clomipramine hydrochloride 50 mg
INDICATIONS AND USAGE Clomipramine hydrochloride capsules, USP are indicated for the treatment of obsessions and compulsions in patients with Obsessive-Compulsive Disorder (OCD). The obsessions or compulsions must cause marked distress, be time-consuming, or significantly interfere with social or occupational functioning, in order to meet the DSM-III-R (circa 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego-dystonic. Compulsions are repetitive, purposeful, and intentional behaviors performed in response to an obsession or in a stereotyped fashion, and are recognized by the person as excessive or unreasonable. The effectiveness of clomipramine hydrochloride for the treatment of OCD was demonstrated in multicenter, placebo-controlled, parallel-group studies, including two 10-week studies in adults and one 8-week study in children and adolescents 10 to 17 years of age. Patients in all studies had moderate-to-severe OCD (DSM-III), with mean baseline ratings on the Yale-Brown Obsessive Compulsive Scale (YBOCS) ranging from 26 to 28 and a mean baseline rating of 10 on the NIMH Clinical Global Obsessive Compulsive Scale (NIMH-OC). Patients taking clomipramine experienced a mean reduction of approximately 10 on the YBOCS, representing an average improvement on this scale of 35% to 42% among adults and 37% among children and adolescents. Clomipramine-treated patients experienced a 3.5 unit decrement on the NIMH-OC. Patients on placebo showed no important clinical response on either scale. The maximum dose was 250 mg/day for most adults and 3 mg/kg/day (up to 200 mg) for all children and adolescents. The effectiveness of clomipramine hydrochloride for long-term use (i.e., for more than 10 weeks) has not been systematically evaluated in placebo-controlled trials. The physician who elects to use clomipramine hydrochloride for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient (see DOSAGE AND ADMINISTRATION ).
upsher-smith laboratories, llc
CAPSULE TURQUOISE 0631 50mg
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HOW SUPPLIED
CLOMIPRAMINE HYDROCHLORIDE capsules, USP
CLOMIPRAMINE HYDROCHLORIDE capsules, USP 25 mg are orange opaque cap & white opaque body, printed with “0630 25mg” on the body in black ink. They are supplied as follows: NDC 0832-0630-11 bottles of 100 NDC 0832-0630-10 bottles of 1000
CLOMIPRAMINE HYDROCHLORIDE capsules, USP 50 mg are aqua blue opaque cap & white opaque body, printed with “0631 50mg” on the body in black ink. They are supplied as follows: NDC 0832-0631-11 bottles of 100 NDC 0832-0631-10 bottles of 1000
CLOMIPRAMINE HYDROCHLORIDE capsules, USP 75 mg are yellow opaque cap & white opaque body, printed with “0632 75mg” on the body in black ink. They are supplied as follows: NDC 0832-0632-11 bottles of 100 NDC 0832-0632-10 bottles of 1000 Storage – Store at 20º to 25ºC (68° to 77°F) [see USP Controlled Room Temperature]. Protect from moisture. Dispense in a tight, light-resistant container, with a child-resistant closure, as required.
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