API

PHENELZINE SULFATE

Drug classification

Antidepressant (monoamine oxidase inhibitor, non-selective MAOI)

Dosage form

TABLET;ORAL

API strength per dosage

EQ 15MG BASE

Dose

Adults: Initial dose 15 mg orally three times daily; increase by 15 mg every few days as needed to 60–90 mg daily in divided doses. Pediatrics: Safety and efficacy not established. Elderly or debilitated: Use lower initial doses and titrate cautiously. Adjust for hepatic impairment; contraindicated in severe hepatic disease.

Mechanism of action

Irreversibly inhibits monoamine oxidase enzymes MAO-A and MAO-B, preventing oxidative deamination of neurotransmitters such as serotonin, norepinephrine, and dopamine, thereby increasing their synaptic concentrations and enhancing monoaminergic neurotransmission in the central nervous system.

Indications

Treatment of major depressive disorder, especially atypical, non-endogenous, or treatment-resistant depression.

Side effects

Hypertensive crisis, orthostatic hypotension, dizziness, headache, insomnia, weight gain, sexual dysfunction, dry mouth, constipation, blurred vision, edema, hepatotoxicity, paresthesia, tremor, agitation.

Pregnancy category

Category C

Precautions

Hypertensive crisis with tyramine-rich foods, serotonin syndrome with serotonergic drugs, interactions with other antidepressants, avoid sympathomimetics, hepatic impairment, renal impairment, history of pheochromocytoma, cardiovascular disease, diabetes mellitus, abrupt discontinuation, elderly sensitivity, monitor for suicidal ideation, avoid alcohol, caution in epilepsy, monitor blood pressure regularly.

Contraindications

Pheochromocytoma, congestive heart failure, severe renal impairment, history of liver disease, abnormal liver function tests, cerebrovascular disease, concomitant use with SSRIs, SNRIs, TCAs, other MAOIs, or sympathomimetics.