Indication

OptafenacTM ophthalmic suspension is indicated for:
• The treatment of post-operative ocular pain and inflammation including cataract surgery
• Inhibition of surgery induced miosis and
• Prevention of post-operative cystoid macular edema (CME)


Dosage & Administration

For post-operative pain & inflammation: Instill 1 drop 3 times daily 1 day prior to cataract surgery and continued on the day of surgery and through the first 2 weeks of the post-operative period. For surgery induced miosis: Instill 1 drop 3 times daily 1 day before surgery & on the day of surgery. For prevention of post-operative cystoid macular edema: Instill 1 drop 3 times daily 1 day before surgery and continued on the day of surgery and through the first 6 weeks of the post-operative period.


Precautions

There is the potential for cross-sensitivity to acetylsalicylic acid, phenylacetic acid derivatives and other nonsteroidal anti-inflammatory agents. Therefore, caution should be used when treating individuals who have previously exhibited sensitivities to these drugs. With some nonsteroidal anti-inflammatory drugs including Nepafenac, there exists the potential for increased bleeding time, so nepafenac should be used with caution in patients with known bleeding tendencies.

 

Topical nonsteroidal anti-inflammatory drugs (NSAIDs) including Nepafenac, 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 of topical NSAIDs may result in epithelial breakdown, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. Patients with evidence of corneal epithelial breakdown should immediately discontinue use of topical NSAIDs including Nepafenac and should be closely monitored for corneal health.

 

Use in special groups
Pregnancy: There are no adequate and well-controlled studies in pregnant women. Nepafenac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

Lactation: It is not known whether this drug is excreted in human milk. So, caution should be exercised when Nepafenac ophthalmic suspension is administered to a nursing mother.

 

Use in children: Safety and effectiveness in pediatric patients below 10 years of age have not been established.

 

Use in elderly patients: No overall differences in safety or effectiveness have been observed between elderly and younger patients.


Product Details


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