clomipramine hydrochloride capsule
INDICATIONS AND USAGE Clomipramine Hydrochloride capsules, USP is 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 egodystonic. 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 capsules, USP 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 CMI 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. CMI-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 capsules, USP 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 ).
leading pharma, llc
CAPSULE YELLOW LP 166
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clomipramine hydrochloride capsule
leading pharma, llc
clomipramine hydrochloride capsule
leading pharma, llc
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HOW SUPPLIED
CLOMIPRAMINE HYDROCHLORIDE capsules USP capsules 25 mg – Opaque orange cap imprinted in black with LP 167 and opaque blue body imprinted in black with LP 167. Bottles of 30………....………...……….....…... NDC 69315-167-03 Bottles of 90………....………...……….....…... NDC 69315-167-09 Bottles of 100………....………...……….....…. NDC 69315-167-01 capsules 50 mg – Opaque yellow cap and body imprinted in black with LP 166. Bottles of 30………..………...……….....…….NDC 69315-166-03 Bottles of 90………....………...……….....…...NDC 69315-166-09 Bottles of 100………..………...……….......… NDC 69315-166-01 capsules 75 mg – Opaque orange cap imprinted in black with LP 165 and opaque white body imprinted in black with with LP 165. Bottles of 30……….………...……….....………NDC 69315-165-03 Bottles of 100……….………...……….....……. NDC 69315-165-01 Storage – Store at 20º to 25ºC (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed, light-resistant container as defined in the USP, using a child-resistant closure.
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