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Topical NSAID (ophthalmic) Pregnancy: SPC §4.6: not recommended during pregnancy, and should not be used by women of childbearing potential not using contraception. There are no adequate data in pregnant women; animal studies have shown reproductive toxicity, although systemic exposure after topical ocular use is negligible so the risk during pregnancy could be considered low. Breast-feeding: can be used during breast-feeding (no effects on the suckling child are anticipated as systemic exposure is negligible).

Nepafenac

Brand names: Nevanac

Nepafenac is a topical ophthalmic non-steroidal anti-inflammatory drug (NSAID) used to prevent and treat postoperative ocular pain and inflammation associated with cataract surgery.

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: One drop in the conjunctival sac of the affected eye(s), plus an additional drop 30 to 120 minutes prior to surgery
Route: Ocular use (eye drops, suspension — the fetched SPC is NEVANAC; §4.8 refers to NEVANAC 1 mg/ml). Shake the bottle well before use.
Frequency: 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 (extendable to the first 3 weeks as directed by the clinician)
SPC §4.2, 'Adults, including the elderly' — indication: prevention and treatment of pain and inflammation associated with cataract surgery. SECOND INDICATION — reduction in the risk of postoperative macular oedema associated with cataract surgery in DIABETIC patients: same dose, 1 drop 3 times daily beginning 1 day prior to surgery, continued on the day of surgery and up to 60 days of the postoperative period as directed by the clinician, with an additional drop 30 to 120 minutes prior to surgery. Geriatric: no overall differences in safety and effectiveness between elderly and younger patients. Paediatric population: safety and efficacy in children and adolescents have not been established; no data are available and use is not recommended in these patients. Method of administration: if more than one topical ophthalmic medicinal product is being used, administer at least 5 minutes apart and give eye ointments last; do not touch the eyelids, surrounding areas or other surfaces with the dropper tip; keep the bottle tightly closed when not in use. Missed dose: apply a single drop as soon as possible before reverting to the regular routine — do not use a double dose to make up for the missed one. The product should not be injected and patients should be instructed not to swallow it, and to avoid sunlight during treatment (§4.4). SEPARATE US PRODUCT, DIFFERENT STRENGTH AND FREQUENCY (openFDA, ILEVRO 0.3% ophthalmic suspension): 'One drop of ILEVRO 0.3% should be applied to the affected eye one time daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period. An additional drop should be administered 30 to 120 minutes prior to surgery.' Do not apply the 3-times-daily regimen to the 0.3% product. Dose quote — SPC §4.2: '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.'

Dose adjustments

Renal

SPC §4.2: has not been studied in patients with hepatic disease or renal impairment; nepafenac is eliminated primarily through biotransformation and 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; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — 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
  • 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

Side effects

  • Punctate keratitis, foreign body sensation and eyelid margin crusting — the most common reactions (0.2–0.4% of patients); punctate keratitis was common (3%) in diabetic patients treated for 60 days or more
  • Uncommon: keratitis, corneal epithelium defect
  • Rare: 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 (potentially sight-threatening): corneal perforation, impaired corneal healing, corneal opacity, corneal scar, ulcerative keratitis, corneal thinning, reduced visual acuity, blurred vision
  • Rare systemic: hypersensitivity, dizziness, headache, nausea, allergic dermatitis, cutis laxa (dermatochalasis); blood pressure increased (frequency not known)

Interactions

  • Topical corticosteroids — both topical NSAIDs and topical steroids may slow or delay healing; concomitant use may increase the potential for healing problems, so exercise caution, particularly in patients at high risk of corneal adverse reactions (SPC §4.4)
  • Medicinal products that may prolong bleeding time — ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas) in conjunction with ocular surgery; use with caution in patients with known bleeding tendencies or receiving such products (SPC §4.4)
  • Anti-infectives — an acute ocular infection may be masked by topical anti-inflammatory products and NSAIDs have no antimicrobial properties; in ocular infection, combined use should be undertaken with care (SPC §4.4)
  • Other topical ophthalmic medicinal products — administer at least 5 minutes apart, eye ointments last (SPC §4.2). No SPC §4.5 text was present in the fetched bundle.

Clinical monograph

How it works

It is a prodrug that is converted within ocular tissues to amfenac, which inhibits cyclo-oxygenase and thereby reduces prostaglandin synthesis, decreasing inflammation and pain.

Prescribing in practice

  • Topical ocular NSAIDs can rarely cause corneal adverse effects such as keratitis or corneal melt, with greater risk in patients with corneal epithelial breakdown, ocular surface disease or concurrent corticosteroid use.
  • Use with caution in patients with known hypersensitivity to other NSAIDs, including aspirin.
  • It may mask the signs of an ongoing eye infection, so infection should be excluded.

Monitoring

Patients should be monitored clinically for corneal integrity and resolution of inflammation, particularly with prolonged use or in at-risk eyes.

Counselling the patient

  • Report any new eye pain, increasing redness or change in vision promptly.
  • Tell your clinician if you have had a previous reaction to aspirin or other anti-inflammatory medicines.
  • Use the drops only for the period advised after your surgery.

Evidence & guidelines

Topical NSAIDs are an established adjunct for managing inflammation after cataract surgery, with efficacy and corneal safety considerations described in the SPC and ophthalmology guidance.

Reference: RCOphth; 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.