Classes
DEA Class; OTC
Common Brand Names; 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
Analgesics, Other
Description
Analgesic and antipyretic; no anti-inflammatory activity or effects on platelet function
Used for fever and pain of mild, moderate, or severe intensity (alone or in combination with opioids)
May be preferred over NSAIDs due to fewer hematologic, gastrointestinal, and renal effects
Indications
Indicated in Analgesia & Fever
Contraindications
Hypersensitivity
Severe active liver disease
Adverse Effects
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
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 Paracetamol-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
Pregnancy and 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%
Maximum Dosage
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
Pediatric
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
How supplied
Paracetamol
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
