Source: FDA, National Drug Code (US) Revision Year: 2021
RETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg is a sterile implant designed to release fluocinolone acetonide locally to the posterior segment of the eye at a nominal initial rate of 0.6 mcg/day, decreasing over the first month to a steady state between 0.3-0.4 mcg/day over approximately 30 months. The drug substance is the synthetic corticosteroid fluocinolone acetonide, represented by the following structural formula:
Chemical Name: Pregna-1,4-diene-3,20-dione,6,9-difluoro-11,21-dihydroxy-16,17-[(1-methyl-ethylidene)bis(oxy)],(6α,11β,16α)-.
Fluocinolone acetonide is a white crystalline powder, insoluble in water, and soluble in methanol. It has a melting point of 265-266ºC.
Each RETISERT consists of a tablet containing 0.59 mg of the active ingredient, Fluocinolone Acetonide, USP, and the following inactives: magnesium stearate, microcrystalline cellulose, and polyvinyl alcohol.
| Dosage Forms and Strengths |
|---|
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0.59 mg fluocinolone acetonide intravitreal implant. |
| How Supplied |
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The implant consists of a tablet encased in a silicone elastomer cup containing a release orifice and a polyvinyl alcohol membrane positioned between the tablet and the orifice. The silicone elastomer cup assembly is attached to a silicone elastomer suture tab with silicone adhesive. Each RETISERT is approximately 3 mm x 2 mm x 5 mm. Each implant is stored in a clear polycarbonate case within a foil pouch within a Tyvek peelable overwrap. Each packaged implant is provided in a carton which includes the package insert. NDC 24208-416-01 0.59 mg 1 count Distributed by: Bausch + Lomb, a division of Bausch Health US, LLC, Bridgewater, NJ 08807 USA Manufactured by: Bausch + Lomb Ireland Limited, Waterford, Ireland |
| Drug | Countries | |
|---|---|---|
| RETISERT | Canada, United States |
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