clomipramine hydrochloride clomipramine hydrochloride capsules 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 1,989) 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 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 capsules USP for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION ).
lupin pharmaceuticals, inc.
CAPSULE ORANGE LU C35
LU C35 CAPSULE ORANGE
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HOW SUPPLIED
CLOMIPRAMINE HYDROCHLORIDE capsuleS USP capsules 25 mg – Size '2' hard gelatin capsules with melon opaque cap imprinted with 'LU' in black ink and ivory opaque body imprinted with 'C35' in black ink containing white to off white granular powder Bottles of 30 (NDC 68180-492-06); Bottles of 60 (NDC 68180-492-07); Bottles of 90 (NDC 68180-492-09) and Bottles of 100 (NDC 68180-492-01) capsules 50 mg – Size '1' hard gelatin capsules with blue opaque cap imprinted with 'LU' in black ink and ivory opaque body imprinted with 'C36' in black ink containing white to off white granular powder Bottles of 30 (NDC 68180-493-06); Bottles of 60 (NDC 68180-493-07); Bottles of 90 (NDC 68180-493-09) and Bottles of 100 (NDC 68180-493-01) capsules 75 mg – Size '1' hard gelatin capsules with yellow opaque cap imprinted with 'LU' in black ink and ivory opaque body imprinted with 'C37' in black ink containing white to off white granular powder Bottles of 30 (NDC 68180-494-06); Bottles of 60 (NDC 68180-494-07); Bottles of 90 (NDC 68180-494-09) and Bottles of 100 (NDC 68180-494-01) Storage – Store at 25ºC (77°F); excursions permitted between 15° to 30°C (59° to 86°F). [See USP Controlled Room Temperature]. Dispense in well-closed containers with a child-resistant closure. Protect from moisture. ANIMAL TOXICOLOGY Phospholipidosis and testicular changes, commonly associated with tricyclic compounds, have been observed with clomipramine hydrochloride. In chronic rat studies, changes related to clomipramine hydrochloride consisted of systemic phospholipidosis, alterations in the testes (atrophy, mineralization) and secondary changes in other tissues. In addition cardiac thrombosis and dermatitis/keratitis were observed in rats treated for 2 years at doses which were 24 and 10 times the maximum recommended human daily dose (MRHD), respectively, on a mg/kg basis, and 4 and 1.5 times the MRHD, respectively, on a mg/m 2 basis. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Nagpur 441 108 INDIA Revised: January 2022 ID#: 269281
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