2.1 Administration Information
Administer PAXIL 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 PAXIL 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 PAXIL 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 PAXIL was demonstrated in patients dosed in a range of 20 mg to 60 mg daily. While the safety of PAXIL 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 [see Clinical Studies (14.4)].
GAD
The starting and recommended dosage in patients with GAD is 20 mg daily. In clinical trials the effectiveness of PAXIL 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 [see Clinical Studies (14.5)].
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.
Screen for Bipolar Disorder Prior to Starting PAXIL
Prior to initiating treatment with PAXIL or another antidepressant, screen patients for a personal or family history of bipolar disorder, mania, or hypomania [see Warnings and Precautions (5.6)].
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 PAXIL. In addition, at least 14 days must elapse after stopping PAXIL before starting an MAOI antidepressant [see Contraindications (4), Warnings and Precautions (5.2)].
2.7 Discontinuation of Treatment With PAXIL
Adverse reactions may occur upon discontinuation of PAXIL [see Warnings and Precautions (5.7)]. Gradually reduce the dosage rather than stopping PAXIL abruptly whenever possible.
