Label Changes for:
Solaraze (diclofenac sodium) gel 3%
December 2011
Changes have been made to the PRECAUTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011
Drug Interactions
- Specific interaction studies between Solaraze® Gel and other topical or oral agents were not performed.
Oral Nonsteroidal Anti-Inflammatory Drugs
- Although low, there is systemic exposure to diclofenac following labeled use of Solaraze Gel. Therefore, concomitant administration of Solaraze® Gel with oral NSAIDS or aspirin may result in increased NSAID adverse effects.
