Butalbital (27 brand names, 3 dosage forms, 1 route)
Available dosage forms: TABLET, CAPSULE, SOLUTION.
Routes of administration: ORAL.
Brand Names
- ALLZITAL
- ANOQUAN
- AXOTAL
- BANCAP
- BUCET
- BUTALBITAL AND ACETAMINOPHEN
- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
- BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
- BUTALBITAL, ASPIRIN AND CAFFEINE
- BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
- BUTALBITAL; ACETAMINOPHEN; CAFFEINE; CODEINE
- BUTAPAP
- ESGIC
- ESGIC-PLUS
- FEMCET
- FIORICET W/ CODEINE
- FIORINAL
- FIORINAL W/CODEINE
- LANORINAL
- MEDIGESIC PLUS …and 7 more
Boxed Warning
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 4000 milligrams per day, and often involve more than one acetaminophen containing product.
Indications and Usage
Butalbital, acetaminophen, and caffeine tablets, USP are 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.
Dosage and Administration
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Contraindications
This product is contraindicated under the following conditions: - Hypersensitivity or intolerance to any component of this product - Patients with porphyria.
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.
Overdosage
Following an acute overdosage of butalbital, acetaminophen, and caffeine, toxicity may result from the barbiturate or the acetaminophen. Toxicity due to caffeine is less likely, due to the relatively small amounts in this formulation.