Optanep Special Precautions

Do not inject. Instruct the patients not to swallow Nepafenac.
Instruct the patients to avoid sunlight during treatment with Nepafenac.
Nepafenac 3 mg/mL eye drops should not be used for reducing postoperative macular edema risk associated with cataract surgery because the safety and efficacy of this dose have not been studied.
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. In patients with evidence of corneal epithelial breakdown, Nepafenac use should be immediately discontinued 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 increases the potential for healing problems. For this reason, caution is advised when Nepafenac is used concomitantly with corticosteroids, especially in patients with a high risk for the side effects described as follows.
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 the risk for occurrence and severity of corneal adverse reactions in patients.
There have been reports that ophthalmic NSAIDs may cause increased bleeding of ocular tissues (including blood in the front chamber of the eye) in conjunction with ocular surgery. Nepafenac should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products that 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. Caution is advised during the concomitant use of anti-infectives in case of ocular infection.
Contact lenses: Wearing contact lens is not recommended during the postoperative period following cataract surgery. Therefore, contact lenses should not be worn during treatment with Nepafenac.
Benzalkonium Chloride: Benzalkonium chloride is widely used as a preservative in ophthalmic products and has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Since Nepafenac contains benzalkonium chloride, close monitoring is required with frequent or prolonged use.
Benzalkonium chloride may cause eye irritation. Avoid contact with soft contact lenses. Remove contact lenses before administration and wait at least 15 minutes to wear them. It is known that it causes discoloration of soft contact lenses.
Nepafenac contains propylene glycol. Propylene glycol may cause eye irritation.
Cross-sensitivity: There is a potential for cross-sensitivity of nepafenac to acetylsalicylic acid, phenylacetic acid derivatives, and other NSAIDs.
Effects on the ability to drive and use machines: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines, such as the usage of any eye drop. If blurred vision occurs after administration, the patient must wait until the vision clears before driving or using machines.
Use in the Elderly: It has the same usage as in adults.