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:

Breckenridge Pharmaceutical, Inc.

INN (International Name):

TRIMIPRAMINE MALEATE

Composition:

TRIMIPRAMINE 25 mg

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 capsules or within 14 days of stopping treatment with trimipramine maleate capsules is contraindicated because of an increased risk of serotonin syndrome. The use of trimipramine maleate capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting trimipramine maleate capsules in a patient who is being treated with MAOIs such as linezolid or intravenous methylene blue is also contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRATION ). Cross-sensitivity between trimipramine maleate capsules and other dibenzazepines is a possibility. The drug is contraindicated during the acute recovery period after a myocardial infarction.

Product summary:

25 mg — #3 Capsules, with a yellow opaque body and blue opaque cap in bottles of 100 (NDC 51991-944-01) and in bottles of 30 (NDC 51991-944-33). Capsules contain white or almost white powder. Printed with TR25 in black ink on the cap. 50 mg — #2 Capsules, with an orange opaque body and blue opaque cap in bottles of 100 (NDC 51991-945-01) and in bottles of 30 (NDC 51991-945-33) Capsules contain white or almost white powder. Printed with TR50 in black ink on the cap. 100 mg — #0 Capsules, with a white opaque body and light blue opaque cap in bottles of 100 (NDC 51991-946-01) and in bottles of 30 (NDC 51991-946-33). Capsules contain white or almost white powder. Printed with TR100 in black ink on the cap. Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Keep bottles tightly closed. Dispense in a tight container. Dispense with Medication Guide available at: www.bpirx.com/products/patientinformation

Authorization status:

Abbreviated New Drug Application

Patient Information leaflet

TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE
Breckenridge Pharmaceutical, Inc.
----------
MEDICATION GUIDE
Trimipramine Maleate (trye-MIP-ra-meen MAL-ee-ate) Capsules
Antidepressant Medicines, Depression and other Serious Mental
Illnesses, and Suicidal Thoughts or
Actions
Dispense with Medication Guide available at:
www.bpirx.com/products/patientinformation
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 sympto

Summary of Product characteristics

TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE
BRECKENRIDGE PHARMACEUTICAL, 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 CAPSULES 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 CAPSULES ARE
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,
20
26
2
4
4
4
or 100 mg of trimipramine as the base. The inactive ingredients
present are lactose
monohydrate and magnesium stearate. The capsule shell contains D&C
Yellow 10 (25
mg), FD&C Blue 1 (25 mg, 50 mg and 100 mg), FD&C Yellow 6 (25 mg, 50
mg), D&C
Red 28 (50 mg), FD&C Red 40 (50 mg), gelati