国家: 美国
语言: 英文
来源: NLM (National Library of Medicine)
CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D)
Lupin Pharmaceuticals, Inc.
ORAL
PRESCRIPTION DRUG
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 t
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/m2 basis. Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States Manufactured by: Lupin Limited Nagpur 441 108 INDIA Revised: January 2022 ID#: 269281
Abbreviated New Drug Application
CLOMIPRAMINE HYDROCHLORIDE- CLOMIPRAMINE HYDROCHLORIDE CAPSULES CAPSULE Lupin Pharmaceuticals, Inc. ---------- Medication Guide Clomipramine Hydrochloride Capsules USP (kloe mip' ra meen hye'' droe klor' ide) Antidepressant Medicines, Depression and other Serious Mental Illnesses, and Suicidal Thoughts or Actions Read the Medication Guide that comes with you or your family member's antidepressant medicine. This Medication Guide is only about the risk of suicidal thoughts and actions with antidepressant medicines. Talk to your, or your family member's, healthcare provider about: • all risks and benefits of treatment with antidepressant medicines • all treatment choices for depression or other serious mental illness What is the most important information I should know about antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions? 1. Antidepressant medicines may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. 2. Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions. Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) bipolar illness (also called manic- depressive illness) or suicidal thoughts or actions. 3. How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? • Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. • Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. • Keep all follow-up visits with the healthcare provider as scheduled. Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or 阅读完整的文件
CLOMIPRAMINE HYDROCHLORIDE- CLOMIPRAMINE HYDROCHLORIDE CAPSULES CAPSULE LUPIN PHARMACEUTICALS, INC. ---------- CLOMIPRAMINE HYDROCHLORIDE CAPSULES USP, 25 MG, 50 MG, AND 75 MG RX ONLY SUICIDALITY AND ANTIDEPRESSANT DRUGS ANTIDEPRESSANTS INCREASED THE RISK COMPARED TO PLACEBO OF SUICIDAL THINKING AND BEHAVIOR (SUICIDALITY) IN CHILDREN, ADOLESCENTS, AND YOUNG ADULTS IN SHORT-TERM STUDIES OF MAJOR DEPRESSIVE DISORDER (MDD) AND OTHER PSYCHIATRIC DISORDERS. ANYONE CONSIDERING THE USE OF CLOMIPRAMINE HYDROCHLORIDE OR ANY OTHER ANTIDEPRESSANT IN A CHILD, ADOLESCENT, OR YOUNG ADULT MUST BALANCE THIS RISK WITH THE CLINICAL NEED. SHORT-TERM STUDIES DID NOT SHOW AN INCREASE IN THE RISK OF SUICIDALITY WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS BEYOND AGE 24; THERE WAS A REDUCTION IN RISK WITH ANTIDEPRESSANTS COMPARED TO PLACEBO IN ADULTS AGED 65 AND OLDER. DEPRESSION AND CERTAIN OTHER PSYCHIATRIC DISORDERS ARE THEMSELVES ASSOCIATED WITH INCREASES IN THE RISK OF SUICIDE. PATIENTS OF ALL AGES WHO ARE STARTED ON ANTIDEPRESSANT THERAPY SHOULD BE MONITORED APPROPRIATELY AND OBSERVED CLOSELY FOR CLINICAL WORSENING, SUICIDALITY, OR UNUSUAL CHANGES IN BEHAVIOR. FAMILIES AND CAREGIVERS SHOULD BE ADVISED OF THE NEED FOR CLOSE OBSERVATION AND COMMUNICATION WITH THE PRESCRIBER. CLOMIPRAMINE HYDROCHLORIDE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS EXCEPT FOR PATIENTS WITH OBSESSIVE COMPULSIVE DISORDER (OCD) _(SEE WARNINGS, CLINICAL_ _WORSENING AND SUICIDE RISK; PRECAUTIONS, INFORMATION FOR PATIENTS;_ _AND PRECAUTIONS, PEDIATRIC USE)_. DESCRIPTION Clomipramine Hydrochloride Capsules USP is an antiobsessional drug that belongs to the class (dibenzazepine) of pharmacologic agents known as tricyclic antidepressants. Clomipramine Hydrochloride Capsules USP are available as capsules of 25, 50, and 75 mg for oral administration. Clomipramine hydrochloride USP is 3-chloro-5-[3-(dimethylamino)propyl]-10,11- dihydro 5_H_-dibenz[_b_,_f _] azepine monohydrochloride, and its structural formula is: C H CLN ● HCL MW = 351.31 Clomipramine h 阅读完整的文件