Clomipramine Hydrochloride 25 MG Oral Capsule
INDICATIONS AND USAGE Clomipramine hydrochloride capsules 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 capsules 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 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 for extended periods should periodically re-evaluate the long-term usefulness of the drug for the individual patient ( see DOSAGE AND ADMINISTRATION ).
Amneal Pharmaceuticals NY LLC
CAPSULE ORANGE AMNEAL 1108
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HOW SUPPLIED Clomipramine Hydrochloride capsules USP, 25 mg are supplied as hard gelatin capsules filled with white to off-white granular powder having ‘AMNEAL’ printed on orange opaque cap and ‘1108’ on pink opaque body with black ink. They are available as follows: Bottles of 30: NDC 69238-1108-3 Bottles of 90: NDC 69238-1108-9 Clomipramine Hydrochloride capsules USP, 50 mg are supplied as hard gelatin capsules filled with white to off-white granular powder having ‘AMNEAL’ printed on yellow opaque cap and ‘1109’ on pink opaque body with black ink. They are available as follows: Bottles of 30: NDC 69238-1109-3 Bottles of 90: NDC 69238-1109-9 Clomipramine Hydrochloride capsules USP, 75 mg are supplied as hard gelatin capsules filled with white to off-white granular powder having ‘AMNEAL’ printed on red opaque cap and ‘1110’ on pink opaque body with black ink. They are available as follows: Bottles of 30: NDC 69238-1110-3 Bottles of 90: NDC 69238-1110-9 Storage – Store at 20º to 25ºC (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed containers with a child-resistant closure. Protect from moisture.
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