ZEBUTAL- butalbital, acetaminophen and caffeine capsule
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.
ZEBUTALŪ Capsules brand of Butalbital, Acetaminophen, and Caffeine is supplied in capsule form for oral administration. Each ZEBUTALŪ Capsule contains:
Butalbital, USP 50 mg
Acetaminophen, USP 500 mg
Caffeine, USP 40 mg
In addition, each capsule contains the following inactive ingredients: Colloidal Silicon Dioxide, Magnesium Stearate, Sodium Lauryl Sulfate, and Sodium Starch Glycolate.
Capsule shell contains: D&C Red #33, D&C Yellow #10, FD&C Red #40, Gelatin and Titanium Dioxide. The imprinting ink contains Titanium Dioxide.
Butalbital (5-allyl-5-isobutyl-barbituric acid), a white, odorless crystalline powder having a slightly bitter taste, is a short to intermediate-acting barbiturate
Acetaminophen (4′-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic
Caffeine (1,3,7-trimethylxanthine),a bitter, white crystalline powder or white-glistening needles, is a central nervous system stimulant.
The 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.
The behavior of the individual components is described below.
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.
Acetaminophen is rapidly absorbed from the gastrointestinal tract and is distributed throughout most body tissues. The plasma half-life is 1.25 to 3 hours, but may be increased by liver damage and following overdosage. Elimination of acetaminophen is principally by liver metabolism (conjugation) and subsequent renal excretion of metabolites. Approximately 85% of an oral dose appears in the urine within 24 hours of administration, most as the glucuronide conjugate, with small amounts of other conjugates and unchanged drug. (See OVERDOSAGE for toxicity information.)
Like most xanthines, caffeine is rapidly absorbed and distributed in all body tissues and fluids, including the CNS, fetal tissues, and breast milk.
INDICATIONS AND USAGE
ZEBUTALŪ Capsules 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.
This product is contraindicated under the following conditions:
Hypersensitivity or intolerance to any component of this product.
Patients with porphyria.
Butalbital is habit-forming and potentially abusable. Consequently, the extended use of this product is not recommended.