Ludiomil Tablet

Maprotiline hydrochloride tablets are indicated for the treatment of depressive illness in patients with depressive neurosis (dysthymic disorder) and manic depressive illness, depressed type (major depressive disorder). Maprotiline is also effective for the relief of anxiety associated with depression.

The mechanism of action of maprotiline is not precisely known. It does not act primarily by stimulation of the central nervous system and is not a monoamine oxidase inhibitor. The postulated mechanism of maprotiline is that it acts primarily by potentiation of central adrenergic synapses by blocking reuptake of norepinephrine at nerve endings. This pharmacologic action is thought to be responsible for the drug's antidepressant and anxiolytic effects.

Adult: As hydrochloride: 25-75 mg daily in 3 divided doses, gradually increased in 25 mg increments at 1-2 wk intervals to 150 mg/day if necessary. Up to 225 mg/day in severely depressed patients.

Elderly: Initial: 25 mg daily. May increase slowly according to response to 50-75 mg daily if needed.

Administration

May be taken with or without food.

Close super vision and careful adjustment of dosage are required when administering maprotiline concomitantly with anticholinergic or sympathomimetic drugs because of the possibility of additive atropine like effects. Concurrent administration of maprotiline with electroshock therapy should be a voided because of the lack of experience in this area.

Caution should be exercised when administering maprotiline to hyperthyroid patients or those on thyroid medication because of the possibility of enhanced potential for cardiovascular toxicity of maprotiline.

Maprotiline should be used with caution in patients receiving guanethidine or similar agents since it may block the pharmacologic effects of these drugs.

The risk of seizures may be increased when maprotiline is taken concomitantly with phenothiazines or when the dos age of benzodiazepines is rapidly tapered in patients receiving maprotiline.

Because of the pharmacologic similarity of maprotiline hydrochloride to the tricyclic antidepressants, the plasma concentration of maprotiline may be increased when the drug is given concomitantly with hepatic enzyme inhibitors (e.g., cimetidine, fluoxetine) and decreased by concomitant administration with hepatic enzyme inducers (e.g., barbiturates, phenytoin), as has occur red with tricyclic antidepressants. Adjustment of the dosage of maprotiline hydrochloride may therefore be necessary in such cases.

Maprotiline hydrochloride tab lets are contraindicated in patients hypersensitive to maprotiline and in patients with known or suspected seizure disorders. It should not be given concomitantly with monoamine oxidase (MAO) inhibitors. A minimum of 14 days should be allowed to elapse after discontinuation of MAO inhibitors before treatment with maprotiline is initiated. Effects should be monitored with gradual increase in dosage until optimum response is achieved. The drug is not recommended for use during the acute phase of myocardial infarction.

Dry mouth, constipation, blurred vision, drowsiness, dizziness, tremor, nervousness, anxiety, insomnia, agitation, confusion, nausea, weakness and fatigue, headache, CV disorders, altered liver function, changes in blood glucose concentrations, allergic skin manifestations.

Pregnancy Category B. Reproduction studies have been performed in female laboratory rabbits, mice, and rats at doses up to 1.3, 7, and 9 times themaximum daily human dose respectively and have revealed no evidence of impaired fertility or harm to the fetus due to maprotiline. There are, however, no adequate and well controlled studies in pregnant women. Be cause animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed.

Labor and Delivery: Although the effect of maprotiline on labor and delivery is unknown, caution should be exercised as with any drug with CNS depressant action

Nursing Mothers: Maprotiline is excreted in breast milk. At steady-state, the concentrations in milk correspond closely to the concentrations in whole blood. Caution should be exercised when maprotiline hydrochloride is administered to a nursing woman.

Urinary retention, prostatic hyperplasia, chronic constipation, untreated angle-closure glaucoma; hyperthyroidism; risk of suicide; may precipitate mania or psychotic symptoms; withdraw gradually; may impair ability to operate machinery. Pregnancy and lactation; elderly.

Deaths may occur from overdosage with this class of drugs. Multiple drug ingestion (including alcohol) is common in deliberate overdose. As the management is complex and changing, it is recommended that the physician contact a poison control center for current information on treatment. Signs and symptoms of toxicity develop rapidly after overdose. There fore, hospital monitoring is required as soon as possible.

Tricyclic Anti-depressant.

Store at 20° to 25°C. Protect from light. Dispense in a tight, light-resistant container as defined in the USP using a child-resistant closure.