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Nevanac is a brand name for Nepafenac. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: NEVANAC 1 mg/ml is 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 (see section 5.1)
Verbatim from this product's EMA label. Tap a section to expand.
Posology 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. 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. Special populations 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. 3 Paediatric population 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.
Geriatric population No overall differences in safety and effectiveness have been observed between elderly and younger patients. Method of administration For ocular use. Patients should be instructed to shake the bottle well before use.
After cap is removed, if tamper evident snap collar is loose, remove before using product. 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. Patients should be instructed to keep the bottle tightly closed when not in use.
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.
2% of patients. Tabulated list of adverse reactions The following adverse reactions are classified according to the following convention: very common (≥1/10), common (≥1/100 to <1/10), uncommon (≥1/1 000 to <1/100), rare (≥1/10 000 to <1/1 000), very rare (<1/10 000), or not known (cannot be estimated from the available data).
Within each frequency grouping, adverse reactions are presented in order of decreasing seriousness. The adverse reactions were obtained from clinical trials and post-marketing reports. 6 System organ classification Adverse reactions Immune system disorders Rare: hypersensitivity Nervous system disorders Rare: dizziness, headache Eye disorders Uncommon: keratitis, punctate keratitis, corneal epithelium defect, foreign body sensation in eyes, eyelid margin crusting 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: corneal perforation, impaired healing (cornea), corneal opacity, corneal scar, reduced visual acuity, eye swelling, ulcerative keratitis, corneal thinning, blurred vision Vascular disorders Not known: blood pressure increased Gastrointestinal disorders Rare: nausea Not known: vomiting Skin and subcutaneous tissue disorders Rare: cutis laxa (dermatochalasis), allergic dermatitis Diabetic patients In the two clinical studies involving 209 patients, diabetic patients were exposed to NEVANAC treatment for 60 days or greater for the prevention of macular oedema post cataract surgery.
The most frequently reported adverse reaction was punctate keratitis which occurred in 3% of patients, resulting in a frequency category of common. 5% of patients, respectively both adverse reactions with a frequency category of uncommon.
Description of selected adverse reactions Clinical trial experience for the long-term use of NEVANAC for the prevention of macular oedema post cataract surgery in diabetic patients is limited. 4). 4). From post-marketing experience with NEVANAC, cases reporting corneal epithelium defect/disorder have been identified.
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. 8). 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.
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 medicinal products.
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.
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 medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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Severity of these cases vary from non serious effects on the epithelial integrity of the corneal epithelium to more serious events where surgical interventions and/or medical therapy are required to regain clear vision. Post-marketing experience with topical NSAIDs suggests that patients with complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases (eg, 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.
When nepafenac is prescribed to a diabetic patient post cataract surgery to prevent macular oedema, the existence of any additional risk factor should lead to reassessment of the foreseen benefit/risk and to intensified patient monitoring.
7 Paediatric population The safety and efficacy of NEVANAC in children and adolescents have not been established. Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.
It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system listed in Appendix V.
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 eye 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.