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:

Mylan Pharmaceuticals Inc.

INN (International Name):

CLOMIPRAMINE HYDROCHLORIDE

Composition:

CLOMIPRAMINE HYDROCHLORIDE 25 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 hydrochloride capsules 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-

Product summary:

Clomipramine Hydrochloride Capsules, USP are available containing 25 mg, 50 mg or 75 mg of clomipramine hydrochloride, USP. The 25 mg capsules are hard shell gelatin capsules with a medium orange opaque cap and pink opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 3025 in black ink on both the cap and the body. They are available as follows: NDC 0378-3025-01 bottles of 100 capsules The 50 mg capsules are hard shell gelatin capsules with a yellow opaque cap and pink opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 3050 in black ink on both the cap and the body. They are available as follows: NDC 0378-3050-01 bottles of 100 capsules The 75 mg capsules are hard shell gelatin capsules with a swedish orange opaque cap and pink opaque body filled with white to off-white powder. The capsules are axially printed with MYLAN over 3075 in black ink on both the cap and body. They are available as follows: NDC 0378-3075-01 bottles of 100 capsules Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Protect from moisture. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure. PHARMACIST: Dispense a Medication Guide with each prescription.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

CLOMIPRAMINE HYDROCHLORIDE- CLOMIPRAMINE HYDROCHLORIDE CAPSULE
Mylan 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 your

Summary of Product characteristics

CLOMIPRAMINE HYDROCHLORIDE- CLOMIPRAMINE HYDROCHLORIDE CAPSULE
MYLAN PHARMACEUTICALS INC.
----------
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 PEDIATRIC
USE).
DESCRIPTION
Clomipramine hydrochloride capsules, USP are an antiobsessional drug
that belong 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 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 MW = 351.3
Clomipramine hydrochloride, USP is a white or slightly yellow,
crystalline powder. It is freely soluble
in water, in methanol, and in methylene