DESCRIPTION
Darvon® (Propoxyphene Hydrochloride, USP) is an odorless, white crystalline powder with
a bitter taste. It is freely soluble in water. Chemically, it is (2S,3R)-(+)-4-(Dimethylamino)-3-
methyl-1,2-diphenyl-2-butanol propionate (ester) hydrochloride, which can be represented by
the accompanying structural formula. Its molecular weight is 375.94.
Each Pulvule® contains 65 mg (172.9 µmol) (No. 365) propoxyphene hydrochloride. It also contains FD&C Red No. 33, FD&C Yellow No. 6, gelatin, magnesium stearate, silicone, starch, titanium dioxide, and other inactive ingredients.
Each Darvon Compound-65 Pulvule® contains 65 mg (172.9 µmol) propoxyphene hydrochloride, 389 mg (2,159 µmol) aspirin, and 32.4 mg (166.8 µmol) caffeine.
Darvon Compound-65 contains FD&C Red No. 3, FD&C Yellow No. 6, gelatin, glutamic acid hydrochloride, iron oxide, kaolin, silicone, titanium dioxide, and other inactive ingredients.
Propoxyphene Napsylate, USP is an odorless, white crystalline powder with a bitter taste. It is very slightly soluble in water and soluble in methanol, ethanol, chloroform, and acetone. Chemically, it is ((alpha)S,1R)-(alpha)-[2-(Dimethylamino)-1-methylethyl]-(alpha)-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.
The acetaminophen component is 4′-Hydroxyacetanilide, a white, odorless, crystalline powder
possessing a slightly bitter taste, and is represented by the following structural formula:
Each tablet of Darvon-N contains 100 mg (176.8 µmol) propoxyphene napsylate. The tablet also contains cellulose, cornstarch, iron oxides, lactose, magnesium stearate, silicon dioxide, stearic acid, and titanium dioxide.
Each tablet of Darvocet-N 50 contains 50 mg (88.4 µmol) propoxyphene napsylate and 325 mg (2,150 µmol) acetaminophen.
Each tablet of Darvocet-N 100 contains 100 mg (176.8 µmol) propoxyphene napsylate and 650 mg (4,300 µmol) acetaminophen.
Each tablet of Darvocet-N also contains amberlite, cellulose, FD&CYellow No. 6, magnesium stearate, stearic acid, titanium dioxide, and other inactive ingredients.
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