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Difluprednate

Pronunciation

(dye floo PRED nate)

Dosage Forms

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Emulsion, Ophthalmic:

Durezol: 0.05% (5 mL) [contains edetate sodium (tetrasodium), polysorbate 80]

Brand Names: U.S.

  • Durezol

Pharmacologic Category

  • Corticosteroid, Ophthalmic

Pharmacology

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)

Use: Labeled Indications

Inflammation/pain: Treatment of inflammation and pain following ocular surgery.

Uveitis: Treatment of endogenous anterior uveitis.

Contraindications

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.

Dosage

Endogenous anterior uveitis: Adults: 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:

US labeling: Infants, Children, Adolescents, and Adults: 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

Canadian labeling: Adults: 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 taper based on response

Dosage adjustment in renal impairment: There are no dosage adjustments provided in the manufacturer’s labeling; however, systemic absorption is limited.

Dosage adjustment in hepatic impairment: There are no dosage adjustments provided in the manufacturer’s labeling; however, systemic absorption is limited.

Administration

Ophthalmic: 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.

Storage

Store at 15°C to 25°C (59°F to 77°F); do not freeze. Protect from light.

Drug Interactions

Ceritinib: Corticosteroids may enhance the hyperglycemic effect of Ceritinib. Monitor therapy

NSAID (Ophthalmic): May enhance the adverse/toxic effect of Corticosteroids (Ophthalmic). Healing of ophthalmic tissue during concomitant administration of ophthalmic products may be delayed. Monitor therapy

Adverse Reactions

Adverse reactions following ocular surgery:

5% to 15%: Ophthalmic: Anterior chamber inflammation, blepharitis, cataract (secondary), conjunctival edema, corneal edema, eye pain, hyperemia (ciliary and conjunctival), photophobia

1% to 5%: Ophthalmic: Decreased visual acuity, iritis, postoperative ophthalmic inflammation, punctate keratitis

<1% (Limited to important or life-threatening): Abnormal healing, corneal changes (pigmentation and striae), crusting of eyelid, episcleritis, eye perforation, eye pruritus, foreign body sensation of eye, increased intraocular pressure, increased lacrimation, injected sclera, local irritation, macular edema, optic nerve damage, secondary infection, uveitis, viral infection

Adverse reactions associated with treatment of endogenous anterior uveitis:

5% to 10%:

Central nervous system: Headache

Ophthalmic: Blurred vision, eye irritation, eye pain, hyperemia (conjunctival and limbal), increased intraocular pressure, iritis, punctate keratitis, uveitis

2% to 5%: Ophthalmic: Anterior chamber inflammation, corneal edema, decreased visual acuity, dry eye syndrome, iridocyclitis, photophobia

Warnings/Precautions

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. The Canadian labeling also contraindicates use in acute untreated bacterial 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 (US labeling) or >14 days (Canadian labeling) 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.

Monitoring Parameters

Intraocular pressure and periodic examination of lens (with prolonged use >28 days)

Pregnancy Risk Factor

C

Pregnancy Considerations

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).

Patient Education

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience headache. Have patient report immediately to prescriber vision changes, ophthalmalgia, severe eye irritation, or light sensitivity (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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