Nazione: Stati Uniti
Lingua: inglese
Fonte: 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 tablets USP is indicated for the relief of the symptom complex of tension (or muscle contraction) headache. Evidence supporting the efficacy and safety of butalbital, acetaminophen, and caffeine tablets USP in the treatment of multiple recurrent headaches is unavailable. Caution in this regard is required because butalbital is habit-forming and potentially abusable. Butalbital, acetaminophen, and caffeine tablets USP is contraindicated under the following conditions: - Hypersensitivity or intolerance to any component of this product. - Patients with porphyria. 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
Butalbital, acetaminophen, and caffeine tablets USP Containing 50 mg butalbital, 325 mg acetaminophen, and 40 mg caffeine. Available as white, round uncoated tablets, engraved WATSON on one side and 3369 on other side supplied in bottles of 100 and 500. Bottles of 100 are supplied with child-resistant closures. Store below 30°C (86°F); dispense in a tight container. Keep out of reach of children. Rx only For all medical inquiries contact: ACTAVIS Medical Communications Parsippany, NJ 07054 1-800-272-5525 Manufactured By: Actavis Laboratories FL, Inc. Fort Lauderdale, FL 33314 USA Distributed By: Actavis Pharma, Inc. Parsippany, NJ 07054 USA Content Updated: August 2014 174241-5
Abbreviated New Drug Application
BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE- BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLET ACTAVIS PHARMA, INC. ---------- BUTALBITAL, ACETAMINOPHEN, AND CAFFEINE TABLETS USP CONTENT UPDATED: AUGUST 2014 RX ONLY 174241-5 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 is 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 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: _Inactive Ingredients: _crospovidone, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch, and stearic acid. CLINICAL PHARMACOLOGY Butalbital, acetaminophen, and caffeine tablets USP 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 prote Leggi il documento completo