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Uroxatral (alfuzosin HCL) extended-release tablet
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
6 ADVERSE REACTIONS
6.2 Post-marketing Experience
Skin and subcutaneous tissue disorders
- added .... toxic epidermal necrolysis
- add to Blood and lymphatic system disorders: thrombocytopenia
USE IN SPECIFIC POPULATIONS
- 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 (LPP 40 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.