Nepafenac

Nepafenac is a prescription medication used to relieve eye pain, swelling, and redness caused by cataract surgery. Nepafenac belongs to a group of drugs called nonsteroidal anti-inflammatory drugs (NSAIDs) which help to stop the release of substances that cause allergy symptoms and inflammation.

This medication comes in the form of eye drops. One drop of nepafenac should be applied to the affected eye(s) 3 times daily beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks after surgery. Remove contact lenses before instilling nepafenac drops.

Common side effects include headache, runny nose and pain or pressure in the face.

Serious side effects have been reported including:

• cross-sensitivity reactions. Caution should be used in patients who are allergic to aspirin other NSAIDs such as diclofenac (Voltaren), ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), or tolmetin (Tolectin) as these patient may also be allergic to nepafenac.
• increased bleeding time of eye tissues. NSAIDs, like nepafenac, may increase bleeding time and should be used with caution in patients with known bleeding tendencies or who are receiving other medications which may prolong bleeding time.
• delayed healing. Topical nonsteroidal anti-inflammatory drugs (NSAIDs) including nepafenac, may slow or delay healing. Topical corticosteroids are also known to slow or delay healing. When topical NSAIDs and topical steroids are used at the same time there may be increased risk for healing problems.
• inflammation of the cornea (keratitis). Use of topical NSAIDs like nepafenac may cause problems related to corneal inflammation, corneal thinning, corneal erosion, corneal ulceration or corneal perforation. These events may cause loss of vision. If you develop any of the following symptoms of keratitis stop taking nepafenac and contact your doctor:
• red or bloody eyes
• eye pain
• feeling that something is in the eye
• sensitivity to light
• blurred or decreased vision
• seeing specks or spots
• teary eyes
• eye discharge or crusting

Do not take nepafenac if you are:

• allergic to any ingredient in nepafenac
• allergic to other NSAIDs

If you take too much nepafenac, or if someone swallows it, call your healthcare provider or local Poison Control Center, or seek emergency medical attention right away.

Storage

Ophthalmic

2–25°C.1

• It is used to treat swelling and pain after cataract surgery.

• If you have an allergy to nepafenac or any other part of nepafenac.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you are more than 24 weeks pregnant.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

Mechanism of Action Section

After topical ocular dosing, Nepafenac penetrates the cornea and is converted by ocular tissue hydrolases to amfenac, a nonsteroidal anti-inflammatory drug. Nepafenac and amfenac are thought to inhibit the action of prostaglandin H synthase (cyclooxygenase), an enzyme required for prostaglandin production.

Pharmacokinetics Section

Following bilateral topical ocular once-daily dosing of Nepafenac ophthalmic suspension, 0.3%, the concentrations of Nepafenac and amfenac peaked at a median time of 0.5 hour and 0.75 hour, respectively on both Day 1 and Day 4. The mean steady-state Cmax for Nepafenac and for amfenac were 0.847 ± 0.269 ng/mL and 1.13 ± 0.491 ng/mL, respectively..

Nepafenac at concentrations up to 3000 ng/mL and amfenac at concentrations up to 1000 ng/mL did not inhibit the in vitro metabolism of 6 specific marker substrates of cytochrome P450 (CYP) isozymes (CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, and CYP3A4). Therefore, drug-drug interactions involving CYP mediated metabolism of concomitantly administered drugs are unlikely.

NDC 0065-1750-07             STERILE

Nepafenac
ophthalmic
suspension,
0.3%

1.7 mL
Alcon®

Pain, inflammation associated with cataract surgery: Ophthalmic:

Ilevro: Instill 1 drop into affected eye(s) once daily, beginning 1 day prior to surgery, the day of surgery, and through the first 2 weeks of the postoperative period. Instill 1 additional drop 30-120 minutes prior to surgery.

Nevanac: Instill 1 drop into affected eye(s) 3 times/day, beginning 1 day prior to surgery, the day of surgery, and through the first 2 weeks of the postoperative period

• Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

• Patient may experience foreign body sensation of eye or eye stickiness. Have patient report immediately to prescriber vision changes, eye pain, or severe eye irritation (HCAHPS).

• Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

Use nepafenac exactly as prescribed by your doctor. Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use this medication while wearing contact lenses. Nepafenac ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Do not use nepafenac ophthalmic for longer than 14 days after your surgery unless your doctor tells you to.

Wash your hands before using the eye drops.

Shake the nepafenac eye drops well just before you use them.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eye and gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the nepafenac eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use nepafenac eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Keep using any other eye drops your doctor has prescribed, including drops to treat glaucoma. Use only the eye medications your doctor has prescribed.

Store nepafenac ophthalmic at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Get emergency medical help if you have any of these signs of an allergic reaction to nepafenac: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

• vision problems;

• crusting or drainage of your eyes;

• swollen eyelids; or

• severe eye pain.

Other common nepafenac side effects may be more likely to occur (some are effects of cataract surgery and not side effects of the medication):

• dry or sticky feeling in the eye;

• feeling like something is in your eye;

• eye redness;

• itching or watering of the eye;

• increased sensitivity to light;

• headache;

• nausea, vomiting; or

• stuffy nose.

Usual Adult Dose for Postoperative Ocular Inflammation:

O.1% ophthalmic suspension:
1 drop instilled in the affected eye(s) three times a day beginning 1 day prior to surgery, on the day of surgery, and for 14 days following surgery.

0.3% ophthalmic suspension:
1 drop instilled in the affected eye(s) once daily beginning 1 day prior to surgery, on the day of surgery, and for 14 days following surgery. An additional drop should be administered 30 to 120 minutes prior to surgery.

Usual Pediatric Dose for Postoperative Ocular Inflammation:

Pediatric patients greater than or equal to 10 years or age:
O.1% ophthalmic suspension:
1 drop instilled in the affected eye(s) three times a day beginning 1 day prior to surgery, on the day of surgery, and for 14 days following surgery.

0.3% ophthalmic suspension:
1 drop instilled in the affected eye(s) once daily beginning 1 day prior to surgery, on the day of surgery, and for 14 days following surgery. An additional drop should be administered 30 to 120 minutes prior to surgery.

0.1% suspension: 1 drop should be applied to the affected eye 3 times per day beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period

0.3% suspension: 1 drop should be applied to the affected eye once a day beginning 1 day prior to cataract surgery, continued on the day of surgery and through the first 2 weeks of the postoperative period; an additional drop should be administered 30 to 120 minutes prior to surgery

Comments:
-This drug may be administered in conjunction with other topical ophthalmic drugs such as beta-blockers, carbonic anhydrase inhibitors, alpha-agonists, cycloplegics, and mydriatics.
-If more than one topical ophthalmic drug is being used, these drugs should be administered at least 5 minutes apart.

Use: Treatment of pain and inflammation associated with cataract surgery