Trimipramine

Trimipramine 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.

Dosage should be initiated at a low level and increased gradually, noting carefully the clinical response and any evidence of intolerance. Lower dosages are recommended for elderly patients and adolescents. Lower dosages are also recommended for outpatients as compared to hospitalized patients who will be under close supervision. It is not possible to prescribe a single dosage schedule of trimipramine capsules that will be therapeutically effective in all patients. The physical psychodynamic factors contributing to depressive symptomatology are very complex, spontaneous remissions or exacerbations of depressive symptoms may occur with or without drug therapy.

Monoamine Oxidase Inhibitors (MAOIs) The use of MAOIs intended to treat psychiatric disorders with trimipramine capsules or within 14 days of stopping treatment with trimipramine capsules is contraindicated because of an increased risk of serotonin syndrome. The use of trimipramine capsules within 14 days of stopping an MAOI intended to treat psychiatric disorders is also contraindicated. Starting trimipramine 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.

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 capsules or any other antidepressant in a child, adolescent, or young adult must balance this risk with the clinical need. Clinical Worsening and Suicide Risk Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs.

Note: The pharmacological similarities among the tricyclic antidepressants require that each of the reactions be considered when trimipramine capsules are administered. Some of the adverse reactions included in this listing have not in fact been reported with trimipramine capsules. Cardiovascular Hypotension, hypertension, tachycardia, palpitation, myocardial infarction, arrhythmias, heart block, stroke. Psychiatric Confusional states (especially the elderly) with hallucinations, disorientation, delusions, anxiety, restlessness, agitation, insomnia and nightmares, hypomania, exacerbation of psychosis. Neurological Numbness, tingling, paresthesias of extremities, incoordination, ataxia, tremors, peripheral neuropathy, extrapyramidal symptoms, seizures, alterations in EEG patterns, tinnitus, syndrome of inappropriate ADH (antidiuretic hormone) secretion.

Cimetidine There is evidence that cimetidine inhibits the elimination of tricyclic antidepressants. Downward adjustment of trimipramine capsules dosage may be required if cimetidine therapy is initiated, upward adjustment if cimetidine therapy is discontinued. Alcohol Patients should be warned that the concomitant use of alcoholic beverages may be associated with exaggerated effects. Catecholamines/Anticholinergics It has been reported that tricyclic antidepressants can potentiate the effects of catecholamines. Similarly, atropine-like effects may be more pronounced in patients receiving anticholinergic therapy. Therefore, particular care should be exercised when it is necessary to administer tricyclic antidepressants with sympathomimetic amines, local decongestants, local anesthetics containing epinephrine, atropine or drugs with an anticholinergic effect.

Store at 20°-25°C (68°-77°F).