Dutasteride/tamsulosin

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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]

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

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

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  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.
  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.