Label Changes for:

Trandate (labetalol hydrochloride) Tablets and Injection

November 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) – November 2010

 

 

PRECAUTIONS

  • Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers (labetalol is an alpha/beta blocker)…
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