TRIMIPRAMINE MALEATE capsule

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

TRIMIPRAMINE MALEATE (UNII: 269K6498LD) (TRIMIPRAMINE - UNII:6S082C9NDT)

Available from:

Actavis Pharma, Inc.

INN (International Name):

TRIMIPRAMINE MALEATE

Composition:

TRIMIPRAMINE 25 mg

Prescription type:

PRESCRIPTION DRUG

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE
ACTAVIS PHARMA, INC.
----------
TRIMIPRAMINE MALEATE CAPSULES, 25 MG, 50 MG
AND 100 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
TRIMIPRAMINE MALEATE 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.
TRIMIPRAMINE
MALEATE IS NOT APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS:
CLINICAL WORSENING
AND SUICIDE RISK, PRECAUTIONS: INFORMATION FOR PATIENTS, AND
PRECAUTIONS:
PEDIATRIC USE.)
DESCRIPTION
Trimipramine maleate is 5-(3-dimethylamino-2-methylpropyl)-10,
11-dihydro-5H-dibenz (b,f) azepine
acid maleate (racemic form).
MOLECULAR FORMULA: C
H N • C H O MOLECULAR WEIGHT: 410.5
Trimipramine maleate capsules contain trimipramine maleate equivalent
to 25 mg, 50 mg or 100 mg of
trimipramine as the base.
Inactive Ingredients: Each capsule contains lactose monohydrate and
magnesium stearate. The capsule
shell contains the following ingredients: D&C Yellow 10 (25 mg and 50
mg), FD&C Blue #1 (25 mg, 50
mg and 100 mg), FD&C Red #40 (50 mg), gelatin, and titanium dioxide.
The capsules are imprinted