SURMONTIL- 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:

Teva Women's Health, Inc.

INN (International Name):

TRIMIPRAMINE MALEATE

Composition:

TRIMIPRAMINE 25 mg

Administration route:

ORAL

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

SURMONTIL is 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 SURMONTIL or within 14 days of stopping treatment with SURMONTIL is contraindicated because of an increased risk of serotonin syndrome. The use of SURMONTIL within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated (see WARNINGS and DOSAGE AND ADMINISTRATION ). Starting SURMONTIL 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 (

Product summary:

SURMONTIL (trimipramine maleate) Capsules 25 mg — Opaque blue and yellow capsule in bottles of 100 (NDC 51285-538-02). Printed OP and 718 50 mg — Opaque blue and orange capsule in bottles of 100 (NDC 51285-539-02). Printed OP and 719 100 mg — Opaque blue and white capsule in bottles of 100 (NDC 51285-554-02). Printed OP and 720 Store at 20°-25°C (68°-77°F) [See USP Controlled Room Temperature]. Keep bottles tightly closed. Dispense in a tight container. Teva Select Brands, Horsham, PA 19044, Division of Teva Pharmaceuticals USA, Inc. SUR-003 Iss.04/2018

Authorization status:

New Drug Application

Patient Information leaflet

SURMONTIL- TRIMIPRAMINE MALEATE CAPSULE
Teva Women's Health, Inc.
----------
MEDICATION GUIDE
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 are new, worse, or worry you:
•
thou

Summary of Product characteristics

SURMONTIL- TRIMIPRAMINE MALEATE CAPSULE
TEVA WOMEN'S HEALTH, INC.
----------
SURMONTIL
(TRIMIPRAMINE MALEATE)
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
SURMONTIL 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.
SURMONTIL IS NOT
APPROVED FOR USE IN PEDIATRIC PATIENTS. (SEE WARNINGS - CLINICAL
WORSENING AND SUICIDE
RISK, PRECAUTIONS - INFORMATION FOR PATIENTS, AND PRECAUTIONS -
PEDIATRIC USE)
DESCRIPTION
SURMONTIL (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
SURMONTIL capsules contain trimipramine maleate equivalent to 25 mg,
50 mg, or 100 mg of
trimipramine as the base. The inactive ingredients present are black
ink, FD&C Blue 1, gelatin, lactose,
magnesium stearate, and titanium dioxide. The 25 mg dosage strength
also contains benzyl alcohol,
D&C Yellow 10, edetate calcium disodium, FD&C Yellow 6, parabens
(butyl, propyl and methyl),
sodium lauryl sulfate, and sodium propionate; the 50 mg dosage
strength