Retisert
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Questions & Answers
Side Effects & Adverse Reactions
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Legal Issues
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FDA Safety Alerts
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Manufacturer Warnings
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FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
RETISERT is indicated for the treatment of chronic non-infectious uveitis affecting the posterior segment of the eye.
History
There is currently no drug history available for this drug.
Other Information
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 µg/day, decreasing over the first month to a steady state between 0.3-0.4 µg/day over approximately 30 months. The drug substance is the synthetic corticosteroid fluocinolone acetonide, represented by the following structural formula:
C24H30F2O6 Mol. Wt. 452.50
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: microcrystalline cellulose, polyvinyl alcohol, and magnesium stearate.
Sources
Retisert Manufacturers
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Bausch & Lomb Incorporated
![Retisert (Fluocinolone Acetonide) Implant [Bausch & Lomb Incorporated]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Retisert | Bausch & Lomb Incorporated
2.1 Dosing InformationRETISERT (fluocinolone acetonide intravitreal implant) 0.59 mg is implanted into the posterior segment of the affected eye through a pars plana incision.
The implant contains one tablet of 0.59 mg of fluocinolone acetonide. RETISERT is designed to release fluocinolone acetonide at a nominal initial rate of 0.6 µg/day, decreasing over the first month to a steady state between 0.3-0.4 µg/day over approximately 30 months. Following depletion of fluocinolone acetonide as evidenced by recurrence of uveitis, RETISERT may be replaced.
2.2 Handling of ImplantCaution should be exercised in handling RETISERT in order to avoid damage to the implant, which may result in an increased rate of drug release from the implant. Thus, RETISERT should be handled only by the suture tab. Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir (which contains a fluocinolone acetonide tablet) from the suture tab. Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.
RETISERT should not be resterilized by any method.
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