"The US Food and Drug Administration (FDA) has approved Akorn Inc's phenylephrine hydrochloride ophthalmic solution (2.5% and 10%), the company has announced.
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Potential For Pigmentation
Advise patients about the potential for increased brown pigmentation of the iris, which may be permanent. Advise patients about the possibility of eyelid skin darkening, which may be reversible after discontinuation of IZBA (travoprost ophthalmic solution 0.003%).
Potential For Eyelash Changes
Advise patients about the possibility of eyelash and vellus hair changes in the treated eye during treatment with IZBA. These changes may result in a disparity between eyes in length, thickness, pigmentation, number of eyelashes or vellus hairs, and/or direction of eyelash growth. Eyelash changes are usually reversible upon discontinuation of treatment.
Handling The Container
Instruct patients to avoid allowing the tip of the dispensing container to contact the eye, surrounding structures, fingers, or any other surface in order to avoid contamination of the solution by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may result from using contaminated solutions.
When To Seek Physician Advice
Advise patients that if they develop an intercurrent ocular condition (e.g., trauma or infection), have ocular surgery, or develop any ocular reactions, particularly conjunctivitis and eyelid reactions, they should immediately seek their physician's advice concerning the continued use of IZBA.
Use With Contact Lenses
Contact lenses should be removed prior to instillation of IZBA and may be reinserted 15 minutes following its administration.
Use With Other Ophthalmic Drugs
If more than one topical ophthalmic drug is being used, the drugs should be administered at least five (5) minutes between applications.
Last reviewed on RxList: 5/29/2014
This monograph has been modified to include the generic and brand name in many instances.
Additional Izba 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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