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 Ilevro 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 Ilevro is administered concomitantly with corticosteroids, particularly in patients at high risk for corneal adverse reactions described as follows.
Post-marketing experience with topical NSAIDs suggests that patients with repeat and/or complicated ocular surgeries, corneal denervation, corneal epithelial defects, diabetes mellitus, ocular surface diseases, dry eye or rheumatoid arthritis 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. Ilevro should be used with caution in patients with known bleeding tendencies or who are receiving other medicinal products which may prolong bleeding time.
Ilevro contains benzalkonium chloride which may cause eye irritation and is known to discolor soft contact lenses. Patients should be advised not to wear contact lenses during treatment with Ilevro.
Benzalkonium chloride has been reported to cause punctate keratopathy and/or toxic ulcerative keratopathy. Close monitoring is required with frequent and/or prolonged use.
There is a potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives, and other non-steroidal anti-inflammatory agents.
An acute ocular infection may be masked by the topical use anti-inflammatory medicinal products. NSAIDs do not have any anti-microbial properties. In case of ocular infection, their use with antiinfectives should be undertaken with care.
Effects on Ability to Drive and Use Machines: Temporary blurred vision or other visual disturbances may affect the ability to drive or use machines. If blurred vision occurs at application, the patient must wait until the vision clears before driving or using machinery.