Jane S. Ricciuti, RPh, MS


October 21, 2003

In This Article


Paxil CR
(paroxetine HCl) Tablets

Manufacturer: GlaxoSmithKline

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 8/28/03)

New Indication: This supplemental new drug application provides for the use of Paxil CR (paroxetine) in the treatment of premenstrual dysphoric disorder (PMDD).

Dosing: The starting dose for paroxetine controlled release tablets is 12.5 mg/d as a single morning dose. Dose changes are recommended at 1-week intervals.

Clinical Summary: Two placebo-controlled trials included 1030 patients with a mean duration of PMDD symptoms of 11 years. Patients were treated with 12.5 or 25 mg/d or placebo throughout the menstrual cycle for a period of 3 menstrual cycles. The visual analogue scale (VAS)-Total score is a patient-rated instrument that was used to assess efficacy and demonstrated that paroxetine was significantly more effective than placebo as measured by change from baseline to the end point on the luteal phase VAS-Total score.

Effectiveness beyond 3 menstrual cycles has not been evaluated in controlled trials.

Paxil CR(paroxetine HCl) Tablets Labeling

Paxil(paroxetine HCl) Tablets