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Neomycin and Polymyxin B Sulfates and Dexamethasone (Neomycin Sulfate / Polymyxin B Sulfate / Dexamethasone Ophthalmic) - Side Effects and Adverse Reactions

 
 



ADVERSE REACTIONS:

Adverse reactions have occurred with steroid/anti-infective combination drugs which can be attributed to the steroid component, the anti-infective component, or the combination.  Exact incidence figures are not available since no denominator of treated patients is available.

Reactions occurring most often from the presence of the anti-infective ingredients are allergic sensitizations.  The reactions due to the steroid component are:  elevation of intraocular pressure (IOP) with possible development of glaucoma, and infrequent optic nerve damage; posterior subcapsular cataract formation; and delayed wound healing.

Secondary Infection:  The development of the secondary infection has occurred after use of combination containing steroids and antimicrobials.  Fungal infections of the cornea are particularly prone to develop coincidentally with long-term applications of steroids.  The possibility of fungal invasion must be considered in any persistent corneal ulceration where steroid treatment has been used.  Secondary bacterial ocular infection following suppression of host responses also occurs.

To report SUSPECTED ADVERSE REACTIONS, contact Fera Pharmaceuticals, LLC at (414) 434-6604, Monday-Friday 9am-5pm EST, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Drug label data at the top of this Page last updated: 2011-07-21

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