Nazione: Stati Uniti
Lingua: inglese
Fonte: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
DirectRX
ACETAMINOPHEN
ACETAMINOPHEN 300 mg
ORAL
PRESCRIPTION DRUG
Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. Codeine-containing products are contraindicated for postoperative pain management in children who have undergone tonsillectomy and/or adenoidectomy. This product should not be administered to patients who have previously exhibited hypersensitivity to codeine or acetaminophen. - Controlled Substance Acetaminophen and codeine phosphate tablets are classified as a Schedule III controlled substance. Abuse and Dependence 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 are classified as a Schedule III controlled substance. Codeine can produce drug dependence of the morp
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET DIRECTRX ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE BOXED WARNING SECTION 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. 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. DESCRIPTION SECTION Acetaminophen and codeine is supplied in tablet form for oral administration. 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: C8H9NO2 M.W. 151.16 Codeine phosphate, 7,8-didehydro-4,5α-epoxy-3-methoxy-17-methylmorphinan-6α-ol phosphate (1:1) (salt) hemihydrate, a white crystalline powder, is a narcotic analgesic and antitussive. It has the following structural formula: C18H21NO3•H3PO4•1/2H2O M.W. 406.37 Each tablet contains: acetaminophen...........................300 mg codeine phosphate.......................15 mg (Warning: May be habit forming) OR acetaminophen...........................300 mg codeine phosphate....................... 30 mg (Warning: May be habit forming) OR acetaminophen...........................300 mg codeine phosphate....................... 60 mg (Warning: May be habit forming) In addition, each tablet contains the following inactive ingredients: corn starch, colloidal silicon dioxide, croscarmellose sodium, magnesium stearate, and microcrystalline cellulose. The 300 mg/60 mg strength tablets also contain crospovidone, povidone, pregelatinized starch, Leggi il documento completo