Maprotiline hydrochloride tablets are used for the management of depressive disorders, including dysthymic disorder (depressive neurosis) and major depressive disorder (depressed phase of manic depressive illness). It also helps in reducing anxiety symptoms that occur along with depression.

The exact mode of action of maprotiline is not clearly established. It does not mainly stimulate the central nervous system and is not classified as a monoamine oxidase inhibitor. Its effect is thought to result from inhibition of norepinephrine reuptake at nerve terminals, which enhances adrenergic neurotransmission. This mechanism contributes to its antidepressant and anti-anxiety properties.

A single daily dose is an alternative to divided daily doses. Therapeutic effects are sometimes seen within 3 to 7 days, although as long as 2 to 3 weeks are usually necessary.

Initial Adult Dosage: An initial dosage of 75 mg daily is suggested for outpatients with mild to moderate depression. However, in some patients, particularly the elderly, an initial dosage of 25 mg daily may be used. Because of the long half-life of maprotiline, the initial dosage should be maintained for 2 weeks. The dosage may then be increased gradually in 25 mg increments as required and tolerated. In most outpatients, a maximum dose of 150 mg daily will result in therapeutic efficacy. It is recommended that this does not be exceeded except in the most severely depressed patients. In such patients, dosage may be gradually increased to a maximum of 225 mg.

More severely depressed, hospitalized patients should be given an initial daily dose of 100 mg to 150 mg which may be gradually increased as required and tolerated. Most hospitalized patients with moderate to severe depression respond to a daily dose of 150 mg although dosages as high as 225 mg may be required in some cases. The daily dosage of 225 mg should not be exceeded.

Elderly Patients: In general, lower dosages are recommended for patients over 60 years of age. Dosages of 50 mg to 75 mg daily are usually satisfactory as maintenance therapy for elderly patients who do not tolerate higher amounts.

Close monitoring and careful dose adjustment are necessary when maprotiline is used together with anticholinergic or sympathomimetic drugs due to the risk of additive atropine-like effects. Concomitant use of maprotiline with electroconvulsive therapy should be avoided because of limited clinical experience.
Caution is required when administering maprotiline to hyperthyroid patients or those receiving thyroid medications, as there may be an increased risk of cardiovascular toxicity.
Maprotiline should be used cautiously in patients taking guanethidine or similar agents, as it may reduce their pharmacological effects.
The risk of seizures may increase when maprotiline is used along with phenothiazines or when benzodiazepines are rapidly reduced in patients receiving maprotiline.
Due to its similarity to tricyclic antidepressants, plasma levels of maprotiline may increase when used with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decrease with hepatic enzyme inducers (e.g., barbiturates, phenytoin). Dose adjustment may therefore be required.

Maprotiline hydrochloride tablets are contraindicated in patients with known hypersensitivity to maprotiline and in those with known or suspected seizure disorders. It should not be used together with monoamine oxidase (MAO) inhibitors. At least 14 days should pass after stopping MAO inhibitors before starting maprotiline. Dosage should be increased gradually with careful monitoring until optimal response is achieved. The drug is not recommended during the acute phase of myocardial infarction.

Cardiovascular: Rare cases of hypotension, hypertension, tachycardia, palpitation, arrhythmia, heart block, and syncope have been reported.

Psychiatric: Nervousness (6%), anxiety (3%), insomnia (2%), and agitation (2%); rarely confusion (especially in elderly), hallucinations, disorientation, delusions, restlessness, nightmares, hypomania, mania, worsening of psychosis, memory impairment, and feelings of unreality.

Neurological: Drowsiness (16%), dizziness (8%), tremor (3%); rarely numbness, tingling, motor hyperactivity, akathisia, seizures, EEG changes, tinnitus, extrapyramidal symptoms, ataxia, and dysarthria.

Anticholinergic: Dry mouth (22%), constipation (6%), blurred vision (4%); rarely accommodation problems, mydriasis, urinary retention, and delayed urination.

Allergic: Rare cases of skin rash, petechiae, itching, photosensitivity, edema, and drug-induced fever.

Gastrointestinal: Nausea (2%); rarely vomiting, epigastric discomfort, diarrhea, bitter taste, abdominal cramps, and difficulty swallowing.

Endocrine: Rare cases of increased or decreased libido, impotence, and changes in blood sugar levels.

Pregnancy Category B. Reproductive studies in female rabbits, mice, and rats at doses up to 1.3, 7, and 9 times the maximum recommended human dose have shown no evidence of impaired fertility or fetal harm due to maprotiline. However, adequate and well-controlled studies in pregnant women are lacking. Since animal studies do not always predict human response, this drug should be used during pregnancy only when clearly necessary.
Labor and Delivery: The effect of maprotiline on labor and delivery is unknown; therefore, caution is advised as with other CNS depressant drugs.
Nursing Mothers: Maprotiline is excreted in breast milk, and its concentration in milk is similar to that in whole blood at steady state. Caution should be exercised when administered to breastfeeding mothers.

The risk of suicide is inherent in patients with severe depression and may persist until significant improvement occurs. Patients should be closely monitored throughout treatment, and prescriptions should be limited to the minimum required quantity. Hypomanic or manic episodes may occur in some patients receiving tricyclic antidepressants, particularly those with cyclic disorders; such effects have been rarely reported with maprotiline. Before elective surgery, maprotiline should be discontinued if clinically possible, due to limited knowledge of its interaction with general anesthetics. Caution is advised in patients with a history of urinary retention or narrow-angle glaucoma because of its anticholinergic effects.

Tricyclic Anti-depressant

Store below 30°C, protected from light and moisture. Keep out of reach of children.