Surmontil

Surmontil,

trademark for an antidepressant (trimipramine maleate).

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Surmontil [sur-mon´til]

trademark for a preparation of trimipramine maleate, a tricyclic antidepressant.

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trimipramine maleate

Apo-Trimip (CA), Novo-Tripramine (CA), Rhotrimine (CA), Surmontil

Pharmacologic class: Dibenzazepine derivative tricyclic

Therapeutic class: Tricyclic antidepressant

Pregnancy risk category C

FDA Boxed Warning

• Drug may increase risk of suicidal thinking and behavior in children and adolescents with major depressive disorder and other psychiatric disorders. Risk must be balanced with clinical need, as depression itself increases suicide risk. With patient of any age, observe closely for clinical worsening, suicidality, and unusual behavior changes when therapy begins. Advise family and caregivers to observe patient closely and communicate with prescriber as needed.
• Drug isn't approved for use in pediatric patients.

Action

Unknown. Thought to inhibit presynaptic norepinephrine and serotonin reuptake at CNS and peripheral receptors, causing increased synaptic concentrations of these neurotransmitters.

Availability

Capsules: 25 mg, 50 mg, 100 mg

⊘Indications and dosages

➣ Depression

Adults: In outpatients, 75 mg/day P.O. in divided doses, increased gradually p.r.n. to a maximum of 200 mg/day; maintenance dosage is 50 to 150 mg/day P.O. for approximately 3 months. In hospitalized patients, 100 mg/day P.O. in divided doses, increased over several days p.r.n. to 200 mg/day; if no improvement occurs in 2 to 3 weeks, may increase to a maximum of 300 mg/day.

Dosage adjustment

• Hepatic disease
• Elderly patients

Off-label uses

• Depression in adolescents

Contraindications

• Hypersensitivity to drug or other dibenzazepines
• Acute recovery phase after myocardial infarction (MI)
• MAO inhibitor use within past 14 days

Precautions

Use cautiously in:
• increased intraocular pressure, angle-closure glaucoma, urinary retention, cardiac or hepatic disease, hyperthyroidism, urethral or ureteral spasm, seizure disorders, severe depression, suicidal ideation or behavior
• elderly patients
• pregnant or breastfeeding patients.

Administration

☞ Don't give within 14 days of MAO inhibitors.

Route	Onset	Peak	Duration
P.O.	Unknown	2 hr	Unknown

Adverse reactions

CNS: confusion, drowsiness, dizziness, asthenia, fatigue, headache, disorientation, hallucinations, delusions, restlessness, anxiety, agitation, insomnia, nightmares, hypomania, psychosis exacerbation, paresthesia, incoordination, ataxia, tremor, peripheral neuropathy, extrapyramidal symptoms, EEG changes, seizures, cerebrovascular accident (CVA), suicide or suicidal ideation (especially in child or adolescent)

CV: hypotension, hypertension, tachycardia, palpitations, heart block, arrhythmias, MI

EENT: blurred vision, mydriasis, abnormal accommodation, tinnitus

GI: nausea, vomiting, diarrhea, constipation, epigastric distress, abdominal cramps, stomatitis, black tongue, dry mouth, paralytic ileus

GU: urinary retention or frequency, delayed voiding, urinary tract dilation, gynecomastia, galactorrhea, increased or decreased libido, erectile dysfunction, testicular swelling

Hematologic: eosinophilia, purpura, thrombocytopenia, agranulocytosis

Hepatic: jaundice, hepatic dysfunction

Metabolic: hyperglycemia, hypoglycemia, syndrome of inappropriate antidiuretic hormone secretion

Skin: rash, petechiae, pruritus, urticaria, alopecia, diaphoresis, flushing, photosensitivity

Other: abnormal taste, swollen face and tongue, weight changes, parotid gland swelling

Interactions

Drug-drug. Anticholinergics (such as some antidepressants, antihistamines, atropine, disopyramide, haloperidol, phenothiazines, quinidine): additive anticholinergic effects

Antihistamines, CNS depressants, opioids, sedative-hypnotics: additive CNS depression

Antithyroid drugs: increased risk of cardiotoxicity

Barbiturates: decreased trimipramine blood level, increased depressant effect

Cimetidine, flecainide, fluoxetine, paroxetine, phenothiazines, quinidine, sertraline: increased trimipramine blood level, greater risk of toxicity

Clonidine: increased risk of hypertensive crisis

Guanethidine: blocked guanethidine effects

Local anesthetics containing epinephrine, local decongestants, sympathomimetic amines: increased effects of these drugs

MAO inhibitors: hypertension, hyperpyrexia, seizures, death

Drug-diagnostic tests. Alanine aminotransferase, aspartate aminotransferase: increased levels

Glucose: increased or decreased level

Drug-herbs. Angel's trumpet, belladonna, henbane, jimsonweed, scopolia: increased anticholinergic effects

Chamomile, hops, kava, scopolia, skullcap, valerian: increased CNS depression

St. John's wort: decreased trimipramine blood level and efficacy

Drug-behaviors. Alcohol use: increased CNS depression

Sun exposure: increased risk of photosensitivity

Patient monitoring

• Monitor neurologic status. Watch for improvement in depression, as well as signs and symptoms of CVA or seizures.
☞ Assess for suicide risk and drug hoarding.
• Monitor CBC and liver function tests. Stay alert for blood dyscrasias and hepatic dysfunction.

Patient teaching

• Tell patient he may take with or without food.
• Instruct patient to use only as prescribed.
• Caution patient not to stop drug abruptly, because doing so may cause nausea, headache, and malaise.
☞ Instruct patient (or parent, as appropriate) to promptly report loss of consciousness, worsening depression, bleeding, bruising, or suicidal thoughts or behavior (especially in child or adolescent).
• Advise patient to avoid alcohol and herbs.
• Tell patient to avoid exposure to sun and to wear sunscreen and protective clothing when going outdoors.
• Caution patient to avoid driving and other hazardous activities until drug effects are known.
• As appropriate, review all other significant and life-threatening adverse reactions and interactions, especially those related to the drugs, tests, herbs, and behaviors mentioned above.

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Surmontil®

Trimipramine, see there