Generic Name

Fluocinolone Acetonide

Brand Names
YUTIQ, Synalar, Flac, Dermotic, Derma-Smoothe, Neo-Synalar, Iluvien, Retisert
FDA approval date: June 11, 1963
Classification: Corticosteroid
Form: Ointment, Cream, Oil, Implant, Solution

What is YUTIQ (Fluocinolone Acetonide)?

Fluocinolone Acetonide ointment is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses.

Approved To Treat

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Brand Information

    YUTIQ (fluocinolone acetonide)
    1INDICATIONS AND USAGE
    YUTIQ
    2DOSAGE FORMS AND STRENGTHS
    YUTIQ is a non-bioerodible intravitreal implant in a drug delivery system containing 0.18 mg fluocinolone acetonide, designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day, and lasting 36 months.
    3DESCRIPTION
    YUTIQ is a sterile non-bioerodible intravitreal implant containing 0.18 mg fluocinolone acetonide in a 36-month sustained-release drug delivery system. YUTIQ is designed to release fluocinolone acetonide at an initial rate of 0.25 mcg/day. YUTIQ is preloaded into a single-dose applicator to facilitate injection of the implant directly into the vitreous. The drug substance is a synthetic corticosteroid, fluocinolone acetonide.
    The chemical name for fluocinolone acetonide is (6α,11β, 16α)-6,9-difluoro-11,21-dihydroxy-16,17-[(1-methylethylidene)bis-(oxy)]-pregna-1,4-diene-3,20-dione. Its chemical structure is:
    Chemical Structure
    MW 452.50; molecular formula C
    Fluocinolone acetonide is a white or almost white, microcrystalline powder, practically insoluble in water, soluble in methanol, ethanol, chloroform and acetone, and sparingly soluble in ether.
    Each YUTIQ consists of a light brown 3.5mm x 0.37mm implant containing 0.18 mg of the active ingredient fluocinolone acetonide and the following inactive ingredients: polyimide tube, polyvinyl alcohol, silicone adhesive and water for injection.
    4CLINICAL STUDIES
    The efficacy of YUTIQ was assessed in two randomized (2:1, YUTIQ: sham-injection), multi-centre, double-masked, parallel-groups studies (NCT #01694186 and #02746991) that enrolled patients with non-infectious uveitis affecting the posterior segment of the eye. The primary efficacy endpoint in both trials was the proportion of patients who experienced a recurrence of uveitis in the study eye within 6 months of follow-up; recurrence was also assessed at 12 months. Recurrence of uveitis was defined as either deterioration in visual acuity, vitreous haze attributable to non-infectious uveitis or the need for rescue medications.
    Figure 2: Time to First Recurrence of Uveitis (ITT: All Randomized Patients)
    Figure 2
    5HOW SUPPLIED/STORAGE AND HANDLING
    YUTIQ
    NDC 71879-136-01
    6PRINCIPAL DISPLAY PANEL - Kit Carton
    NDC 71879-136-01
    0.18 mg
    Contains:
    Each implant contains:
    Dispose of the applicator
    Rx Only. Store at 15° C to
    Principal Display Panel - Kit Carton