Paroxetinedosage

Swallow tablet whole; do not chew or crush. Recommended starting and maximum daily dosage: Indication Starting Dose Maximum Dose MDD 25 mg/day 62.5 mg/day PD 12.5 mg/day 75 mg/day SAD 12.5 mg/day 37.5 mg/day PMDD 12.5 mg/day 25 mg/day For PMDD, dose continuously or intermittently (luteal phase only). If inadequate response to starting dosage, titrate in 12.5 mg per day increments once weekly. Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dose is 12.5 mg per day. Do not exceed 50 mg per day for treatment of MDD and PD and 37.5 mg per day for treatment of SAD. When discontinuing Paroxetine HCL CR, reduce dose gradually.

2.1 Important

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

2.2 Dosage in

Patients with Major Depressive Disorder, Panic Disorder, and Social Anxiety Disorder The recommended initial dosage and maximum dosage of Paroxetine HCL CR in patients with MDD, PD, and SAD are presented in Table 1. In patients with an inadequate response, dosage may be increased in increments of 12.5 mg per day at intervals of at least 1 week, depending on tolerability.

Table 1: Recommended Daily Dosage of Paroxetine HCL CR in Patients with MDD, PD, and SAD Indication Starting Dose Maximum Dose MDD 25 mg 62.5 mg PD 12.5 mg 75 mg SAD 12.5 mg 37.5 mg

2.3 Dosage in

Patients with Premenstrual Dysphoric Disorder The recommended starting dosage in women with PMDD is 12.5 mg per day. Paroxetine HCL 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.

2.4 Screen for

Bipolar Disorder Prior to Starting Paroxetine HCL CR Prior to initiating treatment with Paroxetine HCL CR or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

2.5 Dosage Modifications for

Elderly Patients, Patients with Severe Renal Impairment and Patients with Severe Hepatic Impairment The recommended initial dose of Paroxetine HCL 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.

2.6 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 Paroxetine HCL CR. In addition, at least 14 days must elapse after stopping Paroxetine HCL CR before starting an MAOI antidepressant.

2.7 Discontinuation of

Treatment with Paroxetine HCL CR Adverse reactions may occur upon discontinuation of Paroxetine HCL CR.Gradually reduce the dosage rather than stopping Paroxetine HCL CR abruptly whenever possible.