Ocufenac 0.1% (Ophthalmic Suspension)

Title and Categories

• Ocufenac 0.1% Sterile Ophthalmic Suspension
• Ocufenac 0.3% Sterile Ophthalmic Suspension
• Ophthalmic Non-Steroid drugs

Indications

• Treats post-operative ocular pain and inflammation
• Inhibits surgery induced miosis
• Prevents post-operative cystoid macular edema (CME)
• Post-operative pain and inflammation associated with cataract surgery

Pharmacology

• Nepafenac is a nonsteroidal anti-inflammatory prodrug (NSAID)
• Penetrates the cornea and is converted to Amfenac
• Inhibits the action of cyclooxygenase enzyme

Dosage and Administration

• Instill 1 drop 3 times daily for post-operative pain & inflammation
• Instill 1 drop 3 times daily for surgery induced miosis
• Instill 1 drop 3 times daily for prevention of post-operative CME
• Instill 1 drop once daily for post-operative pain & inflammation with 0.3% Suspension
• Additional drop 30 to 120 minutes prior to surgery with 0.3% Suspension

Contraindications

• Hypersensitivity to any of the ingredients in the formulation or to other NSAIDs

Side Effects

• Foreign body sensation
• Lid margin crusting
• Ocular discomfort
• Ocular hyperemia

Pregnancy and Lactation

• Use during pregnancy only if potential benefit justifies potential risk to the fetus
• Caution should be exercised when administered to a nursing mother

Precautions and Warnings

• Use with caution in patients with known bleeding tendencies or receiving medications which may prolong bleeding time

Use in Special Populations

• Safety and effectiveness in pediatric patients below 18 years of age have not been established
• No overall differences in safety or effectiveness observed between elderly and younger patients

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