Acetaminophen; Butalbital; Caffeine Indications and Dosage
† non-FDA-approved indication
Acetaminophen; Butalbital; Caffeine Indications and Dosage
For the treatment of the symptom complex of tension headache, occasional migraine † and co-existing migraine † and tension-type headaches:
NOTE: Extended and repeated use of acetaminophen; butalbital; caffeine is not recommended because of the potential for physical dependence. According to published guidelines for the acute management of migraine, the use of butalbital-containing analgesics should be limited and carefully monitored due to concerns of overuse, medication-overuse headache, and withdrawal.
NOTE: According to OBRA regulations, butalbital is not to be used in a nursing home patient unless started before admission to the nursing home or given as a single dose for a medical or dental procedure. Discontinuation of butalbital should be attempted in the nursing home patient.
Oral dosage (butalbital/acetaminophen/caffeine 50 mg/325 mg/40 mg tablets or capsules):
Adults, the elderly, and adolescents: 1 - 2 tablets or capsules PO every 4 hours as needed. Do not exceed 6 tablets or capsules in a 24-hour period.
Children: Safe and effective use has not been established.
Oral dosage (butalbital/acetaminophen/caffeine 50 mg/500 mg/40 mg tablets or capsules):
Adults, the elderly, and adolescents: 1 tablet or capsule PO every 4 hours as needed. Do not exceed 6 tablets or capsules in a 24-hour period.
Children: Safe and effective use has not been established.
Oral dosage (liquid containing butalbital/acetaminophen/caffeine 50 mg/325 mg/40 mg per 15 ml):
Adults, the elderly, and adolescents: 15 - 30 ml PO every 4 hours as needed. Do not exceed 90 ml (6 tablespoonfuls) in a 24-hour period.
Children: Safe and effective use has not been established.
Oral dosage (butalbital/acetaminophen/caffeine 50 mg/750 mg/40 mg tablets):
Adults, the elderly, and adolescents: 1 tablet PO every 4 hours as needed. Do not exceed 5 tablets in a 24-hour period.
Children: Safe and effective use has not been established.
Maximum Dosage Limits:
- Adults: Acetaminophen 4 g/day PO, caffeine 240 mg/day PO, or butalbital 300 mg/day PO.
- Elderly: Acetaminophen 4 g/day PO, caffeine 240 mg/day PO, or butalbital 300 mg/day PO.
- Adolescents: Acetaminophen 4 g/day PO, caffeine 240 mg/day PO, or butalbital 300 mg/day PO.
- Children: Safe and effective use has not been established.
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:
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: 11/4/2004 9:37:00 AM ]
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