Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
Propoxyphene Napsylate (UNII: 38M219L1OJ) (propoxyphene - UNII:S2F83W92TK), Acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)
Andrx Pharmaceuticals, Inc.
PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN
TABLET, FILM COATED
ORAL
PRESCRIPTION DRUG
Propoxyphene napsylate and acetaminophen tablets, 100 mg/650 mg 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 acetaminophen
Propoxyphene napsylate and acetaminophen tablets USP, 100 mg/650 mg are available in: The white tablets are capsule shaped, film coated, and debossed with the on one side and “930” on the other. They are available as follows: Bottles of 100 NDC 62037-930-01 Bottles of 500 NDC 62037-930-05 The pink tablets are capsule shaped, film coated, and debossed with the on one side and “931” on the other. They are available as follows: Bottles of 100 NDC 62037-931-01 Bottles of 500 NDC 62037-931-05 Store at 20 to 25°C (68 to 77°F) [see USP Controlled Room Temperature]. Manufactured by: Andrx Pharmaceuticals, Inc. Ft. Lauderdale, FL 33314 Rev date: 01/04 7360
PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN- PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN TABLET, FILM COATED ANDRX PHARMACEUTICALS, INC. ---------- PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN TABLETS USP, 100 MG/650 MG CIV RX ONLY DESCRIPTION Propoxyphene Napsylate, USP is an odorless, white crystalline solid with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is (αS, 1 _R_)-α-[2-(Dimethylamino)-1-methylethyl]-α-phenylphenethyl propionate compound with 2- naphthalenesulfonic acid (1:1) monohydrate, which can be represented by the accompanying structural formula. Its molecular weight is 565.72. Propoxyphene napsylate differs from propoxyphene hydrochloride in that it allows more stable liquid dosage forms and tablet formulations. Because of differences in molecular weight, a dose of 100 mg (176.8 μmol) of propoxyphene napsylate is required to supply an amount of propoxyphene equivalent to that present in 65 mg (172.9 μmol) of propoxyphene hydrochloride. Each tablet of propoxyphene napsylate and acetaminophen contains 100 mg (176.8 μmol) propopoxyphene napsylate and 650 mg (4,300 μmol) acetaminophen. Each tablet also contains colloidal silicon dioxide, croscarmellose sodium, crospovidone, hypromellose 2910 6cP, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 8000, and stearic acid. Each white tablet also contains hypromellose 2910 3cP, hypromellose 2910 6cP, hypromellose 2910 50cP, polydextrose, polyethylene glycol 8000, titanium dioxide and triacetin. Each pink tablet also contains FD&C Red #40 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, polyethylene glycol 8000, titanium dioxide and triacetin. 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 equiv Pročitajte cijeli dokument