Monurol® (Fosfomycin Trometamol) Receives DCA Approval for New Indication Of Perioperative Antibiotic Prophylaxis For Transrectal Prostate Biopsy In Adult Men

January 16, 2024 News

The Drug Control Authority (DCA) has approved Monurol® (fosfomycin trometamol) (MAL20033481AZ) as a perioperative antibiotic prophylaxis for transrectal prostate biopsy in adult men.1 The recommended dosage is 1 sachet of Monurol® 3g approximately 3 hours before, and 24 hours after the procedure.2

 

About Monurol® (Fosfomycin Trometamol)2

Monurol® contains the active substance fosfomycin in the form of trometamol salt. Fosfomycin is an antibiotic (derived from phosphonic acid) with a bactericidal effect. This is based on inhibition of bacterial cell wall synthesis, blocking one of the first steps of peptidoglycan synthesis.

The recommended dosage for the indication of perioperative antibiotic prophylaxis for transrectal prostate biopsy is 1 sachet of Monurol® 3g approximately 3 hours before, and another sachet at 24 hours after the procedure.

 

References:

  1. Additional Indications Approved DCA 387. (Last accessed: 11 October 2023) https://www.npra.gov.my/index.php/en/informationen/new-products-indication/additional-indications-approved.html
  2. Monurol® Prescribing Information, Malaysia, August 2023.

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(KKLIU 3627/ EXP 27.6.2024)

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