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U.S. Department of Health and Human Services

Safety

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Jalyn (Dutasteride and Tamsulosin Hydrochloride) Capsules

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – April 2013

Summary View

 

CONTRAINDICATIONS

  • 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…
 

ADVERSE REACTIONS

  • Reproductive System and Breast Disorders : Testicular pain and testicular swelling.
Postmarketing Experience
  • Psychiatric Disorders: Depressed mood
 

PATIENT INFORMATION

What are the possible side effects of Jalyn?
  • Depressed mood has been reported in patients receiving Dutasteride, an ingredient of Jalyn…