Paroxetinedosage

2 DOSAGE & ADMINISTRATION Shake oral suspension well before administration Recommended starting and maximum daily dosage for MDD, OCD, PD, and PTSD: Indication Starting Dose Maximum Dose MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg Recommended starting dosage for SAD and GAD is 20 mg daily. Elderly patients, patients with severe renal impairment or severe hepatic impairment: Starting dosage is 10 mg daily. Maximum dosage is 40 mg daily. When discontinuing paroxetine, reduce dosage gradually.

2.1 Administration

Information Administer paroxetine oral suspension as a single daily dose in the morning, with or without food. Shake the oral suspension well before administration.

2.2 Recommended

Dosage for MDD, OCD, PD, and PTSD The recommended starting dosages and maximum dosages of paroxetine oral suspension in patients with MDD, OCD, PD, and PTSD are presented in Table 1. In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.

Table 1: Recommended Daily Dosage of Paroxetine Oral Suspension in Patients with MDD, OCD, PD, and PTSD Indication Starting Dose Maximum Dose MDD 20 mg 50 mg OCD 20 mg 60 mg PD 10 mg 60 mg PTSD 20 mg 50 mg

2.3 Recommended

Dosage for SAD and GAD SAD The starting and recommended dosage in patients with SAD is 20 mg daily. In clinical trials the effectiveness of paroxetine oral suspension was demonstrated in patients dosed in a range of 20 mg to 60 mg daily. While the safety of paroxetine oral suspension has been evaluated in patients with SAD at doses up to 60 mg daily, available information does not suggest any additional benefit for doses above 20 mg daily. GAD The starting and recommended dosage in patients with GAD is 20 mg daily. In clinical trials the effectiveness of paroxetine oral suspension in GAD was demonstrated in patients dosed in a range of 20 mg to 50 mg daily. There is not sufficient evidence to suggest a greater benefit to doses higher than 20 mg daily. In patients with an inadequate response, increase dosage in increments of 10 mg per day at intervals of at least 1 week, depending on tolerability.

2.4 Screen for

Bipolar Disorder Prior to Starting Paroxetine Oral Suspension Prior to initiating treatment with paroxetine oral suspension or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania.

2.5 Recommended

Dosage for Elderly Patients, Patients with Severe Renal Impairment, and Patients with Severe Hepatic Impairment The recommended initial dosage is 10 mg per day for elderly patients, patients with severe renal impairment, and patients with severe hepatic impairment. Dosage should not exceed 40 mg/day.

2.6 Switching

Patients to or From a Monoamine Oxidase Inhibitor (MAOI) At least 14 days must elapse between discontinuation of a monoamine oxidase inhibitor (MAOI and initiation of paroxetine oral suspension. In addition, at least 14 days must elapse after stopping paroxetine oral suspension before starting an MAOI antidepressant.

2.7 Discontinuation of

Treatment With Paroxetine Oral Suspension Adverse reactions may occur upon discontinuation of paroxetine oral suspension. Gradually reduce the dosage rather than stopping paroxetine oral suspension abruptly whenever possible.