Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
GM Pharmaceuticals
BUTALBITAL
BUTALBITAL 50 mg in 15 mL
ORAL
PRESCRIPTION DRUG
VANATOL ® S is 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: Babiturates 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 an into
VANATOL ® S (butalbital, acetaminophen and caffeine oral solution) is an orange, tropical fruit punch flavored liquid containing butalbital 50 mg (Warning: May be habit-forming) , acetaminophen 325 mg and caffeine 40 mg per 15 mL, with 7.368% alcohol. It is supplied as follows: 1 fl oz NDC 58809-359-30 Storage: Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Rx only Manufactured for: GM Pharmaceuticals, Inc. Arlington, TX 76015 Manufactured by: Mikart, Inc. Atlanta, GA 30318
Abbreviated New Drug Application
VANATOL S- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE SYRUP GM PHARMACEUTICALS ---------- WARNING 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 VANATOL S (butalbital, acetaminophen and caffeine) is supplied in liquid form for oral administration. Each 15 mL contains: Butalbital USP.................................................... 50 mg WARNING: May be habit-forming. Acetaminophen USP.......................................... 325 mg Caffeine USP...................................................... 40 mg Alcohol ............................................................... 7.368% In addition, this drug product contains the following inactive ingredients: citric acid, ethyl maltol, liquid glucose, glycerin, methylparaben, propylene glycol, propylparaben, purified water, saccharin sodium, sorbitol solution, sucrose, with FD&C yellow #6 as coloring, and natural and artificial flavoring. 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 expe Đọc toàn bộ tài liệu