Nevanac (nepafenac ophthalmic suspension)

Nevanac ophthalmic suspension is indicated for the treatment of pain and inflammation associated with cataract surgery.

Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to the rates in the clinical studies of another drug and may not reflect the rates observed in practice.

Ocular Adverse Reactions

The most frequently reported ocular adverse reactions following cataract surgery were

• capsular opacity,
• decreased visual acuity,
• foreign body sensation,
• increased intraocular pressure, and
• sticky sensation.

These reactions occurred in approximately 5 to 10% of patients.

Other ocular adverse reactions occurring at an incidence of approximately 1 to 5% included

• conjunctival edema,
• corneal edema,
• dry eye,
• lid margin crusting,
• ocular discomfort,
•  ocular hyperemia,
• ocular pain,
• ocular pruritus,
• photophobia,
• tearing and
• vitreous detachment.

Some of these reactions may be the consequence of the cataract surgical procedure.

Non-Ocular Adverse Reactions

Non-ocular adverse reactions reported at an incidence of 1 to 4% included

• headache,
• hypertension,
• nausea/vomiting, and
• sinusitis.

Recommended Dosing

• One drop of Nevanac should be applied to the affected eye three times daily, beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period.

Use with Other Topical Ophthalmic Medications

• Nevanac may be administered in conjunction with other topical ophthalmic medications such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics.
• If more than one topical ophthalmic medication is being used, the medicines must be administered at least 5 minutes apart.

No Information Provided

• There are no adequate and well-controlled studies in pregnant women.
• Because animal reproduction studies are not always predictive of human response, Nevanac should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
• Nevanac is excreted in the milk of lactating 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 Nevanac ophthalmic suspension is administered to a nursing woman.