Description

Nepafenac is a nonsteroidal anti-inflammatory prodrug (NSAID). After installation 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.

Presentation

    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.

Indications

    Nevan Sterile Ophthalmic Suspension:
    The treatment of post-operative ocular pain and inflammation including cataract surgery

    Inhibition of surgery-induced miosis and

    Prevention of postoperative cystoid macular edema (CME).

    Nevan TS Sterile Ophthalmic Suspension:
    Post-operative pain and inflammation associated with cataract surgery.

Dosage & Administration

    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.

Contrainidications

    Contraindicated in patients with previously demonstrated hypersensitivity to any of the ingredients in the formulation or to other NSAIDs.

Warning & Precautions

    Nepafenac should be used with caution in patients with known bleeding tendencies or who are receiving medications which may prolong bleeding time.

Side effects

    Reported side effects are foreign body sensation, lid margin crusting, ocular discomfort, ocular hyperemia etc.

Drug interaction

Use in special groups

    Use in pregnancy: There are no adequate and well-controlled studies on 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.

Packing

    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.