Label Changes for:

Flomax (tamsulosin hydrochloride) Capsules

July 2014

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

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

 

July 2014

WARNINGS AND PRECAUTIONS 

Intraoperative Floppy Iris Syndrome
  • Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract and glaucoma surgery in some patients on or previously treated with alpha1 blockers, including FLOMAX capsules

ADVERSE REACTIONS

Postmarketing Experience
  • erythema multiforme, dermatitis exfoliative, visual impairment, and epistaxis
  • During cataract and glaucoma surgery, a variant of small pupil syndrome known as Intraoperative Floppy Iris Syndrome (IFIS) has been reported in association with alpha1 blocker therapy

 

July 2011

5 WARNINGS AND PRECAUTIONS

5.5 Intraoperative Floppy Iris Syndrome
  • Intraoperative Floppy Iris Syndrome (IFIS) has been observed during cataract surgery in some patients on or previously treated .... [see Adverse Reactions (6.2)]
  • IFIS may increase the risk of eye complications during and after.....

6 ADVERSE REACTIONS

6.2 Postmarketing Experience
  • Infrequent reports of dyspnea.....

17 PATIENT COUNSELING INFORMATION

17.6 FDA-Approved Patient Labeling
Allergic Reactions
  • Rare and more serious allergic reactions may also occur.: Get......
     

 

December 2009

 

USE IN SPECIFIC POPULATIONS 

Pediatric Use
  • Flomax capsules are not indicated for use in pediatric populations
  • Efficacy and positive benefit/risk of tamsulosin hydrochloride was not demonstrated in two studies conducted in patients 2 years to 16 years...

 

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