Land: USA
Sprog: engelsk
Kilde: NLM (National Library of Medicine)
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D), CODEINE PHOSPHATE (UNII: GSL05Y1MN6) (CODEINE - UNII:Q830PW7520)
UAD LABORATORIES
Acetaminophen and Codeine Phosphate
TABLET
650 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. 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, 650 mg/60 mg are available as a capsule-shaped, white, uncoated, unprinted tablet single-scored on one side, in bottles of 100, NDC 0785-6270-01 and in bottles of 500, NDC 0785-6270-50. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container with a child-resistant closure. CAUTION: Federal law prohibits dispensing without prescription.
ACETAMINOPHEN AND CODEINE PHOSPHATE- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLET UAD LABORATORIES ---------- ACETAMINOPHEN AND CODEINE PHOSPHATE TABLETS USP CIII 650 MG/60 MG 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 MW = 151.16 Codeine phosphate, 7,8-didehydro-4, 5 α-epoxy-3-methoxy-17-methylmorphinan-6 α-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 ½H O MW = 406.37 Each tablet contains: Acetaminophen.........................................650 mg Codeine Phosphate....................................60 mg (Warning: May be habit forming) In addition each tablet contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, crospovidone, microcrystalline cellulose, 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. 8 9 2 18 21 3• 3 4• 2 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 milk. The plasma concentration does not correlate with brain concentration or relief of pain; however, codeine is not bound to plasma proteins and does not accumulate in body tissues. The plasma half-life is about 2.9 hours. The elimination of codeine is primarily via the kidneys, and about 90% of an oral dose is excreted by the kid Læs hele dokumentet