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Potent Ophthalmic Corticosteroid — Uveitis / Post-Operative Inflammation Pregnancy: US label, verbatim. PREGNANCY (8.1): 'There are no available data on difluprednate ophthalmic emulsion use in pregnant women to evaluate for a drug- associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Systemic exposure to difluprednate ophthalmic emulsion following ocular administration is low' ... 'In animal reproductive studies, subcutaneous administration of difluprednate to pregnant rabbits and rats throughout organogenesis produced maternal toxicity, embryo-fetal toxicity and teratogenicity in rabbits and fetotoxicity in rats.' LACTATION (8.2): 'Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. The systemic exposure of a breastfeeding woman to difluprednate is expected to be minimal following topical ocular administration, however, the possibility of harm to the breastfed child cannot be ruled out.'

Difluprednate 0.05% Eye Drops

Brand names: Durezol

Difluprednate is a potent topical corticosteroid eye drop used to treat ocular inflammation and pain, including following eye surgery and in endogenous anterior uveitis.

Adult dose

Dose: Endogenous anterior uveitis: 1 drop into the conjunctival sac of the affected eye 4 times daily for 14 days, followed by tapering as clinically indicated. Inflammation and pain associated with ocular surgery: 1 drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response.
Route: Topical ophthalmic — into the conjunctival sac of the affected eye (difluprednate 0.05% ophthalmic emulsion)
Frequency: Uveitis: 4 times daily for 14 days, then taper. Post-ocular surgery: 4 times daily for the first 2 weeks, then 2 times daily for a week, then taper
SOURCE TEXT (US label, Dosage and Administration, verbatim): for ocular surgery, 'instill one drop into the conjunctival sac of the affected eye 4 times daily beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times daily for a week and then a taper based on the response'; for endogenous anterior uveitis, 'Instill one drop into the conjunctival sac of the affected eye 4 times daily for 14 days followed by tapering as clinically indicated.' STRENGTH AND PRODUCT: the only strength in the bundle is the 0.05% ophthalmic emulsion; the labelled product is Sandoz's generic difluprednate ophthalmic emulsion, so the page's brand name (Durezol) is not itself the source. INDICATIONS (verbatim): 'The treatment of inflammation and pain associated with ocular surgery.' and 'The treatment of endogenous anterior uveitis.' NO MAXIMUM AND NO HIGHER-FREQUENCY REGIMEN: the label prints no maximum daily dose and no schedule above 4 times daily, so maxDose is blank. PRESCRIBING GUIDELINES (section 2.3, verbatim): 'The initial prescription and renewal of the medication order beyond one bottle should be made by a physician only after examination of the patient with the aid of magnification, such as slit lamp biomicroscopy, and where appropriate, fluorescein staining. If signs and symptoms fail to improve after two days, the patient should be reevaluated. Not more than one bottle should be prescribed initially, and the prescription should not be refilled without further evaluation.' CONTACT LENSES (section 5.10): not to be instilled while wearing contact lenses; lenses may be reinserted after 10 minutes. PAEDIATRIC (paedDose is null): the label describes a 3-month trial in 79 paediatric patients 0 to 3 years of age with inflammation after cataract surgery and a safety profile similar to prednisolone acetate 1%, but prints no paediatric regimen, so none is written. Children: use a children's formulary. TRUNCATION: the Use in Specific Populations text is cut off at the source-fetch limit; the dosage and administration section is complete. No UK SPC for difluprednate is listed on eMC — this dose is from US prescribing information (Difluprednate Ophthalmic, Sandoz Inc) and must be verified against UK practice.

Dose adjustments

Renal

Not stated in the US label (topical ophthalmic product; no renal dosing statement in any retrieved section).

Hepatic

Not stated in the US label (topical ophthalmic product; no hepatic dosing statement in any retrieved section).

Dose independently re-sourced from US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — clinician-reviewed. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Most active viral diseases of the cornea and conjunctiva, including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia and varicella
  • Mycobacterial infection of the eye
  • Fungal disease of ocular structures

Side effects

  • Intraocular pressure increase: prolonged corticosteroid use may result in glaucoma with damage to the optic nerve and defects in visual acuity and fields of vision (US section 5.1)
  • Posterior subcapsular cataract formation (US section 5.2)
  • Delayed healing and increased incidence of bleb formation after cataract surgery (US section 5.3)
  • Corneal and scleral thinning, with perforation of the globe possible with topical corticosteroids in thin tissue (US section 5.4)
  • Secondary ocular infection (bacterial, viral, fungal) through suppression of the host response (US sections 5.5-5.7)
  • After ocular surgery, 5% to 15%: corneal edema, ciliary and conjunctival hyperemia, eye pain, photophobia, posterior capsule opacification, anterior chamber cells, anterior chamber flare, conjunctival edema and blepharitis (US section 6.1)
  • After ocular surgery, 1% to 5%: reduced visual acuity, punctate keratitis, eye inflammation and iritis (US section 6.1)
  • In endogenous anterior uveitis, 5% to 10%: blurred vision, eye irritation, eye pain, headache, increased IOP, iritis, limbal and conjunctival hyperemia, punctate keratitis and uveitis (US section 6.2)
  • In endogenous anterior uveitis, 2% to 5%: anterior chamber flare, corneal edema, dry eye, iridocyclitis, photophobia and reduced visual acuity (US section 6.2)

Monitoring

  • Intraocular pressure: if used for 10 days or longer, IOP should be routinely monitored (US section 5.1)
  • Re-evaluate if signs and symptoms fail to improve after two days (US sections 2.3, 5.5)
  • Examine with magnification such as slit lamp biomicroscopy, and where appropriate fluorescein staining, before the initial prescription and before renewal beyond one bottle (US section 2.3); renewal beyond 28 days likewise only after such an examination (US section 5.3)
  • History of herpes simplex: great caution and frequent slit lamp microscopy (US section 5.6)
  • Persistent corneal ulceration on a corticosteroid: consider fungal invasion and take a fungal culture when appropriate (US section 5.7)
  • Not for intraocular administration; do not let the dropper tip touch the eye, eyelids or any surface (US sections 5.8, 5.9)
  • Contact lenses: do not instil while wearing them; remove lenses first and reinsert after 10 minutes (US section 5.10)

Clinical monograph

How it works

Difluprednate is a glucocorticoid that binds corticosteroid receptors to inhibit inflammatory mediators and reduce vascular permeability and leucocyte activity in ocular tissue.

Prescribing in practice

  • As a potent topical steroid it can raise intraocular pressure and promote cataract, and may delay healing or worsen and mask ocular infection, so it requires ophthalmic supervision.
  • It is contraindicated in untreated infective eye conditions, including herpes simplex (dendritic) keratitis and most acute purulent infections.
  • Prolonged courses should be tapered to reduce the risk of rebound inflammation.

Monitoring

Monitor intraocular pressure during therapy and review for signs of infection or lens opacity, especially with extended use.

Counselling the patient

  • Shake the bottle if instructed and use the drops exactly as prescribed.
  • Report any eye pain, reduced vision or increasing redness.
  • Keep your follow-up appointments so eye pressure can be checked.

Evidence & guidelines

Topical corticosteroids including difluprednate are used for postoperative ocular inflammation and uveitis, with prescribing guided by the SPC.

Reference: FDA Approval Durezol 2008; SPC Difluprednate 0.05%; Sheppard et al. Trans Am Ophthalmol Soc 2014; RCOphth Uveitis Management Guidelines; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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