Ülke: ABD
Dil: İngilizce
Kaynak: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D)
McKesson Contract Packaging
ACETAMINOPHEN
ACETAMINOPHEN 300 mg
PRESCRIPTION DRUG
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET MCKESSON CONTRACT PACKAGING ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS, USP CIII 0050 0150 0350 RX ONLY DESCRIPTION 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: C H NO 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: C H NO •H PO •1/2H O 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) 8 9 2 18 21 3 3 4 2 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, and stearic acid. CLINICAL PHARMACOLOGY This product combines the analgesic effects of a centrally acting analgesic, codeine, with a peripherally acting analgesic, acetaminophen. PHARMACOKINETICS The behavior of the individual components is described below. Codeine Codeine is readily absorbed from the gastrointestinal tract. It is rapidly distributed from the intravascular spaces to the various body tissues, with preferential uptake by parenchymatous organs such as the liver, spleen and kidney. Codeine crosses the blood-brain barrier, and is found in fetal tissue and breast Belgenin tamamını okuyun