Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
Propoxyphene Hydrochloride (UNII: CB2TL9PS0T) (Propoxyphene - UNII:S2F83W92TK), Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)
Watson Laboratories, Inc.
Propoxyphene Hydrochloride and Acetaminophen
TABLET
65 mg
ORAL
PRESCRIPTION DRUG
Propoxyphene hydrochloride and acetaminophen tablets are indicated for the relief of mild-to-moderate pain, either when pain is present alone or when it is accompanied by fever. Hypersensitivity to propoxyphene or to acetaminophen.
Propoxyphene Hydrochloride and Acetaminophen Tablets 65 mg/650 mg are orange, oblong, unscored tablets, marked 714 , and 65 over 650 on one side of the tablet and WATSON on the other side, containing 65 mg of propoxyphene hydrochloride and 650 mg of acetaminophen available in bottles of 100 and 500. Keep tightly closed. Protect from light. Store at controlled room temperature 15°-30°C (59°-86°F). Dispense in a tight, light-resistant container as defined in the USP.
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN- PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN TABLET WATSON LABORATORIES, INC. ---------- PROPOXYPHENE HCL AND ACETAMINOPHEN TABLETS USP REVISED: SEPTEMBER 2003 RX ONLY 30163-3 DESCRIPTION Propoxyphene hydrochloride is an odorless white crystalline powder with a bitter taste. It is freely soluble in water. Chemically, it is (2_S_, 3_R_)-(+)-4-(Dimethylamino)-3-methyl-1,2-diphenyl-2-butanol propionate (ester) hydrochloride, which can be represented by the following structural formula: C H NO •HCL MOLECULAR WEIG HT: 375.93 Acetaminophen is a white, crystalline powder, possessing a slightly bitter taste. It is soluble in boiling water and freely soluble in alcohol. Chemically, it is 4’-Hydroxyacetanilide, which can be presented by the following structural formula: C H NO MOLECULAR WEIG HT: 151.16 Each tablet, for oral administration, contains 65 mg propoxyphene hydrochloride and 650 mg acetaminophen. In addition, each tablet contains the following inactive ingredients: corn starch, crospovidone, D&C Red No. 30 aluminum lake, D&C Yellow No. 10 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polacrillin potassium, polyethylene glycol, polysorbate 80, povidone, pregelatinized starch, stearic acid, and titanium dioxide. CLINICAL PHARMACOLOGY Propoxyphene is a centrally acting narcotic analgesic agent. Equimolar doses of propoxyphene hydrochloride or napsylate provide similar plasma concentrations. Following administration of 65, 130, or 195 mg of propoxyphene hydrochloride, the bioavailability of propoxyphene is equivalent to that of 100, 200, or 300 mg respectively of propoxyphene napsylate. Peak plasma concentrations of 22 29 2 8 9 2 1 propoxyphene are reached in 2 to 2 / hours. After a 65-mg oral dose of propoxyphene hydrochloride, peak plasma levels of 0.05 to 0.1 mcg/mL are achieved. As shown in Figure 1, the napsylate salt tends to be absorbed more slowly than the hydrochloride. At or near therapeutic doses, this absorption difference is Pročitajte cijeli dokument