Jalyn (Dutasteride and Tamsulosin Hydrochloride) Capsules
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.
WARNINGS AND PRECAUTIONS
Intraoperative Floppy Iris Syndrome
- Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated with alpha adrenergic antagonists, including tamsulosin, which is a component of Jalyn…
- Reproductive System and Breast Disorders : Testicular pain and testicular swelling.
- Psychiatric Disorders: Depressed mood
What are the possible side effects of Jalyn?
- Depressed mood has been reported in patients receiving Dutasteride, an ingredient of Jalyn…