Nevanac

/ Novartis

Adults, including the elderly
For the prevention and treatment of pain and inflammation: 1 drop 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 21 days of the postoperative period, as directed by the clinician. An additional drop should be administered 30 to 120 minutes prior to surgery.
For the reduction in the risk of postoperative macular edema associated with cataract surgery in diabetic patients: 1 drop 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.
Special population
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.
Paediatric population: The safety and efficacy of NEVANAC in children and adolescents have not been established. No data are available.
Geriatric population: No overall differences in safety and effectiveness have been observed between elderly and younger patients.
See prescribing information for full details.

Indicated in adults for prevention and treatment of postoperative pain and inflammation associated with cataract surgery. Reduction in the risk of postoperative macular oedema associated with cataract surgery in diabetic patients.

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.

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.
Ocular effects: Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may be sight threatening. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of NEVANAC and should be monitored closely for corneal health.
Topical NSAIDs may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Therefore, it is recommended that caution should be exercised if NEVANAC is administered concomitantly with corticosteroids, particularly in patients at high risk for corneal adverse reactions described below.
Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (e.g., dry eye syndrome), rheumatoid arthritis or repeat ocular surgeries within a short period of time may be at increased risk for corneal adverse reactions which may become sight threatening. Topical NSAIDs should be used with caution in these patients. Prolonged use of topical NSAIDs may increase patient risk for occurrence and severity of corneal adverse reactions.
There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including hyphaemas ) in conjunction with ocular surgery . NEVANAC should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time.
An acute ocular infection may be masked by the topical use of anti-inflammatory medicines. NSAIDs do not have any antimicrobial properties. In case of ocular infection, their use with anti-infectives should be undertaken with care.
Contact lenses: Contact lens wear is not recommended during the postoperative period following cataract surgery. Therefore, patients should be advised not to wear contact lenses unless clearly indicated by their doctor.
Benzalkonium chloride: NEVANAC contains benzalkonium chloride which may cause irritation and is known to discolour soft contact lenses. If contact lenses need to be used during treatment, patients should be advised to remove contact lenses prior to application and wait at least 15 minutes before reinsertion. Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since NEVANAC contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Cross-sensitivity: There is a potential for cross-sensitivity of nepafenac to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.

The most common reported adverse reactions were keratitis, foreign body sensation and eyelid margin crusting which occurred in between 0.4% and 0.2% of patients.
Diabetic patients: The most frequently reported adverse reaction was punctate keratitis.
See prescribing information for full details.

In vitro studies have demonstrated a very low potential for interaction with other medicinal products and protein binding interactions.
Prostaglandin analogues: There are very limited data on the concomitant use of prostaglandin analogues and NEVANAC. Considering their mechanism of action, the concomitant use of these medicinal products is not recommended.
Concomitant use of topical NSAIDs and topical steroids may increase the potential for healing problems. Concomitant use of NEVANAC with medications that prolong bleeding time may increase the risk of haemorrhage.

Pregnancy: The potential risk for humans is unknown. Since the systemic exposure in non-pregnant women is negligible after treatment with NEVANAC, the risk during pregnancy could be considered low. Nevertheless, as inhibition of prostaglandin synthesis may negatively affect pregnancy and/or embryonal/foetal development and/or parturition and/or postnatal development. NEVANAC is not recommended during pregnancy.
Lactation: It is unknown whether nepafenac is excreted in human milk. Animal studies have shown excretion of nepafenac in the milk of rats. However, no effects on the suckling child are anticipated since the systemic exposure of the breastfeeding woman to nepafenac is negligible. NEVANAC can be used during breastfeeding.
See prescribing information for full details.

No toxic effects are likely to occur in case of overdose with ocular use, nor in the event of accidental oral ingestion.

Storage: Store below 25°C.
Shelf-life: 2 years. Discard 4 weeks after first opening.