acetaminophen (OTC)

Brand and Other Names:Tylenol, Tylenol Arthritis Pain, more...Tylenol Ext, Little Fevers Children's Fever/Pain Reliever, Little Fevers Infant Fever/Pain Reliever, PediaCare Single Dose Acetaminophen Fever Reducer/Pain Reliever
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Dosing & Uses

AdultPediatric

Dosage Forms & Strengths

tablet

  • 325mg
  • 500mg

caplet

  • 325mg
  • 500mg
  • 650mg

capsule

  • 325mg
  • 500mg

caplet, extended-release

  • 650mg

tablet, oral-disintegrating

  • 80mg
  • 160mg

tablet chewable

  • 80mg

solution or suspension, oral

  • 160mg/5mL

liquid oral

  • 160mg/5mL
  • 500mg/5mL

syrup oral

  • 160mg/5mL

Analgesia & Fever

immediate-release

  • Regular strength: 325-650 mg PO/PR q4hr PRN; not to exceed 3250 mg/day; under supervision of healthcare professional, daily doses of up to 4 g/day may be used
  • Extra Strength: 1000 mg PO q6-8hr PRN; not to exceed 3000 mg/day; under supervision of healthcare professional, daily doses of up to 4 g/day may be used:

extended-release

  • 2 capsules (1300 mg) PO q8hr PRN; not to exceed 3.9 g/day

maximum dose

  • Acetaminophen containing products: Not to exceed a cumulative dose of 3.25 g/day of acetaminophen; under supervision of healthcare professional, daily doses of up to 4 g/day may be used
  • Tylenol Extra-Strength (ie, 500 mg/tab or cap): Not to exceed 3 g/day (6 tabs or caps); under supervision of healthcare professional, daily doses of up to 4 g/day may be used

Dosing Considerations

When calculating the maximum daily dose, consider all sources of acetaminophen, including OTC, and routes of administration not to exceed the maximum recommended daily dosing

Renal Impairment

GFR≥50 mL/min: No dosage adjustment necessary

GFR 10-50 mL/min: Administer q6hr

GFR<10mL/min: Administer q8hr

Continuous renal replacement therapy: Administer q6hr

Hepatic Impairment

Use extreme caution; avoid use as much as possible; limit therapy to short-term use at doses not to exceed 2 g/day

Dosage Forms & Strengths

tablet

  • 325mg
  • 500mg

caplet

  • 325mg
  • 500mg
  • 650mg

capsule

  • 325mg
  • 500mg

caplet, extended-release

  • 650mg

tablet, oral-disintegrating

  • 80mg
  • 160mg

tablet chewable

  • 80mg

solution or suspension, oral

  • 160mg/5mL

liquid oral

  • 160mg/5mL
  • 500mg/5mL

syrup oral

  • 160mg5mL

Pain & Fever Relief

Weight-based dosing

  • Oral solution
  • Neonates 28-31 weeks gestation: 10-15 mg/kg/dose PO q12hr prn; may administer an initial load of 20 mg/kg PO; not to exceed 40 mg/kg/day or 48 hr (consecutive) of maximum dose  
  • Neonates 32-37 weeks gestation: 10-15 mg/kg/dose PO q8hr prn; may administer an initial load of 20 mg/kg PO; not to exceed 60 mg/kg/day or 48 hr (consecutive) of maximum dose
  • Neonates 0-9 days: 10-15 mg/kg/dose PO q6-8hr prn; may administer an initial load of 20 mg/kg PO; not to exceed 60 mg/kg/day; or 48 hr (consecutive) of maximum dose
  • Neonates 10-29 days: 10-15 mg/kg/dose PO q4-8hr prn; may administer an initial load of 20 mg/kg PO; not to exceed 90 mg/kg/day; or 48 hr (consecutive) of maximum dose
  • Infants: 10-15 mg/kg/dose PO q4-6hr prn; not to exceed 15 mg/kg/dose or 75 mg/kg/day
  • Children and adolescents <60 kg: 10-15 mg/kg/dose PO q4-6hr prn; not to exceed 15 mg/kg/dose or 1,000 mg/dose, whichever is less or 75 mg/kg/day or 4,000 mg/day, whichever is less

Fixed dosing

  • <6 years: Ask a healthcare provider
  • 6-12 years: 325-650 mg PO q4-6hr; not to exceed 1.625 g/day for not more than 5 days unless directed by healthcare provider
  • >12 years
    • Regular strength: 325-650 mg q4-6hr; not to exceed 3.25 g/day; under supervision of healthcare professional, doses of up to 4 g/day may be used
    • Extra strength: 1000 mg q6hr; not to exceed 3 g/24hr; under supervision of healthcare professional, doses of up to 4 g/day may be used
    • Extended release: 1.3 g q8hr; not to exceed 3.9 g/24hr

Dosing Considerations

When calculating the maximum daily dose, consider all sources of acetaminophen, including OTC, and routes of administration not to exceed the maximum recommended daily dosing

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Interactions

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            Adverse Effects

            Frequency Not Defined

            Angioedema

            Disorientation

            Dizziness

            Pruritic maculopapular rash

            Rash

            Hyperammonemia

            Stevens-Johnson syndrome

            Toxic epidermal necrolysis

            Urticaria

            Gastrointestinal hemorrhage

            Laryngeal edema

            Agranulocytosis

            Leukopenia

            Neutropenia

            Pancytopenia

            Thrombocytopenia

            Thrombocytopenic purpura

            Hepatotoxicity

            Liver failure

            Nephrotoxicity

            Pneumonitis

            Anaphylactoid

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            Warnings

            Contraindications

            Hypersensitivity

            Severe active liver disease

            Cautions

            Hypersensitivity and anaphylactic reactions reported; discontinue immediately if symptoms of allergic or hypersensitivity reactions occur

            Acetaminophen is available in many dosage forms and products, check label carefully to avoid overdose

            Use caution in patients with hepatic impairment or active liver disease

            Risk of hepatotoxicity is higher in patients taking chronic high dose, or use of more than one acetaminophen-containing product

            Use caution in patients with severe renal impairment; consider dosage adjustments

            Consumption of 3 or more alcoholic drinks/day may increase risk of liver damage

            Use with caution in patients with G6PD deficiency

            Use caution in patients with chronic malnutrition

            Risk for rare, but serious skin reactions that can be fatal; these reactions include Stevens-Johnson Syndrome (SJS), toxic epidermal necrolysis (TEN), and acute generalized exanthematous pustulosis (AGEP); symptoms may include skin redness, blisters and rash

            Limit acetaminophen dose from all sources and routes to <4 g/day in adults

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            Pregnancy & Lactation

            Pregnancy

            Drug crosses placenta and can be detected in cord blood, newborn serum, and urine immediately after delivery

            Increased risk of teratogenic effects not reported following maternal use of drug during pregnancy

            Use of normal doses during pregnancy not associated with increased risk of miscarriage or still birth; however, increase in fetal death or spontaneous abortion may be seen with maternal overdose if treatment delayed

            Wheezing and asthma in early childhood associated with frequent maternal use of drug during pregnancy

            Lactation

            Drug is excreted in milk; in general, breastfeeding is generally acceptable if relative infant dose (RID) is <10%; avoid breastfeeding when RID>25%

            Pregnancy Categories

            A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA: Information not available.

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            Pharmacology

            Mechanism of Action

            Acts on hypothalamus to produce antipyresis

            May work peripherally to block pain impulse generation; may also inhibit prostaglandin synthesis in CNS

            Pharmacokinetics

            Peak Plasma Time: 10-60 min (PO immediate-release); 60-120 min (PO extended-release); 6 hr (PO 500 mg, conventional tablet); 8 hr (PO 650 mg, extended-release tablet)

            Peak Plasma Concentration: 2.1 mcg/mL (PO 500 mg, conventional tablet); 1.8 mcg/mL (PO 650 mg, extended-release tablet)

            Onset: 1 hr

            Distribution: 1 L/kg

            Protein Bound: 10 to 25%

            Metabolism: Liver (microsomal enzyme systems); conjugation (glucuronic/sulfuric acid)

            Metabolites: N-acetyl-p-benzoquinoneimine, N-acetylimidoquinone, NAPQI; further metabolized via conjugation with glutathione

            Half-life elimination: 1.25-3 hr (adolescents); 2-5 hr (children); 4 hr (infants); 7 hr (neonates); 2-3 hr (adults)

            Excretion: urine (principally as acetaminophen glucuronide with acetaminophen sulfate/mercaptate)

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            Medscape prescription drug monographs are based on FDA-approved labeling information, unless otherwise noted, combined with additional data derived from primary medical literature.