Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Actavis Pharma, Inc.
BUTALBITAL
BUTALBITAL 50 mg
ORAL
PRESCRIPTION DRUG
Butalbital, Acetaminophen 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 this combination product in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. This product is contraindicated under the following conditions: - Hypersensitivity or intolerance to any component of this product - Patients with porphyria. Butalbital Barbiturates may be habit-forming: Tolerance, psychological dependence, and physical dependence may occur especially following prolonged use of high doses of barbiturates. The average daily dose for the barbiturate addict is usually about 1500 mg. As tolerance to barbiturates develops, the amount needed to maintain the same level of intoxication increases; tolerance to a fatal dosage, however, does not increase more than two-fold. As this occurs, the margin between
Butalbital, Acetaminophen, and Caffeine Capsules USP, 50 mg/300 mg/40 mg Containing 50 mg butalbital, 300 mg acetaminophen, and 40 mg caffeine. Available as hard gelatin capsules with a light blue opaque body and a light blue opaque cap. Cap is imprinted twice with "FIORICET" in black and body is imprinted twice with a three-head profile "" in black. The capsules are supplied in bottles of 100 capsules (NDC 0591-2640-01) and 500 capsules (NDC 0591-2640-05). Store at 20o to 25o C (68o to 77o F) [see USP Controlled Room Temperature]. Dispense in a tight, light-resistant container. Rx only Manufactured by: LGM Pharma Solutions, LLC Irvine, CA 92614 Manufactured for: Teva Pharmaceuticals USA, Inc. Parsippany, NJ 07054 7029-0100-WG-EC Rev. 01/2021
Abbreviated New Drug Application
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULE ACTAVIS PHARMA, INC. ---------- BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE CAPSULES, USP RX ONLY HEPATOTOXICITY Acetaminophen has been associated with cases of acute liver failure, at times resulting in liver transplant and death. Most of the cases of liver injury are associated with the use of acetaminophen at doses that exceed 4000 milligrams per day, and often involve more than one acetaminophen-containing product. DESCRIPTION Butalbital, Acetaminophen, and Caffeine Capsules, USP are supplied in hard-gelatin capsule form for oral administration. Each capsule contains the following active ingredients: Butalbital, USP……………………50 mg Acetaminophen, USP…………….300 mg Caffeine, USP……………………..40 mg _Inactive Ingredients: _sodium lauryl sulfate, talc, microcrystalline cellulose, stearic acid, FD&C red # 40, titanium dioxide, FD&C blue # 1, FD&C yellow # 6, gelatin. Butalbital (5-allyl-5-isobutylbarbituric acid) is a short- to intermediate-acting barbiturate. It has the following structural formula: Acetaminophen (4´-hydroxyacetanilide) is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Caffeine (1,3,7-trimethylxanthine) is a central nervous system stimulant. It has the following structural formula: CLINICAL PHARMACOLOGY This combination drug product is intended as a treatment for tension headache. It consists of a fixed combination of butalbital, acetaminophen, and caffeine. The role each component plays in the relief of the complex of symptoms known as tension headache is incompletely understood. PHARMACOKINETICS The behavior of the individual components is described below. _BUTALBITAL_ Butalbital is well absorbed from the gastrointestinal tract and is expected to distribute to most tissues in the body. Barbiturates in general may appear in breast milk and readily cross the placental barrier. They are bound to plasma and tissue proteins to a vary Olvassa el a teljes dokumentumot