Label Changes for:

Uroxatral (alfuzosin HCl) extended-release tablets

April 2010

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

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

WARNINGS AND PRECAUTIONS

Postural Hypotension
  • Care should be taken when Uroxatral is administered to patients with symptomatic hypotension or patients who have had a hypotensive response to other medications.

DRUG INTERACTIONS

PDE5 Inhibitors
  • Caution is advised when alpha adrenergic blocking agents, including Uroxatral, are coadministered with PDE5 inhibitors. Alpha-adrenergic blockers and PDE5 inhibitors are both vasodilators that can lower blood pressure. Concomitant use of these two drug classes can potentially cause symptomatic hypotension.
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