Label Changes for:
Uroxatral (alfuzosin HCl extended-release tablets)
Changes have been made to the WARNINGS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- September 2008
|The detailed view includes drug products with safety labeling changes to the BOXED WARNING, CONTRAINDICATIONS, WARNINGS, PRECAUTIONS, ADVERSE REACTIONS, or PATIENT PACKAGE INSERT/MEDICATION GUIDE sections. Deletions or editorial revisions made to these sections are not included in this summary. Read about the new physician labeling format.|
Summary of Changes to Contraindications and Warnings
The following sentence was added to the WARNINGS section:
There may be an increased risk of hypotension/postural hypotension and syncope when taking Uroxatral concomitantly with anti-hypertensive medication or nitrates.