País: Estados Unidos
Idioma: inglés
Fuente: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
NuCare Pharmaceuticals, Inc.
ACETAMINOPHEN
ACETAMINOPHEN 300 mg
ORAL
PRESCRIPTION DRUG
Acetaminophen and Codeine Phosphate Tablets, USP are indicated for the relief of mild to moderately severe pain. Codeine-containing products are contraindicated for post-operative pain management in children who have undergone tonsillectomy and/or adenoidectomy. Acetaminophen and Codeine Phosphate Tablets should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. Acetaminophen and Codeine Phosphate Tablets are classified as a Schedule III controlled substance. Codeine can produce drug dependence of the morphine type and, therefore, has the potential for being abused. Psychological dependence, physical dependence and tolerance may develop upon repeated administration, and it should be prescribed and administered with the same degree of caution appropriate to the use of other oral narcotic medications.
Acetaminophen and Codeine Phosphate Tablets, USP 300 mg /30 mg are white, round, flat, beveled edged tablets debossed “IP 33” on obverse and “3” on reverse. They are available as follows: Bottles of 15: NDC 66267-001-15 Bottles of 20: NDC 66267-001-20 Bottles of 24: NDC 66267-001-24 Bottles of 30: NDC 66267-001-30 Bottles of 60: NDC 66267-001-60 Store Acetaminophen and Codeine Phosphate Tablets, USP 300 mg/30 mg at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in tight, light-resistant container as defined in the USP. Questions or Comments? Call 1-877-835-5472 Monday through Friday 9AM-5PM EST. Repackaged by: NuCare Pharmaceuticals, Inc. Orange, CA 92867 Manufactured by: Amneal Pharmaceuticals Hauppauge, NY 11788 Rev. 12-2015-00
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE- ACETAMINOPHEN AND CODEINE TABLET NUCARE PHARMACEUTICALS, INC. ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP 300MG/30MG CIII RX ONLY PRESCRIBING INFORMATION BOXED WARNING WARNING: DEATH RELATED TO ULTRA-RAPID METABOLISM OF CODEINE TO MORPHINE RESPIRATORY DEPRESSION AND DEATH HAVE OCCURRED IN CHILDREN WHO RECEIVED CODEINE FOLLOWING TONSILLECTOMY AND/OR ADENOIDECTOMY AND HAD EVIDENCE OF BEING ULTRA-RAPID METABOLIZERS OF CODEINE DUE TO A CYP2D6 POLYMORPHISM. 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 Each tablet contains: Acetaminophen, USP……………………………………………………..300 mg Codeine Phosphate, USP…………………………………………………...30 mg (Warning: May be habit forming) Inactive ingredients: croscarmellose sodium, crospovidone, lactose monohydrate, magnesium stearate, microcrystalline cellulose, povidone, pregelatinized starch and stearic acid. Acetaminophen and codeine is supplied in tablet form for oral administration. Acetaminophen, 4'-hydroxyacetanlllde, IS a slightly bitter, white, odorless, crystalline powder, is a non- opiate, non-salicylate analgesic and antipyretic. It has the following structural formula: Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-l7-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: CLINICAL PHARMACOLOGY Acetaminophen and Codeine Phosphate Tablets combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen. PHARMACOKINETICS The behavior on the individual components is described below. Codeine Codeine is rapidly abs Leer el documento completo