Overview
DESCRIPTION Each Butalbital and acetaminophen tablets, 50 mg/ 325 mg for oral administration contains: *Butalbital, USP………...….. 50 mg Acetaminophen, USP..……. 325 mg Each Butalbital and acetaminophen tablets, 50 mg/ 300 mg for oral administration contains: *Butalbital, USP………...….. 50 mg Acetaminophen, USP..…….
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 and acetaminophen. 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 and acetaminophen 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
- 50 mg
- 325 mg
- 300 mg
Dosage
DOSAGE AND ADMINISTRATION 50 mg/325 mg: One to two tablets every four hours as needed. Total daily dosage should not exceed six tablets. 50 mg/300 mg : One or two tablets every four hours. Total daily dosage should not exceed six tablets. Extended and repeated use of this product is not recommended because of the potential for physical dependence.
Black Box Warning
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
- No major interactions listed on the FDA label. Always consult a healthcare professional.