Label Changes for:

Cosopt (dorzolamide hydrochloride and timolol maleate) ophthalmic solution

June 2010

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) – June 2010

PRECAUTIONS

Information for Patients
  • Cosopt contains dorzolamide (which 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, including severe skin reactions.

ADVERSE REACTIONS

The following adverse events have occurred either at low incidence (<1%) during clinical trials or have been reported during the use of Cosopt 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
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