Maa: Yhdysvallat
Kieli: englanti
Lähde: NLM (National Library of Medicine)
butalbital (UNII: KHS0AZ4JVK) (butalbital - UNII:KHS0AZ4JVK), aspirin (UNII: R16CO5Y76E) (aspirin - UNII:R16CO5Y76E), caffeine (UNII: 3G6A5W338E) (caffeine - UNII:3G6A5W338E)
MUTUAL PHARMACEUTICAL COMPANY, INC.
butalbital, aspirin, and caffeine
CAPSULE
50 mg
ORAL
PRESCRIPTION DRUG
Butalbital aspirin, and caffeine capsules 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 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 are contraindicated under the following conditions: - Hypersensitivity or intolerance to aspirin, caffeine, or butalbital. - Patients with 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 patients. - Peptic ulcer
Butalbital, aspirin, and caffeine capsules, USP are supplied as follows: Butalbital 50 mg, aspirin 325 mg, caffeine 40 mg capsules are green opaque/white opaque, imprinted MUTUAL/779, on both the cap and the body. Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]. Protect from moisture. DISPENSE IN TIGHT, LIGHT-RESISTANT CONTAINER.
BUTALBITAL, ASPIRIN, AND CAFFEINE- BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULE MUTUAL PHARMACEUTICAL COMPANY, INC. ---------- BUTALBITAL, ASPIRIN, AND CAFFEINE CAPSULES USP CIII RX ONLY DESCRIPTION Each butalbital, aspirin, and caffeine capsule for oral administration contains: butalbital, USP, 50 mg; aspirin, USP, 325 mg; caffeine, USP, 40 mg. Butalbital, 5-allyl-5-isobutyl-barbituric acid, has a molecular formula of C H N O and a molecular weight of 224.26. Aspirin, benzoic acid, 2-(acetyloxy)-, has a molecular formula of C H O and a molecular weight of 180.16. Caffeine, 1, 3, 7-trimethylxanthine, has a molecular formula of C H N O and a molecular weight of 194.19. _Active Ingredients:_ aspirin, USP, butalbital, USP, and caffeine, USP. _Inactive Ingredients:_ alginic acid, corn starch, pregelatinized starch, sodium lauryl sulfate, and talc. The capsule contains: FD&C Blue #2, FDA/E172 yellow iron oxide, gelatin and titanium dioxide. The imprinting ink contains: D&C Yellow #10, FD&C Blue #1, FD&C Blue #2, FD&C Red #40, iron oxide black, and propylene glycol. CLINICAL PHARMACOLOGY Pharmacologically, butalbital, aspirin, and caffeine capsules 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, butalbital, aspirin, and caffeine capsules were shown to have significantly superior clinical effects to either component alone. PHARMACOKINETICS The behavior of the ind Lue koko asiakirja