Difluprednate Ophthalmic

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

Difluprednate is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Difluprednate ophthalmic (for the eye) is used to treat eye pain and inflammation caused by surgery.

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

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

You should not use this medication if you are allergic to difluprednate, or if you have untreated glaucoma, any type of eye infection (including herpes), or an untreated infection in your eyes or elsewhere (including chickenpox).

Before using difluprednate ophthalmic, tell your doctor if you have glaucoma or cataracts.

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 difluprednate ophthalmic while you are wearing regular contact lenses. Wait at least 10 minutes after using difluprednate 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 difluprednate ophthalmic without first talking to your doctor. You may need to use less and less before you stop the medication completely.

This medication 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).

You should not use this medication if you are allergic to difluprednate, or if you have:

• untreated glaucoma;
• any type of eye infection, including herpes; or
• an untreated infection in your eye or elsewhere, including chickenpox.

To make sure you can safely use difluprednate ophthalmic, tell your doctor if you have any of these conditions:

• glaucoma; or
• cataracts.

FDA pregnancy category C. It is not known whether difluprednate 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 difluprednate ophthalmic passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Frequency Not Defined

Increased IOP

Anterior chamber inflammation

Corneal edema

Conjunctival edema

Blepharitis

Cataract

Optic nerve damage

Abnormal healing (after surgery)

Local irritation

Punctate keratitis

Hyperemia

Punctate keratitis

Decreased visual acuity

Eye pain

Photophobia

Postmarketing Reports

Elevated intraocular pressure

Posterior subcapsular cataract formation

Secondary ocular infection

Perforation of the globe

Difluprednate eye drops is used to treat eye pain, redness, and swelling caused by eye surgery. It is also used to treat an eye condition called endogenous anterior uveitis (eye inflammation). difluprednate belongs to the group of medicines known as corticosteroids (steroids or cortisone-like medicines).

difluprednate is available only with your doctor's prescription. .

Your eye doctor will want to examine your eye(s) at regular visits to make sure the medicine is working properly and is not causing unwanted effects.

Difluprednate eye drops are not for long-term use. Steroid eye drops may cause glaucoma (increased pressure inside the eye) or posterior subcapsular cataracts (a rare type of cataract) if used too long Slow or delayed healing may also occur while you are using difluprednate after cataract surgery. You will need to have regular eye exams with your doctor to check for these problems.

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.

If your symptoms do not improve or if your condition becomes worse, check with your doctor.

Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

• Blurred vision
• change in color vision
• decreased vision or other changes in vision
• difficulty seeing at night
• eye discomfort
• eye pain
• eye redness
• increase in blood flow to the whites of the eyes
• increased sensitivity of the eyes to sunlight
• painful irritation of the front clear part of the eye
• sensitivity of the eyes to light
• swelling or redness of the eye and lining of the eyelid

• Eyelid irritation and crusting
• tearing
• throbbing eye pain
• watering of the eyes

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Dry eyes

• Burning, itching, or soreness of the eye
• feeling of having something in the eye

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

This medication is used to treat swelling and pain after eye surgery. It may also be used to treat a certain serious eye problem (endogenous anterior uveitis). This medication belongs to a class of drugs known as corticosteroids.

How to use Difluprednate Drops

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

If you are wearing contact lenses, remove them before using eye drops. Wait at least 10 minutes before replacing your contact lenses.

Tilt your head back, look upward, and pull down the lower eyelid to make a pouch. Hold the dropper directly over your eye and place 1 drop into the pouch. Look downward and gently close your eyes for 1 to 2 minutes. Place one finger at the corner of your eye (near the nose) and apply gentle pressure. This will prevent the medication from draining out. Try not to blink and do not rub your eye. Repeat these steps for your other eye if so directed or if your dose is for more than 1 drop.

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

Use this medication exactly as directed by your doctor. Your doctor may direct you to use this medication more often at the beginning of treatment and then reduce your dose gradually. Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped.

Use this medication regularly to get the most benefit from it. To help you remember, use it at the same time(s) each day. Continue using it for the full time prescribed.

If you are using another kind of eye medication (for example, drops or ointments), wait at least 5 to 10 minutes before applying other medications. Use eye drops before eye ointments to allow the drops to enter the eye.

Tell your doctor if your condition persists or does not improve.

Temporary blurred vision may occur. If this effect persists or worsens, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Use of this medication for prolonged or repeated periods may result in a new fungal infection. Do not use this medication for longer than prescribed.

Tell your doctor right away if any of these unlikely but serious side effects occur: new or increased eye pain/swelling/discharge/redness, eye pain/discomfort in bright light, vision changes.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.