מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
BUTALBITAL (UNII: KHS0AZ4JVK) (BUTALBITAL - UNII:KHS0AZ4JVK), ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CAFFEINE (UNII: 3G6A5W338E) (CAFFEINE - UNII:3G6A5W338E)
Cardinal Health 107, LLC
BUTALBITAL
BUTALBITAL 50 mg
ORAL
PRESCRIPTION DRUG
Butalbital, acetaminophen and caffeine tablets 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 mar
Butalbital, Acetaminophen and Caffeine Tablets, USP Containing 50 mg butalbital, 325 mg acetaminophen and 40 mg caffeine. Available as white, round shaped tablets, debossed "2355" on one side, and debossed "V" on the reverse side. Available Overbagged with 10 tablets per bag, NDC 55154-7147-0 Store at 20° to 25°C (68° to 77°F) with excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] FOR YOUR PROTECTION: DO not use if blister is torn or broken. PACKAGING INFORMATION American Health Packaging unit dose blisters (see How Supplied section) contain drug product from Par Pharmaceutical as follows: (50 mg/325 mg/40 mg / 50 UD) NDC 68084-396-65 packaged from NDC 0603-2544 Distributed by: American Health Packaging Columbus, OH 43217 Distributed By: Cardinal Health Dublin, OH 43017 L52816131220 8239601/0817
Abbreviated New Drug Application
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLET CARDINAL HEALTH 107, LLC ---------- BUTALBITAL, ACETAMINOPHEN AND CAFFEINE TABLETS, USP 8239601/0817 RX ONLY BOXED 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 Tablets, USP are supplied in tablet form for oral administration. Each tablet contains the following active ingredients: butalbital, USP ..................................................50 mg acetaminophen, USP ........................................325 mg caffeine, USP ....................................................40 mg _Inactive Ingredients: _colloidal silicon dioxide, croscarmellose sodium, crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. 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 קרא את המסמך השלם