Riik: Ameerika Ühendriigid
keel: inglise
Allikas: NLM (National Library of Medicine)
Butalbital (UNII: KHS0AZ4JVK) (Butalbital - UNII:KHS0AZ4JVK)
Cardinal Health
Butalbital
Butalbital 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET CARDINAL HEALTH ---------- BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS, USP Rev. 01/09 RX ONLY DESCRIPTION Each tablet, for oral administration contains: Butalbital, USP.......................................................................................50 mg Acetaminophen, USP...........................................................................325 mg Caffeine, USP.........................................................................................40 mg In addition, each tablet contains the following inactive ingredients: Colloidal Silicon Dioxide, FD&C Blue No. 1 Aluminum Lake, Magnesium Stearate, Microcrystalline Cellulose, and Sodium Starch Glycolate. Butalbital (5-allyl-5-isobutylbarbituric acid), is a short to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4’-hydroxyacetanilide), is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine), is a central nervous system stimulant. It has the following structural formula: CLINICAL PHARMACOLOGY This combination drug product is intended as a treatment for tension headache. 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. Elimination of butalbital is primarily via the kidney (59% to 88% of the Lugege kogu dokumenti