= Additional active ingredients
PRESENTATION AND DOSSAGE
EYE DROPS: 5 ml
For the treatment of pain and inflammation associated with cataract surgery.
Patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation or to other NSAIDs. Like other NSAIDs, treatment is also contraindicated in patients in whom attacks of asthma, urticaria, or acute rhinitis are precipitated by acetylsalicylic acid or other NSAIDs.
As with other topical NSAIDs, treatment 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. Use of topical NSAIDs may result in keratitis. In some susceptible patients, continued use 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 and should be closely monitored for corneal health. Postmarketing experience 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 also suggests that use more than 1 day prior to surgery or use beyond 14 days post surgery may increase patient risk for occurrence and severity of corneal adverse events. Use with caution in patients with known bleeding tendencies or who are receiving other medicdbations which may prolong bleeding time. Should not be administered while wearing contact lenses. Instruct patients to avoid sunlight during treatment. Pediatric use: The safety and effectiveness below the age of 10 years have not been established. Geriatric use: No overall differences in safety and effectiveness have been observed between elderly and younger patients.
The most frequently reported ocular adverse events following cataract surgery were capsular opacity, decreased visual acuity, foreign body sensation, increased intraocular pressure, and sticky sensation. Other ocular adverse events included conjunctival edema, corneal edema, dry eye, lid margin crusting, ocular discomfort, ocular hyperemia, ocular pain, ocular pruritus, photophobia, tearing and vitreous detachment. Nonocular adverse events included headache, hypertension, nausea/vomiting, and sinusitis.
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 up to 21 days of the postoperative period, as directed by the clinician. An additional drop should be administrated 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 6- days of the postoperative period. An additional drop should be administrated 30 to 120 minutes prior to surgery.
MANUFACTURER & DISTRIBUTER:
License Holder: Lapidot medicdbal