propoxyphene hydrochloride and acetaminophen- Propoxyphene Hydrochloride and Acetaminophen tablet

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

Propoxyphene Hydrochloride (UNII: CB2TL9PS0T) (Propoxyphene - UNII:S2F83W92TK), Acetaminophen (UNII: 362O9ITL9D) (Acetaminophen - UNII:362O9ITL9D)

제공처:

Watson Laboratories, Inc.

INN (국제 이름):

Propoxyphene Hydrochloride and Acetaminophen

약제 형태:

TABLET

구성:

65 mg

관리 경로:

ORAL

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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.

제품 요약:

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.

제품 특성 요약

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