CLOMIPRAMINE HYDROCHLORIDE
CAPSULES USP,
25 mg, 50 mg and 75 mg
Rx only
DESCRIPTION
Clomipramine hydrochloride is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants.
Clomipramine hydrochloride is 3-chloro-5-[3-(dimethylamino)propyl]-10,11-dihydro-5H-dibenz[b,f]azepine monohydrochloride, and its structural formula is:
Clomipramine hydrochloride is a white to off-white crystalline powder. It is freely soluble in water, in methanol, and in methylene chloride, and insoluble in ethyl ether and in hexane. Its molecular weight is 351.3.
Clomipramine hydrochloride capsules, USP, for oral administration, contain 25 mg, 50 mg, or 75 mg of clomipramine hydrochloride and the following inactive ingredients: colloidal silicon dioxide, corn starch, gelatin, magnesium stearate, pharmaceutical glaze, propylene glycol, red iron oxide, silicon dioxide, sodium lauryl sulfate, synthetic black iron oxide, titanium dioxide, FD&C Red #40, D&C Yellow #10 Aluminum Lake, FD&C Blue #1 Aluminum Lake, FD&C Blue #2 Aluminum Lake, FD&C Red #40 Aluminum Lake. The following additional product specific coloring agents are employed:
25 mg– FD&C Blue #1, D&C Yellow #10, and D&C Red #28
50 mg– D&C Yellow #10 and D&C Red #33
75 mg– FD&C Blue #1
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