Nepafenac - Warnings and Precautions
The following warnings and precautions are taken directly from the US FDA-approved drug label for Nepafenac. This is the same information dispensing pharmacists read.
5 WARNINGS AND PRECAUTIONS Increased bleeding time due to interference with thrombocyte aggregation Delayed healing Corneal effects including keratitis 5.1 Increased Bleeding Time With some NSAIDs including ILEVRO ® 0.3%, there exists the potential for increased bleeding time due to interference with thrombocyte aggregation.
There have been reports that ocularly applied nonsteroidal anti-inflammatory drugs may cause increased bleeding of ocular tissues (including hyphema) in conjunction with ocular surgery.
It is recommended that ILEVRO ® 0.3% be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
5.2 Delayed Healing Topical NSAIDs including ILEVRO ® 0.3%, 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.
5.3 Corneal 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 topical NSAIDs including ILEVRO ® 0.3% and should be closely monitored for corneal health.
Postmarketing 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 events, which may become sight threatening.
Topical NSAIDs should be used with caution in these patients.
Postmarketing experience with topical NSAIDs also suggests that use more than 1 day prior to surgery or use beyond 14 days post-surgery may increase patient risk and severity of corneal adverse events.
5.4 Contact Lens Wear ILEVRO ® 0.3% should not be administered while using contact lenses.
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