Nepafix TS 0.003

INDICATIONS

Nepafenac 0.1% 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).Nepafenac 0.3% Sterile Ophthalmic Suspension: Post-operative pain and inflammation associated with cataract surgery.

PHARMACOLOGY

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.

DOSAGE & ADMINISTRATION

Nepafenac 0.1% 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.

Nepafenac 0.3% 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.

SIDE EFFECTS

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

PREGNANCY & LACTATION

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.

PRECAUTIONS & WARNINGS

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

USE IN SPECIAL POPULATIONS

Use in children: Safety and effectiveness in pediatric patients below 18 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.

THERAPEUTIC CLASS

Ophthalmic Non-Steroid drugs