Label Changes for:

Cosopt (dorzolamide hydrochloride-timolol maleate ophthalmic solution)

October 2008

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) -- October 2008

 

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

 

Sections Modified

PRECAUTIONS

  • General
    • The following text has been added:

“There is an increased potential for developing corneal edema in patients with low endothelial cell counts. Precautions should be used when prescribing Cosopt to this group of patients.”

Hide
(web2)