Butalbital / Acetaminophen / Caffeine

Pronunciation

Pronunciation: BYOO-TAL-bih-tuhl/uh-seet-uh-MIN-oh-fen/kaff-EEN
Class: Nonnarcotic analgesic

Trade Names

Alagesic LQ
- Oral solution acetaminophen 325 mg/caffeine 40 mg/butalbital 50 mg

Capacet
- Capsules acetaminophen 325 mg/caffeine 40 mg/butalbital 50 mg

Dolgic Plus
- Tablets acetaminophen 750 mg/caffeine 40 mg/butalbital 50 mg

Esgic
- Capsules acetaminophen 325 mg/caffeine 40 mg/butalbital 50 mg
- Tablets acetaminophen 325 mg/caffeine 40 mg/butalbital 50 mg

Esgic-Plus
- Tablets acetaminophen 500 mg/caffeine 40 mg/butalbital 50 mg
- Capsules acetaminophen 500 mg/caffeine 40 mg/butalbital 50 mg

Fioricet
- Tablets acetaminophen 325 mg/caffeine 40 mg/butalbital 50 mg

Margesic
- Capsules acetaminophen 325 mg/caffeine 40 mg/butalbital 50 mg

Orbivan
- Capsules acetaminophen 300 mg/caffeine 40 mg/butalbital 50 mg

Repan
- Tablets acetaminophen 325 mg/caffeine 40 mg/butalbital 50 mg

Zebutal
- Capsules acetaminophen 500 mg/caffeine 40 mg/butalbital 50 mg

Pharmacology

Butalbital has generalized depressant effect on CNS and, in very high doses, has peripheral effects. Acetaminophen has analgesic and antipyretic effects; its analgesic effects may be mediated through inhibition of prostaglandin synthetase enzyme complex. Caffeine is thought to produce constriction of cerebral blood vessels.

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Indications and Usage

Relief of symptom complex of tension (or muscle contraction) headache.

Contraindications

Hypersensitivity to acetaminophen, caffeine, or barbiturates; porphyria.

Dosage and Administration

Adults

PO 1 to 2 tablets or capsules or 15 to 30 mL every 4 h (max, 5 to 6 tablets or capsules or 90 mL/day).

Storage/Stability

Store at 68° to 77°F. Protect from light.

Drug Interactions

Beta-blockers (eg, propranolol), corticosteroids, doxycycline, estrogens (including oral contraceptives), felodipine, griseofulvin, nifedipine, phenylbutazone, quinidine, theophylline, warfarin

Effects of these drugs may be decreased.

Carbamazepine, sulfinpyrazone

May increase risk of hepatotoxicity.

MAOIs

May increase CNS effects.

Other CNS depressants (eg, ethanol, narcotics, general anesthetics, tranquilizers, sedative-hypnotics)

Increased drowsiness, dizziness, and other CNS depressive effects may occur.

Tricyclic antidepressants

Antidepressant effect may decrease.

Laboratory Test Interactions

With Chemstrip bG and Dextrostix home blood glucose systems, may cause false decrease in mean glucose values; may give false-positive urinary 5-hydroxyindoleacetic acid test result.

Adverse Reactions

CNS

Drowsiness; dizziness; light-headedness; confusion; sedation.

Dermatologic

Erythema multiforme; rash; toxic epidermal necrolysis.

GI

Abdominal pain; nausea; vomiting; flatulence.

Miscellaneous

Intoxicated feeling; shortness of breath.

Precautions

Warnings

These products contain acetaminophen. Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4,000 mg/day, and often involve more than 1 acetaminophen-containing product.


Monitor

Monitor liver and/or renal function tests in patients with severe hepatic or renal disease.


Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

Safety and efficacy in children have not been established ( Dolgic Plus , Alagesic LQ ). Safety and efficacy in children younger than 12 yr of age not established.

Elderly

Take care in dose selection.

Renal Function

Use with caution.

Hepatic Function

Use with caution.

Special Risk Patients

Use with caution in debilitated patients or patients with acute abdominal conditions.

Drug dependency

Prolonged use may produce drug tolerance and dependency (psychologic and physical).

Overdosage

Symptoms

Blood dyscrasias, coma, confusion, delirium, drowsiness, extrasystoles, hepatic damage, hypoglycemic coma, hypotension, hypovolemic shock, insomnia, nausea, renal tubular necroses, respiratory depression, restlessness, tachycardia, thrombocytopenia, tremor, vomiting.

Patient Information

  • Caution patient that dependency/tolerance may result from regular long-term use.
  • Tell patient to take drug with full glass of water.
  • Instruct patient not to discontinue drug abruptly after long-term regular use.
  • Caution patient to avoid intake of alcoholic beverages and other CNS depressants without health care provider approval.
  • Advise patient to avoid any hazardous activity (driving or smoking) if dizziness, drowsiness, or a decrease in mental acuity occurs.
  • Warn patient that orthostatic hypotension may occur. Instruct patient to change positions slowly and to sit or lie down if symptoms occur.
  • Inform patient to report the following symptoms to health care provider: persistent or recurrent pain before next scheduled dose, difficulty breathing, increased drowsiness, vomiting or yellowing of skin or gums.

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