Pajjiż: Stati Uniti
Lingwa: Ingliż
Sors: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Mayne Pharma Inc.
BUTALBITAL
BUTALBITAL 50 mg
ORAL
PRESCRIPTION DRUG
Zebutal ® (butalbital, acetaminophen and caffeine capsules) USP 50 mg/325 mg/40 mg 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 : 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 incr
Zebutal ® (butalbital, acetaminophen and caffeine capsules) containing butalbital 50 mg (Warning: May be habit-forming) , acetaminophen 325 mg and caffeine 40 mg, are supplied in bottles of 100 capsules, NDC 68308-554-10. Capsules are opaque white body and cap and are imprinted "59743" and “004” in green ink. 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 by: MIKART, LLC Atlanta, GA 30318 Distributed by: MAYNE PHARMA Greenville, NC 27834 Code 785M00 Rev. 05/2019
Abbreviated New Drug Application
ZEBUTAL- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE CAPSULE MAYNE PHARMA INC. ---------- ZEBUTAL 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 Butalbital, acetaminophen and caffeine are supplied in capsule form for oral administration. Each capsule contains: Butalbital ................... 50 mg WARNING: MAY BE HABIT-FORMING. Acetaminophen ........ 325 mg Caffeine ...................... 40 mg In addition, each capsule contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, magnesium stearate and microcrystalline cellulose with capsule shell composed of gelatin, titanium dioxide, and green edible ink. Butalbital (5-allyl-5-isobutylbarbituric acid), a slightly bitter, white, odorless, crystalline powder, is a short to intermediate-acting barbiturate. It has the following structural formula: C H N O MW = 224.26 Acetaminophen (4'-hydroxyacetanilide), a slightly bitter, white, odorless, crystalline powder, is a non-opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: C H NO MW = 151.16 Caffeine (1,3,7-trimethylxanthine), a bitter, white powder or white-glistening needles, is a central nervous system stimulant. It has the following structural formula: C H N O MW = 194.19 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 Aqra d-dokument sħiħ