CLOMIPRAMINE HYDROCHLORIDE- clomipramine hydrochloride capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Bryant Ranch Prepack

INN (International Name):

CLOMIPRAMINE HYDROCHLORIDE

Composition:

CLOMIPRAMINE HYDROCHLORIDE 50 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 Compuls

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLOMIPRAMINE HYDROCHLORIDE- CLOMIPRAMINE HYDROCHLORIDE CAPSULE
Bryant Ranch Prepack
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MEDICATION GUIDE 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.
These include people who have (or have a family history of) bipolar
illness (also called manic-
depressive illness) or suicidal thoughts or actions. 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.
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 family member has
any of the following symptoms,
especially if they are new, worse, or worr

Summary of Product characteristics

CLOMIPRAMINE HYDROCHLORIDE- CLOMIPRAMINE HYDROCHLORIDE CAPSULE
BRYANT RANCH PREPACK
----------
CLOMIPRAMINE HYDROCHLORIDE CAPSULES USP
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 HCL CAPSULES ARE NOT APPROVED FOR USE IN PEDIATRIC
PATIENTS EXCEPT FOR
PATIENTS WITH OBSESSIVE COMPULSIVE DISORDER (OCD). (SEE , , AND ).
WARNINGS: CLINICAL
WORSENING AND SUICIDE RISKPRECAUTIONS: INFORMATION FOR
PATIENTSPRECAUTIONS:
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-5H-
dibenz[b,f]azepine monohydrochloride, and its structural formula is:
C H ClN •HCl
Molecular weight:
351.31
Clomipramine hydrochloride USP is a white to off-white crystalline
p