Adult: As 0.05% ophthalmic emulsion: Instil 1 drop into the conjunctival sac of the affected eye(s) 4 times daily starting 24 hours following surgery, continue for 2 weeks, then decrease frequency to bid for 1 week, then gradually taper dose according to response.
Ophthalmic Endogenous anterior uveitis
Adult: As 0.05% ophthalmic emulsion: Instil 1 drop into the conjunctival sac of the affected eye(s) 4 times daily for 14 days, then taper dose as clinically indicated.
Contraindications
Active viral diseases of the cornea and conjunctiva (e.g. epithelial herpes simplex keratitis, vaccinia, varicella), mycobacterial infection and fungal disease of the eye.
Special Precautions
Patient with glaucoma and history of ocular herpes simplex infection. Pregnancy and lactation.
Adverse Reactions
Significant: Increased intraocular pressure (IOP), optic nerve damage, defects in visual acuity and fields of vision, posterior subcapsular cataract formation (prolonged use); delayed healing and increased incidence of bleb formation; immunosuppression and increased risk of secondary ocular infections (prolonged use). Eye disorders: Blurred vision, corneal oedema; limbal, ciliary and conjunctival hyperaemia; eye pain, photophobia, anterior chamber flare, conjunctival oedema, blepharitis, punctate keratitis, eye inflammation, iritis, striae, episcleritis, eye pruritus, eye irritation, eyelid crusting, foreign body sensation, increased lacrimation, macular oedema, dry eye, iridocyclitis. General disorders and administration site conditions: Application site irritation or discomfort. Nervous system disorders: Headache.
Patient Counseling Information
Remove contact lenses before instillation and reinsert them after 10 minutes.
Monitoring Parameters
Monitor IOP if used for ≥10 days. Perform examination of the lens during prolonged use.
Action
Description: Mechanism of Action: Difluprednate is a corticosteroid that inhibits the inflammatory response including oedema, leucocyte migration, capillary dilation and scar formation. It is thought to act by inducing phospholipase A2 inhibitory proteins (lipocortins) leading to the inhibition of arachidonic acid release, resulting in the suppression of the biosynthesis of potent inflammatory mediators (e.g. prostaglandins, leukotrienes). Pharmacokinetics: Metabolism: Undergoes deacetylation into the active metabolite 6α, 9-difluoroprednisolone 17-butyrate (DFB).
Chemical Structure
Difluprednate Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 443936, Difluprednate. https://pubchem.ncbi.nlm.nih.gov/compound/Difluprednate. Accessed June 25, 2025.
Storage
Store between 15-30°C. Do not freeze. Protect from light.
S01BA16 - difluprednate ; Belongs to the class of corticosteroids. Used in the treatment of inflammation of the eye.
References
Brayfield A, Cadart C (eds). Difluprednate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 09/05/2025.Difluprednate Emulsion (Leading Pharma, LLC). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/05/2025.Difluprednate. UpToDate Lexidrug, AHFS DI (Adult and Pediatric) Online. American Society of Health-System Pharmacists, Inc. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 09/05/2025.Difluprednate. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 09/05/2025.Durezol Emulsion (Sandoz Inc). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 09/05/2025.