Nepafenac is a nonsteroidal anti-inflammatory prodrug (NSAID). After instillation in the eye, it penetrates the cornea and is converted by ocular tissue hydrolase to Amfenac, a potent nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of cyclooxygenase enzyme. This enzyme is required for prostaglandin synthesis.
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Presentation:
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Nevan Sterile Ophthalmic Suspension: Each ml contains Nepafenac INN 1 mg. Nevan TS Sterile Ophthalmic Suspension: Each ml contains Nepafenac INN 3 mg. Preservative: Nevan Sterile Ophthalmic Suspension: Sodium Perborate 0.01%. Nevan TS Sterile Ophthalmic Suspension: Sodium Perborate 0.01%. Vehicle: Nevan Sterile Ophthalmic Suspension: Carbomer 980 USP 0.4%. Nevan TS Sterile Ophthalmic Suspension: Carbomer 980.
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Pharmacology:
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Nepafenac is a nonsteroidal anti-inflammatory prodrug (NSAID). After instillation in the eye, it penetrates the cornea and is converted by ocular tissue hydrolase to Amfenac, a potent nonsteroidal anti-inflammatory drug. Amfenac is thought to inhibit the action of cyclooxygenase enzyme. This enzyme is required for prostaglandin synthesis.
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Indication:
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Nevan Sterile Ophthalmic Suspension: 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). Nevan TS Sterile Ophthalmic Suspension: Post-operative pain and inflammation associated with cataract surgery.
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Dosage & Administration:
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Nevan Sterile Ophthalmic Suspension: 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 CME: 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. Nevan TS Sterile Ophthalmic Suspension: For post-operative pain & inflammation: Instill 1 drop once 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. An additional drop should be administered 30 to 120 minutes prior to surgery.
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Contrainidications:
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Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation or to other NSAIDs.
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Warning & Precautions:
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Nepafenac should be used with caution in patients with known bleeding tendencies or who are receiving medications which may prolong bleeding time.
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Side effects:
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Reported side effects are foreign body sensation, lid margin crusting, ocular discomfort, ocular hyperemia etc.
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Use in special groups:
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Use in 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. Use in 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.
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Packing:
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Nevan Sterile Ophthalmic Suspension: Each plastic dropper bottle contains 5 ml sterile ophthalmic suspension. Nevan TS Sterile Ophthalmic Suspension: Each plastic dropper bottle contains 5 ml sterile ophthalmic suspension.