TRIMIPRAMINE MALEATE capsule

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

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

Verfügbar ab:

Glenmark Pharmaceuticals Inc.,USA

Verabreichungsweg:

ORAL

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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

Produktbesonderheiten:

Trimipramine Maleate Capsules equivalent to 25 mg of Trimipramine are #2 Capsules, light blue opaque cap, yellow opaque body, imprinted “A-293” in black ink on cap and body, filled with white to off-white powder. Capsules are supplied in bottles of: 30 (NDC 68462-804-30) with a child-resistant closure. 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 68462-805-30) with a child-resistant closure. Trimipramine Maleate Capsules equivalent to 100 mg of Trimipramine are #2 Capsules, light blue opaque cap, white opaque body, imprinted “A-295” in black ink on cap and body, filled with white to off-white powder. Capsules are supplied in bottles of: 30 (NDC 68462-806-30) 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. Manufactured by: Elite Laboratories, Inc. Northvale, NJ 07647 Manufactured for: Glenmark Pharmaceuticals, Inc., USA Mahwah, NJ 07430 Manufactured in USA Revised May 2019 IN0529

Berechtigungsstatus:

Abbreviated New Drug Application

Gebrauchsinformation

TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE
Glenmark Pharmaceuticals Inc.,USA
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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,
especia

Fachinformation

TRIMIPRAMINE MALEATE- TRIMIPRAMINE MALEATE CAPSULE
GLENMARK PHARMACEUTICALS INC.,USA
----------
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