CLOMIPRAMINE HYDROCHLORIDE- clomipramine hydrochloride capsule

País: Estados Unidos

Idioma: inglés

Fuente: NLM (National Library of Medicine)

Ingredientes activos:

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

Disponible desde:

Micro Labs Limited

Vía de administración:

ORAL

tipo de receta:

PRESCRIPTION DRUG

indicaciones terapéuticas:

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 1989) diagnosis of OCD. Obsessions are recurrent, persistent ideas, thoughts, images, or impulses that are ego­dystonic. 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

Resumen del producto:

Clomipramine Hydrochloride Capsules, USP Capsules 25 mg – Melon Yellow OP cap / Ivory Opaque body size 3 hard gelatin capsule imprinted in black "M" on cap and "37" on body, filled with white to off white granular powder. Bottles of 30:                          NDC 42571-342-30 Bottles of 90:                          NDC 42571-342-90 Bottles of 100:                        NDC 42571-342-01 Bottles of 500:                        NDC 42571-342-05 Capsules 50 mg – Aqua blue OP cap / Ivory Opaque body size 1 hard gelatin capsule imprinted in black "M" on cap and "38" on body, filled with white to off white granular powder. Bottles of 30:                          NDC 42571-343-30 Bottles of 90:                          NDC 42571-343-90 Bottles of 100:                        NDC 42571-343-01 Capsules 75 mg – Yellow Opaque Cap / Ivory Opaque body size 1 hard gelatin capsule imprinted in black with "M" on cap and "39" on body, filled with white to off white granular powder. Bottles of 30:                          NDC 42571-344-30 Bottles of 90:                          NDC 42571-344-90 Bottles of 100:                        NDC 42571-344-01 Storage – Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Dispense in well-closed, light-resistant containers with child resistant closure. Protect from moisture.

Estado de Autorización:

Abbreviated New Drug Application

Información para el usuario

CLOMIPRAMINE HYDROCHLORIDE - CLOMIPRAMINE HYDROCHLORIDE CAPSULE
Micro Labs Limited
----------
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 family

Ficha técnica

CLOMIPRAMINE HYDROCHLORIDE - CLOMIPRAMINE HYDROCHLORIDE CAPSULE
MICRO LABS LIMITED
----------
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
CAPSULES, USP 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 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-
5H-dibenz[b,f ]azepine monohydrochloride, and its structural formula
is:
Clomipramine hydrochloride USP is a white to faint