Presumed to be linked to potentiation of serotonergic activity in the central nervous system resulting from inhibition of neuronal reuptake of serotonin (5-hydroxy-tryptamine, 5-HT). Based on the mechanism of action of SNRIs and SSRIs, including paroxetine hydrochloride, and the potential for serotonin syndrome, caution is advised when PAXIL is coadministered with other drugs that may affect the serotonergic neurotransmitter systems.

PAXIL is indicated for the treatment of major depressive disorder.

PAXIL should be administered as a single daily dose with or without food, usually in the morning. The recommended initial dose is 20 mg/day.

The most commonly observed adverse events associated with the use of paroxetine were: Asthenia, sweating, nausea, decreased appetite, somnolence, dizziness, insomnia, tremor, nervousness, ejaculatory disturbance, and other male genital disorders.

The use of MAOIs intended to treat depression with, or within 14 days of treatment with, PAXIL is contraindicated (see WARNINGS).

During premarketing testing, hypomania or mania occurred in approximately 1.0% of unipolar patients treated with PAXIL compared to 1.1% of active-control and 0.3% of placebo-treated unipolar patients. In a subset of patients classified as bipolar, the rate of manic episodes was 2.2% for PAXIL and 11.6% for the combined active-control groups. As with all drugs effective in the treatment of major depressive disorder, PAXIL should be used cautiously in patients with a history of mania.