Label Changes for:
Flomax (tamsulosin hydrochloride) Capsules
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)
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
- 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
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
- Rare and more serious allergic reactions may also occur.: Get......
USE IN SPECIFIC POPULATIONS
- 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...