Pays: États-Unis
Langue: anglais
Source: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK)
Marnel Pharmaceuticals, LLC
BUTALBITAL
BUTALBITAL 50 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
MARGESIC- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE MARNEL PHARMACEUTICALS, LLC ---------- 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. DESCRIPTION Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration. Each capsule contains: Butalbital ................... 50 mg WARNING: May be habit-forming. Acetaminophen ........ 325 mg Caffeine ...................... 40 mg In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate. microcrystalline cellulose with capsule shell composed of gelatin (silicon dioxide and sodium lauryl sulfate are added as manufacturing aides) and titanium dioxide. Imprinting ink composed of n-butyl alcohol, pharmaceutical glaze modified in SD-45, propylene glycol, SDA-3A alcohol, titanium dioxide, D&C Yellow No. 10 Aluminum Lake and FD&C Blue No. 1 Aluminum Lake. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula: C H N O MW = 224 .26 Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: 11 16 2 3 C H NO MW = 151.16 Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula: C H N O MW = 194 .19 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 rel Lire le document complet