Navstel

Navstel

Generic Name: balanced salt ophthalmic solution with hypromellose, dextrose and glutathione

Company: Alcon Laboratories, Inc.

Treatment for: Intraocular Irrigation

FDA Approves Navstel

The United States Food and Drug Administration (FDA) has approved Navstel (balanced salt ophthalmic solution with hypromellose, dextrose and glutathione) for use as an intraocular irrigating solution during surgical procedures involving perfusion of the eye.

Dosage and Administration

The solution should be used according to the standard technique employed by the operating surgeon.

Dosage Forms and Strengths

250 mL: 250 mL bottle filled with 240 mL Part I and 10 mL vial filled with 10 mL Part II of sterile intraocular irrigating solution

500 mL: 500 mL bottle filled with 480 mL Part I and 20 mL vial filled with 20 mL Part II of sterile intraocular irrigating solution

Contraindications

None

Warnings and Precautions

Do not use this container for more than one patient since Navstel Solution does not contain a preservative.

Adverse Reactions

The most frequently reported adverse reaction in patients exposed to Navstel Solution was increased intraocular pressure, occurring in 12% of patients.

To report SUSPECTED ADVERSE REACTIONS, contact Alcon Laboratories, Inc. at 1-800-757-9195 or FDA at 1800-FDA-1088 or www.fda.gov/medwatch.

Navstel Patient Counseling Information

Patients should be advised to seek immediate care from an ophthalmologist if the eye becomes red, sensitive to light, pain increases or a decrease in vision develops in the days following Navstel Solution administration.