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Label Changes for:

Uroxatral (alfuzosin HCL) extended-release tablets

December 2010

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2010



Pediatric Use
  • Uroxatral is not indicated for use in the pediatric population.
  • Efficacy of alfuzosin hydrochloride was not demonstrated in a randomized, double-blind, placebo-controlled, efficacy and safety trial conducted in 172 patients ages 2 to 16 years with elevated detrusor leak point pressure (LPP40 cm H2O) of neurologic origin treated with alfuzosin hydrochloride using pediatric formulations. The trial included a 12-week efficacy phase followed by a 40-week safety extension period. No...
  • Alfuzosin hydrochloride was not studied in patients below the age of 2.