Gatifloxacin - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Gatifloxacin. This is the same information dispensing pharmacists read.
5 WARNINGS AND PRECAUTIONS Hypersensitivity Growth of Resistant Organisms with Prolonged Use Corneal Endothelial Cell Injury 5.1 Hypersensitivity Some patients receiving topical ophthalmic gatifloxacin experienced hypersensitivity reactions including anaphylactic reactions, angioedema (including pharyngeal, laryngeal, or facial edema), dyspnea, urticaria, and itching, even following a single dose.
Rare cases of Stevens-Johnson Syndrome were reported in association with topical ophthalmic gatifloxacin use.
If an allergic reaction to gatifloxacin occurs, discontinue the drug [see Patient Counseling Information ].
5.2 Growth of Resistant Organisms with Prolonged Use Prolonged use of gatifloxacin ophthalmic solution 0.5 % may result in overgrowth of nonsusceptible organisms, including fungi.
If superinfection occurs, discontinue use and institute alternative therapy.
Whenever clinical judgment dictates, examine the patient with the aid of magnification, such as slit lamp biomicroscopy and where appropriate, fluorescein staining.
5.3 Corneal Endothelial Cell Injury Gatifloxacin ophthalmic solution 0.5 % is for topical ophthalmic use.
Gatifloxacin ophthalmic solution 0.5 % may cause corneal endothelial cell injury if introduced directly into the anterior chamber of the eye.
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