Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Actavis Pharma, Inc.
BUTALBITAL
BUTALBITAL 50 mg
ORAL
PRESCRIPTION DRUG
Butalbital, Aspirin, and Caffeine Capsules, 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 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. - 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 the syndrome of nasal polyps, angioedema and bronchospastic reactivity to aspirin or other nonsteroidal anti-inflammatory drugs. Anaphylactoid reactions have occurred in such patient
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 (NDC 0591-3219-01) are supplied with child-resistant closures. Below 25°C (77°F); tight container. Protect from moisture. Rx only For all medical inquiries contact: Actavis Parsippany, NJ 07054 1-888-838-2872 Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 Content Updated: April 2021
New Drug Application Authorized Generic
BUTALBITAL, ASPIRIN, AND CAFFEINE- BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE ACTAVIS PHARMA, INC. ---------- BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES, USP C-III CONTENT UPDATED: APRIL 2021 RX ONLY DESCRIPTION Butalbital, Aspirin, and Caffeine Capsules, USP are 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 11 16 2 3 9 8 4 Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula: 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, USP in tension headache has been established in double-blind, placebo-controlled, multi-clinic trials. A factorial design study compared Butalbital, Aspirin, and Caffeine Capsules, USP with each of its major components. This study demonstrated that each component contributes to the efficacy of Butalbital, Aspirin, and Caffeine Capsules, USP 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 comple Izlasiet visu dokumentu