Prozac Pulvules (fluoxetine hydrochloride) capsules for oral use and Prozac Weekly (fluoxetine hydrochloride) delayed-release capsules
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – June 2011
WARNINGS AND PRECAUTIONS
Use in Patients with
- Concomitant Illness: added text related to cautious use in patients with Acute Narrow-Angle Glaucoma.
Clinical Trials Experience
- Added text related to occasional persistence of sexual dysfunction following discontinuation of fluoxetine treatment.
- Added the term "memory impairment."