Страна: САЩ
Език: английски
Източник: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Lannett Company, Inc.
BUTALBITAL
BUTALBITAL 50 mg
ORAL
PRESCRIPTION DRUG
Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules are indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy of butalbital, aspirin, caffeine and codeine phosphate capsules is derived from 2 multi-clinic trials that compared patients with tension headache randomly assigned to 4 parallel treatments: 1) butalbital, aspirin, caffeine and codeine; 2) codeine; 3) butalbital, aspirin and caffeine; 4) placebo. Response was assessed over the course of the first 4 hours of each of 2 distinct headaches, separated by at least 24 hours. The combination product of butalbital, aspirin, caffeine and codeine proved statistically significantly superior to each of its components and to placebo on measures of pain relief. Evidence supporting the efficacy and safety of butalbital, aspirin, caffeine and codeine in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because codeine and butalbital are habit
Each yellow and blue Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsule USP 50 mg/325 mg/ 40 mg/30 mg is imprinted JSP 507 Bottles of 100 NDC 0527-1312-01 Bottles of 500 NDC 0527-1312-05 Store and Dispense Below 25°C (77°F); in a tight, light resistant container. Manufactured for: Lannett Company, Inc. Philadelphia, PA 19136 Manufactured by: Jerome Stevens Pharmaceuticals, Inc. Bohemia, NY 11716 Rev. 02/08 MG #11583
Abbreviated New Drug Application
BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE- BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULE LANNETT COMPANY, INC. ---------- BUTALBITAL, ASPIRIN, CAFFEINE AND CODEINE PHOSPHATE CAPSULES, USP CIII RX ONLY DESCRIPTION Each capsule for oral administration contains: codeine phosphate, USP . . . . . . . . . . . . 30 mg (1/2 gr) butalbital, USP . . . . . . . . . . . . . . . . . . . . . . . . . . 50 mg caffeine, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 mg aspirin, USP . . . . . . . . . . . . . . . . . . . . . . . . . . . 325 mg Codeine phosphate occurs as fine, white, needle-shaped crystals, or white, crystalline powder. It is affected by light. Its chemical name is 7,8-didehydro-4,5α-epoxy-3-methoxy-17- methylmorphinan-6α- ol phosphate (1:1) (salt) hemihydrate. Its molecular weight is 406.37 and its molecular formula is C H NO •H PO •½H O. Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder, is a short- to intermediate-acting barbiturate. Its molecular weight is 224.26 and its molecular formula is C H N O . Caffeine, 1,3,7-trimethylxanthine, is a central nervous stimulant which occurs as a white powder or white glistening needles. Its molecular weight is (anhydrous) 194.19 and its molecular formula is C H N O . 18 21 3 3 4 2 11 16 2 3 8 10 4 2 Aspirin is benzoic acid, 2-(acetyloxy)-, with a molecular formula of C H O and its molecular weight is 180.16. _Inactive Ingredients:_ D&C Yellow #10, D&C Yellow #10 Aluminum Lake, D&C Red #33, D&C Red #28, FD&C Blue #1, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Blue #10 Aluminum Lake, FD&C Red #40 Aluminum Lake, gelatin, microcrystalline cellulose, pregelatinized starch, talc, titanium dioxide, stearic acid, colloidal silicon dioxide. CLINICAL PHARMACOLOGY Butalbital, Aspirin, Caffeine and Codeine Phosphate Capsules is a combination drug product intended as a treatment for tension headache. PHARMACOKINETICS Bioavailability: The bioavailability of the components of the fixed combina Прочетете целия документ