국가: 미국
언어: 영어
출처: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE ANHYDROUS - UNII:UX6OWY2V7J)
Apotheca, Inc.
ACETAMINOPHEN
ACETAMINOPHEN 300 mg
ORAL
PRESCRIPTION DRUG
Acetaminophen and codeine phosphate tablets are indicated for the relief of mild to moderately severe pain. 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 300 mg/30 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed "2064" and "V" on one side and debossed "3" on the reverse side. They are supplied in bottles of 30, 50, 60, 90, 100, 120, 180, 500 and 1000. Acetaminophen and Codeine Phosphate Tablets 300 mg/60 mg are white, round, flat-faced, beveled edge, scored (bisect bar) tablets, debossed "2065" and "V" on one side and debossed "4" on the reverse side. They are supplied in bottles of 100, 500 and 1000.
Abbreviated New Drug Application
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET APOTHECA, INC. ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII 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: 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: 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, and Stearic Acid. (TEVA PHARMACEUTICALS). In addition each tablet contains the following inactive ingredients: magnesium stearate, microcrystalline cellulose, povidone, pregelatinized corn starch, sodium metabisulfite, sodium starch glycolate and stearic acid. (VINTAGE PHARMACEUTICALS) 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 전체 문서 읽기