PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN tablet, film coated

Țară: Statele Unite ale Americii

Limbă: engleză

Sursă: NLM (National Library of Medicine)

Ingredient activ:

Propoxyphene Napsylate (UNII: 38M219L1OJ) (propoxyphene - UNII:S2F83W92TK), Acetaminophen (UNII: 362O9ITL9D) (acetaminophen - UNII:362O9ITL9D)

Disponibil de la:

Andrx Pharmaceuticals, Inc.

INN (nume internaţional):

PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN

Forma farmaceutică:

TABLET, FILM COATED

Calea de administrare:

ORAL

Tip de prescriptie medicala:

PRESCRIPTION DRUG

Indicații terapeutice:

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

Rezumat produs:

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

Caracteristicilor produsului

PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN- PROPOXYPHENE NAPSYLATE AND
ACETOMINOPHEN TABLET, FILM COATED
ANDRX PHARMACEUTICALS, INC.
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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