Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
STAT RX USA LLC
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: - Hypersensitivity or intolerance to aspirin, caffeine, or butalbital. Hypersensitivity or intolerance to aspirin, caffeine, or butalbital. - Patients with a hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von Willebrand’s disease, the thrombocytopenias, thrombasthenia and other ill-defined hereditary platelet dysfunctions, severe vitamin K deficiency and severe liver damage). Patients with a hemorrhagic diathesis (e.g., hemophilia, hypoprothrombinemia, von Willebrand’s disease, the thrombocytopenias,
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 Address medical inquiries to: WATSON Medical Communications P.O. Box 1953 Morristown, NJ 07962-1953 800-272-5525 Watson Laboratories, Inc . Corona, CA 92880 USA Revised: June 2009 190110 S0609
New Drug Application Authorized Generic
BUTALBITAL, ASPIRIN, AND CAFFEINE - BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE STAT RX USA LLC ---------- BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES, USP C-III REVISED: JUNE 2009 RX ONLY 1901100609 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 weight 224.26 Aspirin (benzoic acid, 2-(acetyloxy)-) is an analgesic, antipyretic, and anti-inflammatory. It has the following structural formula: C H O molecular weight 180.16 Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula: 11 16 2 3 9 8 4 C H N O molecular weight 194.19 _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 the head, neck, and shoulder region). For each symptom and the symptom complex as a whole, b Прочитайте повний документ