Label Changes for:

Minipress (prazosin hydrochloride) 1, 2, and 5 mg Capsules

April 2009

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

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) -- April 2009

 

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 View

 

Brand (Generic) Name

Sections Modified

Minipress (prazosin hydrochloride) 1, 2, and 5 mg Capsules

PRECAUTIONS

  • General subheading added
    • Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients treated with alpha-1 blockers.

ADVERSE REACTIONS

  • Post-marketing experience
    • Special Senses subheading added
      • During cataract surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha-1 blocker therapy.
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