acetaminophen (Tylenol, Tylenol Arthritis Pain, Tylenol Ext, Little Fevers Children's Fever/Pain Reliever, Little Fevers Infant Fever/Pain Reliever, PediaCare Single Dose Acetaminophen Fever Reducer/Pain Reliever)
Classes: Analgesics, Other
Dosing and uses of Tylenol, Tylenol Infants' Drops (acetaminophen)
Adult dosage forms and strengths
tablet
- 325mg
- 500mg
caplet
- 325mg
- 500mg
- 650mg
capsule
- 500mg
gelcap/geltaB
- 500mg
caplet, extended-release
- 650mg
tablet, chewable
- 80mg
tablet, oral-disintegrating
- 80mg
- 160mg
oral solution/suspension
- 160mg/5mL
- 80mg/0.8mL (oral drops)
liquid oraL
- 500mg/5mL
- 160mg/15mL
- 500mg/15mL
syrup oraL
- 160mg5mL
elixir
- 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
Renal Impairment
Longer dosing intervals and reduced total dose may be warranted in patients with severe renal impairment (CrCl ≤30 mL/min)
Hepatic Impairment
Use with caution with any type of liver disease
Pediatric dosage forms and strengths
tablet
- 325mg500mg
caplet
- 325mg
- 500mg
- 650mg
capsule
- 500mg
gelcap/geltaB
- 500mg
caplet, extended-release
- 650mg
tablet, chewable
- 80mg
tablet, oral-disintegrating
- 80mg
- 160mg
oral solution/suspension
- 160mg/5mL
- 80mg/0.8mL (oral drops)
liquid oraL
- 500mg/5mL
- 160mg/15mL
- 500mg/15mL
syrup oraL
- 160mg5mL
elixir
- 160mg/5mL
Pain & Fever Relief
Weight-based dosing
- <12 years: 10-15 mg/kg/dose PO q4-6hr; not to exceed 5 doses/24hr
Fixed dosing
- <6 years: Ask a healthcare provider
- 6-12 years: 325 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: 650 mg q4-6hr; not to exceed 3.25 g/24hr; 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
Tylenol, Tylenol Infants' Drops (acetaminophen) adverse (side) 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
Warnings
Contraindications
Hypersensitivity
Severe active liver disease
Cautions
Acetaminophen is available in many dosage forms and products, check label carefully to avoid overdose
Repeated administration in patients with anemia or cardiac, pulmonary, or renal disease
Risk of hepatotoxicity is higher in alcoholics, chronic high dose, or use of more than one acetaminophen-containing product
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
Pregnancy and lactation
Pregnancy category: B
Crosses placenta, safe to use in all stages of pregnancy short term
Lactation: Excreted in breast milk; compatible with breastfeeding
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.
Pharmacology of Tylenol, Tylenol Infants' Drops (acetaminophen)
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)
