Each tablet contains:
maprotiline hydrochloride 25 or 75 mg
Treatment of depressive illness in patients with depressive neurosis (dysthymic disorder) and manic depressive illness, depressed type (major depressive disorder). Also effective for relief of anxiety associated with depression
Dosage and administration:
Outpatients with Mild to Moderate Depression:
Initial: 75mg/day for 2 weeks (25mg/day may be used in some patients)
Titrate: May increase gradually in 25mg increments as required and tolerated
Titrate: May increase gradually as required and tolerated
Keep dosages during prolonged maintenance therapy at the lowest effective level; may reduce dose to 75-150mg/day
Pregnancy and breastfeeding:
Pregnancy category B, caution in nursing.
Hypersensitivity to maprotiline, known/suspected seizure disorders, use during or within 14 days after discontinuation of MAOIs, use during the acute phase of myocardial infarction (MI).
Warning and precautions:
Not approved for treatment of bipolar depression.
May precipitate mixed/manic episode in patients at risk for bipolar disorder.
Seizures and hypomanic/manic episodes may occur.
Extreme caution with history of MI and history or presence of cardiovascular disease (CVD) due to possibility of conduction defects, arrhythmias, MI, strokes, and tachycardia.
Pupillary dilation may occur; may trigger an angle closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Caution with hyperthyroidism or with history of urinary retention or narrow-angle glaucoma.
Discontinue with evidence of pathological neutrophil depression; perform leukocyte and differential counts if fever and sore throat develop during therapy.
Dry mouth, drowsiness, dizziness, nervousness, constipation, blurred vision, weakness/fatigue, headache, anxiety, and tremor.
Possible additive atropine-like effects with anticholinergic/sympathomimetic drugs; close supervision and careful dose adjustment required.
Avoid with electroshock therapy.
Caution with thyroid medication; may enhance potential for cardiovascular toxicity.
Caution with guanethidine or similar agents; may block the effects of these drugs.
May increase risk of seizure with phenothiazines and medications known to lower seizure threshold, or when dose of benzodiazepine is rapidly tapered.
May increase levels with hepatic enzyme inhibitors (eg, cimetidine, fluoxetine) and may decrease levels with hepatic enzyme inducers (eg, barbiturates, phenytoin); adjustment of maprotiline dose may be necessary.
Discontinue for as long as clinically feasible prior to elective surgery due to possible interaction with general anesthetics.
Store below 30 °C.
Protect from light.