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:

Bryant Ranch Prepack

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Trimipramine Maleate Capsules are indicated for the relief of symptoms of depression. Endogenous depression is more likely to be alleviated than other depressive states. In studies with neurotic outpatients, the drug appeared to be equivalent to amitriptyline in the less-depressed patients but somewhat less effective than amitriptyline in the more severely depressed patients. In hospitalized depressed patients, trimipramine and imipramine were equally effective in relieving depression. The use of MAOIs intended to treat psychiatric disorders with trimipramine maleate or within 14 days of stopping treatment with trimipramine maleate is contraindicated because of an increased risk of serotonin syndrome. The use of trimipramine maleate within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting trimipramine maleate in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also co

Product summary:

Trimipramine Maleate Capsules equivalent to 50 mg of Trimipramine are #2 Capsules, light blue opaque cap, medium orange opaque body, imprinted “A-294” in black ink on cap and body, filled with white to off-white powder. Capsules are supplied in bottles of: 30 (NDC 72162-2062-03) with a child-resistant closure. Dispense in a tight, light-resistant container as defined in the USP. Preserve in tight container. Protect from excessive heat. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Protect from Moisture. Keep this and all medication out of the reach of children. Keep tightly closed.

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE
Bryant Ranch Prepack
----------
MEDICATION GUIDE
TRIMIPRAMINE MALEATE CAPSULES
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 member has
any of the following symptoms,
especially if they a

Summary of Product characteristics

TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE
BRYANT RANCH PREPACK
----------
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.
20
26
2
4
4
4
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 capsule