PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN tablet, film coated

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

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

Tilgjengelig fra:

Andrx Pharmaceuticals, Inc.

INN (International Name):

PROPOXYPHENE NAPSYLATE AND ACETOMINOPHEN

Legemiddelform:

TABLET, FILM COATED

Sammensetning:

100 mg

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

Propoxyphene Napsylate and Acetaminophen Tablets, 100 mg/500 mg are indicated for the relief of mild to moderate pain, either when pain is present alone or when it is accompanied by fever. CONTRAINDICATIONS Hypersensitivity to propoxyphene or acetaminophen.

Produkt oppsummering:

Propoxyphene napsylate and acetaminophen tablets, USP 100 mg/500 mg are available as brown, film coated, capsule shaped tablets debossed with Andrx logo “” on one side and “882” on the other. Bottles of 100 Tablets            NDC# 62037-882-01 Bottles of 500 Tablets            NDC# 62037-882-05 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container with a child-resistant closure. Information, including a description of the dosage form and maximum daily dosage, is available to patients receiving a propoxyphene napsylate product. The acute lethal doses of the hydrochloride and napsylate salts of propoxyphene were determined in 4 species. The results shown in Figure 2 indicate that, on a molar basis, the napsylate salt is less toxic than the hydrochloride. This may be due to the relative insolubility and retarded absorption of propoxyphene napsylate. Figure 2 Some indication of the relative insolubility and retarded absorption of propoxyphene napsylate was obtained by measuring plasma propoxyphene levels in 2 groups of 4 dogs following oral administration of equimolar doses of the 2 salts. As shown in Figure 3 , the peak plasma concentration observed with propoxyphene hydrochloride was much higher than that obtained after administration of the napsylate salt. Although none of the animals in this experiment died, 3 of the 4 dogs given propoxyphene hydrochloride exhibited convulsive seizures during the time interval corresponding to the peak plasma levels. The 4 animals receiving the napsylate salt were mildly ataxic but not acutely ill. Figure 3: Plasma propoxyphene concentrations in dogs following large doses of the hydrochloride and napsylate salts. Figure 3 Manufactured by: Andrx Pharmaceuticals, Inc. Ft. Lauderdale, FL 33331 Rev. date: 01/05 7520

Preparatomtale

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/500 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 per USP.
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.
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.
Each tablet of propoxyphene napsylate and acetaminophen tablets, USP
contains 100 mg propoxyphene
napsylate and 500 mg acetaminophen. Each tablet also contains
colloidal silicon dioxide,
croscarmellose sodium, crospovidone, FD&C blue #2 aluminum lake, FD&C
red #40 aluminum lake,
FD&C yellow #5 aluminum lake, hypromellose 2910, magnesium stearate,
microcrystalline cellulose,
polyethylene glycol, polyvinyl alcohol, povidone, pregelatinized
starch, stearic acid, talc 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