Fluocinolone (EENT)
Brand names: Retisert
Drug class:
Antineoplastic Agents
Usage of Fluocinolone (EENT)
Uveitis
Management of chronic noninfectious uveitis affecting the posterior segment of the eye (designated an orphan drug by FDA for this use).
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How to use Fluocinolone (EENT)
Administration
Ophthalmic Administration
Surgically implant intravitreally through a pars plana incision into posterior segment of eye.
Maintain aseptic technique prior to and during the procedure to ensure sterility of the surgical field and implants. Do not resterilize implants by any method.
Handle implants only by the suture tab to avoid damaging the implant; damage may increase rate of drug release.
Avoid simultaneous implantation into both eyes in order to minimize risk of bilateral postoperative infections.
Following depletion of fluocinolone acetonide from the implant, may remove the implant and replace with a new one to continue therapy.
During implantation and explantation, avoid applying sheer forces on the implant that could disengage the silicone cup reservoir from the suture tab.
Dosage
Available as fluocinolone acetonide; dosage expressed in terms of the salt.
Pediatric Patients
Uveitis OphthalmicChildren ≥12 years of age: 0.59 mg (1 implant) in affected eye(s) approximately every 30 months.
Adults
Uveitis Ophthalmic0.59 mg (1 implant) in affected eye(s) approximately every 30 months.
Warnings
Contraindications
Warnings/Precautions
Warnings
Surgical ComplicationsPotential complications accompanying insertion of the implant may include cataract formation, choroidal or retinal detachment, temporary decrease in visual acuity, endophthalmitis, hypotony, increased intraocular pressure (IOP), exacerbation of intraocular inflammation, vitreous hemorrhage, vitreous loss, and wound dehiscence.
Immediate and temporary decrease in visual acuity in the implanted eye will occur in most patients and may persist for 1–4 weeks after implantation.
Increased Intraocular PressureRisk of glaucoma with prolonged use of corticosteroids; monitor periodically for elevated IOP (e.g., every 3–6 months, more frequently in immediate postimplantation period). Use with caution in the presence of glaucoma.
Approximately 60% of patients expected to require drug therapy to reduce IOP within 34 weeks after implantation. Within 2 years of implantation, 32% of patients expected to require filtering procedures for IOP control.
Immunosuppressive EffectsRisk of prolongation or exacerbation of ocular viral infections (e.g., herpes simplex) with ophthalmic corticosteroids. Use with extreme caution in patients with history of herpes simplex.
Risk of secondary ocular infection (bacterial, fungal, or viral) with prolonged use of corticosteroids. Consider possibility of fungal infection if persistent corneal ulceration occurs.
In acute purulent conditions, corticosteroids may mask or enhance existing infections.
Wound Healing ComplicationsUse of ophthalmic corticosteroids after cataract surgery may delay healing and increase bleb formation.
General Precautions
Proper Handling of ImplantsExercise caution in order to maintain sterility of and avoid damage to the implant. (See Administration under Dosage and Administration.)
Specific Populations
PregnancyCategory C.
LactationCaution if used in nursing women. Not known whether ocular administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in milk.
Systemically administered corticosteroids appear in milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other adverse effects.
Pediatric UseSafety and efficacy not established in children <12 years of age.
Geriatric UseNo substantial differences in safety and efficacy relative to younger adults.
Common Adverse Effects
Cataracts, increased IOP, ocular pain, and surgical complications (e.g., cataract fragments in the eye, injury, mechanical complications, migration or expulsion of implant; wound complications or wound dehiscence) reported in 50–90% of patients.
Reduced visual acuity, conjunctival hemorrhage or hyperemia, glaucoma, blurred vision, abnormal sensation in the eye, ocular irritation or inflammation, hypotony, pruritus, vitreous floaters or hemorrhage, ptosis, maculopathy, eyelid edema, increased tearing, and dry eye reported in 10–35% of patients.
Headache was most frequent systemic effect.
What other drugs will affect Fluocinolone (EENT)
No formal drug interaction studies have been performed to date. However, because of limited systemic exposure, only intraocular interactions would be expected.
Disclaimer
Every effort has been made to ensure that the information provided by Drugslib.com is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Drugslib.com information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Drugslib.com does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Drugslib.com's drug information does not endorse drugs, diagnose patients or recommend therapy. Drugslib.com's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners.
The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Drugslib.com does not assume any responsibility for any aspect of healthcare administered with the aid of information Drugslib.com provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.
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