Dosage Forms
Excipient information presented when available (limited, particularly for generics); consult specific product labeling.
Emulsion, Ophthalmic:
Durezol: 0.05% (5 mL) [contains edetate disodium, polysorbate 80]
Pharmacology
Mechanism of Action
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.
Pharmacokinetics/Pharmacodynamics
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 and Administration
Dosing: Adult
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
Dosing: Geriatric
Refer to adult dosing.
Dosing: Pediatric
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 (Sheppard 2014; Slabaugh 2012)
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
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
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. Monitor therapy
Ritodrine: Corticosteroids may enhance the adverse/toxic effect of Ritodrine. Monitor therapy
Adverse Reactions
>10%: Ophthalmic: Anterior chamber inflammation, blepharitis, cataract (secondary), conjunctival edema, corneal edema, eye pain, ocular hyperemia (ciliary, conjunctival, limbal), photophobia
1% to 10%:
Central nervous system: Headache
Ophthalmic: Blurred vision, decreased visual acuity, dry eye syndrome, eye irritation, increased intraocular pressure, iridocyclitis, iritis, ophthalmic inflammation (postoperative), punctate keratitis, uveitis
<1%, postmarketing, and/or case reports: Corneal changes (pigmentation and striae), crusting of eyelid, episcleritis, eye pruritus, foreign body sensation of eye, increased lacrimation, injected sclera, local discomfort, local irritation, macular edema
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.
- 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.
Monitoring Parameters
Intraocular pressure and periodic examination of lens (with prolonged use >28 days)
Pregnancy
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
What is this drug used for?
- It is used to treat eye swelling.
- It is used to treat eye pain.
Frequently reported side effects of this drug
- Headache
Other side effects of this drug: Talk with your doctor right away if you have any of these signs of:
- Vision changes
- Eye pain
- Severe eye irritation
- Sensitivity to lights
- Signs of a significant reaction like 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. Talk to your doctor if you have questions.
Consumer Information Use and Disclaimer: This information should not be used to decide whether or not to take this medicine or any other medicine. Only the healthcare provider has the knowledge and training to decide which medicines are right for a specific patient. This information does not endorse any medicine as safe, effective, or approved for treating any patient or health condition. This is only a brief summary of general information about this medicine. It does NOT include all information about the possible uses, directions, warnings, precautions, interactions, adverse effects, or risks that may apply to this medicine. This information is not specific medical advice and does not replace information you receive from the healthcare provider. You must talk with the healthcare provider for complete information about the risks and benefits of using this medicine.
