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Ozurdex

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Ozurdex

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OZURDEX®
(dexamethasone) Intravitreal Implant

DRUG DESCRIPTION

OZURDEX® is an intravitreal implant containing 0.7 mg (700 mcg) dexamethasone in the NOVADUR® solid polymer drug delivery system. OZURDEX® is preloaded into a single-use, specially designed DDS® applicator to facilitate injection of the rod-shaped implant directly into the vitreous. The NOVADUR® system contains poly (D,L-lactide-co-glycolide) PLGA intravitreal polymer matrix without a preservative. The chemical name for dexamethasone is Pregna-1,4-diene-3,20-dione, 9-fluoro-11,17,21-trihydroxy-16-methyl-, (11β,16α)-. Its structural formula is:

OZURDEX® (dexamethasone) Structural Formula Illustration

MW 392.47;       molecular formula: C22H29FO5

Dexamethasone occurs as a white to cream-colored crystalline powder having not more than a slight odor, and is practically insoluble in water and very soluble in alcohol.

The PLGA matrix slowly degrades to lactic acid and glycolic acid.

Last reviewed on RxList: 9/17/2012
This monograph has been modified to include the generic and brand name in many instances.

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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