, ibuprofen free; wild berry flavor]Tylenol Dissolve Packs: 500 mg (12 ea, 32 ea) [berry flavor]Solution, Intravenous: Generic: 10 mg/mL (50 mL, 100 mL); 1000 mg/100 mL (100 mL)Solution, Intravenous [preservative free]: Ofirmev: 10 mg/mL (100 mL [DSC])Generic: 10 mg/mL (100 mL)Solution, Oral: Pain & Fever Childrens: 160 mg/5 mL (118 mL [DSC], 473 mL [DSC]) [alcohol free, aspirin free, sugar free; contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, sodium benzoate]Generic: 160 mg/5 mL (5 mL, 10.15 mL, 20.3 mL, 118 mL, 473 mL); 325 mg/10.15 mL (10.15 mL); 650 mg/20.3 mL (20.3 mL)Suppository, Rectal: FeverAll Adults: 650 mg (50 ea) [contains polysorbate 80]FeverAll Childrens: 120 mg (6 ea, 50 ea) [contains polysorbate 80]FeverAll Infants: 80 mg (1 ea, 6 ea, 50 ea) [contains polysorbate 80]FeverAll Junior Strength: 325 mg (6 ea, 50 ea) [contains polysorbate 80]Suspension, Oral: Aurophen Childrens: 160 mg/5 mL (118 mL [DSC]) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate; cherry flavor]BetaTemp Childrens: 160 mg/5 mL (118 mL) [contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate]Childrens Acetaminophen: 160 mg/5 mL (5 mL) [alcohol free, aspirin free; contains butylparaben, fd&c red #40 (allura red ac dye), polysorbate 80, propylene glycol, sodium benzoate]Childrens Acetaminophen: 160 mg/5 mL (5 mL) [alcohol free, aspirin free; contains butylparaben, fd&c red #40 (allura red ac dye), polysorbate 80, propylene glycol, sodium benzoate; strawberry flavor]Childrens Non-Aspirin: 160 mg/5 mL (118 mL)GoodSense Pain & Fever Child: 160 mg/5 mL (118 mL) [alcohol free, aspirin free, dye free, gluten free, ibuprofen free; contains propylene glycol, propylparaben, sodium benzoate, sorbitol]GoodSense Pain & Fever Child: 160 mg/5 mL (118 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c blue #1 (brilliant blue), propylene glycol, sodium benzoate, sorbitol; grape flavor]GoodSense Pain & Fever Child: 160 mg/5 mL (118 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol]GoodSense Pain & Fever Child: 160 mg/5 mL (118 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol; cherry flavor]GoodSense Pain & Fever Infants: 160 mg/5 mL (30 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c blue #1 (brilliant blue), propylene glycol, sodium benzoate, sorbitol]GoodSense Pain & Fever Infants: 160 mg/5 mL (30 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol]Mapap Childrens: 160 mg/5 mL (118 mL [DSC]) [contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate]Nortemp: 160 mg/5 mL (118 mL [DSC]) [alcohol free, aspirin free; contains butylparaben, fd&c red #40 (allura red ac dye), polysorbate 80, propylene glycol, sodium benzoate; cotton candy flavor]Nortemp Infants: 80 mg/0.8 mL (30 mL [DSC]) [alcohol free, aspirin free, sugar free; contains fd&c yellow #6 (sunset yellow), methylparaben, propylene glycol, saccharin sodium, sodium benzoate]Pain & Fever Childrens: 160 mg/5 mL (118 mL [DSC]) [alcohol free, aspirin free, dye free, gluten free, ibuprofen free; contains butylparaben, propylene glycol, sodium benzoate; cherry flavor]Pain & Fever Infants: 160 mg/5 mL (59 mL [DSC]) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol]Pain Relief Childrens: 160 mg/5 mL (118 mL) [cherry flavor]Panadol Childrens: 160 mg/5 mL (118 mL) [aspirin free, ibuprofen free; contains benzoic acid, fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, saccharin sodium; raspberry flavor]Panadol Infants: 160 mg/5 mL (54.7 mL) [aspirin free, ibuprofen free; contains benzoic acid, fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, saccharin sodium; raspberry flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free; cherry flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, dye free, ibuprofen free]Tylenol Childrens: 160 mg/5 mL (120 mL, 240 mL) [alcohol free, aspirin free, dye free, ibuprofen free; cherry flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate; strawberry flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; contains fd&c blue #1 (brilliant blue), sodium benzoate; grape flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; contains fd&c red #40 (allura red ac dye), sodium benzoate]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; contains sodium benzoate, sorbitol; grape flavor]Tylenol Childrens Pain + Fever: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; bubble-gum flavor]Tylenol for Children + Adults: 160 mg/5 mL (240 mL) [alcohol free, aspirin free, dye free, ibuprofen free, paraben free; cherry flavor]Tylenol Infants Pain+Fever: 160 mg/5 mL (60 mL) [alcohol free, aspirin free, dye free, ibuprofen free]Tylenol Infants Pain+Fever: 160 mg/5 mL (30 mL) [alcohol free, aspirin free, dye free, ibuprofen free; cherry flavor]Tylenol Infants Pain+Fever: 160 mg/5 mL (60 mL) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c blue #1 (brilliant blue), propylene glycol, sodium benzoate, sorbitol]Tylenol Infants Pain+Fever: 160 mg/5 mL (30 mL) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c blue #1 (brilliant blue), propylene glycol, sodium benzoate, sorbitol; grape flavor]Tylenol Infants Pain+Fever: 160 mg/5 mL (60 mL) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol; cherry flavor]Generic: 160 mg/5 mL (5 mL, 10.15 mL, 20.3 mL, 59 mL, 118 mL); 650 mg/20.3 mL (20.3 mL)Syrup, Oral: Triaminic Fever Reducer: 160 mg/5 mL (59 mL, 118 mL) [alcohol free, aspirin free, ibuprofen free; contains benzoic acid, edetate (edta) disodium, fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol); bubble-gum flavor]Triaminic Fever Reducer: 160 mg/5 mL (59 mL, 118 mL) [alcohol free, aspirin free, ibuprofen free; contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), sodium benzoate; grape flavor]Tablet, Oral: Acetaminophen Extra Strength: 500 mgAcetaminophen Extra Strength: 500 mg [scored]Acetaminophen Extra Strength: 500 mg [contains corn starch]Acetaminophen Extra Strength: 500 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]Acetaminophen Extra Strength: 500 mg [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]Acetaminophen Extra Strength: 500 mg [aspirin free]Acetaminophen Extra Strength: 500 mg [scored; aspirin free]Acetaminophen Extra Strength: 500 mg [aspirin free; contains corn starch]Acetaminophen Extra Strength: 500 mg [aspirin free, sodium free]Aminofen: 500 mg [DSC]Aminofen: 325 mg [DSC] [antihistamine free, caffeine free, salt free, sugar free]GoodSense Pain Relief Extra St: 500 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]GoodSense Pain Relief Extra St: 500 mg [DSC] [gluten free; contains corn starch, edetate (edta) disodium, fd&c red #40(allura red ac)aluminum lake, quinoline (d&c yellow #10) aluminum lake]GoodSense Pain Relief Extra St: 500 mg [gluten free; contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]Healthy Mama Shake That Ache: 500 mgMapap: 325 mg [DSC], 500 mg [DSC]Non-Aspirin: 325 mgNon-Aspirin: 325 mg, 500 mg [contains corn starch]Non-Aspirin Extra Strength: 500 mgNon-Aspirin Pain Reliever: 325 mg [DSC] [contains methylparaben, propylparaben]Pain & Fever: 325 mg [DSC]Pain & Fever Extra Strength: 500 mg [DSC]Pain Relief Extra Strength: 500 mgPain Relief Extra Strength: 500 mg [contains corn starch]Pain Relief Extra Strength: 500 mg [DSC] [contains methylparaben, propylparaben]Pain Relief Extra Strength: 500 mg [aspirin free]Pain Relief Extra Strength: 500 mg [aspirin free; contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]Pain Relief Regular Strength: 325 mg [contains methylparaben, propylparaben]Panadol Extra Strength: 500 mg [contains fd&c blue #1 (brill blue) aluminum lake, fd&c red #40(allura red ac)aluminum lake, quinoline (d&c yellow #10) aluminum lake]Pharbetol: 325 mgPharbetol Extra Strength: 500 mg [aspirin free]Tactinal: 325 mg [DSC] [scored/varied; aspirin free]Tactinal Extra Strength: 500 mg [DSC] [aspirin free]Tylenol: 325 mg [scored]Tylenol: 325 mg [contains corn starch, fd&c red #40(allura red ac)aluminum lake]Tylenol: 325 mg [DSC] [contains fd&c red #40(allura red ac)aluminum lake]Tylenol Extra Strength: 500 mgTylenol Extra Strength: 500 mg [contains butylparaben, edetate (edta) calcium disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), methylparaben, polysorbate 80, propylparaben, quinoline yellow (d&c yellow #10)]Tylenol Extra Strength: 500 mg [contains butylparaben, edetate (edta) calcium disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), methylparaben, propylparaben, quinoline yellow (d&c yellow #10)]Tylenol Extra Strength: 500 mg [contains corn starch, fd&c red #40(allura red ac)aluminum lake]Tylenol Extra Strength: 500 mg [contains fd&c red #40(allura red ac)aluminum lake]Tylenol Extra Strength: 500 mg [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]Generic: 325 mg, 500 mgTablet Chewable, Oral: Childrens APAP: 80 mg [scored; contains aspartame, fd&c yellow #6(sunset yellow)alumin lake; fruit flavor]Childrens Non-Aspirin: 80 mgChildrens Tactinal: 80 mg [DSC] [aspirin free, ibuprofen free]Mapap Childrens: 80 mg [aspirin free, ibuprofen free; contains fd&c blue #1 (brill blue) aluminum lake; grape flavor]Mapap Childrens: 160 mg [scored; aspirin free, ibuprofen free; bubble-gum flavor]7T Gummy ES: 500 mg [DSC] [aspirin free, ibuprofen free]Tylenol Childrens Chewables: 160 mg [aspirin free, ibuprofen free]Tylenol Childrens Chewables: 160 mg [aspirin free, ibuprofen free; contains fd&c blue #1 (brilliant blue)]Generic: 160 mg, 325 mg [DSC]Tablet Extended Release, Oral: 8 Hour Pain Reliever: 650 mgAcetaminophen 8 Hour: 650 mg [aspirin free; contains corn starch]Arthritis Pain Relief: 650 mgGoodSense Pain Relief: 650 mg [DSC] [contains fd&c red #40(allura red ac)aluminum lake]Mapap Arthritis Pain: 650 mg [gluten free]Tylenol 8 Hour: 650 mgTylenol 8 Hour Arthritis Pain: 650 mgGeneric: 650 mgGeneric Equivalent Available: USMay be product dependentDosage Forms: CanadaExcipient information presented when available (limited, particularly for generics); consult specific product labeling.Solution, Intravenous: Generic: 10 mg/mL (100 mL)Administration: AdultOral: May administer without regard to food; may administer with food to decrease possible GI upset; shake drops and suspension well before use; do not crush or chew ER products.Bariatric surgery: Caplet and tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Switch to IR formulation (tablet or adult strength liquid). Avoid children's liquid formulation due to sugar content and volume needed to achieve adult doses.Injection: For IV infusion only. Administer undiluted over 15 minutes. Attach an administration set in accordance with the manufacturer’s recommendations; may vary by product. If dose to be administered (eg, 650 mg) is not equivalent to an available formulation (eg, 500 mg per 50 mL or 1,000 mg per 100 mL) then withdraw appropriate dose and place into separate empty, sterile container (eg, glass bottle, plastic IV container, syringe) for administration.Rectal: Remove wrapper; insert suppository well up into the rectum.Administration: PediatricOral: Administer with food to decrease GI upset; shake drops and suspension well before use; do not crush or chew extended-release products.Parenteral: For IV infusion only. May administer undiluted over 15 minutes per the manufacturer. In neonatal patients, infusion of undiluted and diluted solutions over 15 to 30 minutes has been reported (Ref). Use within 6 hours of opening vial or transferring to another container. Discard any unused portion; single-use vials only.Rectal: Remove wrapper; insert suppository well up into the rectum.Use: Labeled IndicationsFever: Temporary reduction of fever.Pain:Injection: Management of mild to moderate pain in patients ≥2 years of age; management of moderate to severe pain when combined with opioid analgesia in patients ≥2 years.Oral, Rectal: Temporary relief of minor aches, pains, and headache.Medication Safety IssuesSound-alike/look-alike issues: Acephen may be confused with AcipHexAcetaminophen may be confused with acetazolamideFeverALL may be confused with Fiberall Triaminic Children's Fever Reducer Pain Reliever may be confused with Triaminic cough and cold productsTylenol may be confused with atenolol, timolol, Tylenol PM, TyloxInfusion bottles of ropivacaine and IV acetaminophen look similar. Potentially fatal mix-ups have been reported in which a glass bottle of Naropin was mistaken for Ofirmev in perioperative areas.Other safety concerns:Duplicate therapy issues: This product contains acetaminophen, which may be a component of combination products. Do not exceed the maximum recommended daily dose of acetaminophen.Infant concentration change: All children’s and infant acetaminophen products are available as 160 mg/5 mL. Some remaining infant concentrated solutions of 80 mg/0.8 mL and 100 mg/mL may still be available on pharmacy shelves or in patient homes. Check concentrations closely prior to administering or dispensing and verify concentration available to patients prior to recommending a dose (November 2011).Injection: Reports of 10-fold overdose errors using the parenteral product have occurred in the U.S. and Europe; calculation of doses in "mg" and subsequent administration of the dose in "mL" using the commercially available concentration of 10 mg/mL contributed to these errors. Expressing doses as mg and mL, as well as pharmacy preparation of doses,may decrease error potential (Dart, 2012; ISMP, 2012).International issues:Depon [Greece] may be confused with Depen brand name for penicillamine [US]; Depin brand name fornifedipine [India]; Dipen brand name for diltiazem [Greece]Duorol [Spain] may be confused with Diuril brand name for chlorothiazide [US, Canada] Paralen [Czech Republic] may be confused with Aralen brand name for chloroquine [US, Mexico]Adverse Reactions (Significant): ConsiderationsHepatotoxicityAcute hepatotoxicity may result from intentional or unintentional overdose in adult and pediatric patients. In pediatric patients, unintentional overdose can be a result of accidental ingestion, supratherapeutic dosing, more frequent administration than recommended, and use of multiple acetaminophen-containing products; hepatotoxicity has also been rarely reported with recommended dosages (Ref).Spontaneous resolution occurs with or without treatment in ~65% of cases, although some cases may progress to acute liver failure leading to liver transplantation or death (Ref); a mortality of ~0.4% has been reported (Ref). Acetaminophen is one of the most commonly reported products causing drug-induced liver injury (Ref), with ~50% of cases of acute hepatic failure in the US attributed to acetaminophen (Ref). Minor increased alanine aminotransferase (ALT) and increased aspartate aminotransferase (AST) may occur during chronic acetaminophen therapy that are rarely symptomatic; resolution generally occurs with discontinuation or dose reduction, but may also occur with continuation of the same dose (Ref).Mechanism: Dose-related; direct toxic effect through formation of toxic metabolite, N-acetyl-p-benzoquinoneimine (NAPQI) that binds to cellular proteins, including mitochondrial proteins. Toxic free radicals, including peroxynitrite, may also cause damage inside the mitochondria (Ref).Onset: Rapid; usually starts 24 to 72 hours after ingestion with marked elevations in serum ALT and AST, followed at 48 to 96 hours by clinical symptoms (Ref).Risk factors:• Dose:ο Pediatric: Toxicity is likely to occur with single ingestions >150 mg/kg or when the maximum daily acetaminophen dose is >75 mg/kg/day (maximum of 5 daily doses) up to 4,000 mg/day from all sources (Ref).ο Adult: Toxicity is likely to occur with single ingestions >250 mg/kg or >12,000 mg over a 24-hour period (Ref). Asymptomatic elevation of ALT may occur following maximal therapeutic doses of acetaminophen (4,000 mg/day) for ≥4 days (Ref).• Multiple acetaminophen-containing products: An unintentional overdose may occur in adult and pediatric patients who take multiple acetaminophen or acetaminophen-containing combination products (Ref).• Chronic alcohol ingestion: Chronic alcoholics who take therapeutic doses of acetaminophen are NOT at an increased risk of hepatotoxicity (Ref). In contrast, chronic alcoholics who ingest repeated supratherapeutic doses of acetaminophen are at an increased risk for hepatotoxicity (Ref).• Concomitant medications and herbal products: Although use of products that induce CYP2E1 enzymes (eg, carbamazepine, phenobarbital, phenytoin, isoniazid, rifampin) have been postulated to predispose to acetaminophen hepatotoxicity by enhanced production of NAPQI, there is little evidence, aside from case reports, that drug interactions increase the risk of liver injury (Ref).• Nutritional status: Malnutrition and fasting may increase the risk (Ref)• Age: Pediatric patients are less susceptible, whereas elderly patients are at a higher risk (Ref)• Delay to treatment with N-acetylcysteine (NAC): Most patients with acetaminophen overdose who receive treatment with NAC within 8 hours of ingestion will not develop hepatotoxicity (Ref)Adverse ReactionsThe following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.Oral, Rectal: Frequency not defined:Dermatologic: Erythema of skin, skin blister, skin rashOtic: Hearing lossIV: >10%: Gastrointestinal: Nausea (adults: 34%; neonates, infants, children, and adolescents: ≥5%), vomiting (adults: 15%; neonates, infants, children, and adolescents: ≥5%)1% to 10%:Cardiovascular: Hypertension, hypotension, peripheral edema (adults)Dermatologic: Pruritus (neonates, infants, children, and adolescents: ≥5%)Endocrine & metabolic: Hypoalbuminemia (neonates, infants, children, and adolescents), hypokalemia, hypomagnesemia (neonates, infants, children, and adolescents), hypophosphatemia (neonates, infants, children, and adolescents)Gastrointestinal: Constipation (neonates, infants, children, and adolescents: ≥5%), diarrhea (neonates, infants, children, and adolescents)Genitourinary: Oliguria (neonates, infants, children, and adolescents)Hematologic & oncologic: AnemiaHepatic: Increased serum aspartate aminotransferase (Watkins 2006)Local: Infusion-site pain, pain at injection siteNervous system: Agitation (neonates, infants, children, and adolescents), anxiety (adults), fatigue (adults), headache, insomnia (adults: 7%), trismus (adults)Neuromuscular & skeletal: Muscle spasm (≥1%)Respiratory: Abnormal breath sounds (adults), atelectasis (neonates, infants, children, and adolescents), dyspnea (adults), pleural effusion (neonates, infants, children, and adolescents), pulmonary edema (neonates, infants, children, and adolescents), stridor (adults), wheezing (adults)Postmarketing (all formulations):Dermatologic: Acute generalized exanthematous pustulosis (FDA 2016), Stevens-Johnson syndrome (FDA 2016), toxic epidermal necrolysis (Watanabe 2016; FDA 2016)Hepatic: Acute hepatic failure, hepatotoxicity (Ramachandran 2019, Yoon 2016), increased serum alanine aminotransferase (Watkins 2006)Hypersensitivity: Anaphylaxis (Ho 2008, Numata 2016), hypersensitivity reaction (Thomspon 2019)ContraindicationsInjection: Hypersensitivity to acetaminophen or any component of the formulation; severe hepatic impairment or severe active liver diseaseOTC labeling: When used for self-medication, do not use with other drug products containing acetaminophen or if allergic to acetaminophen or any of the inactive ingredientsWarnings/PrecautionsDisease-related concerns:• G6PD deficiency: Use with caution in patients with known G6PD deficiency.• Hepatic impairment: Use with caution in patients with hepatic impairment or active liver disease; use of the IV formulation is contraindicated in patients with severe hepatic impairment or severe active liver disease.• Hypovolemia: Use the IV formulation with caution in patients with severe hypovolemia (eg, due to dehydration or blood loss).Dosage form specific issues:• Aspartame: Some products may contain aspartame, which is metabolized to phenylalanine and must be avoided (or used with caution) in patients with phenylketonuria.• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol and/or sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol and/or benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP ["Inactive" 1997]; Zar 2007).Other warnings/precautions:• Dosage limit: Limit acetaminophen dose from all sources (prescription, OTC, combination products) and all routes of administration (IV, oral, rectal) to <4 g/day (adults).• Self-medication (OTC use): When used for self-medication, patients should be instructed to contact health care provider if symptoms get worse or new symptoms appear, redness or swelling is present in the painful area, fever lasts >3 days (all ages), or pain (excluding sore throat) lasts longer than: Children ≥12 years, Adolescents, and Adults: 10 days; Infants and Children <12 years: 5 days. When treating children with sore throat, if sore throat is severe, persists for >2 days, or is followed by fever, rash, headache, nausea, or vomiting, consult health care provider immediately.Warnings: Additional Pediatric ConsiderationsProphylactic use of acetaminophen to reduce fever and discomfort associated with vaccination is not recommended by the Advisory Committee on Immunization Practices (ACIP). Additionally, the ACIP does not recommend prophylactic acetaminophen to reduce risk of febrile seizure in infants and children with or without a history of febrile seizures. Antipyretics have not been shown to prevent febrile seizures (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; in the trial evaluating 459 infants (including 226 who received acetaminophen), antibody geometric mean concentrations (GMCs) for targeted vaccine immune response markers were lower in significantly more infants in the acetaminophen group compared with control. Before the booster dose, children who received prophylactic acetaminophen had lower antibody GMCs for all vaccine serotypes than children in the control group; this effect persisted after boosting even in the absence of additional acetaminophen doses. The clinical significance of this reduction in immune response has not been established (Prymula 2009). Antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011).Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).Metabolism/Transport EffectsSubstrate of CYP1A2 (minor), CYP2A6 (minor), CYP2C9 (minor), CYP2D6 (minor), CYP2E1 (major), CYP3A4 (minor), UGT1A1, UGT1A6, UGT1A9, UGT2B15; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potentialDrug InteractionsNote: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed).For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.Alcohol (Ethyl): May enhance the hepatotoxic effect of Acetaminophen. Risk C: Monitor therapyBusulfan: Acetaminophen may increase the serum concentration of Busulfan.Risk C: Monitor therapyCarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapyDapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapyDasatinib: Acetaminophen may enhance the hepatotoxic effect of Dasatinib. Dasatinib may increase the serum concentration of Acetaminophen.Management: Avoid coadministration of acetaminophen and dasatinib if possible. If coadministration is unavoidable, monitor for signs/symptoms of hepatotoxicity, particularly in patients with greater acetaminophen exposure. Risk D: Consider therapy modificationFlucloxacillin: May enhance the adverse/toxic effect of Acetaminophen. Specifically, the risk for high anion gap metabolic acidosis may be increased. Risk C: Monitor therapyFosphenytoin-Phenytoin: May decrease the serum concentration of Acetaminophen. Specifically, serum concentrations of acetaminophen may be decreased (leading to decreased efficacy), but the formation of the toxic N-acetyl-p-benzoquinone imine (NAPQI) metabolite may be increased (leading to increased hepatotoxicity). Risk C: Monitor therapyImatinib: Acetaminophen may enhance the hepatotoxic effect of Imatinib.Risk C: Monitor therapyImmune Checkpoint Inhibitors: Acetaminophen may diminish the therapeutic effect of Immune Checkpoint Inhibitors.Risk C: Monitor therapyIsoniazid: May enhance the hepatotoxic effect of Acetaminophen. Isoniazid may increase the metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor therapyLamoTRIgine: Acetaminophen may decrease the serum concentration of LamoTRIgine.Risk C: Monitor therapyLocal Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased.Risk C: Monitor therapyLorlatinib: May decrease the serum concentration of Acetaminophen. Risk C: Monitor therapyMetyraPONE: May increase the serum concentration of Acetaminophen. More importantly, by inhibiting the conjugative metabolism of acetaminophen, metyrapone may shift the metabolism towards the oxidative route that produces a hepatotoxic metabolite. Risk X: Avoid combinationMipomersen: Acetaminophen may enhance the hepatotoxic effect of Mipomersen.Risk C: Monitor therapyMitapivat: May decrease the serum concentration of UGT1A1 Substrates. Risk C: Monitor therapyNitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapyPHENobarbital: May increase the metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor therapyPhenylephrine (Systemic): Acetaminophen may increase the serum concentration of Phenylephrine (Systemic).Risk C: Monitor therapyPrilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia.Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia.Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapyPrimidone: May increase the metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor therapyProbenecid: May increase the serum concentration of Acetaminophen. Probenecid may also limit the formation of at least one major non-toxic metabolite, possibly increasing the potential for formation of the toxic NAPQI metabolite. Management: Consider limiting acetaminophen use in combination with probenecid. Probenecid may reduce clearance of acetaminophen to one of its non-toxic metabolities, increasing the risk for acetaminophen toxicity, even a lower doses. Risk D: Consider therapy modificationRifAMPin: May enhance the hepatotoxic effect of Acetaminophen. RifAMPin may decrease the serum concentration of Acetaminophen. Risk C: Monitor therapySodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia.Risk C: Monitor therapySORAfenib: Acetaminophen may enhance the hepatotoxic effect of SORAfenib. SORAfenib may increase the serum concentration of Acetaminophen.Management: Avoid coadministration of acetaminophen and sorafenib if possible. If coadministration is unavoidable, monitor for signs/symptoms of hepatotoxicity, particularly in patients with greater acetaminophen exposure. Risk D: Consider therapy modificationVaccines: Acetaminophen may diminish the therapeutic effect of Vaccines.Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modificationVitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. This appears most likely with daily acetaminophen doses exceeding 1.3 or 2 g/day for multiple consecutive days.Risk C: Monitor therapyFood InteractionsRate of absorption may be decreased when given with food. Management: Administer without regard to food.Pregnancy ConsiderationsAcetaminophen crosses the placenta (Naga Rani 1989; Nitsche 2017; Towers 2018).Based on epidemiological data, an increased risk of major congenital malformations has not been observed following maternal use of acetaminophen during pregnancy. The use of acetaminophen in recommended doses during pregnancy has not been associated with an increased risk of miscarriage or still birth; however, an increase in fetal death or spontaneous abortion may be seen following maternal overdose if treatment is delayed (Li 2003; Rebordosa 2009; Riggs 1989). A possible association between prenatal constriction of the ductus arteriosus following maternal use during the third trimester has been investigated. Based on available data, an increased risk is not likely associated with short-term use of acetaminophen at recommended doses (Allegaert 2019; Dathe 2019; Hauben 2021; Hutson 2021). Additional adverse events such as wheezing and asthma in early childhood, adverse effects on male reproductive development, and adverse neurodevelopmental effects such as attention-deficit/hyperactivity disorder (ADHD) or autism spectrum disorder following in utero acetaminophen exposure have been evaluated in multiple studies; outcome data are inconclusive due to study limitations (variety of evaluation methods and/or indications for acetaminophen use, recall bias, etc), and causal associations have not been established (Kwok 2022; Lourido-Cebreiro 2017; Patel 2022; Scialli 2010; Singh 2021; SMFM 2017; Sznajder 2022; Tadokoro-Cuccaro 2022).Maternal fever is associated with adverse fetal outcomes, including neural tube defects, oral clefts, and congenital heart defects. Treatment of maternal fever with an antipyretic may reduce these risks (Dreier 2014).Due to pregnancy-induced physiologic changes, some pharmaco*kinetic properties of acetaminophen may be altered. Dose adjustments are not recommended (Brookhuis 2021; Kulo 2014).Acetaminophen is the preferred initial treatment for acute migraine headache in pregnant patients (ACOG 2022). Acetaminophen is considered appropriate for the treatment of pain and fever in pregnancy (SMFM 2017) and is recommended for the treatment of fever in pregnant patients diagnosed with influenza (ACOG 2018). Acetaminophen may be used as part of a multimodal approach to pain relief following cesarean delivery (ACOG 2019).Acetaminophen is recommended to be used at the lowest effective dose for the shortest duration of time to effectively treat the mother and protect the health of the fetus (Kilcoyne 2017).Breastfeeding ConsiderationsAcetaminophen is present in breast milk.Data related to the presence of acetaminophen in breast milk are available from multiple sources (Berlin 1980; Bitzén 1981; Hurden 1980; Notarianni 1987).• Eleven patients 2 to 22 months' postpartum were administered a single oral dose of acetaminophen 650 mg. Plasma concentrations of acetaminophen were measured in 2 women during the first 6 hours after dosing. Acetaminophen appeared in the maternal milk and saliva in similar concentrations within 15 minutes (peak: 10 to 15 mcg/mL at 1 to 2 hours). Acetaminophen was no longer present in breast milk 12 hours after dosing. The mean half-life of acetaminophen in breast milk was 2.28 hours (range: 1.35 to 3.5 hours). Authors of the study calculated the estimated exposure to the breastfeeding infant to be 0.14% of the maternal dose (range: 0.04% to 0.23%). Acetaminophen was not detected in the urine of breastfeeding infants (Berlin 1980).• In a study of 3 breastfeeding women given acetaminophen 500 mg orally, peak concentrations were observed 2 hours after the dose in both the milk (4 mcg/mL) and serum (5 to 7 mcg/mL). The mean half-life of acetaminophen was 2.74 hours in the plasma and 2.64 hours in breast milk (Bitzén 1981).• A study evaluated 6 infants (2 to 6 days of age) exposed to acetaminophen via breast milk. The maternal dose of acetaminophen was 1 to 2 g taken 2 to 4 hours prior to breastfeeding. Acetaminophen, acetaminophen glucuronide, and acetaminophen sulfate were detected in the urine of all 6 infants. Other metabolites were also found in some samples, and it was assumed all metabolites were synthesized by the infants. Following maternal use of acetaminophen 1 g, the authors estimated exposure to the breastfeeding infant to be 1.85% of the weight-adjusted maternal dose (Notarianni 1987).• The presence of acetaminophen in breast milk was studied in 11 women, 3 to 9 days postpartum given acetaminophen 1 g orally. Multiple paired milk and serum samples were obtained over 4 hours. Breast milk concentrations of acetaminophen were 2.1 to 15.9 mcg/mL (n=32) (Hurden 1980). Using a breast milk concentration of 15.9 mcg/mL, the estimated exposure of acetaminophen to the breastfed infant would be 2.385 mg/kg/day (relative infant dose [RID]: 3.98% based on a therapeutic infant dose of 60 mg/kg/day).• In general, breastfeeding is considered acceptable when the RID is <10% (Anderson 2016; Ito 2000).A rash likely caused by acetaminophen was observed in a 2-month-old fully breastfed infant. Following maternal use of acetaminophen 1 g once daily for 2 days, a maculopapular rash appeared on the baby’s upper trunk and face, which resolved within 24 hours. Two weeks later, another maternal dose of acetaminophen 1 g was taken when a similar rash appeared after the infant was breastfed 3 times following the dose (Matheson 1985). A prospective cohort study evaluated the outcomes of breastfed infants whose mothers were taking various medications. Within the study, 43 mother-infant pairs reported acetaminophen exposure (dose, duration, and relationship to breastfeeding not provided). There were no cases of diarrhea, drowsiness, or irritability in the breastfed infants (Ito 1993).Acetaminophen is the preferred initial treatment for acute migraine headache in lactating patients (ACOG 2022). Nonopioid analgesics are preferred for lactating patients who require pain control peripartum or for surgery outside of the postpartum period (ABM [Martin 2018]; ABM [Reece-Stremtan 2017]; Sachs 2013). Acetaminophen is one of the preferred non-narcotic agents (Sachs 2013) and is considered compatible with breastfeeding when used in usual recommended doses (WHO 2002).Dietary ConsiderationsSome products may contain phenylalanine and/or sodium.Monitoring Parameters Serum acetaminophen levels: Where acute overdose suspected and with long-term use in patients with hepatic disease; relief of pain or feverMechanism of ActionAlthough not fully elucidated, the analgesic effects are believed to be due to activation of descending serotonergic inhibitory pathways in the CNS. Interactions with other nociceptive systems may be involved as well (Smith 2009). Antipyresis is produced from inhibition of the hypothalamic heat-regulating center.Pharmaco*kineticsOnset of action:Oral: <1 hour.IV: Analgesia: 5 to 10 minutes; Antipyretic: Within 30 minutes.Peak effect: IV: Analgesic: 1 hour.Duration:IV, Oral: Analgesia: 4 to 6 hours.IV: Antipyretic: ≥6 hours.Absorption:Oral: Primarily absorbed in small intestine (rate of absorption dependent upon gastric emptying); minimal absorption from stomach; varies by dosage form. Absorption is delayed in neonates in the first few days of life (Anderson 2002).Rectal: Delayed and erratic absorption; varies by dosage form and age (Allegaert 2020).Distribution: Vd:Neonates and Infants <2 years: Vd: Median range: 0.85 to 0.95 L/kg (Hammer 2020); up to 1.5 L/kg has been reported in extremely premature neonates (Anderson 2002).Children: Vss: 1.2 ± 0.3 L/kg.Adolescents: Vss: 1.1 ± 0.3 L/kg.Adults: Vss: 0.8 ± 0.2 L/kg.Protein binding: 10% to 25% at therapeutic concentrations; 8% to 43% at toxic concentrations.Metabolism: At normal therapeutic dosages, primarily hepatic metabolism to sulfate and glucuronide conjugates, while a small amount is metabolized by CYP2E1 to a highly reactive intermediate, N-acetyl-p-benzoquinone imine (NAPQI), which is conjugated rapidly with glutathione and inactivated to nontoxic cysteine and mercapturic acid conjugates. At toxic doses (as little as 4 g daily), glutathione conjugation becomes insufficient to meet the metabolic demand causing an increase in NAPQI concentrations, which may cause hepatic cell necrosis. Neonates (especially preterm neonates) demonstrate higher sulfate metabolites and lower glucuronide metabolites compared to adults (Flint 2017). Oral administration is subject to first-pass metabolism.Bioavailability:Oral: Infants and Children <6 years: ~72% (range: 11% to 91%) (Kleiber 2019).Half-life elimination: Prolonged following toxic doses.Neonates (Van Lingen 1999):GA 28 to 32 weeks: 11 ± 5.7 hours (range: 3.5 to 25.2 hours).GA 32 to 36 weeks: 4.8 ± 1.2 hours (range: 3.6 to 6.8 hours).Infants and Children <2 years: Median range: 2.4 to 2.8 hours (range: 1.2 to 5.4 hours) (Zuppa 2011).Children 2 to <12 years: Median range: 2.6 to 2.8 hours (range: 2.2 to 4.9 hours) (Zuppa 2011).Adolescents: 2.9 ± 0.7 hours (manufacturer's labeling).Adults: 2.4 ± 0.6 hours (manufacturer's labeling); may be slightly prolonged in severe renal insufficiency (CrCl <30 mL/minute): 2 to 5.3 hours.Time to peak, serum:Oral: Immediate release: Adults: 10 to 60 minutes (may be delayed in acute overdoses).IV:Infants and Children <2 years: Median range: 0.25 to 0.29 hours (range: 0 to 1.4 hours) (Zuppa 2011).Children 2 to <12 years: Median range: 0.18 to 0.27 hours (range: 0 to 0.75 hours) (Zuppa 2011).Children ≥12 years and Adolescents: Median range: 0.25 to 0.33 hours (range: 0 to 0.4 hours) (Zuppa 2011).Adults: 15 minutes.Rectal:Neonates (van Lingen 1999):GA 28 to 32 weeks: Median: 3.9 hours.GA 32 to 36 weeks: Median: 5.1 hours.Infants and Children: 2.37 ± 1.1 hours (range: 0.43 to 5.26 hours) (Hahn 2000).Excretion: Urine (<5% unchanged; 60% to 80% as glucuronide metabolites; 20% to 30% as sulfate metabolites; ~8% cysteine and mercapturic acid metabolites).Pharmaco*kinetics: Additional ConsiderationsHepatic function impairment: The half-life may increase 2-fold or more in patients with liver disease.Pricing: USCapsules (Tylenol Oral)325 mg (per each): $0.20Chewable (Acetaminophen Oral)160 mg (per each): $6.29Chewable (Mapap Childrens Oral)80 mg (per each): $0.08160 mg (per each): $0.09Chewable (Tylenol Childrens Chewables Oral)160 mg (per each): $0.29Gel (ElixSure Fever/Pain Oral)160 mg/5 mL (per mL): $0.04Liquid (Acetaminophen Oral)160 mg/5 mL (per mL): $0.06Liquid (Mapap Acetaminophen Extra Str Oral)500 mg/15 mL (per mL): $0.02Pack (Tylenol Childrens Pain + Fever Oral)160 mg (per each): $0.38Pack (Tylenol Dissolve Packs Oral)500 mg (per each): $0.36Solution (Acetaminophen Childrens Oral)160 mg/5 mL (per mL): $0.02Solution (Acetaminophen Intravenous)10 mg/mL (per mL): $0.09 - $0.45Solution (Acetaminophen Oral)160 mg/5 mL (per mL): $0.18 - $0.39Suppository (FeverAll Adults Rectal)650 mg (per each): $0.66Suppository (FeverAll Childrens Rectal)120 mg (per each): $0.80Suppository (FeverAll Infants Rectal)80 mg (per each): $0.80Suppository (FeverAll Junior Strength Rectal)325 mg (per each): $0.80Suspension (Acetaminophen Oral)160 mg/5 mL (per mL): $0.22Suspension (Panadol Childrens Oral)160 mg/5 mL (per mL): $0.05Suspension (Panadol Infants Oral)160 mg/5 mL (per mL): $0.08Suspension (Tylenol Childrens Oral)160 mg/5 mL (per mL): $0.06Suspension (Tylenol Childrens Pain + Fever Oral)160 mg/5 mL (per mL): $0.06Suspension (Tylenol for Children + Adults Oral)160 mg/5 mL (per mL): $0.05Suspension (Tylenol Infants Pain+Fever Oral)160 mg/5 mL (per mL): $0.16Syrup (Triaminic Fever Reducer Oral)160 mg/5 mL (per mL): $0.08Tablet, controlled release (Acetaminophen ER Oral)650 mg (per each): $0.07 - $0.10Tablet, controlled release (Tylenol 8 Hour Arthritis Pain Oral)650 mg (per each): $0.13Tablet, controlled release (Tylenol 8 Hour Oral)650 mg (per each): $0.18Tablets (Acetaminophen Oral)325 mg (per each): $0.01 - $0.06500 mg (per each): $0.02 - $0.08Tablets (Healthy Mama Shake That Ache Oral)500 mg (per each): $0.06Tablets (Panadol Extra Strength Oral)500 mg (per each): $0.14Tablets (Pharbetol Extra Strength Oral)500 mg (per each): $0.03Tablets (Pharbetol Oral)325 mg (per each): $0.02Tablets (Tylenol Extra Strength Oral)500 mg (per each): $0.12Tablets (Tylenol Oral)325 mg (per each): $0.05Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursem*nt or purchasing functions or considered to be an exact price for a single product and/or manufacturer.Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions.In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data.Pricing data is updated monthly.Brand Names: InternationalA-Mol (TH);Acamol (CL, IL, LI);Acamol To-Go (IL);Acamoli Baby (IL);Acamoli Forte suppositories for Kids (IL);Accelio (JP);Acemol (VN);ACET suppositories (SG);Acetab (VN);Acetalgan (EG);Acetalgin (CH);Acetamol (IT);Acicur-P (PY);Actimol (MY);Adinol (CR, DO, GT, HN, MX, NI, SV);Adol (BH, EG, ET, JO, KW, LB, QA, SA);Adolin (PA);Adorem (CO);Afebrin (HK);Afebryl (LU);Agap Fast (PL);Agomol (TZ);Alcocin (IN);Alginox (EC);Alvedon (SE);Amadol (AU);Ametrex (CO);Amol (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);Analgiser (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);Analphen (MX);Angela (TH);Antalgic (ZW);Antamol (JO);Apacet (LI);Apap (LI);Apimol (ZW);Aptamol (IN);Arfen (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, MY, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW);Atamel (PE);Avadol (MY);Axcel (MY);Ben-U-Ron (CH, PT);ben-u-ron (HU);Benuron (JP);Betamol (ZW);Biogesic (SG);Biogesic Suspension (HK);Biopain (PH);Blimol (UA);Calapol (ID);Calonal (JP);Calpol (AE, BF, BJ, CI, CY, EG, ET, GH, GM, GN, IE, IQ, IR, JO, JP, KE, KW, LB, LK, LR, LY, MA, ML, MR, MT, MU, MW, NE, NG, OM, PR, QA, SA, SC, SD, SI, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW);Causalon (AR);Cemol (TH);Cetal (ET);Cetapain (ID);Cetapyrin (LK);Cetta (TH);Champ Syrup (KR);Children's Bufferin (CN);Children's S Tylenol (KR);Christamol (HK);Claradol (MA);Cotemp (TH);Croix Blanche (LU);Curpol (LU);Dafalgan (BE, LU);Dafalgan odis (LU);Dailyal (LV);Daleron (HR, SI);Demneq (NL);Den-U-Ron (CN);Denamol (TH);Depon (TR);Dirox (AR);Dismifen (MX);Dol-Stop (LU);Dolan Infantil (GT, HN, NI, SV);Dolex (UY);Dolgesic (ES);Doliprane (FR, IN, LB, MA);Dolitabs (FR);Dolomol (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);Dolorol (ZA);Dolprone (LU);Doluvital (MX);Dolviran (MX);Dumin (LK);Efermol (PY);Efferalgan (HR, HU, LT, LU, LV, UA);Efferalgan 500 (CR, DO, EE, GT, HN, NI, PA, SV);Efferalganodis (FR);Elgan (UA);Eneffa (BH);Enelfa (LU);Eterfix (ID);Europain (HK);Fast (BD);Fbridol (ET);Febridol (AU);Febrile Free (PH);Fervex (BR);Fevadol (BH, QA);Fibralgin (HR);Filanc (MX);Fortolin (CN, HK);Gelocatil (ES);Geluprane 500 (FR);Hapacol (MY);Hapacol Jr (MY);Hedex (IE);Hoemal (MY);Hoemal Junior (MY);Influgan (UA);Kelvin (ET, LK);Lekadol (HR);Lemgrip (BE, LU);Lonarid mono (LU);Lotemp (TH);Lupocet (HR);Maccabimol (IL);Mafidol (PE);Medipyrin (SK);Mejoralito Junior (MX);Mejoralito Pediátrico (MX);Meldol (ZW);Metagesic (PH);Mexalen (AT, CZ, HU);Minopan (KR);Momentum (LU);Mypara (TH);Napafen (EC);Napamol (ZA);Napaton (TW);Napran (PH);Naprex (ID);NEBS (JP);Neuridon (LU);Nordinet Infantil (MX);Normotemp (EC);Novadol (ZW);Nufadol (ID);Omnipap (PL);Omol (QA);Pacemol (KR);Padolieve (IE);Pamol (DK, JO, NZ);Pamol 650 (SG);Panadol (AE, AU, BE, BF, BG, BJ, CH, CI, CL, CN, CY, CZ, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, HK, HU, ID, IE, IL, IQ, IR, IT, JO, KE, KR, KW, LB, LK, LR, LU, LV, LY, MA, ML, MR, MT, MU, MW, NE, NG, NL, NZ, OM, PE, PK, PL, PT, QA, RO, RU, SA, SC, SD, SG, SK, SL, SN, SY, TH, TN, TW, TZ, UA, UG, YE, ZM, ZW);Panadol Actifast (MY, SG);Panadol Extend (SG);Panadol for Children (SG);Panadon (HR);Panadrex (BH, ET);Panamax (AU);Panodil (DK, NO, SE);Para-IV (PH);Paracet (IS, NO, ZW);Paracetamol (HR);Paracetamol Pharmavit (HU);Paracetamol-ratiopharm (LU);Paracetol (LK);Paracil (MY);Paracip (LV);Paragin (TH);Paralgin (AU);Paralief (IE);Paramol (IL, LB, RO, TW);Paramol Kat Drops (IL);Parapaed (DE);Parapaed Junior (NZ);Parapaed Six Plus (NZ);Parapane (AU);Paratabs (IS);Parcemol (HK);Parcemol Forte (HK);Parmol (HK);Paromon (HK);Parvid (PH);Paximol (SG);Pe-Tam (LU);Pedipan (KR);Penral-Night (KR);Perdolan Mono (LU);Perfalgan (AE, AT, BG, BH, CH, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HR, IE, IL, IN, IS, IT, JO, KR, KW, LB, LT, MT, NZ, PL, PT, QA, RO, RU, SA, SE, SI, SK, TR, VN, ZA);Pharmacen-M (MX);Pinex (NO);Pireta (ID);Plicet (HR);Poro (ID, MY, PH, SG, TH);Portem (CR, DO, GT, HN, NI, PA, SV);Prest (NL);Progesic (HK);Raperon (KR);Rapidene (LK);Rapidol (CL);Reliv (SE);Remedol (MT, PR, TR);Revanin (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW);Rhinapen elixir (KR);Rubophen (HU);Salzone (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW);Sanmol (PH);Sanmol Infusion (ID);Saridon (CO);Sedalito (MX);Sedalmerck (CR, DO, GT, HN, NI, PA, SV);Selegesic (PH);Sensamol (IL);Setamol (HK);Setopain (KR);Setopain ER (KR);Sinebriv (PL);Sinedol (DO, MX);Strimol (ZW);Supadol mono (LU);Suspen ER (KR);Tafirol (PE);Tamin (TZ);Tamoliv (ID);Tasmen (KR);Tempol (MY);Tempra (ID, JP, LU, MX);Tempte (TW);Teramol (PH);Teramol Forte (PH);Tipol (IE);Toniker (TW);Turpan (ID);Tylenol (BR, CH, DE, JP, KR, MX, NL, PH, PT, QA, TH, VE);Tylenol 8-hour (TH);Tylenol Acetaminophen Extended Relief (CN);Tylenol ER (KR);Tylenol Extra Fuerte (PY);Tylenol Forte (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);Tylex (BB, BM, BS, BZ, CR, DO, GT, GY, HN, JM, MX, NI, PA, SR, SV, TT);Umbral (EC);Winadol (CO, VE);Xcel (BD);Xebramol (TH);XL-Dol Infantil (MX);Z-Mol (PY)For country code abbreviations (show table)Acephen (acetaminophen suppositories) [prescribing information]. South Plainfield, NJ: G&W Laboratories; April 2014.Acetaminophen injection for IV [prescribing information]. Bethlehem, PA: B. Braun Medical Inc; February 2021.Achterbergh R, Lammers LA, Kuijsten L, Klümpen HJ, Mathôt RAA, Romijn JA. Effects of nutritional status on acetaminophen measurement and exposure. Clin Toxicol (Phila). 2019;57(1):42-49. doi:10.1080/15563650.2018.1487563 [PubMed 29974811]Ahlfors CE. Benzyl alcohol, kernicterus, and unbound bilirubin. J Pediatr. 2001;139(2):317-319. [PubMed 11487763]Alade SL, Brown RE, Paquet A. Polysorbate 80 and E-Ferol toxicity. Pediatrics. 1986;77(4):593-597. [PubMed 3960626]Alander SW, Dowd MD, Bratton SL, Kearns GL. Pediatric acetaminophen overdose: risk factors associated with hepatocellular injury. Arch Pediatr Adolesc Med. 2000;154(4):346-350. [PubMed 10768670]Allegaert K. A critical review on the relevance of paracetamol for procedural pain management in neonates. 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Acetaminophen (paracetamol): Pediatric drug information

CloseAcetaminophen (paracetamol): Pediatric drug informationAcetaminophen (paracetamol): Pediatric drug information(For additional information see "Acetaminophen (paracetamol): Drug information" and see "Acetaminophen (paracetamol): Patient drug information")For abbreviations, symbols, and age group definitions used in Lexicomp (show table)ALERT: US Boxed WarningRisk of medication errors and hepatotoxicity (injection):Take care when prescribing, preparing, and administering acetaminophen injection to avoid dosing errors that could result in accidental overdose and death. In particular, be careful to ensure the following: the dose in milligrams and milliliters is not confused; the dosing is based on weight for patients less than 50 kg; infusion pumps are properly programmed; and the total daily dose of acetaminophen from all sources does not exceed maximum daily limits.Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed the maximum daily limits, and often involve more than 1 acetaminophen-containing product.Brand Names: US7T Gummy ES [DSC];8 Hour Pain Reliever [OTC];Acetaminophen 8 Hour [OTC];Acetaminophen Extra Strength [OTC];Aminofen [OTC] [DSC];Apra [OTC];Arthritis Pain Relief [OTC];Aurophen Childrens [OTC] [DSC];BetaTemp Childrens [OTC];Childrens Acetaminophen [OTC];Childrens APAP [OTC];Childrens Non-Aspirin [OTC];Childrens Silapap [OTC];Childrens Tactinal [OTC] [DSC];Ed-APAP [OTC];ElixSure Fever/Pain [OTC];FeverAll Adults [OTC];FeverAll Childrens [OTC];FeverAll Infants [OTC];FeverAll Junior Strength [OTC];GoodSense Pain & Fever Child [OTC];GoodSense Pain & Fever Infants [OTC];GoodSense Pain Relief Extra St [OTC];GoodSense Pain Relief [OTC] [DSC];Healthy Mama Shake That Ache [OTC];Liquid Pain Relief [OTC];M-PAP [OTC];Mapap Acetaminophen Extra Str [OTC];Mapap Arthritis Pain [OTC];Mapap Childrens [OTC];Mapap [OTC];Non-Aspirin Extra Strength [OTC];Non-Aspirin Pain Reliever [OTC] [DSC];Non-Aspirin [OTC];Nortemp Infants [OTC] [DSC];Nortemp [OTC] [DSC];Ofirmev [DSC];Pain & Fever Childrens [OTC] [DSC];Pain & Fever Extra Strength [OTC] [DSC];Pain & Fever Infants [OTC] [DSC];Pain & Fever [OTC] [DSC];Pain Relief Childrens [OTC];Pain Relief Extra Strength [OTC];Pain Relief Regular Strength [OTC];Pain Relief [OTC];Panadol Childrens [OTC];Panadol Extra Strength [OTC];Panadol Infants [OTC];Pharbetol Extra Strength [OTC];Pharbetol [OTC];Tactinal Extra Strength [OTC] [DSC];Tactinal [OTC] [DSC];Triaminic Fever Reducer [OTC];Tylenol 8 Hour Arthritis Pain [OTC];Tylenol 8 Hour [OTC];Tylenol Childrens Chewables [OTC];Tylenol Childrens Pain + Fever [OTC];Tylenol Childrens [OTC];Tylenol Dissolve Packs [OTC];Tylenol Extra Strength [OTC];Tylenol for Children + Adults [OTC];Tylenol Infants Pain+Fever [OTC];Tylenol [OTC]Therapeutic CategoryAnalgesic, Nonopioid;AntipyreticDosing: NeonatalNote: All sources of acetaminophen (eg, prescription, OTC, combination products) should be considered when evaluating a patient's maximum daily dose. While recommended doses are generally considered safe, hepatotoxicity has been reported (rarely) even with doses below recommendations (Ref).Fever:Oral: Limited data available: Preterm and term neonates (Ref):GA 28 to 32 weeks: Oral: 10 to 15 mg/kg/dose every 6 to 12 hours as needed; maximum daily dose: 40 mg/kg/day.GA 33 to 36 weeks or term neonates <10 days: Oral: 10 to 15 mg/kg/dose every 6 to 8 hours as needed; maximum daily dose: 60 mg/kg/day.Term neonates ≥10 days: Oral: 10 to 15 mg/kg/dose every 4 to 6 hours as needed; do not exceed 5 doses in 24 hours; maximum daily dose: 75 mg/kg/day.IV: Preterm and term neonates (Ref):PMA <32 weeks: IV: 7.5 to 10 mg/kg/dose every 6 to 8 hours as needed; maximum reported daily dose: 40 mg/kg/day.PMA 32 to 36 weeks: IV: 7.5 to 12.5 mg/kg/dose every 6 hours as needed; maximum daily dose: 50 mg/kg/day.PMA >36 weeks: IV: 10 to 15 mg/kg/dose every 6 hours as needed; maximum daily dose: 60 mg/kg/day.Rectal: Limited data available: Preterm and term neonates (Ref):GA 28 to 32 weeks: Rectal: 15 to 20 mg/kg/dose every 12 hours as needed; maximum daily dose: 40 mg/kg/day.GA 33 to 36 weeks or term neonates <10 days: Rectal: 15 to 20 mg/kg/dose every 8 hours as needed; maximum daily dose: 60 mg/kg/day.Term infants ≥10 days: Rectal: 20 mg/kg/dose every 6 to 8 hours as needed; do not exceed 5 doses in 24 hours; maximum daily dose: 75 mg/kg/day.Pain: Note: Monotherapy for procedural pain has not been found to be effective in neonates; for postoperative pain, acetaminophen should be used as adjunctive analgesia and as part of combination therapy (pharmacologic and nonpharmacologic) due to its opioid-sparing effects (Ref).Oral: Limited data available: Preterm and term neonates (Ref):GA 28 to 32 weeks: Oral: 10 to 15 mg/kg/dose every 6 to 12 hours as needed; maximum daily dose: 40 mg/kg/day.GA 33 to 36 weeks or term neonates <10 days: Oral: 10 to 15 mg/kg/dose every 6 to 8 hours as needed; maximum daily dose: 60 mg/kg/day.Term neonates ≥10 days: Oral: 10 to 15 mg/kg/dose every 4 to 6 hours as needed; do not exceed 5 doses in 24 hours; maximum daily dose: 75 mg/kg/day.Note: Based on pharmaco*kinetic modeling studies, some experts suggest starting with a loading dose of 25 mg/kg to attain target concentrations (Ref).IV: Limited data available; efficacy results variable; optimal dose not established: Preterm and term neonates (Ref). Note: Maximum daily doses derived from manufacturer's labeling for fever.PMA <32 weeks:Loading dose (optional): IV: 20 mg/kg.Maintenance dose: IV: 7.5 to 10 mg/kg/dose every 6 to 8 hours; maximum reported daily dose: 40 mg/kg/day.PMA 32 to 36 weeks:Loading dose (optional): IV: 20 mg/kg.Maintenance dose: IV: 7.5 to 12.5 mg/kg/dose every 6 hours; maximum daily dose: 50 mg/kg/day.PMA >36 weeks:Loading dose (optional): IV: 20 mg/kg.Maintenance dose: IV: 7.5 to 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day.Rectal: Preterm and term neonates (Ref):GA 28 to 32 weeks: Rectal: Loading dose (optional): 35 mg/kg; 15 to 20 mg/kg/dose every 12 hours; maximum daily dose: 40 mg/kg/day.GA 33 to 36 weeks or term neonates <10 days: Rectal: Loading dose: 30 mg/kg or 35 mg/kg; then 15 to 20 mg/kg/dose every 8 hours; maximum daily dose: 60 mg/kg/day.Term infants ≥10 days: Rectal: Loading dose: 30 mg/kg or 35 mg/kg; then 20 mg/kg/dose every 6 to 8 hours; do not exceed 5 doses in 24 hours; maximum daily dose: 75 mg/kg/day.Patent ductus arteriosus (PDA):Treatment: GA ≤34 weeks: IV, Oral: Usual dose: 15 mg/kg/dose every 6 hours for 3 days; reported duration is variable (2 to 7 days) (Ref). A retrospective study comparing oral to IV acetaminophen in neonates <32 weeks GA found patients in the oral acetaminophen group experienced a higher closure rate compared to the IV group (79% vs 40%) (Ref).Prophylaxis or early targeted treatment in the first day of life: Limited data available; optimal dose and duration not established.GA ≤34 weeks: IV: Loading dose: 15 to 20 mg/kg, followed by 7.5 mg/kg/dose every 6 hours for 3 to 5 days. Dosing based on 3 randomized trials that compared acetaminophen use within the first 12 hours of life to placebo or no intervention; 2 studies administered acetaminophen prophylactically to neonates born at <32 to 34 weeks GA and 1 study administered early targeted treatment to neonates born at <29 weeks GA who were shown to have PDA ≥1 mm at 6 hours of life. Acetaminophen use was associated with a lower incidence of PDA within the first 5 days of life and a reduction in the need for PDA treatment (Ref).Dosing: Altered Kidney Function: Neonatal:IV:Mild to moderate impairment: There are no neonatal-specific recommendations in the manufacturer's labeling.Severe impairment (CrCl <30 mL/minute): The manufacturer's labeling for IV acetaminophen states that longer dosing intervals and a reduced total daily dose may be warranted in patients with severe kidney impairment; use with caution.Dosing: PediatricNote: Oral liquids are available in multiple concentrations (eg, 160 mg/5 mL, 500 mg/5 mL, 500 mg/15 mL); precautions should be taken to verify and avoid confusion between the different concentrations; dose should be clearly presented as "mg."Pain or feverPain (mild to moderate) or fever: Note: All sources of acetaminophen (eg, prescription, OTC, combination products) should be considered when evaluating a patient's maximum daily dose. To lower the risk for hepatotoxicity, limit daily dose to ≤75 mg/kg/day (maximum of 5 daily doses), not to exceed 4,000 mg/day; while recommended doses are generally considered safe, hepatotoxicity has been reported (rarely) even with doses below recommendations (Ref).Oral:Weight-directed dosing: Infants, Children, and Adolescents: 10 to 15 mg/kg/dose every 4 to 6 hours as needed (Ref); do not exceed 5 doses in 24 hours; maximum daily dose: 75 mg/kg/day not to exceed 4,000 mg/day.Fixed dosing:Oral suspension, chewable tablets: Infants and Children <12 years: Consult specific product formulations for appropriate age groups. See table; use of weight to select dose is preferred; if weight is not available, then use age; doses may be repeated every 4 hours; maximum: 5 doses/day.Acetaminophen Dosing (Oral)Weight (preferred)AAgeDosage(mg)kglbsAManufacturer’s recommendations are based on weight in pounds (OTC labeling); weight in kg listed here is derived from pounds and rounded; kg weight listed also is adjusted to allow for continuous weight ranges in kg. OTC labeling instructs consumer to consult with physician for dosing instructions in infants and children under 2 years of age.2.7 to 5.36 to 110 to 3 mo405.4 to 8.112 to 174 to 11 mo808.2 to 10.818 to 231 to 2 y12010.9 to 16.324 to 352 to 3 y16016.4 to 21.736 to 474 to 5 y24021.8 to 27.248 to 596 to 8 y320 to 32527.3 to 32.660 to 719 to 10 y325 to 40032.7 to 43.272 to 9511 y480 to 500Immediate-release solid dosage formulations: Note: Actual OTC dosing recommendations may vary by product and/or manufacturer:Children 6 to 11 years: 325 mg every 4 to 6 hours; maximum daily dose: 1,625 mg/day; Note: Do not use more than 5 days unless directed by a physician.Children ≥12 years and Adolescents:Regular strength: 650 mg every 4 to 6 hours; maximum daily dose: 3,250 mg/day unless directed by a physician; under physician supervision daily doses ≤4,000 mg may be used.Extra strength: 1,000 mg every 6 hours; maximum daily dose: 3,000 mg/day unless directed by a physician; under physician supervision daily doses ≤4,000 mg may be used.Extended release: Children ≥12 years and Adolescents: 1,300 mg every 8 hours; maximum daily dose: 3,900 mg/day.IV:Infants and Children <2 years:Manufacturer’s labeling: Fever: 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day.Alternate dosing: Limited data available: Pain and fever: 7.5 to 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day (Ref).Children ≥2 years (Ref):<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day.≥50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 1,000 mg; maximum daily dose: 75 mg/kg/day not to exceed 4,000 mg/day.Adolescents:<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day.≥50 kg: 1,000 mg every 6 hours or 650 mg every 4 hours; maximum single dose: 1,000 mg; maximum daily dose: 4,000 mg/day.Rectal:Weight-directed dosing: Limited data available: Infants and Children <12 years: 10 to 20 mg/kg/dose every 4 to 6 hours as needed; do not exceed 5 doses in 24 hours (Ref); maximum daily dose: 75 mg/kg/day not to exceed 1,625 mg/day.Fixed dosing:Infants 6 to 11 months: 80 mg every 6 hours; maximum daily dose: 320 mg/day.Infants and Children 12 to 36 months: 80 mg every 4 to 6 hours; maximum daily dose: 400 mg/day.Children >3 to 6 years: 120 mg every 4 to 6 hours; maximum daily dose: 600 mg/day.Children >6 up to 12 years: 325 mg every 4 to 6 hours; maximum daily dose: 1,625 mg/day.Children ≥12 years and Adolescents: 650 mg every 4 to 6 hours; maximum daily dose: 3,900 mg/day.Pain; peri-/postoperative management; adjunct to opioid therapyPain; peri-/postoperative management; adjunct to opioid therapy: IV:Infants and Children <2 years: Limited data available: 7.5 to 15 mg/kg/dose every 6 hours; maximum daily dose: 60 mg/kg/day (Ref).Children ≥2 years (Ref):<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day.≥50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 1,000 mg; maximum daily dose: 75 mg/kg/day not to exceed 4,000 mg/day.Adolescents:<50 kg: 15 mg/kg/dose every 6 hours or 12.5 mg/kg/dose every 4 hours; maximum single dose: 15 mg/kg up to 750 mg; maximum daily dose: 75 mg/kg/day not to exceed 3,750 mg/day.≥50 kg: 1,000 mg every 6 hours or 650 mg every 4 hours; maximum single dose: 1,000 mg; maximum daily dose: 4,000 mg/day.Rectal: Limited data available: Children:Loading dose: 40 mg/kg for 1 dose, in most trials, the dose was administered postoperatively (Ref); a maximum dose of 1,000 mg was most frequently reported. However, in one trial evaluating 24 older pediatric patients (all patients ≥25 kg; mean age: ~13 years), the data suggested that a dose of 1,000 mg does not produce therapeutic serum concentrations (target for study: >10 mcg/mL) compared to a 40 mg/kg dose (up to ~2,000 mg); the resultant Cmax was: 7.8 mcg/mL (1,000 mg dose group) vs 15.9 mcg/mL (40 mg/kg dose group). Note: Therapeutic serum concentrations for analgesia have not been well-established (Ref).Maintenance dose: 20 to 25 mg/kg/dose every 6 hours as needed for 2 to 3 days has been suggested if further pain control is needed postoperatively; maximum daily dose: 100 mg/kg/day not to exceed 4,000 mg/day; therapy longer than 5 days has not been evaluated (Ref).Note: In the majority of trials, suppositories were not divided due to unequal distribution of drug within suppository; doses were rounded to the nearest mg amount using 1 or 2 suppositories of available product strengths.Dosing: Kidney Impairment: PediatricAltered kidney function: Infants, Children, and Adolescents:Oral, rectal: Mild to severe impairment: There are no dosage adjustments provided in the manufacturer's labeling; based on adult pharmaco*kinetic studies, dosage adjustment may not be necessary for short courses. In adult pharmaco*kinetic studies, plasma concentrations of acetaminophen did not differ in renal impairment patients when compared to healthy patients for short courses of treatment (ie, 3 days); however, accumulation of the glucuronide and sulfate conjugate metabolites in renal impairment has been described following a single dose of acetaminophen up to repeat dosing for 10 days; the clinical significance of this finding is unknown (Ref).IV:Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling.Severe impairment (CrCl <30 mL/minute): The manufacturer's labeling for IV acetaminophen states that longer dosing intervals and a reduced total daily dose may be warranted in patients with severe kidney impairment; use with caution.Hemodialysis, intermittent: Acetaminophen and its conjugates are readily dialyzable (Ref): No dosage adjustment necessary when used for mild to moderate pain (Ref).Peritoneal dialysis: Not dialyzed (Ref): No dosage adjustment necessary when used for mild to moderate pain (Ref).Dosing: Hepatic Impairment: PediatricUse with caution. Limited, low-dose therapy is usually well-tolerated in hepatic disease/cirrhosis; however, cases of hepatotoxicity at daily acetaminophen dosages <4,000 mg/day have been reported. Avoid chronic use in hepatic impairment.Dosing: Adult(For additional information see "Acetaminophen (paracetamol): Drug information")Note: Safety: Acetaminophen-induced hepatotoxicity, which can be life threatening, has been associated with doses >4 g/day. Although doses up to 4 g/day are generally well tolerated (Ref), hepatotoxicity has been reported rarely at this dose limit (Ref). Due to this risk, some experts recommend a lower maximum dose of 3 g/day in adults with normal liver function, particularly when used for longer durations (eg, >7 days) for pain (Ref). Heavy alcohol use, malnutrition, fasting, low body weight, advanced age, febrile illness, select liver disease, and use of drugs that interact with acetaminophen metabolism may increase risk of hepatotoxicity; a lower total daily dose (eg, 2 g/day) or avoidance may be preferred (Ref). When calculating total daily dose, confirm that all sources (eg, prescription, OTCs, combinations) are included.Pain and/or feverPain (mild to moderate) and/or fever (monotherapy or as an adjunct): Oral: 325 to 650 mg every 4 to 6 hours as needed or 1 g every 6 hours as needed; maximum dose: 4 g/day (Ref). See "Note: Safety" above regarding maximum dose.OTC labeling (patient-guided therapy): Note: Dosage recommendations, including maximum doses, vary among OTC manufacturers.Immediate release:Regular strength (325 mg/tablet): 2 tablets (650 mg) every 4 to 6 hours as needed; maximum daily dose: 10 tablets/day (3.25 g/day).Extra strength (500 mg/tablet): 2 tablets (1 g) every 6 hours as needed; maximum daily dose: 6 tablets/day (3 g/day).Extended release (650 mg/tablet): 2 tablets (1.3 g) every 8 hours as needed; maximum daily dose: 6 tablets/day (3.9 g/day).IV:≥50 kg: 650 mg every 4 hours or 1 g every 6 hours; maximum single dose: 1 g/dose; maximum daily dose: 4 g/day.<50 kg: 12.5 mg/kg every 4 hours or 15 mg/kg every 6 hours; maximum single dose: 15 mg/kg/dose (≤750 mg/dose); maximum daily dose: 75 mg/kg/day (≤3.75 g/day). Note: Some experts recommend this reduced dosing if used in patients with chronic alcoholism, malnutrition, or dehydration regardless of weight (Ref).Rectal: 325 to 650 mg every 4 to 6 hours as needed (Ref); maximum daily dose: 3.9 g/day. Note: Absorption is irregular; bioavailability may be reduced by ~10% to 20% relative to oral administration (Ref).Dosing: Kidney Impairment: AdultThe renal dosing recommendations are based upon the best available evidence and clinical expertise. Senior Editorial Team: Bruce Mueller, PharmD, FCCP, FASN, FNKF; Jason A. Roberts, PhD, BPharm (Hons), B App Sc, FSHP, FISAC; Michael Heung, MD, MS.IV, Oral, Rectal:Mild to severe impairment: No dosage adjustment likely to be necessary. The manufacturer's labeling for IV acetaminophen states that longer dosing intervals and a reduced total daily dose may be warranted in patients with severe kidney impairment (CrCl ≤30 mL/minute); however, acetaminophen concentrations and half-life are increased but similar to those in patients with normal renal function (Ref). Glucuronide and sulfate conjugate metabolites accumulate in renal impairment, but the clinical effects are unknown (Ref).Hemodialysis, intermittent (thrice weekly): Acetaminophen and its conjugates are readily dialyzable (Ref): No dosage adjustment necessary (Ref).Peritoneal dialysis: Not dialyzed (Ref): No dosage adjustment necessary (Ref).CRRT: Dialyzed (Ref): No dosage adjustment necessary (Ref).PIRRT (eg, sustained, low-efficiency diafiltration): No dosage adjustment necessary (Ref).Dosing: Hepatic Impairment: AdultOral: Use with caution and consider dosage adjustment or avoiding use, depending on degree of hepatic impairment and other patient-specific factors. Although limited data exist, low-dose therapy (maximum: ≤2 to 3 g/day) is usually well tolerated in patients with chronic liver disease or cirrhosis, provided patients are not actively drinking alcohol; however, the presence of other factors increasing the risk of acetaminophen-induced hepatoxicity (eg, malnutrition, fasting, low body weight, advanced age, febrile illness, concurrent use of drugs that interact with acetaminophen metabolism) must also be taken into consideration (Ref). Some experts would limit the maximum dose to ≤2 g/day in any patient with advanced chronic liver disease or cirrhosis (provided the patient is not actively drinking alcohol) and would avoid use in any patient with severe alcoholic hepatitis or acute liver injury. Avoiding use is also recommended by some experts in patients with advanced chronic liver disease or cirrhosis who are actively drinking alcohol, malnourished, not eating, or receiving a concomitant interacting medication. For short-term or one-time use, a maximum of ≤4 g/day may be considered in lower risk patients with chronic liver disease or early-stage compensated cirrhosis who are not actively drinking alcohol (Ref).IV:Mild to moderate impairment: There are no dosage adjustments provided in the manufacturer's labeling. Use with caution; a reduced total daily dosage may be warranted.Severe impairment: Use is contraindicated.Dosage Forms: USExcipient information presented when available (limited, particularly for generics); consult specific product labeling.[DSC] = Discontinued productCapsule, Oral: Mapap: 500 mg [aspirin free; contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]Tylenol: 325 mg [aspirin free; contains fd&c red #40 (allura red ac dye), soybeans (glycine soja)]Elixir, Oral: Apra: 160 mg/5 mL (120 mL, 240 mL, 480 mL, 3840 mL) [contains alcohol, usp]Pain Relief Childrens: 160 mg/5 mL (118 mL, 237 mL, 473 mL) [alcohol free, aspirin free; contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), saccharin sodium, sodium benzoate, sorbitol]Generic: 160 mg/5 mL (473 mL [DSC])Gel, Oral: ElixSure Fever/Pain: 160 mg/5 mL (120 mL) [alcohol free, aspirin free; contains butylparaben, carbomer 934p, polyethylene glycol (macrogol); bubble-gum flavor]ElixSure Fever/Pain: 160 mg/5 mL (120 mL) [alcohol free, aspirin free; contains butylparaben, carbomer 934p, polyethylene glycol (macrogol); cherry flavor]ElixSure Fever/Pain: 160 mg/5 mL (120 mL) [alcohol free, aspirin free; contains butylparaben, carbomer 934p, polyethylene glycol (macrogol); grape flavor]Liquid, Oral: Acetaminophen Extra Strength: 500 mg/15 mL (237 mL [DSC]) [alcohol free, aspirin free; contains fd&c blue #1 (brilliant blue), polyethylene glycol (macrogol), quinoline yellow (d&c yellow #10), saccharin sodium, sodium benzoate]Childrens Silapap: 160 mg/5 mL (118 mL, 237 mL, 473 mL) [alcohol free, sugar free; contains fd&c red #40 (allura red ac dye), methylparaben, propylene glycol, saccharin sodium, sodium benzoate; cherry flavor]Ed-APAP: 160 mg/5 mL (236 mL) [alcohol free; contains fd&c red #40 (allura red ac dye), saccharin sodium, sodium benzoate; cherry flavor]Liquid Pain Relief: 160 mg/5 mL (473 mL [DSC]) [contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), saccharin sodium, sodium benzoate; cherry flavor]Liquid Pain Relief: 160 mg/5 mL (473 mL) [alcohol free, aspirin free; contains fd&c red #40 (allura red ac dye), methylparaben, polyethylene glycol (macrogol), propylene glycol, propylparaben]M-PAP: 160 mg/5 mL (120 mL, 473 mL) [alcohol free, aspirin free, sugar free; contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), saccharin sodium, sodium benzoate; cherry flavor]Mapap: 160 mg/5 mL (118 mL [DSC], 473 mL [DSC]) [alcohol free, aspirin free; contains benzoic acid, fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, sodium benzoate]Mapap Acetaminophen Extra Str: 500 mg/15 mL (237 mL) [contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, saccharin sodium, sodium benzoate; cherry flavor]Pain Relief: 500 mg/15 mL (237 mL) [alcohol free, aspirin free; contains fd&c red #40 (allura red ac dye), methylparaben, polyethylene glycol (macrogol), propylene glycol, propylparaben]Generic: 160 mg/5 mL (118 mL, 473 mL)Packet, Oral: Tylenol Childrens Pain + Fever: 160 mg (18 ea, 30 ea) [aspirin free, ibuprofen free; wild berry flavor]Tylenol Dissolve Packs: 500 mg (12 ea, 32 ea) [berry flavor]Solution, Intravenous: Generic: 10 mg/mL (50 mL, 100 mL); 1000 mg/100 mL (100 mL)Solution, Intravenous [preservative free]: Ofirmev: 10 mg/mL (100 mL [DSC])Generic: 10 mg/mL (100 mL)Solution, Oral: Pain & Fever Childrens: 160 mg/5 mL (118 mL [DSC], 473 mL [DSC]) [alcohol free, aspirin free, sugar free; contains fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, sodium benzoate]Generic: 160 mg/5 mL (5 mL, 10.15 mL, 20.3 mL, 118 mL, 473 mL); 325 mg/10.15 mL (10.15 mL); 650 mg/20.3 mL (20.3 mL)Suppository, Rectal: FeverAll Adults: 650 mg (50 ea) [contains polysorbate 80]FeverAll Childrens: 120 mg (6 ea, 50 ea) [contains polysorbate 80]FeverAll Infants: 80 mg (1 ea, 6 ea, 50 ea) [contains polysorbate 80]FeverAll Junior Strength: 325 mg (6 ea, 50 ea) [contains polysorbate 80]Suspension, Oral: Aurophen Childrens: 160 mg/5 mL (118 mL [DSC]) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate; cherry flavor]BetaTemp Childrens: 160 mg/5 mL (118 mL) [contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate]Childrens Acetaminophen: 160 mg/5 mL (5 mL) [alcohol free, aspirin free; contains butylparaben, fd&c red #40 (allura red ac dye), polysorbate 80, propylene glycol, sodium benzoate]Childrens Acetaminophen: 160 mg/5 mL (5 mL) [alcohol free, aspirin free; contains butylparaben, fd&c red #40 (allura red ac dye), polysorbate 80, propylene glycol, sodium benzoate; strawberry flavor]Childrens Non-Aspirin: 160 mg/5 mL (118 mL)GoodSense Pain & Fever Child: 160 mg/5 mL (118 mL) [alcohol free, aspirin free, dye free, gluten free, ibuprofen free; contains propylene glycol, propylparaben, sodium benzoate, sorbitol]GoodSense Pain & Fever Child: 160 mg/5 mL (118 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c blue #1 (brilliant blue), propylene glycol, sodium benzoate, sorbitol; grape flavor]GoodSense Pain & Fever Child: 160 mg/5 mL (118 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol]GoodSense Pain & Fever Child: 160 mg/5 mL (118 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol; cherry flavor]GoodSense Pain & Fever Infants: 160 mg/5 mL (30 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c blue #1 (brilliant blue), propylene glycol, sodium benzoate, sorbitol]GoodSense Pain & Fever Infants: 160 mg/5 mL (30 mL) [alcohol free, aspirin free, gluten free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol]Mapap Childrens: 160 mg/5 mL (118 mL [DSC]) [contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate]Nortemp: 160 mg/5 mL (118 mL [DSC]) [alcohol free, aspirin free; contains butylparaben, fd&c red #40 (allura red ac dye), polysorbate 80, propylene glycol, sodium benzoate; cotton candy flavor]Nortemp Infants: 80 mg/0.8 mL (30 mL [DSC]) [alcohol free, aspirin free, sugar free; contains fd&c yellow #6 (sunset yellow), methylparaben, propylene glycol, saccharin sodium, sodium benzoate]Pain & Fever Childrens: 160 mg/5 mL (118 mL [DSC]) [alcohol free, aspirin free, dye free, gluten free, ibuprofen free; contains butylparaben, propylene glycol, sodium benzoate; cherry flavor]Pain & Fever Infants: 160 mg/5 mL (59 mL [DSC]) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol]Pain Relief Childrens: 160 mg/5 mL (118 mL) [cherry flavor]Panadol Childrens: 160 mg/5 mL (118 mL) [aspirin free, ibuprofen free; contains benzoic acid, fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, saccharin sodium; raspberry flavor]Panadol Infants: 160 mg/5 mL (54.7 mL) [aspirin free, ibuprofen free; contains benzoic acid, fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), propylene glycol, saccharin sodium; raspberry flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free; cherry flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, dye free, ibuprofen free]Tylenol Childrens: 160 mg/5 mL (120 mL, 240 mL) [alcohol free, aspirin free, dye free, ibuprofen free; cherry flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate; strawberry flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; contains fd&c blue #1 (brilliant blue), sodium benzoate; grape flavor]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; contains fd&c red #40 (allura red ac dye), sodium benzoate]Tylenol Childrens: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; contains sodium benzoate, sorbitol; grape flavor]Tylenol Childrens Pain + Fever: 160 mg/5 mL (120 mL) [alcohol free, aspirin free, ibuprofen free; bubble-gum flavor]Tylenol for Children + Adults: 160 mg/5 mL (240 mL) [alcohol free, aspirin free, dye free, ibuprofen free, paraben free; cherry flavor]Tylenol Infants Pain+Fever: 160 mg/5 mL (60 mL) [alcohol free, aspirin free, dye free, ibuprofen free]Tylenol Infants Pain+Fever: 160 mg/5 mL (30 mL) [alcohol free, aspirin free, dye free, ibuprofen free; cherry flavor]Tylenol Infants Pain+Fever: 160 mg/5 mL (60 mL) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c blue #1 (brilliant blue), propylene glycol, sodium benzoate, sorbitol]Tylenol Infants Pain+Fever: 160 mg/5 mL (30 mL) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c blue #1 (brilliant blue), propylene glycol, sodium benzoate, sorbitol; grape flavor]Tylenol Infants Pain+Fever: 160 mg/5 mL (60 mL) [alcohol free, aspirin free, ibuprofen free; contains butylparaben, fd&c red #40 (allura red ac dye), propylene glycol, sodium benzoate, sorbitol; cherry flavor]Generic: 160 mg/5 mL (5 mL, 10.15 mL, 20.3 mL, 59 mL, 118 mL); 650 mg/20.3 mL (20.3 mL)Syrup, Oral: Triaminic Fever Reducer: 160 mg/5 mL (59 mL, 118 mL) [alcohol free, aspirin free, ibuprofen free; contains benzoic acid, edetate (edta) disodium, fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol); bubble-gum flavor]Triaminic Fever Reducer: 160 mg/5 mL (59 mL, 118 mL) [alcohol free, aspirin free, ibuprofen free; contains edetate (edta) disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), polyethylene glycol (macrogol), sodium benzoate; grape flavor]Tablet, Oral: Acetaminophen Extra Strength: 500 mgAcetaminophen Extra Strength: 500 mg [scored]Acetaminophen Extra Strength: 500 mg [contains corn starch]Acetaminophen Extra Strength: 500 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]Acetaminophen Extra Strength: 500 mg [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]Acetaminophen Extra Strength: 500 mg [aspirin free]Acetaminophen Extra Strength: 500 mg [scored; aspirin free]Acetaminophen Extra Strength: 500 mg [aspirin free; contains corn starch]Acetaminophen Extra Strength: 500 mg [aspirin free, sodium free]Aminofen: 500 mg [DSC]Aminofen: 325 mg [DSC] [antihistamine free, caffeine free, salt free, sugar free]GoodSense Pain Relief Extra St: 500 mg [contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), fd&c yellow #6 (sunset yellow)]GoodSense Pain Relief Extra St: 500 mg [DSC] [gluten free; contains corn starch, edetate (edta) disodium, fd&c red #40(allura red ac)aluminum lake, quinoline (d&c yellow #10) aluminum lake]GoodSense Pain Relief Extra St: 500 mg [gluten free; contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]Healthy Mama Shake That Ache: 500 mgMapap: 325 mg [DSC], 500 mg [DSC]Non-Aspirin: 325 mgNon-Aspirin: 325 mg, 500 mg [contains corn starch]Non-Aspirin Extra Strength: 500 mgNon-Aspirin Pain Reliever: 325 mg [DSC] [contains methylparaben, propylparaben]Pain & Fever: 325 mg [DSC]Pain & Fever Extra Strength: 500 mg [DSC]Pain Relief Extra Strength: 500 mgPain Relief Extra Strength: 500 mg [contains corn starch]Pain Relief Extra Strength: 500 mg [DSC] [contains methylparaben, propylparaben]Pain Relief Extra Strength: 500 mg [aspirin free]Pain Relief Extra Strength: 500 mg [aspirin free; contains fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye)]Pain Relief Regular Strength: 325 mg [contains methylparaben, propylparaben]Panadol Extra Strength: 500 mg [contains fd&c blue #1 (brill blue) aluminum lake, fd&c red #40(allura red ac)aluminum lake, quinoline (d&c yellow #10) aluminum lake]Pharbetol: 325 mgPharbetol Extra Strength: 500 mg [aspirin free]Tactinal: 325 mg [DSC] [scored/varied; aspirin free]Tactinal Extra Strength: 500 mg [DSC] [aspirin free]Tylenol: 325 mg [scored]Tylenol: 325 mg [contains corn starch, fd&c red #40(allura red ac)aluminum lake]Tylenol: 325 mg [DSC] [contains fd&c red #40(allura red ac)aluminum lake]Tylenol Extra Strength: 500 mgTylenol Extra Strength: 500 mg [contains butylparaben, edetate (edta) calcium disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), methylparaben, polysorbate 80, propylparaben, quinoline yellow (d&c yellow #10)]Tylenol Extra Strength: 500 mg [contains butylparaben, edetate (edta) calcium disodium, fd&c blue #1 (brilliant blue), fd&c red #40 (allura red ac dye), methylparaben, propylparaben, quinoline yellow (d&c yellow #10)]Tylenol Extra Strength: 500 mg [contains corn starch, fd&c red #40(allura red ac)aluminum lake]Tylenol Extra Strength: 500 mg [contains fd&c red #40(allura red ac)aluminum lake]Tylenol Extra Strength: 500 mg [contains fd&c red #40(allura red ac)aluminum lake, fd&c yellow #6(sunset yellow)alumin lake]Generic: 325 mg, 500 mgTablet Chewable, Oral: Childrens APAP: 80 mg [scored; contains aspartame, fd&c yellow #6(sunset yellow)alumin lake; fruit flavor]Childrens Non-Aspirin: 80 mgChildrens Tactinal: 80 mg [DSC] [aspirin free, ibuprofen free]Mapap Childrens: 80 mg [aspirin free, ibuprofen free; contains fd&c blue #1 (brill blue) aluminum lake; grape flavor]Mapap Childrens: 160 mg [scored; aspirin free, ibuprofen free; bubble-gum flavor]7T Gummy ES: 500 mg [DSC] [aspirin free, ibuprofen free]Tylenol Childrens Chewables: 160 mg [aspirin free, ibuprofen free]Tylenol Childrens Chewables: 160 mg [aspirin free, ibuprofen free; contains fd&c blue #1 (brilliant blue)]Generic: 160 mg, 325 mg [DSC]Tablet Extended Release, Oral: 8 Hour Pain Reliever: 650 mgAcetaminophen 8 Hour: 650 mg [aspirin free; contains corn starch]Arthritis Pain Relief: 650 mgGoodSense Pain Relief: 650 mg [DSC] [contains fd&c red #40(allura red ac)aluminum lake]Mapap Arthritis Pain: 650 mg [gluten free]Tylenol 8 Hour: 650 mgTylenol 8 Hour Arthritis Pain: 650 mgGeneric: 650 mgGeneric Equivalent Available: USMay be product dependentDosage Forms: CanadaExcipient information presented when available (limited, particularly for generics); consult specific product labeling.Solution, Intravenous: Generic: 10 mg/mL (100 mL)Administration: PediatricOral: Administer with food to decrease GI upset; shake drops and suspension well before use; do not crush or chew extended-release products.Parenteral: For IV infusion only. May administer undiluted over 15 minutes per the manufacturer. In neonatal patients, infusion of undiluted and diluted solutions over 15 to 30 minutes has been reported (Ref). Use within 6 hours of opening vial or transferring to another container. Discard any unused portion; single-use vials only.Rectal: Remove wrapper; insert suppository well up into the rectum.Administration: AdultOral: May administer without regard to food; may administer with food to decrease possible GI upset; shake drops and suspension well before use; do not crush or chew ER products.Bariatric surgery: Caplet and tablet, extended release: Some institutions may have specific protocols that conflict with these recommendations; refer to institutional protocols as appropriate. Switch to IR formulation (tablet or adult strength liquid). Avoid children's liquid formulation due to sugar content and volume needed to achieve adult doses.Injection: For IV infusion only. Administer undiluted over 15 minutes. Attach an administration set in accordance with the manufacturer’s recommendations; may vary by product. If dose to be administered (eg, 650 mg) is not equivalent to an available formulation (eg, 500 mg per 50 mL or 1,000 mg per 100 mL) then withdraw appropriate dose and place into separate empty, sterile container (eg, glass bottle, plastic IV container, syringe) for administration.Rectal: Remove wrapper; insert suppository well up into the rectum.Storage/StabilityInjection: Store intact vials and bags at 20°C to 25°C (68°F to 77°F); do not refrigerate or freeze. Some products must be protected from light (eg, B. Braun PAB container); refer to manufacturer’s labeling for product-specific details. Nonintact (in use) storage time varies by product (eg, use immediately [B. Braun PAB container] or within 6 hours [Ofirmev]; refer to manufacturer’s labeling for product-specific details). Discard any unused portion.Oral formulations: Store at 20°C to 25°C (68°F to 77°F); avoid excessive heat (40°C [104°F]). Avoid high humidity (chewable tablets).Suppositories: Store at 2°C to 27°C (25°F to 80°F); do not freeze.UseOral:Immediate release:Oral suspension, chewable tablets: Relief of minor aches and pains due to the common cold, flu, sore throat, headaches, and toothaches; reduction of fever (All indications: OTC products: FDA approved in infants and children <12 years; consult specific product formulations for appropriate age groups).Caplet/tablet: Relief of minor aches and pains due to the common cold, headaches, minor pain of arthritis, backache, menstrual cramps, muscle aches, and toothaches (All indications: OTC products: FDA approved in ages ≥6 years and adults; consult specific product formulation for appropriate age group).Extended release: Relief of minor aches and pains due to the common cold, headaches, backache, muscle aches, menstrual cramps, toothaches, and minor pain of arthritis; reduction of fever (All indications: OTC products: FDA approved in ages ≥12 or 18 years and adults; consult specific product formulations for appropriate age groups).Parenteral: Reduction of fever (FDA approved in pediatric patients [age not specified] and adults); treatment of mild to moderate pain (FDA approved in ages ≥2 years and adults); treatment of moderate to severe pain when combined with opioid analgesia (FDA approved in ages ≥2 years and adults).Rectal: Relief of minor aches, pains, and headaches; reduction of fever (All indications: OTC products: FDA approved in ages ≥6 months and adults; consult specific product formulation for appropriate age group); has also been used for management of postoperative pain.Medication Safety IssuesSound-alike/look-alike issues: Acephen may be confused with AcipHexAcetaminophen may be confused with acetazolamideFeverALL may be confused with Fiberall Triaminic Children's Fever Reducer Pain Reliever may be confused with Triaminic cough and cold productsTylenol may be confused with atenolol, timolol, Tylenol PM, TyloxInfusion bottles of ropivacaine and IV acetaminophen look similar. Potentially fatal mix-ups have been reported in which a glass bottle of Naropin was mistaken for Ofirmev in perioperative areas.Other safety concerns:Duplicate therapy issues: This product contains acetaminophen, which may be a component of combination products. Do not exceed the maximum recommended daily dose of acetaminophen.Infant concentration change: All children’s and infant acetaminophen products are available as 160 mg/5 mL. Some remaining infant concentrated solutions of 80 mg/0.8 mL and 100 mg/mL may still be available on pharmacy shelves or in patient homes. Check concentrations closely prior to administering or dispensing and verify concentration available to patients prior to recommending a dose (November 2011).Injection: Reports of 10-fold overdose errors using the parenteral product have occurred in the U.S. and Europe; calculation of doses in "mg" and subsequent administration of the dose in "mL" using the commercially available concentration of 10 mg/mL contributed to these errors. Expressing doses as mg and mL, as well as pharmacy preparation of doses,may decrease error potential (Dart, 2012; ISMP, 2012).International issues:Depon [Greece] may be confused with Depen brand name for penicillamine [US]; Depin brand name fornifedipine [India]; Dipen brand name for diltiazem [Greece]Duorol [Spain] may be confused with Diuril brand name for chlorothiazide [US, Canada] Paralen [Czech Republic] may be confused with Aralen brand name for chloroquine [US, Mexico]Adverse Reactions (Significant): ConsiderationsHepatotoxicityAcute hepatotoxicity may result from intentional or unintentional overdose in adult and pediatric patients. In pediatric patients, unintentional overdose can be a result of accidental ingestion, supratherapeutic dosing, more frequent administration than recommended, and use of multiple acetaminophen-containing products; hepatotoxicity has also been rarely reported with recommended dosages (Ref).Spontaneous resolution occurs with or without treatment in ~65% of cases, although some cases may progress to acute liver failure leading to liver transplantation or death (Ref); a mortality of ~0.4% has been reported (Ref). Acetaminophen is one of the most commonly reported products causing drug-induced liver injury (Ref), with ~50% of cases of acute hepatic failure in the US attributed to acetaminophen (Ref). Minor increased alanine aminotransferase (ALT) and increased aspartate aminotransferase (AST) may occur during chronic acetaminophen therapy that are rarely symptomatic; resolution generally occurs with discontinuation or dose reduction, but may also occur with continuation of the same dose (Ref).Mechanism: Dose-related; direct toxic effect through formation of toxic metabolite, N-acetyl-p-benzoquinoneimine (NAPQI) that binds to cellular proteins, including mitochondrial proteins. Toxic free radicals, including peroxynitrite, may also cause damage inside the mitochondria (Ref).Onset: Rapid; usually starts 24 to 72 hours after ingestion with marked elevations in serum ALT and AST, followed at 48 to 96 hours by clinical symptoms (Ref).Risk factors:• Dose:ο Pediatric: Toxicity is likely to occur with single ingestions >150 mg/kg or when the maximum daily acetaminophen dose is >75 mg/kg/day (maximum of 5 daily doses) up to 4,000 mg/day from all sources (Ref).ο Adult: Toxicity is likely to occur with single ingestions >250 mg/kg or >12,000 mg over a 24-hour period (Ref). Asymptomatic elevation of ALT may occur following maximal therapeutic doses of acetaminophen (4,000 mg/day) for ≥4 days (Ref).• Multiple acetaminophen-containing products: An unintentional overdose may occur in adult and pediatric patients who take multiple acetaminophen or acetaminophen-containing combination products (Ref).• Chronic alcohol ingestion: Chronic alcoholics who take therapeutic doses of acetaminophen are NOT at an increased risk of hepatotoxicity (Ref). In contrast, chronic alcoholics who ingest repeated supratherapeutic doses of acetaminophen are at an increased risk for hepatotoxicity (Ref).• Concomitant medications and herbal products: Although use of products that induce CYP2E1 enzymes (eg, carbamazepine, phenobarbital, phenytoin, isoniazid, rifampin) have been postulated to predispose to acetaminophen hepatotoxicity by enhanced production of NAPQI, there is little evidence, aside from case reports, that drug interactions increase the risk of liver injury (Ref).• Nutritional status: Malnutrition and fasting may increase the risk (Ref)• Age: Pediatric patients are less susceptible, whereas elderly patients are at a higher risk (Ref)• Delay to treatment with N-acetylcysteine (NAC): Most patients with acetaminophen overdose who receive treatment with NAC within 8 hours of ingestion will not develop hepatotoxicity (Ref)Adverse ReactionsThe following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.Oral, Rectal: Frequency not defined:Dermatologic: Erythema of skin, skin blister, skin rashOtic: Hearing lossIV: >10%: Gastrointestinal: Nausea (adults: 34%; neonates, infants, children, and adolescents: ≥5%), vomiting (adults: 15%; neonates, infants, children, and adolescents: ≥5%)1% to 10%:Cardiovascular: Hypertension, hypotension, peripheral edema (adults)Dermatologic: Pruritus (neonates, infants, children, and adolescents: ≥5%)Endocrine & metabolic: Hypoalbuminemia (neonates, infants, children, and adolescents), hypokalemia, hypomagnesemia (neonates, infants, children, and adolescents), hypophosphatemia (neonates, infants, children, and adolescents)Gastrointestinal: Constipation (neonates, infants, children, and adolescents: ≥5%), diarrhea (neonates, infants, children, and adolescents)Genitourinary: Oliguria (neonates, infants, children, and adolescents)Hematologic & oncologic: AnemiaHepatic: Increased serum aspartate aminotransferase (Watkins 2006)Local: Infusion-site pain, pain at injection siteNervous system: Agitation (neonates, infants, children, and adolescents), anxiety (adults), fatigue (adults), headache, insomnia (adults: 7%), trismus (adults)Neuromuscular & skeletal: Muscle spasm (≥1%)Respiratory: Abnormal breath sounds (adults), atelectasis (neonates, infants, children, and adolescents), dyspnea (adults), pleural effusion (neonates, infants, children, and adolescents), pulmonary edema (neonates, infants, children, and adolescents), stridor (adults), wheezing (adults)Postmarketing (all formulations):Dermatologic: Acute generalized exanthematous pustulosis (FDA 2016), Stevens-Johnson syndrome (FDA 2016), toxic epidermal necrolysis (Watanabe 2016; FDA 2016)Hepatic: Acute hepatic failure, hepatotoxicity (Ramachandran 2019, Yoon 2016), increased serum alanine aminotransferase (Watkins 2006)Hypersensitivity: Anaphylaxis (Ho 2008, Numata 2016), hypersensitivity reaction (Thomspon 2019)ContraindicationsInjection: Hypersensitivity to acetaminophen or any component of the formulation; severe hepatic impairment or severe active liver diseaseOTC labeling: When used for self-medication, do not use with other drug products containing acetaminophen or if allergic to acetaminophen or any of the inactive ingredientsWarnings/PrecautionsDisease-related concerns:• G6PD deficiency: Use with caution in patients with known G6PD deficiency.• Hepatic impairment: Use with caution in patients with hepatic impairment or active liver disease; use of the IV formulation is contraindicated in patients with severe hepatic impairment or severe active liver disease.• Hypovolemia: Use the IV formulation with caution in patients with severe hypovolemia (eg, due to dehydration or blood loss).Dosage form specific issues:• Aspartame: Some products may contain aspartame, which is metabolized to phenylalanine and must be avoided (or used with caution) in patients with phenylketonuria.• Benzyl alcohol and derivatives: Some dosage forms may contain benzyl alcohol and/or sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol and/or benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.• Polysorbate 80: Some dosage forms may contain polysorbate 80 (also known as Tweens). Hypersensitivity reactions, usually a delayed reaction, have been reported following exposure to pharmaceutical products containing polysorbate 80 in certain individuals (Isaksson 2002; Lucente 2000; Shelley 1995). Thrombocytopenia, ascites, pulmonary deterioration, and renal and hepatic failure have been reported in premature neonates after receiving parenteral products containing polysorbate 80 (Alade 1986; CDC 1984). See manufacturer's labeling.• Propylene glycol: Some dosage forms may contain propylene glycol; large amounts are potentially toxic and have been associated hyperosmolality, lactic acidosis, seizures and respiratory depression; use caution (AAP ["Inactive" 1997]; Zar 2007).Other warnings/precautions:• Dosage limit: Limit acetaminophen dose from all sources (prescription, OTC, combination products) and all routes of administration (IV, oral, rectal) to <4 g/day (adults).• Self-medication (OTC use): When used for self-medication, patients should be instructed to contact health care provider if symptoms get worse or new symptoms appear, redness or swelling is present in the painful area, fever lasts >3 days (all ages), or pain (excluding sore throat) lasts longer than: Children ≥12 years, Adolescents, and Adults: 10 days; Infants and Children <12 years: 5 days. When treating children with sore throat, if sore throat is severe, persists for >2 days, or is followed by fever, rash, headache, nausea, or vomiting, consult health care provider immediately.Warnings: Additional Pediatric ConsiderationsProphylactic use of acetaminophen to reduce fever and discomfort associated with vaccination is not recommended by the Advisory Committee on Immunization Practices (ACIP). Additionally, the ACIP does not recommend prophylactic acetaminophen to reduce risk of febrile seizure in infants and children with or without a history of febrile seizures. Antipyretics have not been shown to prevent febrile seizures (NCIRD/ACIP 2011). One study reported that routine prophylactic administration of acetaminophen to prevent fever prior to vaccination decreased the immune response of some vaccines; in the trial evaluating 459 infants (including 226 who received acetaminophen), antibody geometric mean concentrations (GMCs) for targeted vaccine immune response markers were lower in significantly more infants in the acetaminophen group compared with control. Before the booster dose, children who received prophylactic acetaminophen had lower antibody GMCs for all vaccine serotypes than children in the control group; this effect persisted after boosting even in the absence of additional acetaminophen doses. The clinical significance of this reduction in immune response has not been established (Prymula 2009). Antipyretics may be used to treat fever or discomfort following vaccination (NCIRD/ACIP 2011).Some dosage forms may contain propylene glycol; in neonates, large amounts of propylene glycol delivered orally, intravenously (eg, >3,000 mg/day), or topically have been associated with potentially fatal toxicities which can include metabolic acidosis, seizures, renal failure, and CNS depression; toxicities have also been reported in children and adults including hyperosmolality, lactic acidosis, seizures, and respiratory depression; use caution (AAP 1997; Shehab 2009).Metabolism/Transport EffectsSubstrate of CYP1A2 (minor), CYP2A6 (minor), CYP2C9 (minor), CYP2D6 (minor), CYP2E1 (major), CYP3A4 (minor), UGT1A1, UGT1A6, UGT1A9, UGT2B15; Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potentialDrug InteractionsNote: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed).For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions programAlcohol (Ethyl): May enhance the hepatotoxic effect of Acetaminophen. Risk C: Monitor therapyBusulfan: Acetaminophen may increase the serum concentration of Busulfan.Risk C: Monitor therapyCarBAMazepine: May increase the metabolism of Acetaminophen. This may 1) diminish the effect of acetaminophen; and 2) increase the risk of liver damage. Risk C: Monitor therapyDapsone (Topical): May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Risk C: Monitor therapyDasatinib: Acetaminophen may enhance the hepatotoxic effect of Dasatinib. Dasatinib may increase the serum concentration of Acetaminophen.Management: Avoid coadministration of acetaminophen and dasatinib if possible. If coadministration is unavoidable, monitor for signs/symptoms of hepatotoxicity, particularly in patients with greater acetaminophen exposure. Risk D: Consider therapy modificationFlucloxacillin: May enhance the adverse/toxic effect of Acetaminophen. Specifically, the risk for high anion gap metabolic acidosis may be increased. Risk C: Monitor therapyFosphenytoin-Phenytoin: May decrease the serum concentration of Acetaminophen. Specifically, serum concentrations of acetaminophen may be decreased (leading to decreased efficacy), but the formation of the toxic N-acetyl-p-benzoquinone imine (NAPQI) metabolite may be increased (leading to increased hepatotoxicity). Risk C: Monitor therapyImatinib: Acetaminophen may enhance the hepatotoxic effect of Imatinib.Risk C: Monitor therapyImmune Checkpoint Inhibitors: Acetaminophen may diminish the therapeutic effect of Immune Checkpoint Inhibitors.Risk C: Monitor therapyIsoniazid: May enhance the hepatotoxic effect of Acetaminophen. Isoniazid may increase the metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor therapyLamoTRIgine: Acetaminophen may decrease the serum concentration of LamoTRIgine.Risk C: Monitor therapyLocal Anesthetics: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Local Anesthetics. Specifically, the risk for methemoglobinemia may be increased.Risk C: Monitor therapyLorlatinib: May decrease the serum concentration of Acetaminophen. Risk C: Monitor therapyMetyraPONE: May increase the serum concentration of Acetaminophen. More importantly, by inhibiting the conjugative metabolism of acetaminophen, metyrapone may shift the metabolism towards the oxidative route that produces a hepatotoxic metabolite. Risk X: Avoid combinationMipomersen: Acetaminophen may enhance the hepatotoxic effect of Mipomersen.Risk C: Monitor therapyMitapivat: May decrease the serum concentration of UGT1A1 Substrates. Risk C: Monitor therapyNitric Oxide: May enhance the adverse/toxic effect of Methemoglobinemia Associated Agents. Combinations of these agents may increase the likelihood of significant methemoglobinemia. Risk C: Monitor therapyPHENobarbital: May increase the metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor therapyPhenylephrine (Systemic): Acetaminophen may increase the serum concentration of Phenylephrine (Systemic).Risk C: Monitor therapyPrilocaine: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Prilocaine. Combinations of these agents may increase the likelihood of significant methemoglobinemia.Management: Monitor patients for signs of methemoglobinemia (e.g., hypoxia, cyanosis) when prilocaine is used in combination with other agents associated with development of methemoglobinemia.Avoid lidocaine/prilocaine in infants receiving such agents. Risk C: Monitor therapyPrimidone: May increase the metabolism of Acetaminophen. Specifically, formation of the hepatotoxic NAPQI metabolite may be increased. Risk C: Monitor therapyProbenecid: May increase the serum concentration of Acetaminophen. Probenecid may also limit the formation of at least one major non-toxic metabolite, possibly increasing the potential for formation of the toxic NAPQI metabolite. Management: Consider limiting acetaminophen use in combination with probenecid. Probenecid may reduce clearance of acetaminophen to one of its non-toxic metabolities, increasing the risk for acetaminophen toxicity, even a lower doses. Risk D: Consider therapy modificationRifAMPin: May enhance the hepatotoxic effect of Acetaminophen. RifAMPin may decrease the serum concentration of Acetaminophen. Risk C: Monitor therapySodium Nitrite: Methemoglobinemia Associated Agents may enhance the adverse/toxic effect of Sodium Nitrite. Combinations of these agents may increase the likelihood of significant methemoglobinemia.Risk C: Monitor therapySORAfenib: Acetaminophen may enhance the hepatotoxic effect of SORAfenib. SORAfenib may increase the serum concentration of Acetaminophen.Management: Avoid coadministration of acetaminophen and sorafenib if possible. If coadministration is unavoidable, monitor for signs/symptoms of hepatotoxicity, particularly in patients with greater acetaminophen exposure. Risk D: Consider therapy modificationVaccines: Acetaminophen may diminish the therapeutic effect of Vaccines.Management: Consider avoiding routine prophylactic use of acetaminophen before or during vaccine administration when possible. Acetaminophen is still recommended to treat fevers and/or pain that occurs after vaccination. Risk D: Consider therapy modificationVitamin K Antagonists (eg, warfarin): Acetaminophen may enhance the anticoagulant effect of Vitamin K Antagonists. This appears most likely with daily acetaminophen doses exceeding 1.3 or 2 g/day for multiple consecutive days.Risk C: Monitor therapyFood InteractionsRate of absorption may be decreased when given with food. Management: Administer without regard to food.Dietary ConsiderationsSome products may contain phenylalanine and/or sodium.Pregnancy ConsiderationsAcetaminophen crosses the placenta (Naga Rani 1989; Nitsche 2017; Towers 2018).Based on epidemiological data, an increased risk of major congenital malformations has not been observed following maternal use of acetaminophen during pregnancy. The use of acetaminophen in recommended doses during pregnancy has not been associated with an increased risk of miscarriage or still birth; however, an increase in fetal death or spontaneous abortion may be seen following maternal overdose if treatment is delayed (Li 2003; Rebordosa 2009; Riggs 1989). A possible association between prenatal constriction of the ductus arteriosus following maternal use during the third trimester has been investigated. Based on available data, an increased risk is not likely associated with short-term use of acetaminophen at recommended doses (Allegaert 2019; Dathe 2019; Hauben 2021; Hutson 2021). Additional adverse events such as wheezing and asthma in early childhood, adverse effects on male reproductive development, and adverse neurodevelopmental effects such as attention-deficit/hyperactivity disorder (ADHD) or autism spectrum disorder following in utero acetaminophen exposure have been evaluated in multiple studies; outcome data are inconclusive due to study limitations (variety of evaluation methods and/or indications for acetaminophen use, recall bias, etc), and causal associations have not been established (Kwok 2022; Lourido-Cebreiro 2017; Patel 2022; Scialli 2010; Singh 2021; SMFM 2017; Sznajder 2022; Tadokoro-Cuccaro 2022).Maternal fever is associated with adverse fetal outcomes, including neural tube defects, oral clefts, and congenital heart defects. Treatment of maternal fever with an antipyretic may reduce these risks (Dreier 2014).Due to pregnancy-induced physiologic changes, some pharmaco*kinetic properties of acetaminophen may be altered. Dose adjustments are not recommended (Brookhuis 2021; Kulo 2014).Acetaminophen is the preferred initial treatment for acute migraine headache in pregnant patients (ACOG 2022). Acetaminophen is considered appropriate for the treatment of pain and fever in pregnancy (SMFM 2017) and is recommended for the treatment of fever in pregnant patients diagnosed with influenza (ACOG 2018). Acetaminophen may be used as part of a multimodal approach to pain relief following cesarean delivery (ACOG 2019).Acetaminophen is recommended to be used at the lowest effective dose for the shortest duration of time to effectively treat the mother and protect the health of the fetus (Kilcoyne 2017).Monitoring ParametersLiver enzymes in patients with prolonged use or in populations with reduced hepatic function (eg, neonates). Monitor serum concentrations when acute overdose is suspected or with long-term use in patients with hepatic disease.Mechanism of ActionAlthough not fully elucidated, the analgesic effects are believed to be due to activation of descending serotonergic inhibitory pathways in the CNS. Interactions with other nociceptive systems may be involved as well (Smith 2009). Antipyresis is produced from inhibition of the hypothalamic heat-regulating center.Pharmaco*kinetics (Adult data unless noted)Onset of action:Oral: <1 hour.IV: Analgesia: 5 to 10 minutes; Antipyretic: Within 30 minutes.Peak effect: IV: Analgesic: 1 hour.Duration:IV, Oral: Analgesia: 4 to 6 hours.IV: Antipyretic: ≥6 hours.Absorption:Oral: Primarily absorbed in small intestine (rate of absorption dependent upon gastric emptying); minimal absorption from stomach; varies by dosage form. Absorption is delayed in neonates in the first few days of life (Anderson 2002).Rectal: Delayed and erratic absorption; varies by dosage form and age (Allegaert 2020).Distribution: Vd:Neonates and Infants <2 years: Vd: Median range: 0.85 to 0.95 L/kg (Hammer 2020); up to 1.5 L/kg has been reported in extremely premature neonates (Anderson 2002).Children: Vss: 1.2 ± 0.3 L/kg.Adolescents: Vss: 1.1 ± 0.3 L/kg.Adults: Vss: 0.8 ± 0.2 L/kg.Protein binding: 10% to 25% at therapeutic concentrations; 8% to 43% at toxic concentrations.Metabolism: At normal therapeutic dosages, primarily hepatic metabolism to sulfate and glucuronide conjugates, while a small amount is metabolized by CYP2E1 to a highly reactive intermediate, N-acetyl-p-benzoquinone imine (NAPQI), which is conjugated rapidly with glutathione and inactivated to nontoxic cysteine and mercapturic acid conjugates. At toxic doses (as little as 4 g daily), glutathione conjugation becomes insufficient to meet the metabolic demand causing an increase in NAPQI concentrations, which may cause hepatic cell necrosis. Neonates (especially preterm neonates) demonstrate higher sulfate metabolites and lower glucuronide metabolites compared to adults (Flint 2017). Oral administration is subject to first-pass metabolism.Bioavailability:Oral: Infants and Children <6 years: ~72% (range: 11% to 91%) (Kleiber 2019).Half-life elimination: Prolonged following toxic doses.Neonates (Van Lingen 1999):GA 28 to 32 weeks: 11 ± 5.7 hours (range: 3.5 to 25.2 hours).GA 32 to 36 weeks: 4.8 ± 1.2 hours (range: 3.6 to 6.8 hours).Infants and Children <2 years: Median range: 2.4 to 2.8 hours (range: 1.2 to 5.4 hours) (Zuppa 2011).Children 2 to <12 years: Median range: 2.6 to 2.8 hours (range: 2.2 to 4.9 hours) (Zuppa 2011).Adolescents: 2.9 ± 0.7 hours (manufacturer's labeling).Adults: 2.4 ± 0.6 hours (manufacturer's labeling); may be slightly prolonged in severe renal insufficiency (CrCl <30 mL/minute): 2 to 5.3 hours.Time to peak, serum:Oral: Immediate release: Adults: 10 to 60 minutes (may be delayed in acute overdoses).IV:Infants and Children <2 years: Median range: 0.25 to 0.29 hours (range: 0 to 1.4 hours) (Zuppa 2011).Children 2 to <12 years: Median range: 0.18 to 0.27 hours (range: 0 to 0.75 hours) (Zuppa 2011).Children ≥12 years and Adolescents: Median range: 0.25 to 0.33 hours (range: 0 to 0.4 hours) (Zuppa 2011).Adults: 15 minutes.Rectal:Neonates (van Lingen 1999):GA 28 to 32 weeks: Median: 3.9 hours.GA 32 to 36 weeks: Median: 5.1 hours.Infants and Children: 2.37 ± 1.1 hours (range: 0.43 to 5.26 hours) (Hahn 2000).Excretion: Urine (<5% unchanged; 60% to 80% as glucuronide metabolites; 20% to 30% as sulfate metabolites; ~8% cysteine and mercapturic acid metabolites).Pharmaco*kinetics: Additional ConsiderationsHepatic function impairment: The half-life may increase 2-fold or more in patients with liver disease.Additional Information2 mg propacetamol (prodrug) = 1 mg paracetamol = 1 mg acetaminophenAcetaminophen (15 mg/kg/dose given orally every 6 hours for 24 hours) did not relieve the intraoperative or the immediate postoperative pain associated with neonatal circumcision; some benefit was seen 6 hours after circumcision (Howard, 1994).There is currently no scientific evidence to support alternating acetaminophen with ibuprofen in the treatment of fever (Mayoral, 2000).Based on recommendations provided by the Food and Drug Administration (FDA), all over-the-counter (OTC) pediatric single-ingredient acetaminophen liquid products are now only available as a single concentration of 160 mg/5 mL; the transition began in 2011. The concentration 80 mg/0.8 mL is no longer available in the US. The recommended mg/kg dose is unaffected.Pricing: USCapsules (Tylenol Oral)325 mg (per each): $0.20Chewable (Acetaminophen Oral)160 mg (per each): $6.29Chewable (Mapap Childrens Oral)80 mg (per each): $0.08160 mg (per each): $0.09Chewable (Tylenol Childrens Chewables Oral)160 mg (per each): $0.29Gel (ElixSure Fever/Pain Oral)160 mg/5 mL (per mL): $0.04Liquid (Acetaminophen Oral)160 mg/5 mL (per mL): $0.06Liquid (Mapap Acetaminophen Extra Str Oral)500 mg/15 mL (per mL): $0.02Pack (Tylenol Childrens Pain + Fever Oral)160 mg (per each): $0.38Pack (Tylenol Dissolve Packs Oral)500 mg (per each): $0.36Solution (Acetaminophen Childrens Oral)160 mg/5 mL (per mL): $0.02Solution (Acetaminophen Intravenous)10 mg/mL (per mL): $0.09 - $0.45Solution (Acetaminophen Oral)160 mg/5 mL (per mL): $0.18 - $0.39Suppository (FeverAll Adults Rectal)650 mg (per each): $0.66Suppository (FeverAll Childrens Rectal)120 mg (per each): $0.80Suppository (FeverAll Infants Rectal)80 mg (per each): $0.80Suppository (FeverAll Junior Strength Rectal)325 mg (per each): $0.80Suspension (Acetaminophen Oral)160 mg/5 mL (per mL): $0.22Suspension (Panadol Childrens Oral)160 mg/5 mL (per mL): $0.05Suspension (Panadol Infants Oral)160 mg/5 mL (per mL): $0.08Suspension (Tylenol Childrens Oral)160 mg/5 mL (per mL): $0.06Suspension (Tylenol Childrens Pain + Fever Oral)160 mg/5 mL (per mL): $0.06Suspension (Tylenol for Children + Adults Oral)160 mg/5 mL (per mL): $0.05Suspension (Tylenol Infants Pain+Fever Oral)160 mg/5 mL (per mL): $0.16Syrup (Triaminic Fever Reducer Oral)160 mg/5 mL (per mL): $0.08Tablet, controlled release (Acetaminophen ER Oral)650 mg (per each): $0.07 - $0.10Tablet, controlled release (Tylenol 8 Hour Arthritis Pain Oral)650 mg (per each): $0.13Tablet, controlled release (Tylenol 8 Hour Oral)650 mg (per each): $0.18Tablets (Acetaminophen Oral)325 mg (per each): $0.01 - $0.06500 mg (per each): $0.02 - $0.08Tablets (Healthy Mama Shake That Ache Oral)500 mg (per each): $0.06Tablets (Panadol Extra Strength Oral)500 mg (per each): $0.14Tablets (Pharbetol Extra Strength Oral)500 mg (per each): $0.03Tablets (Pharbetol Oral)325 mg (per each): $0.02Tablets (Tylenol Extra Strength Oral)500 mg (per each): $0.12Tablets (Tylenol Oral)325 mg (per each): $0.05Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursem*nt or purchasing functions or considered to be an exact price for a single product and/or manufacturer.Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions.In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data.Pricing data is updated monthly.Brand Names: InternationalA-Mol (TH);Acamol (CL, IL, LI);Acamol To-Go (IL);Acamoli Baby (IL);Acamoli Forte suppositories for Kids (IL);Accelio (JP);Acemol (VN);ACET suppositories (SG);Acetab (VN);Acetalgan (EG);Acetalgin (CH);Acetamol (IT);Acicur-P (PY);Actimol (MY);Adinol (CR, DO, GT, HN, MX, NI, SV);Adol (BH, EG, ET, JO, KW, LB, QA, SA);Adolin (PA);Adorem (CO);Afebrin (HK);Afebryl (LU);Agap Fast (PL);Agomol (TZ);Alcocin (IN);Alginox (EC);Alvedon (SE);Amadol (AU);Ametrex (CO);Amol (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);Analgiser (AE, BH, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);Analphen (MX);Angela (TH);Antalgic (ZW);Antamol (JO);Apacet (LI);Apap (LI);Apimol (ZW);Aptamol (IN);Arfen (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, MY, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW);Atamel (PE);Avadol (MY);Axcel (MY);Ben-U-Ron (CH, PT);ben-u-ron (HU);Benuron (JP);Betamol (ZW);Biogesic (SG);Biogesic Suspension (HK);Biopain (PH);Blimol (UA);Calapol (ID);Calonal (JP);Calpol (AE, BF, BJ, CI, CY, EG, ET, GH, GM, GN, IE, IQ, IR, JO, JP, KE, KW, LB, LK, LR, LY, MA, ML, MR, MT, MU, MW, NE, NG, OM, PR, QA, SA, SC, SD, SI, SL, SN, SY, TN, TZ, UG, YE, ZM, ZW);Causalon (AR);Cemol (TH);Cetal (ET);Cetapain (ID);Cetapyrin (LK);Cetta (TH);Champ Syrup (KR);Children's Bufferin (CN);Children's S Tylenol (KR);Christamol (HK);Claradol (MA);Cotemp (TH);Croix Blanche (LU);Curpol (LU);Dafalgan (BE, LU);Dafalgan odis (LU);Dailyal (LV);Daleron (HR, SI);Demneq (NL);Den-U-Ron (CN);Denamol (TH);Depon (TR);Dirox (AR);Dismifen (MX);Dol-Stop (LU);Dolan Infantil (GT, HN, NI, SV);Dolex (UY);Dolgesic (ES);Doliprane (FR, IN, LB, MA);Dolitabs (FR);Dolomol (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);Dolorol (ZA);Dolprone (LU);Doluvital (MX);Dolviran (MX);Dumin (LK);Efermol (PY);Efferalgan (HR, HU, LT, LU, LV, UA);Efferalgan 500 (CR, DO, EE, GT, HN, NI, PA, SV);Efferalganodis (FR);Elgan (UA);Eneffa (BH);Enelfa (LU);Eterfix (ID);Europain (HK);Fast (BD);Fbridol (ET);Febridol (AU);Febrile Free (PH);Fervex (BR);Fevadol (BH, QA);Fibralgin (HR);Filanc (MX);Fortolin (CN, HK);Gelocatil (ES);Geluprane 500 (FR);Hapacol (MY);Hapacol Jr (MY);Hedex (IE);Hoemal (MY);Hoemal Junior (MY);Influgan (UA);Kelvin (ET, LK);Lekadol (HR);Lemgrip (BE, LU);Lonarid mono (LU);Lotemp (TH);Lupocet (HR);Maccabimol (IL);Mafidol (PE);Medipyrin (SK);Mejoralito Junior (MX);Mejoralito Pediátrico (MX);Meldol (ZW);Metagesic (PH);Mexalen (AT, CZ, HU);Minopan (KR);Momentum (LU);Mypara (TH);Napafen (EC);Napamol (ZA);Napaton (TW);Napran (PH);Naprex (ID);NEBS (JP);Neuridon (LU);Nordinet Infantil (MX);Normotemp (EC);Novadol (ZW);Nufadol (ID);Omnipap (PL);Omol (QA);Pacemol (KR);Padolieve (IE);Pamol (DK, JO, NZ);Pamol 650 (SG);Panadol (AE, AU, BE, BF, BG, BJ, CH, CI, CL, CN, CY, CZ, EE, EG, ES, ET, FI, FR, GB, GH, GM, GN, GR, HK, HU, ID, IE, IL, IQ, IR, IT, JO, KE, KR, KW, LB, LK, LR, LU, LV, LY, MA, ML, MR, MT, MU, MW, NE, NG, NL, NZ, OM, PE, PK, PL, PT, QA, RO, RU, SA, SC, SD, SG, SK, SL, SN, SY, TH, TN, TW, TZ, UA, UG, YE, ZM, ZW);Panadol Actifast (MY, SG);Panadol Extend (SG);Panadol for Children (SG);Panadon (HR);Panadrex (BH, ET);Panamax (AU);Panodil (DK, NO, SE);Para-IV (PH);Paracet (IS, NO, ZW);Paracetamol (HR);Paracetamol Pharmavit (HU);Paracetamol-ratiopharm (LU);Paracetol (LK);Paracil (MY);Paracip (LV);Paragin (TH);Paralgin (AU);Paralief (IE);Paramol (IL, LB, RO, TW);Paramol Kat Drops (IL);Parapaed (DE);Parapaed Junior (NZ);Parapaed Six Plus (NZ);Parapane (AU);Paratabs (IS);Parcemol (HK);Parcemol Forte (HK);Parmol (HK);Paromon (HK);Parvid (PH);Paximol (SG);Pe-Tam (LU);Pedipan (KR);Penral-Night (KR);Perdolan Mono (LU);Perfalgan (AE, AT, BG, BH, CH, CZ, DE, DK, EE, EG, ES, FI, FR, GB, GR, HR, IE, IL, IN, IS, IT, JO, KR, KW, LB, LT, MT, NZ, PL, PT, QA, RO, RU, SA, SE, SI, SK, TR, VN, ZA);Pharmacen-M (MX);Pinex (NO);Pireta (ID);Plicet (HR);Poro (ID, MY, PH, SG, TH);Portem (CR, DO, GT, HN, NI, PA, SV);Prest (NL);Progesic (HK);Raperon (KR);Rapidene (LK);Rapidol (CL);Reliv (SE);Remedol (MT, PR, TR);Revanin (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW);Rhinapen elixir (KR);Rubophen (HU);Salzone (BF, BJ, CI, ET, GH, GM, GN, KE, LR, MA, ML, MR, MU, MW, NE, NG, SC, SD, SL, SN, TN, TZ, UG, ZM, ZW);Sanmol (PH);Sanmol Infusion (ID);Saridon (CO);Sedalito (MX);Sedalmerck (CR, DO, GT, HN, NI, PA, SV);Selegesic (PH);Sensamol (IL);Setamol (HK);Setopain (KR);Setopain ER (KR);Sinebriv (PL);Sinedol (DO, MX);Strimol (ZW);Supadol mono (LU);Suspen ER (KR);Tafirol (PE);Tamin (TZ);Tamoliv (ID);Tasmen (KR);Tempol (MY);Tempra (ID, JP, LU, MX);Tempte (TW);Teramol (PH);Teramol Forte (PH);Tipol (IE);Toniker (TW);Turpan (ID);Tylenol (BR, CH, DE, JP, KR, MX, NL, PH, PT, QA, TH, VE);Tylenol 8-hour (TH);Tylenol Acetaminophen Extended Relief (CN);Tylenol ER (KR);Tylenol Extra Fuerte (PY);Tylenol Forte (AE, CY, EG, IQ, IR, JO, KW, LB, LY, OM, QA, SA, SY, YE);Tylex (BB, BM, BS, BZ, CR, DO, GT, GY, HN, JM, MX, NI, PA, SR, SV, TT);Umbral (EC);Winadol (CO, VE);Xcel (BD);Xebramol (TH);XL-Dol Infantil (MX);Z-Mol (PY)For country code abbreviations (show table)Acephen (acetaminophen suppositories) [prescribing information]. 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Eur J Clin Pharmacol. 1981;20(2):123-125. doi:10.1007/BF00607148 [PubMed 7262173]Böhler J, Donauer J, Keller F. Pharmaco*kinetic principles during continuous renal replacement therapy: drugs and dosage. Kidney Int Suppl. 1999;(72):S24-S288. [PubMed 10560800]Bosilkovska M, Walder B, Besson M, Daali Y, Desmeules J. Analgesics in patients with hepatic impairment: pharmacology and clinical implications. Drugs. 2012;72(12):1645-1669. [PubMed 22867045]Brindle ME, McDiarmid C, Short K, et al. Consensus guidelines for perioperative care in neonatal intestinal surgery: Enhanced Recovery After Surgery (ERAS) Society recommendations. World J Surg. 2020;44(8):2482-2492. doi:10.1007/s00268-020-05530-1 [PubMed 32385680]Brookhuis SAM, Allegaert K, Hanff LM, Lub-de Hooge MN, Dallmann A, Mian P. Modelling tools to characterize acetaminophen pharmaco*kinetics in the pregnant population. Pharmaceutics. 2021;13(8):1302. doi:10.3390/pharmaceutics13081302 [PubMed 34452263]Buck ML. 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Accessed August 12, 2021.Dang D, Wang D, Zhang C, Zhou W, Zhou Q, Wu H. Comparison of oral paracetamol versus ibuprofen in premature infants with patent ductus arteriosus: a randomized controlled trial. PLoS One. 2013;8(11):e77888. doi:10.1371/journal.pone.0077888 [PubMed 24223740]Dart RC, Bailey E. Does therapeutic use of acetaminophen cause acute liver failure? Pharmacotherapy. 2007;27(9):1219-1230. doi: 10.1592/phco.27.9.1219. [PubMed 17723075]Dart RC, Erdman AR, Olson KR, et al; American Association of Poison Control Centers. Acetaminophen poisoning: an evidence-based consensus guideline for out-of-hospital management. Clin Toxicol (Phila). 2006;44(1):1-18. doi:10.1080/15563650500394571 [PubMed 16496488]Dart RC, Rumack BH. Intravenous acetaminophen in the United States: iatrogenic dosing errors. Pediatrics. 2012;129(2):349-353. doi: 10.1542/peds.2011-2345 [PubMed 22271694]Dash SK, Kabra NS, Avasthi BS, Sharma SR, Padhi P, Ahmed J. 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