Durezol is a corticosteroid medicine. It prevents the release of substances in the body that cause inflammation.

Durezol ophthalmic emulsion is used to treat eye pain and inflammation caused by surgery.

Durezol is also used to treat anterior uveitis, inflammation that affects the front part of the eye.

You should not use Durezol if you have untreated glaucoma, any type of eye infection (including herpes), or an untreated infection in your eyes or elsewhere (including chickenpox).

Do not allow the tip of the dropper to touch any surface, including your eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

Do not use Durezol ophthalmic emulsion while you are wearing regular contact lenses. Wait at least 10 minutes after using the eye drops before putting in the lenses. Do not wear any contact lens that has not been approved by your doctor.

Talk with your doctor if your symptoms do not improve after 2 days of treatment. Do not stop using Durezol without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Durezol may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Call your doctor at once if you have sudden eye irritation or pain, severe eye redness or itching, pain behind your eyes, sudden vision changes, severe headache, slow healing after your eye surgery, signs of new eye infection (swelling, draining, crusting), tunnel vision, seeing halos around lights, or changes in the color or appearance of your iris (the colored part of your eye).

Use Durezol ophthalmic emulsion exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets.

Your doctor may prescribe 2 separate bottles of this medicine, one to use in each eye. This is to keep from passing infection from one eye to the other. Be sure to mark each bottle for the right or left eye, and use the eye drops from that bottle only in that eye.

To apply the Durezol eye drops:

• Wash your hands before using 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 eyes for 1 to 2 minutes with your head tipped down, without blinking or squinting. 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 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 this medicine while wearing soft contact lenses. Durezol ophthalmic emulsion may contain a preservative that can discolor soft contact lenses. Wait at least 10 minutes after using this medicine before putting in your contact lenses. Do not wear any contact lens that has not been approved by your doctor.

Call your doctor if your symptoms do not improve after 2 days of treatment.

If you use Durezol for longer than 10 days, you may need frequent vision tests to check the pressure inside your eyes.

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

You should not stop using this medicine suddenly. Follow your doctor's instructions about tapering your dose.

Usual Adult Dose of Durezol for Postoperative Ocular Inflammation:

Instill 1 drop into the conjunctival sac of the affected eye 4 times per day beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times per day for a week and then a taper based on the response

Use: Treatment of inflammation and pain associated with ocular surgery

Usual Adult Dose of Durezol for Uveitis:

Instill 1 drop into the conjunctival sac of the affected eye 4 times per day for 14 days followed by tapering as clinically indicated

Use: Treatment of endogenous anterior uveitis

Usual Pediatric Dose of Durezol for Postoperative Ocular Inflammation:

Instill 1 drop into the conjunctival sac of the affected eye 4 times per day beginning 24 hours after surgery and continuing throughout the first 2 weeks of the postoperative period, followed by 2 times per day for a week and then a taper based on the response

Use: Treatment of inflammation and pain associated with ocular surgery

Usual Pediatric Dose of Durezol for Uveitis:

Instill 1 drop into the conjunctival sac of the affected eye 4 times per day for 14 days followed by tapering as clinically indicated

Use: Treatment of endogenous anterior uveitis

You should not use Durezol if you are allergic to difluprednate, or if you have any type of bacterial, fungal, or viral infection of the eye (including herpes).

To make sure Durezol is safe for you, tell your doctor if you have ever had:

• glaucoma; or

• cataracts.

It is not known whether difluprednate will harm an unborn baby. Tell your doctor if you are pregnant.

It may not be safe to breast-feed while using this medicine. Ask your doctor about any risk.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Durezol may cause blurred vision and may impair your reactions. Avoid driving or hazardous activity until you know how this medicine will affect you.

Do not share this medicine with another person, even if they have the same symptoms you have.

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

Call your doctor at once if you have:

• pain behind your eyes, sudden vision changes;

• slow healing after your eye surgery;

• eye pain, tunnel vision, or seeing halos around lights; or

• signs of new eye infection, such as swelling, draining, or crusting of your eyes.

Common Durezol side effects may include:

• eye itching or irritation;

• blurred vision;

• watery eyes;

• headache;

• feeling like something is in your eye; or

• your eyes may be more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Medicine used in the eyes is not likely to be affected by other drugs you use. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.