"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Handling the Bottle
Patients should be instructed that the Rescula bottle must be maintained intact and to avoid allowing the tip of the bottle to contact surrounding structures, fingers, or any other unintended surface in order to avoid contamination of the bottle or applicator by common bacteria known to cause ocular infections. Serious infections may result from using contaminated solutions.
Potential for Iris Darkening
Patients should be advised about the potential for increased brown iris pigmentation which is likely to be permanent.
Potential For Eyelid Skin Darkening
Patients should be informed about the possibility of eyelid skin darkening, which may be reversible after discontinuation of Rescula.
Use with Contact Lenses
Patients should be advised that Rescula contains benzalkonium chloride, which may be absorbed by soft contact lenses. Contact lenses should be removed prior to application of Rescula and may be reinserted 15 minutes following its administration.
If more than one topical ophthalmic therapy is being used patients should be instructed to administer the drugs at least 5 minutes apart.
Last reviewed on RxList: 1/3/2013
This monograph has been modified to include the generic and brand name in many instances.
Additional Rescula Information
Report Problems to the Food and Drug Administration
You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.
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