Generic Name: Difluprednate
Chemical Name: 6α,9-difluoro-11β,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate
Molecular Formula: C27H34F2O7
CAS Number: 23674-86-4
Medically reviewed on August 1, 2017
Uses for Durezol
Postoperative Ocular Inflammation and Pain
Durezol Dosage and Administration
Apply topically to the eye as an ophthalmic emulsion.1
Not for intraocular administration.1
Avoid contamination of the preparation container.1
Do not wear contact lenses during therapy.1
If used with other topical ophthalmic drugs (e.g., β-adrenergic blocking agents, carbonic anhydrase inhibitors, α-agonists, cycloplegics, mydriatics) separate administration by 10 minutes.3
Postoperative Ocular Inflammation and Pain
Initially, 1 drop into the conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery and continuing for 2 weeks.1 Then decrease to 1 drop twice daily for 1 week.1 Thereafter, taper based on response.1
Cautions for Durezol
Known hypersensitivity to difluprednate, other corticosteroids, or any ingredient in the formulation.3
Risk of glaucoma (with damage to optic nerve), defects in visual acuity and fields of vision, and posterior subcapsular cataract formation with prolonged use of corticosteroids.1 a Use with caution in glaucoma because IOP may increase.1
Risk of secondary ocular infections (bacterial, fungal, or viral) with prolonged use of corticosteroids.1 a Consider possibility of fungal invasion if persistent corneal ulceration occurs.1 a Obtain fungal culture when appropriate.1
Use of corticosteroids in patients with a history of herpes simplex infections other than epithelial herpes simplex keratitis, in which corticosteroids are contraindicated, requires great caution;1 slit-lamp microscopy is essential.a
Evaluation of Ocular Condition
Initial prescription or renewal of medication order >28 days should be provided only after examination of the patient with the aid of magnification (e.g., slit-lamp biomicroscopy and fluorescein staining where appropriate).1 3
Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects.1
No substantial differences in safety and efficacy relative to younger adults.1
Common Adverse Effects
Corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema, blepharitis.1
Deacetylated to active metabolite.1
Corticosteroids inhibit edema, fibrin deposition, capillary dilation, leukocyte migration, capillary proliferation, fibroblast proliferation, deposition of collagen, and scar formation associated with inflammation.1 a
Mechanism of ocular effects is unknown.1 Corticosteroids may induce phospholipase A2 inhibitory proteins; these proteins may inhibit release of arachidonic acid, thus controlling biosynthesis of potent mediators of inflammation (e.g., prostaglandins, leukotrienes).1
Advice to Patients
Importance of learning and adhering to proper administration techniques to avoid contamination of the tip of the container.1
Importance of administering other topical ophthalmic preparations 10 minutes apart from difluprednate administration.3
Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1
Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any concomitant illnesses.1
Importance of informing patients of other important precautionary information.1 (See Cautions.)
Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.
Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.
AHFS DI Essentials. © Copyright 2018, Selected Revisions August 1, 2009. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.
1. Sirion Therapeutics, Inc. Durezol (difluprednate) ophthalmic emulsion 0.05% prescribing information. Tampa, FL; 2008 Sep.
2. Stevens E. Sirion Therapeutics announces FDA approval of Durezol for treatment of postoperative ocular inflammation and pain. Reuters. 2008 Jun 24. From Reuters website (http://www.reuters.com/article/pressRelease/idUS165959+24-Jun-2008+PRN20080624?sp=true).
3. Sirion Therapeutics, Tampa, FL: Personal communication.
a. AHFS drug information 2009. McEvoy GK, ed. EENT corticosteroids general statement. Bethesda, MD: American Society of Health-Systems Pharmacists; 2009:2879-81.
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