Acetaminophen Indications and Dosage
- arthralgia
- dental pain
- dysmenorrhea
- fever
- headache
- migraine †
- mild pain
- myalgia
- osteoarthritis
† non-FDA-approved indication
Acetaminophen Indications and Dosage
For the treatment of mild pain or fever; or for the temporary relief of headache, myalgia, back pain, dental pain (e.g., toothache), dysmenorrhea, arthralgia, or minor aches and pains associated with the common cold or flu:
NOTE: Acetaminophen should not be used for self-medication of pain for longer than 10 days in adults or 5 days in children. In addition, acetaminophen should not be used for self-medication of marked fever (greater than 39.5 degrees C or 103.1 degrees F), fever persisting longer than 3 days, or recurrent fever, unless directed by a physician.
Oral or rectal dosage (regular-release formulations):
Adults and adolescents >= 12 years: 325 - 650 mg PO or PR every 4 - 6 hours, as needed. Alternatively, 1000 mg PO or PR, 2 - 4 times per day can be given. It is important to note that doses effective for acute pain relief (1 - 2 tablets/day) may not be effective in chronic pain states, which require higher daily doses. Do not exceed single doses of 1 g/dose or 4 g/day.
Children < 12 years and infants: 10 - 15 mg/kg PO or PR every 4 - 6 hours. Do not exceed 5 doses in 24 hours.
Neonates: 10 - 15 mg/kg PO or PR every 6 - 8 hours as needed.
Oral dosage (extended-release formulations):
Adults and adolescents >= 12 years: 650 - 1300 mg PO every 8 hours as needed. Total daily dose should not exceed 6 extended-release tablets or 4 g per day. For self-medication, use of extended-release products is not recommended for children < 18 years of age.
Children < 12 years: Safe and effective use not established.
For minor osteoarthritis pain:
Oral dosage:
Adults: The American College of Rheumatology has recommended acetaminophen as first-line therapy for osteoarthritis of the hip or knee. In a randomized, double-blind trial, acetaminophen 4 g/day PO was as effective as ibuprofen in doses of 2.4 or 1.2 g/day for the short-term relief of joint pain and improvement of function in patients with osteoarthritis of the knee. Due to a ceiling effect where side effects increase to negate any analgesic benefit, do not exceed single doses of 1 g/dose or 4 g/day.
For the treatment of headache pain due to acute migraine † :
Oral or rectal dosage:
Adults and adolescents: Single doses of 500 - 1000 mg PO or PR have been utilized. Due to a ceiling effect where side effects increase to negate any analgesic benefit, do not exceed single doses of 1 g/dose or 4 g/day.
Children >= 4 years: In one clinical trial, single doses of 15 mg/kg PO were twice as effective as placebo in reducing severe or moderate headache pain within 2 hours.
Maximum Dosage Limits:
- Adults: 1000 mg/dose PO/PR or 4 g/day PO/PR for most formulations. For the extended-release oral product, 1300 mg/dose PO, with the same overall daily dose limits as other formulations.
- Adolescents: 1000 mg/dose PO/PR or 4 g/day PO/PR for most formulations. For the extended-release oral product, 1300 mg/dose PO, with the same overall daily dose limits as other formulations.
- Children 6 - 12 years: 75 mg/kg/day PO/PR or 4 g/day PO/PR, whichever is less. Extended-release oral product should not be used.
- Children < 6 years: 75 mg/kg/day PO/PR or 4 g/day PO/PR, whichever is less, of a suitable children’s formulation. Extended-release oral product should not be used.
- Infants: 75 mg/kg/day PO/PR of a suitable infant formulation.
Patients with hepatic impairment:
Acetaminophen should be used with extreme caution in patients with impaired hepatic function or with a history of overdose. Acetaminophen should not be used in patients a history of alcoholism. Patients with stable hepatic disease may receive therapeutic doses of acetaminophen for episodic pain of short duration (< 5 days).
Patients with renal impairment:
Acetaminophen is the analgesic of choice for episodic pain in patients with underlying renal disease but, chronic use should be discouraged. Dosage should be modified depending on clinical response and degree of renal impairment, but no quantitative recommendations are available.
† non-FDA approved indication
[ Last revised: 6/14/2006 2:38:00 PM ]
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