Trimipramine Maleate

Pronunciation: trye-MIP-ra-meen MAL-ee-ate
Class: Tricyclic compound

Trade Names

Surmontil
- Capsules 25 mg
- Capsules 50 mg
- Capsules 100 mg

Apo-Trimip (Canada)

Pharmacology

Mechanism of action is not known.

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Indications and Usage

Relief of symptoms of depression.

Contraindications

Hypersensitivity to any tricyclic antidepressant; use in combination with an MAOI or within 14 days of treatment with an MAOI; during acute recovery phase following an MI. Cross-sensitivity may occur among the dibenzazepines.

Dosage and Administration

Adolescents and Elderly

PO Initially, 50 mg/day, with gradual incremental increases up to 100 mg/day, depending on response and tolerance.

Hospitalized Patients
Adults

PO Initially, 100 mg/day. This may be gradually increased in a few days to 200 mg/day, depending on response and tolerance. If improvement does not occur in 2 to 3 wk, the dose may be increased to a max of 250 to 300 mg/day.

Outpatients and Office Patients
Adults

PO Initially, 75 mg/day in divided doses, increased to 150 mg/day. Doses of more than 200 mg/day are not recommended. Maintenance therapy ranges from 50 to 150 mg/day.

Storage/Stability

Store tablets at controlled room temperature (68° to 77°F).

Drug Interactions

Alcohol, CNS depressants

Depressant effects may be additive.

Anticholinergics/Catecholamines

Effects of the catecholamine or anticholinergic may be potentiated.

Cimetidine

May cause increased trimipramine blood levels.

Cisapride, sparfloxacin

Contraindicated in patients receiving tricyclic antidepressants.

Clonidine

Loss of BP control and possibly life-threatening elevations in BP.

Drugs inhibiting CYP2D6 (amiodarone, fluoxetine, quinidine)

Trimipramine blood levels may be elevated, increasing the pharmacologic and adverse reactions.

Guanethidine

Effects may be blocked by trimipramine.

MAOIs

May cause hyperpyretic crisis, severe seizures, and death when given with trimipramine.

SSRIs (eg, sertraline)

Risk of serotonin syndrome may be increased.

Laboratory Test Interactions

None well documented.

Adverse Reactions

Cardiovascular

Arrhythmias, heart block, hypertension, hypotension, MI, palpitation, stroke, tachycardia.

CNS

Agitation, alterations in EEG patterns, anxiety, ataxia, confusional states (especially in the elderly), delusions, disorientation, dizziness, drowsiness, exacerbation of psychosis, extrapyramidal symptoms, fatigue, hallucinations, headache, hypomania, incoordination, insomnia, manic and hypomanic episodes, nightmares, numbness, paresthesias of extremities, peripheral neuropathy, restlessness, seizures, tingling, tremors, weakness.

Dermatologic

Alopecia, perspiration.

EENT

Blurred vision, disturbances of accommodation, mydriasis, tinnitus.

Endocrine

Breast enlargement and galactorrhea (females), gynecomastia (males), impotence, increased and decreased blood glucose, increased and decreased libido, testicular swelling.

GI

Abdominal cramps, anorexia, black tongue, constipation, diarrhea, dry mouth, epigastric distress, nausea, paralytic ileus, peculiar taste, stomatitis, vomiting.

Genitourinary

Delayed micturition, dilation of urinary tract, urinary frequency, urinary retention.

Hematologic

Bone marrow suppression (including agranulocytosis, eosinophilia, purpura, thrombocytopenia).

Hepatic

Altered liver function, jaundice.

Metabolic

SIADH, weight gain or loss.

Miscellaneous

Allergy (including edema of face and hands, itching, petechiae, photosensitivity, skin rash, urticaria), flushing, parotid swelling.

Precautions

Warnings

Antidepressants increased the risk of suicidal thinking and behavior in short-term studies in children and adolescents with major depressive disorder and other psychiatric disorders. Closely observe patients who are started on therapy for clinical worsening, suicidality, or unusual changes in behavior.


Pregnancy

Category C .

Children

Safety and efficacy not established.

Hepatic Function

Use with caution.

Special Risk Patients

Use with caution in patients with CV disease, increased IOP, history of urinary retention, history of narrow-angle glaucoma, hyperthyroidism, or history of seizure disorder.

Schizophrenia

Activation of psychosis may occur.

Suicide

Supervise depressed patients at risk during initial therapy. Prescribe the smallest quantity consistent with good patient management in order to reduce the risk of overdose.

Withdrawal

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

Overdosage

Symptoms

Agitation, cardiac arrhythmias, CNS depression (including coma), confusion, dilated pupils, disturbed concentration, drowsiness, hyperactive reflexes, hyperpyrexia, hypothermia, muscle rigidity, seizures, severe hypotension, stupor, transient visual hallucinations, vomiting.

Patient Information

  • Advise patient to read the Medication Guide before using product the first time and with each refill.
  • Advise patient and caregiver to be alert for abnormal changes in mood or thinking and to immediately report the following symptoms to health care provider: anxiety, agitation, hostility or aggression, impulsivity, irritability, panic attacks, suicidal thoughts and behavior.
  • Advise patient that medication will be started at a low dose and then increased as tolerated until max benefit is obtained.
  • Advise patient to take prescribed dose without regard to meals, but to take with food if stomach upset occurs.
  • Advise patient that if a dose is missed, to skip that dose and take the next dose at the regularly scheduled time. Caution patient to never take 2 doses at the same time.
  • Advise patient not to change the dose or stop taking unless advised by health care provider.
  • Inform patient that it may take 1 to 4 wk to note improvement in symptoms and to continue with the prescribed therapy once improvement has been noted.
  • Advise patient to take frequent sips of water, suck on ice chips or sugarless hard candy, or chew sugarless gum if dry mouth occurs.
  • Advise patient to avoid alcoholic beverages while taking medication.
  • Advise patient that drug may impair judgment, thinking, or reflexes, and to use caution while driving or performing other tasks requiring mental alertness until tolerance is determined.
  • Advise patient to contact health care provider if rash, hives, or other symptoms of an allergic reaction occur, or if experiencing bothersome adverse reactions, such as unusual sweating, headache, drowsiness, nausea, tremors, or changes in sexual function.
  • Caution patient to avoid unnecessary exposure to ultraviolet (UV) light (eg, sunlight, tanning booths) and to use sunscreen and wear protective clothing when exposed to UV light until tolerance is determined.

Copyright © 2009 Wolters Kluwer Health.

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