DrugBuyers.Com: Butalbital, Acetaminophen and Caffeine

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets, USP) is supplied in tablet form for oral administration.

Each tablet contains:

butalbital*, USP ........................................................ 50 mg
*warning: May be habit-forming.
acetaminophen, USP .................................................325 mg
caffeine, USP ............................................................ 40 mg
Active Ingredients: butalbital, USP, acetaminophen, USP, and caffeine, USP

Inactive Ingredients: crospovidone, FD&C Blue #1, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.

Butalbital: (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following molecular formula: C11H16N2O3 with molecular weight 224.26.

Acetaminophen: (4-hydroxyacetanilide), is a non- opiate, non-salicylate analgesic and antipyretic. It has the following molecular formula: C8H9NO2 with molecular weight 151.16.

Caffeine: (1 ,3,7- trimethylxanthine), is a central nervous system stimulant. It has the following molecular formula: C8H10N4O2 with molecular weight 194.19

Fioricet® (Butalbital, Acetaminophen, and Caffeine Tablets) is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.

Evidence supporting the efficacy and safety of this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit- forming and potentially abusable.

This product may impair mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. Such tasks should be avoided while taking this product.

Alcohol and other CNS depressants may produce an additive CNS depression, when taken with this combination product, and should be avoided.

Butalbital may be habit-forming. Patients should take the drug only for as long as it is prescribed, in the amounts prescribed, and no more frequently than prescribed.

WARNINGS

Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.

PRECAUTIONS

General

Butalbital, acetaminophen and caffeine tablets should be prescribed with caution in certain special- risk patients, such as the elderly or debilitated, and those with severe impairment or renal or hepatic function, or acute abdominal conditions.

Information for Patients

See PATIENT INFORMATION section.

Laboratory Tests

In patients with severe hepatic or renal disease, effects of therapy should be monitored with serial liver and/or renal function tests.

Drug Interactions

The CNS effects of butalbital may be enhanced by monoamine oxidase (MAO) inhibitors. Butalbital, acetaminophen and caffeine may enhance the effects of: other narcotic analgesics, alcohol, general anesthetics, tranquilizers such as chlordiazepoxide, sedative-hypnotics, or other CNS depressants, causing increased CNS depression.

Drug/Laboratory Test Interactions

Acetaminophen may produce false-positive test results for urinary 5-hydroxyindoleacetic acid.

Pregnancy

Teratogenic Effects: Pregnancy Category C: Animal reproduction studies have not been conducted with this combination product. It is also not known whether butalbital, acetaminophen and caffeine can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only when clearly needed.

Nonteratogenic Effects: Withdrawal seizures were reported in a two-day-old male infant whose mother had taken a butalbital-containing drug during the last two months of pregnancy. Butalbital was found in the infants serum. The infant was given phenobarbital 5 mg/kg, which was tapered without further seizure or other withdrawal symptoms.

Nursing Mothers

Caffeine, barbiturates and acetaminophen are excreted in breast milk in small amounts, but the significance of their effects on nursing infants is not known. Because of potential for serious adverse reactions in nursing infants from butalbital, acetaminophen and caffeine, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother.

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

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