Ocular allergy/inflammation:
Indications for: DUREZOL
Post-op inflammation and pain associated with ocular surgery. Endogenous anterior uveitis.
Clinical Trials:
Ocular Surgery
The efficacy of Durezol was evaluated in 2 randomized, double-masked, placebo-controlled trials in which subjects with an anterior chamber cell grade greater than or equal to "2" (a cell count of 11 or higher) after cataract surgery. Patients were randomly assigned to receive 1 drop of Durezol or placebo (vehicle) self-administered either 2 or 4 times a day for 14 days, beginning the day after surgery. The presence of complete clearing (a cell count of 0) was assessed 3, 8, and 15 days post surgery using a slit lamp binocular microscope.
In the intent-to-treat analyses of both studies, a significant benefit was seen in the 4 times per day Durezol-treated group in ocular inflammation, at Days 8 and 15, and reduction of pain at Days 3, 8, and 15 when compared with placebo.
Endogenous Anterior Uveitis
The efficacy of Durezol was evaluated in 2 randomized, double masked active controlled trials in which patients who presented with endogenous anterior uveitis were treated with either Durezol 4 times daily or prednisolone acetate ophthalmic suspension 1%, 8 times daily for 14 days.
Both studies demonstrated that Durezol was equally effective as prednisolone acetate ophthalmic suspension 1% in treating subjects with endogenous anterior uveitis.
Adult Dosage:
Post-op inflammation/pain: 1 drop into affected eye(s) 4 times daily beginning 24hrs after surgery, continue for 2 weeks post-op, followed by 2 times daily for a week, then taper based on response. Uveitis: 1 drop into affected eye(s) 4 times daily for 14 days, followed by tapering as clinically indicated.
Children Dosage:
Not recommended.
DUREZOL Contraindications:
Ocular fungal, viral, or mycobacterial infections.
DUREZOL Warnings/Precautions:
Do not administer while wearing contacts. Corneal or scleral thinning. Glaucoma. History of herpes simplex. May mask or exacerbate ocular infections. Monitor IOP and for secondary infections in prolonged therapy (>10 days). Pregnancy (Cat.C). Nursing mothers.
DUREZOL Classification:
Steroid.
Adverse Reactions:
Corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells and flare, conjunctival edema, blepharitis, blurred vision, eye irritation, headache, iritis, limbal hyperemia, punctate keratitis, uveitis; cataract formation, corneal perforation. Prolonged use may increase: IOP, optic nerve damage, visual acuity and field defects. May delay healing and increase bleb formation after cataract surgery.
Generic Drug Availability:
YES
How Supplied:
Emulsion—5mL
