Surmontil (Trimipramine) Drug Information: Description, User Reviews, Drug Side Effects, Interactions

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February 9, 2012

Surmontil

Prescription Anxiety Medications »

What are anxiety medications and how do they work?

Anxiety is both a normal and useful response to potentially stressful or dangerous situations. It helps by increasing our awareness of what's going on around us and in other ways. For most people, the anxiety is short lived and normally goes away once the situation has passed. But that is not the case for an estimated 40 million adults in the United States who have some type of anxiety disorder and experience ongoing and unwarranted psychological distress. That distress may also manifest itself in physical symptoms such as muscle tension, headaches, or chest pain.

Anxiety medications include multiple types of drugs that are used to treat the symptoms of anxiety disorders. The three most commonly prescribed types of anxiety medication are antidepressants, anti-anxiety medications -- also known as anxiolytics -- and beta-blockers. The first two types of anxiety medications work primarily by affecting the ba...

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SURMONTIL®
(trimipramine maleate)

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 (trimipramine) 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 ther-apy should be monitored appropriately and observed closely for clinical worsening, suici-dality, or unusual changes in behavior. Families and caregivers should be advised of the need for close observation and communication with the prescriber. Surmontil (trimipramine) is not approved for use in pediatric patients. (See WARNINGS: Clinical Worsening and Suicide Risk, PRECAUTIONS: Information for Patients, and PRECAUTIONS: Pediatric Use)

DRUG DESCRIPTION

Surmontil (trimipramine maleate) is 5-(3-dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form).

Surmontil (trimipramine maleate) structural formula illustration

Molecular Formula: C₂₀H₂₆N₂ • C₄H₄O₄ 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 also contains benzyl alcohol, D&C Red 28, edetate calcium disodium, FD&C Red 40, FD&C Yellow 6, parabens (butyl, propyl and methyl), sodium lauryl sulfate, and sodium propionate.

Trimipramine maleate is prepared as a racemic mixture which can be resolved into levorotatory and dextrorotatory isomers. The asymmetric center responsible for optical isomerism is marked in the formula by an asterisk. Trimipramine maleate is an almost odorless, white or slightly cream-colored, crystalline substance, melting at 140°-144° C. It is very slightly soluble in ether and water, is slightly soluble in ethyl alcohol and acetone, and freely soluble in chloroform and methanol at 20° C.

What are the possible side effects of trimipramine (Surmontil)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these...

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