Label Changes for:
Trusopt (dorzolamide hydrochloride ophthalmic solution)
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) – June 2010
Information for Patients
- Trusopt is a sulfonamide and although administered topically is absorbed systemically. Therefore the same types of adverse reactions that are attributable to sulfonamides may occur with topical administration. Patients should be advised that if serious or unusual reactions including severe skin reactions or signs of hypersensitivity occur, they should discontinue the use of the product
The following adverse events have occurred either at low incidence (<1%) during clinical trials or have been reported during the use of Trusopt in clinical practice where these events were reported voluntarily from a population of unknown size and frequency of occurrence cannot be determined precisely.
- Stevens-Johnson syndrome
- toxic epidermal necrolysis