Trimipramine Maleate 25 mg/1
Trimipramine Maleate · CAPSULE · Elite Laboratories, Inc.
Trimipramine maleate is a tricyclic antidepressant medication taken by mouth as a capsule to treat depression and certain other mental health conditions. It works by affecting certain chemicals in the brain that influence mood and emotional well-being.
Key Facts
- Brand Name
- Trimipramine Maleate
- Generic Name
- Trimipramine Maleate
- NDC Code (Product)
64850-850- Manufacturer
- Elite Laboratories, Inc.
- Strength
- 25 mg/1
- Dosage Form
- CAPSULE
- Route
- ORAL
- Marketing Status
- Application #
- ANDA077361
- Marketing Start
- 11/21/2011
Recall History
No Recall HistorySide Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage & Administration
DOSAGE AND ADMINISTRATION 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 maleate 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. Consequently, the recommended dosage regimens are furnished as a guide which may be modified by factors such as the age of the patient, chronicity and severity of the disease, medical condition of the patient, and degree of psychotherapeutic support. Most antidepressant drugs have a lag period of ten days to four weeks before a therapeutic response is noted. Increasing the dose will not shorten this period but rather increase the incidence of adverse reactions. Usual Adult Dose Outpatients and Office P…
Warnings
WARNINGS 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. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide. There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during the early phases of treatment. Pooled analyses of short-term placebo-controlled trials of antidepressant drugs (SSRIs and others) showed that these drugs increase the risk of suicidal thinking and behavior (suicidality) in children, adolescents, and young adults (aged 18 to 24) with major depressive disorder (MDD) and other psychiatric disorders. Short-term studies did not show an increase in the risk of suicidality with antidepressants compared to placebo in adults beyond age …
Contraindications
CONTRAINDICATIONS Monoamine Oxidase Inhibitors (MAOIs) 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 contraindicated because of an increased risk of serotonin syndrome (see WARNINGS and DOSAGE AND ADMINISTRTION ). Hypersensitivity to Tricyclic Antidepressants Cross-sensitivity between trimipramine maleate and other dibenzazepines is a possibility. Myocardial Infarction The drug is contraindicated during the acute recovery period after a myocardial infarction.
Drug Interactions
Drug Interactions Cimetidine There is evidence that cimetidine inhibits the elimination of tricyclic antidepressants. Downward adjustment of trimipramine maleate 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. In resistant cases of depression in adults, a dose of 2.5 mg/kg/day may have to be exceeded. If a higher dose is needed, ECG monitoring should be maintained during the initiation of therapy and at appropriate intervals during stabilization of dose Drugs Metabolized by P450 2D6 The biochemical activity of the dru…
Adverse Reactions
ADVERSE REACTIONS Note: The pharmacological similarities among the tricyclic antidepressants require that each of the reactions be considered when trimipramine maleate is administered. Some of the adverse reactions included in this listing have not in fact been reported with trimipramine maleate. 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. Anticholinergic Dry mouth and rarely, associated sublingual adenitis; blurred vision, disturbances of accommodation, mydriasis, constipation, paralytic ileus; urinary retention, delayed micturition, dilation of the urinary tract. Allergic Skin rash, petechiae, urticaria, itching, photosensitization, edema of face and t…
Frequently Asked Questions
What is Trimipramine Maleate used for?
Trimipramine maleate is a tricyclic antidepressant medication taken by mouth as a capsule to treat depression and certain other mental health conditions. It works by affecting certain chemicals in the brain that influence mood and emotional well-being.
Is Trimipramine Maleate a controlled substance?
Trimipramine Maleate is not classified as a controlled substance by the DEA.
What is the generic name for Trimipramine Maleate?
The generic name for Trimipramine Maleate is Trimipramine Maleate. There are no other listed brand versions of Trimipramine Maleate.
What is the NDC code for Trimipramine Maleate 25 mg/1?
The NDC (National Drug Code) for Trimipramine Maleate 25 mg/1 is 64850-850, listed by Elite Laboratories, Inc..
Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.
Data from openFDA · Public domain (CC0 1.0)