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Paracetamol

    Brands

    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

     

    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

    Indicated in Analgesia & Fever

    Hypersensitivity

    Severe active liver disease

    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

    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

    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%

    Adults

    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

    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