CLOMIPRAMINE HYDROCHLORIDE capsule

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

Zydus Pharmaceuticals USA Inc.

Administreringssätt:

ORAL

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Clomipramine hydrochloride capsules, USP 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 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 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

Produktsammanfattning:

Clomipramine Hydrochloride Capsules USP, 25 mg are white to off white powder filled in size "2" capsule with opaque pink cap printed with '1065' in black ink and opaque light pink body and are supplied as: NDC 70710-1065-3 in bottle of 30 capsules with child-resistant closure NDC 70710-1065-9 in bottle of 90 capsules with child-resistant closure NDC 70710-1065-1 in bottle of 100 capsules Clomipramine Hydrochloride Capsules USP, 50 mg are white to off white powder filled in size "1" capsule with opaque yellow cap printed with '1066' in black ink and opaque light pink body and are supplied as: NDC 70710-1066-3 in bottle of 30 capsules with child-resistant closure NDC 70710-1066-9 in bottle of 90 capsules with child-resistant closure NDC 70710-1066-1 in bottle of 100 capsules Clomipramine Hydrochloride Capsules USP, 75 mg are white to off white powder filled in size "1" capsule with opaque dark pink cap printed with '1067' in black ink and opaque light pink body and are supplied as: NDC 70710-1067-3 in bottle of 30 capsules with child-resistant closure NDC 70710-1067-9 in bottle of 90 capsules with child-resistant closure NDC 70710-1067-1 in bottle of 100 capsules Storage Store at 20ºC to 25ºC (68°F to 77°F) [see USP Controlled Room Temperature]. Dispense in tight, light-resistant 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. Medication Guide available at www.zydususa.com/medguides or call 1-877-993-8779. Manufactured by: Cadila Healthcare Limited Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 Rev.:06/21

Bemyndigande status:

Abbreviated New Drug Application

Bipacksedel

CLOMIPRAMINE HYDROCHLORIDE - CLOMIPRAMINE HYDROCHLORIDE CAPSULE
Zydus Pharmaceuticals USA Inc.
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Medication Guide
Clomipramine Hydrochloride (kloe mip' ra meen hye'' droe klor' ide)
Capsules, USP
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 your

Produktens egenskaper

CLOMIPRAMINE HYDROCHLORIDE - CLOMIPRAMINE HYDROCHLORIDE CAPSULE
ZYDUS PHARMACEUTICALS USA INC.
----------
CLOMIPRAMINE HYDROCHLORIDE CAPSULES, USP
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 are an antiobsessional drug
that belongs to
the class (dibenzazepine) of pharmacologic agents known as tricyclic
antidepressants.
Clomipramine hydrochloride is 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:
MOLECULAR FORMULA = C
H CLN .HCL
MOLECULAR WEIGHT = 351.31
Clomipramine hydrochloride, USP