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NSAID — Topical Ophthalmic (COX-1 and COX-2 Inhibitor)

Nepafenac 0.1% / 0.3% Eye Drops

Brand names: Nevanac 0.1%, Yellox 0.09%

Nepafenac 0.1% / 0.3% eye drops are a topical non-steroidal anti-inflammatory (NSAID) ophthalmic suspension used to prevent and treat pain and inflammation associated with cataract surgery and to reduce the risk of post-operative macular oedema.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Prevention and treatment of postoperative ocular pain and inflammation associated with cataract surgery: 1 drop of nepafenac 1 mg/ml (0.1%) eye drops suspension into the conjunctival sac of the affected eye(s) three times daily, beginning 1 day before cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period (extendable to the first 3 weeks as directed by the clinician), plus one additional drop 30 to 120 minutes before surgery
Route: Ocular (topical) — instilled into the conjunctival sac. SCOPE: the fetched source is the 1 mg/ml (0.1%) suspension only. The 0.3% once-daily preparation named on this page is NOT in this bundle and no figure for it is published here.
Frequency: Three times daily
VERBATIM (SPC section 4.2, Adults including the elderly): 'For the prevention and treatment of pain and inflammation, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and for the first 2 weeks of the postoperative period. Treatment can be extended to the first 3 weeks of the postoperative period as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery.' SECOND LICENSED USE OF THE SAME 0.1% PRODUCT (verbatim): 'For the reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients, the dose is 1 drop of NEVANAC in the conjunctival sac of the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery.' — same drop and frequency, longer duration. THE STRENGTH IS PINNED BY THE SOURCE PRODUCT NAME (NEVANAC 1 mg/ml = 0.1%), which is why a dose expressed as a drop count is publishable here. NO MAXIMUM DOSE is stated anywhere in the fetched SPC, so maxDose is deliberately left empty rather than restating the dose. METHOD OF ADMINISTRATION (verbatim): 'For ocular use. Patients should be instructed to shake the bottle well before use ... If more than one topical ophthalmic medicinal product is being used, the medicinal product must be administered at least 5 minutes apart. Eye ointments should be administered last. To prevent contamination of the dropper tip and solution, care must be taken not to touch the eyelids, surrounding areas or other surfaces with the dropper tip of the bottle ... If a dose is missed, a single drop should be applied as soon as possible before reverting to regular routine. Do not use a double dose to make up for the 1 missed.' SECTION 4.4 WARNINGS (verbatim): 'The product should not be injected. Patients should be instructed not to swallow NEVANAC. Patients should be instructed to avoid sunlight during treatment with NEVANAC.'

Dose adjustments

Renal

SPC section 4.2 verbatim (patients with renal or hepatic impairment): 'NEVANAC has not been studied in patients with hepatic disease or renal impairment. Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular administration. No dose adjustment is warranted in these patients.'

Hepatic

SPC section 4.2 verbatim (patients with renal or hepatic impairment): 'NEVANAC has not been studied in patients with hepatic disease or renal impairment. Nepafenac is eliminated primarily through biotransformation and the systemic exposure is very low following topical ocular administration. No dose adjustment is warranted in these patients.'

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • Hypersensitivity to the active substance or to any of the excipients listed in section 6.1
  • Hypersensitivity to other nonsteroidal anti-inflammatory drugs (NSAIDs)
  • Patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs
  • Not licensed in children and adolescents: 'The safety and efficacy of NEVANAC in children and adolescents have not been established. No data are available. Its use is not recommended in these patients until further data become available.'
  • Not for use by women of childbearing potential who are not using contraception (section 4.6)
  • Must not be injected, and must not be swallowed (section 4.4)

Side effects

  • In clinical studies involving 2314 patients receiving NEVANAC 1 mg/ml the most common adverse reactions were punctate keratitis, foreign body sensation and eyelid margin crusting, occurring in between 0.4% and 0.2% of patients
  • Uncommon (eye disorders): keratitis, punctate keratitis, corneal epithelium defect, foreign body sensation in eyes, eyelid margin crusting
  • Rare (eye disorders): iritis, choroidal effusion, corneal deposits, eye pain, ocular discomfort, dry eye, blepharitis, eye irritation, eye pruritus, eye discharge, allergic conjunctivitis, increased lacrimation, conjunctival hyperaemia
  • Not known (eye disorders): corneal perforation, impaired healing of the cornea, corneal opacity, corneal scar, reduced visual acuity, eye swelling, ulcerative keratitis, corneal thinning, blurred vision
  • Rare: hypersensitivity; dizziness; headache; nausea; cutis laxa (dermatochalasis); allergic dermatitis. Not known: vomiting; blood pressure increased
  • In diabetic patients treated for 60 days or more for prevention of macular oedema post cataract surgery (two studies, 209 patients), punctate keratitis occurred in 3% (frequency category common), with corneal epithelium defect in 1% and allergic dermatitis in 0.5%; ocular adverse reactions in diabetic patients may occur at a higher frequency than in the general population
  • Section 4.4 sight-threatening risk: continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation in susceptible patients
  • Increased bleeding of ocular tissues (including hyphaemas) in conjunction with ocular surgery has been reported with ophthalmic NSAIDs
  • Benzalkonium chloride (an excipient) may cause eye irritation, discolours soft contact lenses, and has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy
  • Sections 4.4 and 4.8 in this bundle are truncated at the source-fetch limit — this list may be incomplete

Monitoring

  • Corneal health: 'Patients with evidence of corneal epithelial breakdown should immediately discontinue use of NEVANAC and should be monitored closely for corneal health'
  • Close monitoring is required with frequent or prolonged use because the product contains benzalkonium chloride, which has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy
  • Higher-risk groups needing extra caution and surveillance: complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface disease (e.g. dry eye syndrome), rheumatoid arthritis, or repeat ocular surgeries within a short period
  • Bleeding: use with caution in patients with known bleeding tendencies or receiving other medicinal products that may prolong bleeding time, and watch for increased bleeding of ocular tissues around surgery
  • Infection: an acute ocular infection may be masked by topical anti-inflammatory use — NSAIDs have no antimicrobial properties, so use with anti-infectives requires care
  • Concomitant topical corticosteroids: both slow or delay healing, so exercise caution when they are given together, particularly in patients at high risk for corneal adverse reactions
  • Contact lenses: contact lens wear is not recommended in the postoperative period after cataract surgery; if lenses must be used, remove before application and wait at least 15 minutes before reinsertion
  • Note: the fetched SPC has no dedicated monitoring section; the items above are drawn from sections 4.2, 4.4 and 4.8

Clinical monograph

How it works

Nepafenac is a prodrug that penetrates the cornea and is converted by intraocular hydrolases to amfenac, which inhibits cyclo-oxygenase and reduces prostaglandin-mediated ocular inflammation; the 0.3% formulation allows once-daily dosing.

Prescribing in practice

  • Topical ocular NSAIDs can impair corneal epithelial healing and, rarely, cause corneal melt or perforation, so use with particular caution in patients with diabetes, rheumatoid arthritis, dry eye, repeated ocular surgery or corneal denervation.
  • Concomitant use with topical corticosteroids may increase the potential for corneal adverse effects and warrants closer review of corneal status.
  • Confirm which strength is prescribed, as the 0.1% and 0.3% products differ in dosing frequency.

Monitoring

Monitor corneal integrity on slit-lamp examination, especially if symptoms persist or in higher-risk corneas, and stop if epithelial breakdown develops.

Counselling the patient

  • Shake the bottle before use and use only the strength and frequency prescribed.
  • Report any increasing eye pain, redness or sensitivity to light, as the drop should be stopped if the cornea is affected.
  • Avoid contact lens wear during treatment unless specifically advised otherwise.

Evidence & guidelines

Topical NSAIDs reduce post-cataract-surgery inflammation and cystoid macular oedema, with the MHRA and SPC highlighting the class risk of corneal epithelial adverse effects.

Reference: MHRA NSAIDs Corneal Melting Warning; ESCRS Post-Cataract Inflammation Guidelines; SPC Nevanac; 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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