Durezol

— THERAPEUTIC CATEGORIES —
  • Ocular allergy/inflammation
PAGE CONTENTS
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  • Generic Name & Formulations
  • Indications
  • Dosage and Administration
  • Contraindications
  • Boxed Warnings
  • Warnings/Precautions
  • Pharmacokinetics
  • Interactions
  • Adverse Reactions
  • Clinical Trials
  • Note
  • Patient Counseling

    • Durezol Generic Name & Formulations

    Legal Class

    Rx

    General Description

    Difluprednate 0.05%; oph emulsion.

    Pharmacological Class

    Steroid.

    How Supplied

    Emulsion—5mL

    How Supplied

    Durezol (difluprednate ophthalmic emulsion) 0.05% is a sterile, aqueous topical ophthalmic emulsion supplied in an opaque plastic bottle with a controlled drop tip and a pink cap in the following sizes: 5 mL in a 8 mL bottle.

    Storage

    Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Do not freeze. Protect from light. When not in use, keep the bottles in the protective carton.

    Manufacturer

    Alcon Laboratories, Inc.

    Generic Availability

    YES

    Durezol Indications

    Indications

    Post-op inflammation and pain associated with ocular surgery. Endogenous anterior uveitis.

    Durezol Dosage and Administration

    Adult

    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

    Not recommended.

    Durezol Contraindications

    Contraindications

    Ocular fungal, viral, or mycobacterial infections.

    Contraindications

    The use of Durezol, as with other ophthalmic corticosteroids, is contraindicated in most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, and also in mycobacterial infection of the eye and fungal disease of ocular structures.

    Durezol Boxed Warnings

    Not Applicable

    Durezol Warnings/Precautions

    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.

    Warnings/Precautions

    Intraocular Pressure Increase

    • Prolonged use of corticosteroids may result in glaucoma with damage to the optic nerve, defects in visual acuity and fields of vision. Use caution when using steroids in the presence of glaucoma. 

    • Monitor intraocular pressure if this product is used for 10 days or longer.

    Cataracts

    • Use of corticosteroids may result in posterior subcapsular cataract formation. 

    Delayed Healing

    • May delay healing and increase the incidence of bleb formation. In those diseases causing thinning of the cornea or sclera, perforations have been known to occur with the use of topical steroids. 

    • The initial prescription and renewal of the medication order beyond 28 days should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining.

    Bacterial Infections

    • Prolonged use of corticosteroids may suppress the host response and thus increase the hazard of secondary ocular infections. In acute purulent conditions, steroids may mask infection or enhance existing infection. 

    • Reevaluate patients if signs and symptoms fail to improve after 2 days.

    Viral Infections

    • Must use great caution in patients with a history of herpes simplex. May prolong the course and may exacerbate the severity of many viral infections of the eye (including herpes simplex).

    Fungal Infections

    • Risk of developing fungal infections of the cornea with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use. Fungal culture should be taken when appropriate.

    Topical Ophthalmic Use Only

    • Durezol is not indicated for intraocular administration.

    Contact Lens Wear

    • Durezol should not be instilled while wearing contact lenses. Remove contact lenses prior to instillation of Durezol. The preservative in Durezol may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Durezol.

    Pregnancy Considerations

    Pregnancy Teratogenic Effects: Pregnancy Category C

    • Since the use of difluprednate during human pregnancy has not been evaluated and cannot rule out the possibility of harm, Durezol should be used during pregnancy only if the potential benefit justifies the potential risk to the embryo or fetus.

    Nursing Mother Considerations

    It is not known whether topical ophthalmic administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use caution when Durezol is administered to a nursing woman.

    Pediatric Considerations

    A similar safety profile was observed in pediatric patients comparing Durezol to prednisolone acetate ophthalmic suspension, 1%.

    Geriatric Considerations

    No overall differences in safety or effectiveness have been observed between elderly and younger patients.

    Durezol Pharmacokinetics

    Metabolism

    Deacetylation.

    Durezol Interactions

    Not Applicable

    Durezol Adverse Reactions

    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.

    Durezol Clinical Trials

    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.

    Durezol Note

    Not Applicable

    Durezol Patient Counseling

    Patient Counseling

    Risk of Contamination 

    • This product is sterile when packaged. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the emulsion. Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

    Risk of Secondary Infection 

    • If pain develops, or if redness, itching, or inflammation becomes aggravated, advise patients to consult a physician.

    Contact Lens Wear 

    • Durezol should not be instilled while wearing contact lenses. Advise patients to remove contact lenses prior to instillation of Durezol. The preservative in Durezol may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of Durezol.

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