Does Surmontil (trimipramine) cause side effects?

Surmontil (trimipramine) is a tricyclic antidepressant (TCA) used to treat major depression. Surmontil works by raising the brain's level of the neurotransmitter norepinephrine to more normal levels. It also has anti-cholinergic actions (opposing the effects of the neurotransmitter, acetylcholine) which cause many of its side effects. Surmontil also acts as a sedative. 

Common side effects of Surmontil include:

If Surmontil is discontinued abruptly, you may experience withdrawal symptoms such as

Serious side effects of Surmontil include

  • impaired mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery,
  • increased the risk of seizures in patients with seizures, and
  • increased risk of suicidal thinking and behavior in children and adolescents with depression and other psychiatric disorders. 

Drug interactions of Surmontil include other medications and drugs that slow the brain's processes, such as

Reserpine when taken with Surmontil can cause a stimulatory effect.

Surmontil and other TCAs should not be used with monoamine oxidase inhibitors (MAOIs) because it may result in high fever, convulsions and even death.

Surmontil affects heart rhythm and should not be administered with

Safe use of Surmontil during pregnancy has not been established. If it is to be administered to pregnant patients or women of childbearing potential, the benefits must be weighed against the potential hazards to the fetus.

Safe use of Surmontil during lactation has not been established. If it is to be administered to nursing mothers, the benefits must be weighed against the potential hazards to the child. Consult your doctor before breastfeeding

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

Trimipramine may impair the mental and/or physical abilities required for the performance of potentially hazardous tasks such as driving a car or operating machinery. The anti-cholinergic effects of trimipramine may cause:

  • confusion,
  • delirium,
  • short-term memory problems,
  • disorientation,
  • impaired attention,
  • dry mouth,
  • constipation,
  • difficulty urinating (especially in men with enlarged prostates),
  • blurred vision,
  • decreased sweating with increased body temperature,
  • sexual dysfunction, and
  • worsening of glaucoma.

Older adults are especially sensitive to the anti-cholinergic effects of trimipramine.

Sucking hard candy or chewing gum can help prevent dry mouth.

Trimipramine can increase a person's sensitivity to sunlight; patient's taking trimipramine should wear sunscreen and avoid sun exposure.

Since trimipramine can impair the body's ability to sweat and adapt to hot environments, patients should avoid saunas and excessive heat.

Trimipramine is used with caution in patients with seizures since it can increase the risk of seizures.

If trimipramine is discontinued abruptly headache, nausea, and general discomfort may occur. Therefore, it is recommended that the dose of antidepressant be reduced gradually when therapy is discontinued.

Antidepressants increased the risk of suicidal thinking and behavior in short-term studies in children and adolescents with depression and other psychiatric disorders. Anyone considering the use of trimipramine or any other antidepressant in a child or adolescent must balance this risk with the clinical need.

Patients who are started on therapy should be closely observed for clinical worsening, suicidal thinking or behavior, and unusual changes in behavior.

Surmontil (trimipramine) side effects list for healthcare professionals

Note: The pharmacological similarities among the tricyclic antidepressants require that each of the reactions be considered when Surmontil is administered. Some of the adverse reactions included in this listing have not in fact been reported with Surmontil.

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 tongue.

Hematologic

Bone marrow depression including agranulocytosis, eosinophilia; purpura; thrombocytopenia. Leukocyte and differential counts should be performed in any patient who develops fever and sore throat during therapy; the drug should be discontinued if there is evidence of pathological neutrophil depression.

Gastrointestinal

Nausea and vomiting, anorexia, epigastric distress, diarrhea, peculiar taste, stomatitis, abdominal cramps, black tongue.

Endocrine

Gynecomastia in the male; breast enlargement and galactorrhea in the female; increased or decreased libido, impotence; testicular swelling; elevation or depression of blood sugar levels.

Other

Jaundice (simulating obstructive); altered liver function; weight gain or loss; perspiration; flushing; urinary frequency; drowsiness, dizziness, weakness, and fatigue; headache; parotid swelling; alopecia.

Withdrawal Symptoms

Though not indicative of addiction, abrupt cessation of treatment after prolonged therapy may produce nausea, headache, and malaise.

What drugs interact with Surmontil (trimipramine)?

Cimetidine

  • There is evidence that cimetidine inhibits the elimination of tricyclic antidepressants. Downward adjustment of Surmontil 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 drug metabolizing isozyme cytochrome P450 2D6 (debrisoquin hydroxylase) is reduced in a subset of the caucasian population (about 7-10% of caucasians are so called “poor metabolizers”); reliable estimates of the prevalence of reduced P450 2D6 isozyme activity among Asian, African, and other populations are not yet available.
  • Poor metabolizers have higher than expected plasma concentrations of tricyclic antidepressants (TCAs) when given usual doses.
  • Depending on the fraction of drug metabolized by P450 2D6, the increase in plasma concentration may be small, or quite large (8 fold increase in plasma AUC of the TCA).
  • In addition, certain drugs inhibit the activity of the isozyme and make normal metabolizers resemble poor metabolizers.
  • An individual who is stable on a given dose of TCA may become abruptly toxic when given one of these inhibiting drugs as concomitant therapy.
  • The drugs that inhibit cytochrome P450 2D6 include some that are not metabolized by the enzyme (quinidine; cimetidine) and many that are substrates for P450 2D6 (many other antidepressants, phenothiazines, and the Type 1C antiarrhythmics propafenone and flecainide).
  • While all the selective serotonin reuptake inhibitors (SSRIs), e.g., fluoxetine, sertraline, and paroxetine, inhibit P450 2D6, they may vary in the extent of inhibition.
  • The extent to which SSRI TCA interactions may pose clinical problems will depend on the degree of inhibition and the pharmacokinetics of the SSRI involved.
  • Nevertheless, caution is indicated in the coadministration of TCAs with any of the SSRIs and also in switching from one class to the other. Of administration of TCAs with any of the SSRIs and also in switching from one class to the other.
  • Of particular importance, sufficient time must elapse before initiating TCA treatment in a patient being withdrawn from fluoxetine, given the long half-life of the parent and active metabolite (at least 5 weeks may be necessary).
  • Concomitant use of tricyclic antidepressants with drugs that can inhibit cytochrome P450 2D6 may require lower doses than usually prescribed for either the tricyclic antidepressant or the other drug.
  • Furthermore, whenever one of these other drugs is withdrawn from co-therapy, an increased dose of tricyclic antidepressant may be required. It is desirable to monitor TCA plasma levels whenever a TCA is going to be co-administered with another drug known to be an inhibitor of P450 2D6.

Monoamine Oxidase Inhibitors (MAOIs)

  • See prescribing information.

Serotonergic Drugs

  • See prescribing information.

Summary

Surmontil (trimipramine) is a tricyclic antidepressant (TCA) used to treat major depression. Common side effects of Surmontil include anti-cholinergic effects, and increased sensitivity to sunlight. Safe use of Surmontil during pregnancy has not been established. Safe use of Surmontil during lactation has not been established.

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Medically Reviewed on 6/9/2020
References
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Professional side effects and drug interactions sections courtesy of the U.S. Food and Drug Administration.
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