Butalbital, Acetaminophen, And Caffeine Prescribing Information
Butalbital, acetaminophen, and caffeine tablets USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache.
Evidence supporting the efficacy and safety of butalbital, acetaminophen, and caffeine tablets USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable.
One or 2 tablets every 4 hours as needed. Total daily dosage should not exceed 6 tablets.
Extended and repeated use of butalbital, acetaminophen, and caffeine tablets USP is not recommended because of the potential for physical dependence.
Butalbital, acetaminophen, and caffeine tablets USP is contraindicated under the following conditions:
- Hypersensitivity or intolerance to any component of this product.
- Patients with porphyria.
The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling.
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.