Country: United States
Language: English
Source: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
West-ward Pharmaceutical Corp
BUTALBITAL
BUTALBITAL 50 mg
ORAL
PRESCRIPTION DRUG
Butalbital, Aspirin, and Caffeine Tablets, USP are 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 in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Hypersensitivity to aspirin, caffeine, or barbiturates. Patients with porphyria.
Butalbital, Aspirin, and Caffeine Tablets, USP 50 mg/325 mg/40 mg are White, Round, Unscored Tablets; Debossed “West-ward 785” on one side. Bottles of 30 tablets Bottles of 50 tablets Bottles of 100 tablets Bottles of 500 tablets Bottles of 1000 tablets Unit Dose Boxes of 100 tablets Store at 20-25o C (68-77o F) [See USP Controlled Room Temperature]. Protect from light and moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. Manufactured By: West-ward Pharmaceutical Corp Eatontown, NJ 07724 Revised. January 2012
Abbreviated New Drug Application
BUTALBITAL, ASPIRIN AND CAFFEINE- BUTALBITAL, ASPIRIN AND CAFFEINE TABLET WEST-WARD PHARMACEUTICAL CORP ---------- BUTALBITAL, ASPIRIN AND CAFFEINE TABLETS, USP R ONLY REV. 01/12 DESCRIPTION: Each Butalbital, Aspirin, and Caffeine Tablet, USP for oral administration contains: Butalbital, USP 50 mg Aspirin, USP 325 mg Caffeine, USP 40 mg Butalbital, 5-allyl-5-isobutyl-barbituric acid, a white odorless crystalline powder; is a short-to intermediate-acting barbiturate. Its structural formula is as follows: Aspirin, salicylic acid acetate, is a non-opiate analgesic, anti-inflammatory and antipyretic agent. It occurs as a white, crystalline tabular or needle-like powder and is odorless or has a faint odor. Its structural formula is as follows: Caffeine, 1,3,7-trimethylxanthine, is a central nervous system stimulant which occurs as a white powder or white glistening needles. It also has a bitter taste. Its structural formula is as follows: CII X Inactive Ingredients: Hydrogenated Vegetable Oil, Microcrystalline Cellulose, Sodium Starch Glycolate, Starch 1500 and Talc. CLINICAL PHARMACOLOGY Pharmacologically, butalbital, aspirin, and caffeine combines the analgesic properties of aspirin with the anxiolytic and muscle relaxant properties of butalbital. The clinical effectiveness of butalbital, aspirin, and caffeine in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials. A factorial design study compared butalbital, aspirin, and caffeine with each of its major components. This study demonstrated that each component contributes to the efficacy of butalbital, aspirin, and caffeine in the treatment of the target symptoms of tension headache (headache pain, psychic tension, and muscle contraction in the head, neck, and shoulder region). For each symptom and the symptom complex as a whole, butalbital, aspirin, and caffeine was shown to have significantly superior clinical effects to either component alone. PHARMACOKINETICS : The behavior of the individual components is described below Read the complete document