Label Changes for:
Jalyn (Dutasteride and Tamsulosin Hydrochloride) Capsules
Changes have been made to the CONTRAINDICATIONS, WARNINGS, PRECAUTIONS and ADVERSE REACTIONS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013
- Patients with previously demonstrated, clinically significant hypersensitivity (e.g., serious skin reactions, angioedema, urticaria, pruritus, respiratory symptoms) to Dutasteride, other 5 alpha-reductase inhibitors, tamsulosin, or any other component of JALYN.