Important Administrative Instructions

Administer PAXIL CR as a single daily dose in the morning, with or without food. Swallow tablets whole and do not chew or crush.

Dosage in Patients with Major Depressive Disporder, Panic Disorder, and Social Anxiety Disporder

The recommended initial dosage and maximum dosage of PAXIL CR in patients with MDD, PD, and SAD are presented in Table 1.

In patients with an inadequate response, dosage may be increased inincrements of 12.5 mg per day at intervals of at least 1 week, depending on tolerability.

Table 1: Recommended Daily Dosage of PAXIL CR in Patients with MDD, PD, and SAD

Dosage in Patients with Prementrual Dysphoric Disorder

The recommended starting dosage in women with PMDD is 12.5 mg per day. PAXIL CR may be administered either continuously (every day throughout the menstrual cycle) or intermittently (only during the luteal phase of the menstrual cycle, i.e., starting the daily dosage 14 days prior to the anticipated onset of menstruation and continuing through the onset of menses). Intermittent dosing is repeated with each new cycle.

In patients with an inadequate response, the dosage may be increased to the maximum recommended dosage of 25 mg per day, depending on tolerability. Institute dosage adjustments at intervals of at least 1 week.

Screen for Bipolar Disorder Prior to Starting Paxil CR

Prior to initiating treatment with Paxil CR or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.6)].

Dosage Modifications for Elderly Patients, Patients with Severe Renal Impairment and Patients with Severe Hepatic Impairment

The recommended initial dose of PAXIL CR is 12.5 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment. Reduce initial dose and increase up-titration intervals if necessary. Dosage should not exceed 50 mg per day for MDD or PD and should not exceed 37.5 mg per day for SAD [see Use in Specific Populations (8.5, 8.6)].

Switching Patients to or From a Monoamine Oxidase Inhibitor Antidepressant

At least 14 days must elapse between discontinuation of an monoamine oxidase inhibitor (MAOI) antidepressant and initiation of PAXIL CR. In addition, at least 14 days must elapse after stopping PAXIL CR before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].

Discontinuation of Treatment with Paxil CR

Adverse reactions may occur upon discontinuation of PAXIL CR [see Warnings and Precautions (5.6)]. Gradually reduce the dosage rather than stopping Paxil CR abruptly whenever possible.