Dutasteride/tamsulosin

Dutasteride/tamsulosin
Combination of
Dutasteride5α-Reductase inhibitor
TamsulosinAlpha-1 blocker
Clinical data
Trade namesJalyn
AHFS/Drugs.comProfessional Drug Facts
License data
Pregnancy
category
  • AU: X (High risk)
Routes of
administration		By mouth
ATC code
Legal status
Legal status
Identifiers
CAS Number
KEGG

Dutasteride/tamsulosin, sold under the brand name Jalyn among others, is a medication produced by GlaxoSmithKline for the treatment of adult male symptomatic benign prostatic hyperplasia (BPH).[3] It is a combination of two previously existing medications: dutasteride, brand name Avodart, and tamsulosin, brand name Flomax. It contains 0.5 mg of dutasteride and 0.4 mg of tamsulosin hydrochloride.[2]

Jalyn was the result of the CombAT (Combination of Avodart and Tamsulosin) trial of 2008. It was approved by the U.S. Food and Drug Administration (FDA) on June 14, 2010.[4] In June 2011, the FDA approved a label change to warn of "Increased Risk of High-grade Prostate Cancer" from Jalyn.[5]

References

  1. ^ https://www.tga.gov.au/resources/prescription-medicines-registrations/dutalosin-ksj-pharmatech
  2. ^ a b "Jalyn - dutasteride and tamsulosin hydrochloride capsule". DailyMed. U.S. National Library of Medicine. Retrieved 28 December 2020.
  3. ^ Keating GM (May 2012). "Dutasteride/tamsulosin: in benign prostatic hyperplasia". Drugs & Aging. 29 (5): 405–19. doi:10.2165/11208920-000000000-00000. PMID 22550968. S2CID 209142875.
  4. ^ "Approval Package for: Dutasteride 0.5 mg/Tamsulosin hydrochloride 0.4 mg" (PDF). Center for Drug Evaluation and Research. Food and Drug Administration. 14 June 2010. Archived from the original (PDF) on July 26, 2015.
  5. ^ "Detailed View: Safety Labeling Changes: Jalyn (dutasteride and tamsulosin) capsules". Center for Drug Evaluation and Research. U.S. Food and Drug Administration. June 2011. Archived from the original on 6 January 2012.
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