Nepafenac Ophthalmic

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

• Nevanac^®

Pregnancy Category: C

Lactation: use caution

Pregnancy Categories

A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

NA:Information not available.

Nepafenac is a nonsteroidal anti-inflammatory drug (NSAID). It reduces pain and inflammation in the eyes.

Nepafenac ophthalmic (for the eyes) is used to reduce pain and swelling after cataract surgery.

Nepafenac ophthalmic may also be used for other purposes not listed in this medication guide.

You should not use nepafenac ophthalmic if you are allergic to it.

Before using nepafenac ophthalmic, tell your doctor if you are allergic to any other eye drops, or if you have diabetes, dry eye syndrome, arthritis, or a bleeding or blood-clotting disorder such as hemophilia.

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

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 touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

You should not use nepafenac ophthalmic if you are allergic to it.

To make sure nepafenac ophthalmic is safe for you, tell your doctor if you have:

• diabetes;
• dry eye syndrome;
• an allergy to any other eye drops;
• arthritis; or
• a bleeding or blood-clotting disorder, such as hemophilia.

FDA pregnancy category C. It is not known whether nepafenac ophthalmic will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether nepafenac ophthalmic passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

In the U.S.

• Ilevro
• Nevanac

Available Dosage Forms:

• Suspension

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: NSAID

Your eye doctor will check your or your child's eyes at regular visits to make sure it is working properly and is not causing unwanted effects.

If your or your child's symptoms do not improve within a few days or if they become worse, check with your doctor.

Slow or delayed healing may occur while you or your child are using nepafenac. Ask your doctor before using nepafenac together with a topical corticosteroid (eg, betamethasone, hydrocortisone).

Using nepafenac may increase risk of having corneal (front part of the eye) problems, including keratitis. Check with your eye doctor right away if you or your child have blurred vision, changes in vision, or eye redness, irritation, or pain while using nepafenac.

Make sure your doctor knows if you are pregnant. Do not use nepafenac during the later part of a pregnancy, unless your doctor tells you to.

If you hurt your eye or develop an eye infection, talk with your doctor right away. You may need to change your medicine or stop using it.

Do not use other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Nepafenac is a nonsteroidal anti-inflammatory drug (NSAID). It reduces pain and inflammation in the eyes.

Nepafenac ophthalmic (for the eyes) is used to reduce pain and swelling after cataract surgery.

Nepafenac ophthalmic may also be used for other purposes not listed in this medication guide.

This medication is used to relieve eye pain, irritation, and redness following cataract eye surgery. Nepafenac belongs to a class of drugs known as nonsteroidal anti-inflammatory drugs (NSAIDs). It works by blocking certain natural substances (prostaglandins) in your body that cause pain and swelling.

How to use Nepafenac Drops, Suspension

Apply this medication to the operated eye(s) as directed by your doctor. The instructions for use depend on the strength of the eye drops prescribed. Follow your doctor's instructions.

If you are using nepafenac 0.1% eye drops, apply it usually 3 times daily starting 1 day before surgery, and continue use on the day of surgery and for 2 weeks after surgery, or as directed by your doctor.

If you are using nepafenac 0.3% eye drops, apply it usually once daily starting 1 day before surgery, and continue use on the day of surgery and for 2 weeks after surgery, or as directed by your doctor. Your doctor may also instruct you to apply an additional drop one-half hour to 2 hours before surgery.

To apply eye drops, wash your hands first. Shake the bottle well before each dose. To avoid contamination, do not touch the dropper tip or let it touch your eye or any other surface.

This medication should not be used while wearing contact lenses. Consult your doctor or pharmacist for details.

Tilt your head back, look upward, and gently pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place one drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed.

Do not rinse the dropper. Replace the dropper cap after each use.

If you are using another kind of eye medication (e.g., drops or ointments), wait at least 5 minutes before applying other medications. Use eye drops before eye ointments to allow the eye drops to enter the eye.

This medication is usually used for up to 14 days after eye surgery or as directed by your doctor. Do not start using this medication early, use it more often than prescribed, or continue using it for longer than directed by your doctor. Prolonged use of nepafenac eye drops (more than 2 weeks) may increase the risk of very serious side effects of the eye.

Inform your doctor if your condition persists or worsens.

Before using nepafenac, tell your doctor or pharmacist if you are allergic to it; or to aspirin, or to other NSAIDs (e.g., ibuprofen, celecoxib); or if you have any other allergies. This product may contain inactive ingredients (such as preservatives like benzalkonium chloride), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: aspirin-sensitive asthma (a history of worsening breathing with runny/stuffy nose after taking aspirin or other NSAIDs).

Before using this medication, tell your doctor or pharmacist your medical history, especially of: bleeding problems, previous eye surgery, other eye problems (e.g., dry eye syndrome, corneal problems), diabetes, rheumatoid arthritis, asthma, nasal polyps.

Your vision may be temporarily unstable after applying this drug. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before using this medication, women of childbearing age should talk with their doctor(s) about the benefits and risks (such as miscarriage, trouble getting pregnant). Tell your doctor if you are pregnant or if you plan to become pregnant. During pregnancy, this medication should be used only when clearly needed. It is not recommended for use during the first and last trimesters of pregnancy due to possible harm to the unborn baby and interference with normal labor/delivery.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless told to do so by your doctor. A different medication may be necessary in that case.

Missed Dose

If you miss a dose use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store in the refrigerator or at room temperature between 36-77 degrees F (2-25 degrees C) away from light and moisture. Do not freeze. Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.