Difluprednate (Ophthalmic)

Difluprednate eye drops are used to relieve eye pain, redness, and swelling that can happen after eye surgery. It is also used to treat a condition called endogenous anterior uveitis, which is eye inflammation. This medicine is part of a group called corticosteroids (steroids or cortisone-like medicines).

This medicine is available only with your doctor's prescription.

Your eye doctor will want to check your eye(s) regularly to ensure the medicine is working properly and not causing any unwanted effects.

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

If you injure your eye or get an eye infection, contact your doctor immediately. You may need to change your medicine or stop using it.

If your symptoms do not get better or if your condition worsens, consult your doctor.

In deciding to use a medicine, you and your doctor need to consider the risks of taking the medicine against its benefits. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, carefully read the label or package ingredients.

Pediatric

There have not been appropriate studies on how difluprednate eye drops affect children. Safety and effectiveness have not been established.

Geriatric

Research so far has not shown any specific problems in elderly patients that would limit the use of difluprednate eye drops.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication while breastfeeding. Consider the potential benefits against the potential risks before using this medication during breastfeeding.

Interactions with Medicines

Some medicines should not be used together at all, while in other cases, two different medicines may be used together even if an interaction could happen. In these situations, your doctor may want to adjust the dose, or other precautions may be necessary. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken at or around mealtime or with certain foods due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about using your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect how you can use this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

• Cataract surgery—Use with caution. May cause delayed healing.

• Eye infection (fungus, mycobacterial) or
• Eye infection, virus (e.g., herpes simplex)—Should not be used in patients with these conditions.

• Glaucoma—Use with caution. May worsen this condition.

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:

More common

• 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

Less common

• 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:

Less common

• Dry eyes

Rare

• 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.

In the U.S.

• Durezol

Available Dosage Forms:

• Emulsion

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Adrenal Glucocorticoid

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

To use the eye drops:

• First, wash your hands. Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
• If you think you did not get the drop of medicine into your eye properly, use another drop.
• Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Always keep the container tightly closed.

If you are using this medicine after an eye surgery, use one bottle for each eye only. Use of the same bottle of eye drops for both eyes is not recommended.

The preservative used in these eye medicines may be absorbed by soft contact lenses and cause irritation of your eyes. Contact lenses should be taken out before you use difluprednate. Lenses may be put back in the eyes 10 minutes after you have used the medicine.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For ophthalmic dosage form (eye drops): For eye pain, redness, and swelling caused by eye surgery: Adults—Use one drop in the affected eye(s) four times a day. Start using the medicine 24 hours after surgery, and keep using it until your doctor tells you to stop. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor. For endogenous anterior uveitis: Adults—Use one drop in the affected eye(s) four times a day for 14 days. Your doctor may adjust your dose if needed. Children—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep the eye drop bottle in the protective carton when not in use.