Negara: Amerika Serikat
Bahasa: Inggris
Sumber: NLM (National Library of Medicine)
butalbital (UNII: KHS0AZ4JVK) (butalbital - UNII:KHS0AZ4JVK), aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E), caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E)
Rebel Distributors Corp
butalbital
butalbital 50 mg
ORAL
PRESCRIPTION DRUG
Butalbital, Aspirin, and Caffeine Capsules, USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of Butalbital, Aspirin, and Caffeine Capsules, USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Butalbital, Aspirin, and Caffeine Capsules, USP is contraindicated under the following conditions: Butalbital, Aspirin, and Caffeine Capsules, USP is controlled by the Drug Enforcement Administration and is classified under Schedule III. Butalbital Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1,500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to
Butalbital, Aspirin, and Caffeine Capsules, USP Green cap with a yellow body. Cap is imprinted with “WATSON” in red. Body is imprinted with “3219” in red. Bottles of 100 are supplied with child-resistant closures. Store and Dispense Below 25°C (77°F); tight container. Protect from moisture. Rx only Watson Laboratories, Inc . Corona, CA 92880 USA BASPC01/07 S0107 Repackaged by: Rebel Distributors Corp Thousand Oaks, CA 91320
Abbreviated New Drug Application
BUTALBITAL, ASPIRIN, AND CAFFEINE- BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE REBEL DISTRIBUTORS CORP ---------- BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES RX ONLY DESCRIPTION Butalbital, Aspirin, and Caffeine Capsules, USP is supplied in capsule form for oral administration. Each capsule contains the following active ingredients: butalbital, USP . . . . . . . . . . . . . .50 mg aspirin, USP . . . . . . . . . . . . . . .325 mg caffeine, USP . . . . . . . . . . . . . . .40 mg Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula: C H N O MOLECULAR WEIG HT 224 .26 Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula: C H O MOLECULAR WEIG HT 180.16 Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula: C H N O MOLECULAR WEIG HT 194 .19 _Inactive Ingredients:_ microcrystalline cellulose, pregelatinized starch, and talc. Gelatin capsules contain 11 16 2 3 9 8 4 8 10 4 2 _Inactive Ingredients:_ microcrystalline cellulose, pregelatinized starch, and talc. Gelatin capsules contain D&C Yellow No. 10, FD&C Green No. 3, and gelatin. The capsules are printed with edible ink containing red iron oxide. CLINICAL PHARMACOLOGY Pharmacologically, Butalbital, Aspirin, and Caffeine Capsules, USP combines the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital. The clinical effectiveness of butalbital, aspirin, and caffeine capsules in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials. A factorial design study compared butalbital, aspirin, and caffeine capsules with each of its major components. This study demonstrated that each component contributes to the efficacy of butalbital, aspirin, and caffeine capsules in the treatment of the target symptoms of tension headache (headache pain, psychic tension, and muscle contraction in th Baca dokumen lengkapnya