CLOMIPRAMINE HYDROCHLORIDE- clomipramine hydrochloride capsules capsule

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

Aktiv ingrediens:

CLOMIPRAMINE HYDROCHLORIDE (UNII: 2LXW0L6GWJ) (CLOMIPRAMINE - UNII:NUV44L116D)

Tilgjengelig fra:

Lupin Pharmaceuticals, Inc.

Administreringsrute:

ORAL

Resept typen:

PRESCRIPTION DRUG

Indikasjoner:

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

Produkt oppsummering:

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

Autorisasjon status:

Abbreviated New Drug Application

Informasjon til brukeren

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

Preparatomtale

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