Introduction

Maprotiline hydrochloride, USP is a tetracyclic anti depressant, available as 25 mg, 50 mg and 75 mg tab lets for oral administration. Its chemical name is N-methyl-9,10-ethanoanthra cene-9(10H)-propylamine hydrochloride.

Maprotiline hydrochloride is a fine, white to off-white, practically odorless crystalline powder. It is freely soluble in methanol and chloroform, slightly soluble in water, and practically insoluble in isooctane. The tablets contain the following inactive ingredients: col loidal silicon dioxide, cros carmel lose sodium, hypromellose, magnesium stearate, microcrystalline cellulose, polydextrose, polyethylene glycol, pregelatinized starch (corn), sodium lauryl sulfate, titanium di ox ide and triacetin. Additionally, the 50 mg tablet contains FD&C Blue No. 1 Aluminum Lake.

Uses

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.

Pharmacology

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

Contraindications

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 a gradual increase in dosage until optimum response is achieved. The drug is not recommended for use during the acute phase of myocardial infarction.