NEVANAC® (Nepafenac) Eye Drops, 5 ml

What is NEVANAC® (Nepafenac) Eye Drops?

NEVANAC® (Nepafenac) Eye Drops is a nonsteroidal anti-inflammatory drug (NSAID) used in ophthalmology. This medication is designed to reduce pain and inflammation following cataract surgery. It is available as a 5 ml bottle of eye drops, where each milliliter contains 1.0 mg of the active ingredient nepafenac.

What are the Ingredients in NEVANAC® Eye Drops?

Each milliliter of NEVANAC® Eye Drops contains:

• Active ingredient: Nepafenac 1.0 mg
• Inactive ingredients: Benzalkonium chloride, carbomer (974 P), tyloxapol, disodium edetate, mannitol, sodium chloride, hydrochloric acid and/or sodium hydroxide (for pH adjustment), purified water.

What Does NEVANAC® Eye Drops Look Like?

NEVANAC® Eye Drops is a uniform suspension that ranges in color from light yellow to light orange.

How Does NEVANAC® Eye Drops Work?

Pharmacodynamics

Nepafenac is a prodrug, which means it is converted into its active form after being administered. Once instilled in the eyes, nepafenac penetrates the cornea and is hydrolyzed into amfenac, an active NSAID. Amfenac works by inhibiting the enzyme prostaglandin-H-synthase (cyclooxygenase), which is essential for the production of prostaglandins that cause inflammation and pain.

Pharmacokinetics

After eye drops are administered, nepafenac is quickly converted to amfenac in the eye. The peak plasma concentrations (Cmax) of nepafenac and amfenac are approximately 0.310 ± 0.104 ng/ml and 0.422 ± 0.121 ng/ml, respectively. Amfenac then undergoes extensive metabolism to form more polar metabolites, primarily through hydroxylation and conjugation processes.

What Are the Indications for NEVANAC® Eye Drops?

NEVANAC® Eye Drops are indicated for:

• Preventing and treating postoperative pain and inflammation associated with cataract surgery.
• Reducing the risk of postoperative macular edema in diabetic patients undergoing cataract surgery.

How Should NEVANAC® Eye Drops Be Used?

Dosage and Administration

For eye instillation:

• Shake the bottle well before use.
• Postoperative pain and inflammation: Instill one drop in the affected eye(s) three times daily, beginning one day before cataract surgery and continuing for up to 21 days post-surgery. An additional drop should be instilled 30 to 120 minutes prior to surgery.
• Postoperative macular edema (diabetic patients): Instill one drop in the affected eye(s) three times daily, starting one day before cataract surgery and continuing for up to 60 days post-surgery. An additional drop should be instilled 30 to 120 minutes prior to surgery.

Special Instructions

• Avoid touching the dropper tip to any surface to prevent contamination.
• Close the bottle tightly after each use.
• If using multiple ophthalmic medications, allow at least 5 minutes between applications.

What Are the Possible Side Effects of NEVANAC® Eye Drops?

Local Side Effects (Uncommon)

• Keratitis
• Iritis
• Choroidal effusion
• Corneal deposits
• Eye pain
• Photophobia
• Eye discomfort, foreign body sensation
• Blurred vision
• Dry eye
• Eye discharge
• Allergic conjunctivitis, eye itching
• Crusting of the eyelid margin
• Increased tear production
• Conjunctival hyperemia

Systemic Side Effects (Uncommon)

• Headache
• Nausea
• Hypersensitivity reactions

Note: Diabetic patients may experience ocular side effects more frequently.

What Are the Contraindications for NEVANAC® Eye Drops?

NEVANAC® Eye Drops should not be used by individuals with:

• Hypersensitivity to nepafenac or any of its components.
• History of asthma, urticaria, or acute rhinitis following the use of aspirin or other NSAIDs.

Are There Any Drug Interactions with NEVANAC® Eye Drops?

Interactions with other medications are unlikely. However, the concurrent use of NEVANAC® and prostaglandin analogs is not recommended due to their opposing mechanisms of action.

What Precautions Should Be Taken?

• Avoid sunlight: Patients should avoid exposure to sunlight during treatment.
• Monitor diabetic patients: Close monitoring is required for diabetic patients using NEVANAC® to prevent macular edema.
• Potential for keratitis: Long-term use may lead to keratitis, corneal thinning, and even corneal perforation, necessitating immediate cessation of the drug.
• Masking infections: NSAIDs can mask symptoms of eye infections. Use cautiously with antibacterial agents if an infection is present.
• Bleeding risk: Use cautiously in patients with a history of bleeding disorders or those taking blood thinners.

Storage and Handling of NEVANAC® Eye Drops

• Storage: Store at temperatures not exceeding 30°C (86°F). Keep out of reach of children.
• Shelf Life: 2 years. Once opened, use within 4 weeks. Do not use past the expiration date.