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Acetaminophen ER

Class
Antipyretics
Subclass
Anilides
Generic name
Acetaminophen, paracetamol ER ER
Brand names
Tylenol 8hr®
Common formulations
Film-coated tablet
See also
Acetaminophen (Tylenol®, Ofirmev®, Acephen®, Feverall®)
Dosage and administration
Adults patients
Fever
Maintenance: 1,300 mg PO TID PRN
Maximum: 3,900 mg per day
PainMild-to-moderate
Maintenance: 1,300 mg PO TID PRN
Maximum: 3,900 mg per day
Indications for use
Labeled indications
Adults
Symptomatic relief of fever
Symptomatic relief of pain (mild-to-moderate)
Safety risks
Boxed warnings
Hepatotoxicity
Use extreme caution when using large doses. Do not use doses larger than 4,000 mg per day.
Contraindications
Hypersensitivity to acetaminophen or its components
Severe hepatic impairment or severe active liver disease
Warnings and precautions
ALF
Use extreme caution in patients with underlying liver disease or using alcohol while taking acetaminophen.
Specific populations
Renal impairment
eGFR 0-90 mL/min/1.73 m²
Use acceptable. No dose adjustment required.
Renal replacement therapy
Continuous renal replacement
Use acceptable. No dose adjustment required.
Intermittent hemodialysis
Use acceptable. No dose adjustment required.
Peritoneal dialysis
Use acceptable. No dose adjustment required.
Hepatic impairment
Child-Pugh A (mild)
Use with caution.
Child-Pugh B (moderate)
Use with caution.
Child-Pugh C (severe)
Do not use.
Pregnancy and breastfeeding
Pregnancy
All trimesters • Australia Category: A
Generally acceptable for use.
Breastfeeding
Acceptable for use during breastfeeding.
Undetectable levels in breastfed infants.
No overt adverse effects reported in breastfed infants.
Adverse reactions
Very common > 10%
Nausea
Common 1-10%
Constipation, dizziness, dyspepsia, facial sweating, headache, somnolence, vomiting
Uncommon < 1%
Itching
Unknown frequency
Acute liver failure, ↑ liver enzymes
Interactions
Drug(s)
Check Interactions
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