Difluprednate Ophthalmic

WHY is this medicine prescribed?

Difluprednate ophthalmic is used to treat eye swelling and pain after eye surgery. Difluprednate ophthalmic is in a class of medications called corticosteroids. It works by stopping the release of certain natural substances that cause swelling and pain.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

HOW should this medicine be used?

Difluprednate ophthalmic comes as an emulsion (liquid) to apply to the eye. It is usually applied to the affected eye(s) 4 times a day beginning 24 hours after surgery and continuing for 2 weeks, and then 2 times a day for 1 week. Your doctor will probably decrease your dose gradually depending on your condition and how you respond to treatment. Use difluprednate eye drops at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use difluprednate ophthalmic exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

When you use difluprednate eye drops, be careful not to let the tip of the bottle touch your eyes, fingers, face, or any surface. If the tip does touch another surface, bacteria may get into the eye drops. Using eye drops that are contaminated with bacteria may cause serious damage to the eye or loss of vision. If you think your eye drops have become contaminated, call your doctor or pharmacist.

To use the eye drops, follow these steps:

1. Wash your hands thoroughly with soap and water.
2. Check the dropper tip to make sure that it is not chipped or cracked.
3. Avoid touching the dropper tip against your eye or anything else; eyedrops and dropper must be kept clean.
4. While tilting your head back, pull down the lower lid of your eye with your index finger to form a pocket.
5. Hold the dropper (tip down) with the other hand, as close to the eye as possible without touching it.
6. Brace the remaining fingers of that hand against your face.
7. While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid.
8. Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor. Try not to blink or squeeze your eyelids.
9. Place a finger on the tear duct and apply gentle pressure.
10. Wipe any excess liquid from your face with a tissue.
11. If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop.
12. Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip.
13. Wash your hands to remove any medication.

What SPECIAL PRECAUTIONS should I follow?

Before using difluprednate eye drops,

• tell your doctor and pharmacist if you are allergic to difluprednate, other steroid medications, or any other medications, or any of the ingredients in difluprednate eye drops. Ask your pharmacist for a list of the ingredients.

• tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.

• if you are using another eyedrop medication, use the eye medications at least 10 minutes apart.

• tell your doctor if you currently have an any type of eye infection. Your doctor will probably tell you not to use difluprednate eye drops.

• tell your doctor if you have or have ever had glaucoma (condition in which increased pressure in the eye can lead to gradual loss of vision) or herpes simplex virus (a virus that causes sores to form on the face, lips, genitals, and rectum and can also cause eye infections.)

• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using difluprednate eye drops, call your doctor.

• tell your doctor if you wear contact lenses. Your doctor may tell you that you should not wear contact lenses during your treatment with difluprednate eye drops.

• you should know that difluprednate eye drops may slow healing after surgery, increase the risk of certain complications after cataract surgery, and increase your chances of getting an eye infection or worsen an infection that you already have. Call your doctor right away if your pain and swelling do not improve or if you have any of the following symptoms: eye redness, itching, tearing, or discharge; feeling that something is in your eye; seeing floating spots; sensitivity to light; or red, swollen, or crusty eyelids.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

Apply the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not apply extra eye drops to make up for a missed dose.

What SIDE EFFECTS can this medicine cause?

Some side effects can be serious. If you experience any of these symptoms or those listed in the SPECIAL PRECAUTIONS section, call your doctor immediately:

• blurred vision
• decrease in vision
• seeing a glare from lights or sun

Difluprednate eye drops may increase the risk of developing glaucoma when used for a longer period of time. If you use difluprednate eye drops for 10 days or longer, your doctor will probably monitor the pressure in your eyes. Talk to your doctor about the risks of using this medication.

Difluprednate eye drops may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What should I know about STORAGE and DISPOSAL of this medication?

Keep this medication in the original bottle inside the protective carton, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Do not freeze.

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

What should I do in case of OVERDOSE?

If someone swallows difluprednate eye drops, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

What OTHER INFORMATION should I know?

Keep all appointments with your doctor. Your doctor will probably perform certain tests on your eyes before and during your treatment.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.