Version May 2024
Endogenous anterior uveitis: Ophthalmic: Instill 1 drop into conjunctival sac of the affected eye(s) 4 times daily for 14 days, then taper as clinically indicated.
Inflammation/pain associated with ocular surgery: Ophthalmic: Instill 1 drop in conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery, continue for 2 weeks, then decrease to 2 times daily for 1 week, then taper based on response.
There are no dosage adjustments provided in the manufacturer's labeling; however, systemic absorption is limited.
There are no dosage adjustments provided in the manufacturer's labeling; however, systemic absorption is limited.
Refer to adult dosing.
(For additional information see "Difluprednate: Pediatric drug information")
Endogenous anterior uveitis: Limited data available: Children ≥2 years and Adolescents: Ophthalmic: Instill 1 drop into conjunctival sac of the affected eye(s) 4 times daily for 14 days, then taper as clinically indicated (Ref).
Inflammation associated with ocular surgery: Infants, Children, and Adolescents: Ophthalmic: Instill 1 drop in conjunctival sac of the affected eye(s) 4 times daily beginning 24 hours after surgery, continue for 2 weeks, then decrease to 2 times daily for 1 week, then taper based on response; the initial efficacy trials were in patients 0 to 3 years of age with congenital cataracts (Ref).
Infants, Children, and Adolescents: There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
Infants, Children, and Adolescents: There are no dosage adjustments provided in manufacturer's labeling; however, dosage adjustment unlikely due to low systemic absorption.
The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified.
>10%: Ophthalmic: Anterior chamber inflammation (2% to 15%), blepharitis (5% to 15%), conjunctival edema (5% to 15%), corneal edema (2% to 15%), eye pain (5% to 15%), ocular hyperemia (including ciliary, conjunctival, limbal: 5% to 15%), photophobia (2% to 15%), secondary cataract (5% to 15%)
1% to 10%:
Nervous system: Headache (5% to 10%)
Ophthalmic: Blurred vision (5% to 10%), decreased visual acuity (1% to 5%), dry eye syndrome (2% to 5%), eye irritation (5% to 10%), increased intraocular pressure (5% to 10%), iridocyclitis (2% to 5%), iritis (1% to 10%), ophthalmic inflammation (1% to 5%), punctate keratitis (1% to 10%)
<1%:
Local: Application-site irritation, local discomfort (application site)
Ophthalmic: Corneal changes (pigmentation and striae), crusting of eyelid, episcleritis, eye pruritus, foreign body sensation of eye, increased lacrimation, injected sclera, macular edema
Active viral (including herpes simplex keratitis, vaccinia, varicella) infections of the cornea or conjunctiva, fungal infection of ocular structures, or mycobacterial ocular infections
Canadian labeling: Additional contraindications (not in US labeling): Hypersensitivity to difluprednate, any component of the formulation, or to other corticosteroids; acute untreated ocular bacterial infection.
Concerns related to adverse effects:
• Cataracts: Prolonged use of corticosteroids may result in posterior subcapsular cataract formation. Use following cataract surgery may delay healing or increase the incidence of bleb formation.
• Corneal perforation: Perforation may occur with topical steroids in diseases which cause thinning of the cornea or sclera.
• Exacerbation of infections: May exacerbate severity of infections. Use extreme caution in patients with history of ocular herpes simplex. Re-evaluate after 2 days if symptoms have not improved. Use is contraindicated in most viral diseases of the cornea and conjunctiva and with fungal or mycobacterial ocular infections.
• Glaucoma: Use with caution in presence of glaucoma. Prolonged use of corticosteroids may result in elevated intraocular pressure (IOP); damage to the optic nerve; and defects in visual acuity and fields of vision. Monitor IOP in any patient receiving treatment for ≥10 days.
• Immunosuppression: May mask infection or enhance existing infection. The possibility of corneal fungal infection should be considered with persistent corneal ulceration during prolonged therapy; obtain cultures when appropriate.
Special populations:
• Contact lens wearers: Contains sorbic acid which may be absorbed by contact lenses; remove contacts prior to administration and wait 10 minutes before reinserting.
Other warnings/precautions:
• Appropriate use: For ophthalmic use only; not for intraocular administration. Initial prescription and renewal of medication for >28 days should be made by health care provider only after examination with the aid of magnification such as slit lamp biomicroscopy or fluorescein staining (if appropriate). To avoid contamination, do not touch tip of container to any surface.
Pediatric patients may be at increased risk for elevations in intraocular pressure (IOP) when using difluprednate for uveitis (Birnbaum 2011; Slabaugh 2012). In one retrospective review (n=27, age range: 6 to 63 years), four of the five children (80%) treated with difluprednate had an increase in IOP of ≥5 mm Hg (two had increase ≥20 mm Hg ) compared to seven out of 22 adults (32%) (three had increase ≥20 mm Hg). Elevation of IOP responded to discontinuation of difluprednate or the addition of glaucoma medications (Birnbaum 2011). Another retrospective review of pediatric uveitis patients (n=14, age range: 7 to 18 years) described a higher incidence of cataracts in addition to increased IOP in this patient population (Slabaugh 2012).
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Emulsion, Ophthalmic:
Durezol: 0.05% (5 mL) [contains edetate (edta) disodium, polysorbate 80]
Generic: 0.05% (5 mL)
Yes
Emulsion (Difluprednate Ophthalmic)
0.05% (per mL): $9.26 - $44.84
Emulsion (Durezol Ophthalmic)
0.05% (per mL): $52.32
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Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Emulsion, Ophthalmic:
Durezol: 0.05% (5 mL) [contains edetate (edta) sodium (tetrasodium), polysorbate 80]
Ophthalmic: For topical ophthalmic use only; not for intraocular administration. Wash hands prior to use and avoid touching tip of dropper. Remove contact lenses prior to use. Do not reinsert contact lenses within 10 minutes of difluprednate eye drops. The use of the same bottle for both eyes is not recommended in surgical patients.
Ophthalmic: For ophthalmic use only. Wash hands prior to use. Avoid contact of bottle tip with skin or eye; ocular solutions can become contaminated by common bacteria known to cause ocular infections. Serious damage to the eye and subsequent loss of vision may occur from using contaminated solutions. Remove contact lenses prior to administration and wait at least 10 minutes before reinserting soft contact lenses. The use of the same bottle for both eyes is not recommended in surgical patients.
Inflammation/pain: Treatment of inflammation and pain following ocular surgery.
Uveitis: Treatment of endogenous anterior uveitis.
Durezol may be confused with Durasal
KIDs List: Difluprednate, when used pediatric patients <18 years of age, is identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be used with caution due to risk of increased intraocular pressure (weak recommendation, low quality of evidence) (PPA [Meyers 2020]).
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Nonsteroidal Anti-Inflammatory Agents (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Risk C: Monitor therapy
Adverse events have been observed in animal reproduction studies. The amount of difluprednate absorbed systemically following ophthalmic administration is below the limit of quantification (<50 ng/mL).
It is not known if difluprednate is excreted in breast milk; however, systemic corticosteroids are excreted in breast milk. Because systemic absorption may cause adverse effects, the manufacturer recommends that caution be exercised when administering difluprednate to nursing women.
Intraocular pressure and periodic examination of lens (with prolonged use >28 days)
Corticosteroids inhibit the inflammatory response including edema, capillary dilation, leukocyte migration, and scar formation. Difluprednate penetrates cells readily to induce the production of lipocortins. These proteins modulate the activity of prostaglandins and leukotrienes.
Absorption: Systemic: Exposure to active metabolite is negligible with ocular administration
Metabolism: Undergoes deacetylation to an active metabolite (DFB)
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