Overview
DESCRIPTION Butalbital, Acetaminophen, and caffeine capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: Butalbital, USP……………………50 mg Acetaminophen, USP…………….300 mg Caffeine, USP……………………..40 mg Inactive Ingredients: FD&C blue # 1, FD&C red # 40, gelatin, microcrystalline cellulose, stearic acid, talc, titanium...
Mechanism of Action
CLINICAL PHARMACOLOGY This combination drug product is intended as a treatment for tension headache. It consists of a fixed combination of butalbital, acetaminophen, and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood. Pharmacokinetics The behavior of the individual components is described below. Butalbital Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a varying degree and binding increases directly as a function of lipid solubility.
Indications
- INDICATIONS AND USAGE Butalbital, Acetaminophen, and Caffeine capsules, 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.
Common Doses
- Refer to label
Dosage
DOSAGE AND ADMINISTRATION 1 or 2 capsules every 4 hours as needed. Total daily dosage should not exceed 6 capsules. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Black Box Warning
Hepatotoxicity 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.
Contraindications
- CONTRAINDICATIONS This product is contraindicated under the following conditions: Hypersensitivity or intolerance to any component of this product Patients with porphyria.
Side Effects
- ADVERSE REACTIONS Frequently Observed The most frequently reported adverse reactions are drowsiness, lightheadedness, dizziness, sedation, shortness of breath, nausea, vomiting, abdominal pain, and intoxicated feeling. Infrequently Observed All adverse events tabulated below are classified as infrequent. Central Nervous System: headache, shaky feeling, tingling, agitation, fainting, fatigue, heavy eyelids, high energy, hot spells, numbness, sluggishness, seizure.
Interactions
- 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.