Application Nr Approved Date Route Status External Links
ANDA074947 1998-04-30 Oral RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

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 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 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 For Extended Periods Should Periodically Reevaluate The Long-Term Usefulness Of The Drug For The Individual Patient (see Dosage And Administration).

All Formulated Excipients (8 Total)

Name Structure Kind Function Status
1. Silicon Dioxide SILICON DIOXIDE Unresolved AC-Anticaking agent , MISC-Miscellaneous , STAB-Stabilizer GRAS-Generally recognized as safe.
2. Gelatin GELATIN Unresolved
3. Magnesium Stearate MAGNESIUM STEARATE Molecular AF-Antifoaming (or defoaming) agent , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
4. Shellac SHELLAC Unresolved
5. Propylene Glycol PROPYLENE GLYCOL Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Ferric Oxide Red FERRIC OXIDE RED Molecular
7. Sodium Lauryl Sulfate SODIUM LAURYL SULFATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , SANI-Sanitizing agent , SDA-Solubilizing & dispersing agent REG-Food additives for which a petition has been filed and a regulation issued.
8. Titanium Dioxide TITANIUM DIOXIDE Unresolved DYE-Dye

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Clomipramine Hydrochloride CLOMIPRAMINE HYDROCHLORIDE ZINC20248