XINEP - Nepafenac Ophthalmic Suspension

Composition w/v   Nepafenac B.P  0.1%  Benzalkonium chloride solution IP 0.02% Sterile Aqueous Vehicle q.s. Dosage form Ophthalmic Suspension  Category NSAID Description XINEP nepafenac ophthalmic suspension 0.1% is a sterile, topical, nonsteroidal anti inflammatory (NSAID). After topical ocular dosing, nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of prostaglandin H synthase (cyclo oxygenase), an enzyme required for prostaglandin production. Indications Xinep nepafenac ophthalmic suspension is indicated for the treatment of pain and inflammation associated with cataract surgery. Dosage One drop of Xinep should be applied to the affected eye(s) three-times-daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the post operative period. Contraindications Xinep is contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formula or to other NSAIDs. Warnings & 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  Precautions Topical nonsteroidal anti-inflammatory drugs (NSAIDs) including Xinep , 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.  Pregnancy Category C: Xinep should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.  Nursing Mothers:  Xinep ophthalmic suspension is excreted in the milk of pregnant rats. It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Xinep ophthalmic suspension is administered to a nursing woman.  Pediatric Use: The safety and effectiveness of Xinep in pediatric patients below the age of 10 years have not been established.  Storage Store in a cool & dark place Presentation Xinep is available in plastic bottle of 5 ml