Overview
Butalbital, Acetaminophen and Caffeine Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients: butalbital, USP 50 mg acetaminophen, USP 325 mg caffeine, USP 40 mg Inactive Ingredients: silicon dioxide, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid.
Mechanism of Action
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
- Butalbital, acetaminophen and caffeine tablets 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
One or two tablets every four 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.
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 ... BOXED 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
- This product is contraindicated under the following conditions: – Hypersensitivity or intolerance to any component of this product – Patients with porphyria.
Side Effects
- 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
- No major interactions listed on the FDA label. Always consult a healthcare professional.