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(trimipramine maleate) Capsules
Suicidality and Antidepress ant Drugs
Antidepress ants increased the risk compared to placebo of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults in short-term studies of major depressivedis order (MDD) and other psychiatricdis orders. Anyone considering the use of SURMONTIL or any other antidepres s ant 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 antidepress ants compared to placebo in adults beyond age 24; there
was a reduction in risk with antidepress ants compared to placebo in adults aged 65 and older. Depress ion and certain other pschiatricdis orders are themselves associated with increases in the risk of suicide. Patients of all ages who are started on antidepress anttherapy 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 us e in pediatric patients. (See WARNINGS - Clinical Worsening and Suicide Risk, PATIENT INFORMATION, and PRECAUTIONS - Pediatric Use)
SURMONTIL (trimipramine maleate) is 5-(3-dimethylamino-2-methylpropyl)-10,11-dihydro-5H-dibenz (b,f) azepine acid maleate (racemic form).
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; difficult breathing; swelling of your face, lips, tongue, or throat.
Report any new or worsening symptoms to your doctor, 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:
- a feeling that you might pass out;
- new or...
What are the precautions when taking trimipramine (Surmontil)?
See also the Warning section.
Before taking trimipramine, tell your doctor or pharmacist if you are allergic to it; or to other tricyclic antidepressants (e.g., amitriptyline, imipramine); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood problems (e.g., agranulocytosis, thrombocytopenia), breathing problems (e.g., asthma, chronic obstructive pulmonary disorder-COPD), diabetes, electroshock therapy, personal or family history of glaucoma (angle-closure type), heart problems (e.g., recent heart attack, arrhythmias, coronary artery disease, heart...
Last reviewed on RxList: 1/19/2016
This monograph has been modified to include the generic and brand name in many instances.
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