DrugindexOnline^{2nd edition}

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

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

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

Trade Names:
Fioricet
- Tablets 325 mg actaminophen/40 mg caffeine/50 mg butalbital

Trade Names:
Margesic
- Capsules 325 mg acetaminophen/40 mg caffeine/50 mg butalbital

Trade Names:
Medigesic
- Capsules 325 mg acetaminophen/40 mg caffeine/50 mg butalbital

Trade Names:
Repan
- Tablets 325 mg acetaminophen/40 mg caffeine/50 mg butalbital

Trade Names:
Triad
- Capsules 325 mg acetaminophen/40 mg caffeine/50 mg butalbital

Mechanism of Action

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.

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 every 4 h; max, 6 tablets or capsules/day.

Storage/Stability

Store in airtight, light-resistant container at room temperature.

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; lightheadedness; confusion.

Dermatologic

Rash.

GI

Nausea; vomiting; flatulence.

Precautions

Pregnancy

Category C .

Lactation

Undetermined.

Children

Safety and efficacy in children younger than 12 yr of age not established.

Drug dependency

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

Overdosage

Symptoms

Blood dyscrasias, respiratory depression, hepatic damage, drowsiness, confusion, coma, hypotension, tachycardia, hypovolemic shock, nausea, vomiting, insomnia, restlessness, tremor.

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.