Description
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). This medicine belongs to the group of medicines known as corticosteroids (steroids or cortisone-like medicines).
This medicine is available only with your doctor's prescription.
This product is available in the following dosage forms:
- Emulsion
Before Using
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:
Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.
Pediatric
Appropriate studies performed to date have not demonstrated pediatric-specific problems that would limit the usefulness of difluprednate eye drops in children 3 years of age and younger to treat swelling after cataract surgery. However, safety and efficacy have not been established in children to treat endogenous anterior uveitis.
Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of difluprednate eye drops in the elderly.
Breastfeeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.
Drug Interactions
Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.
Other Interactions
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.
Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
- Cataract or
- Cornea (part of the eye) problems, history of or
- Glaucoma or
- Herpes simplex infection, history of or
- Sclera (part of the eye) problems, history of—Use with caution. May make this condition worse.
- Cataract surgery—Use with caution. May cause delayed healing and increase the risk of unwanted effects.
- Fungal eye infection or
- Herpes simplex eye infection or
- Mycobacterial (tuberculosis) eye infection or
- Vaccinia (smallpox) eye infection or
- Varicella (chickenpox) eye infection—Should not be used in patients with these conditions.
Proper Use
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:
- Wash your hands with soap and water before and after you use this medicine.
- Tilt your head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the eyelid away from the eye to make a space. Drop the medicine into this space.
- Let go of the eyelid and gently close the eye. Do not blink. Keep the eye closed 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, repeat the process with another drop.
- To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). Also, keep the container tightly closed. Serious damage to the eye and possible loss of vision may result from using contaminated eye medicines.
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.
Remove contact lenses before you use the eye drops. Wait for at least 10 minutes before putting the contact lenses back in.
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—One drop in the affected eye(s) 4 times a day. Start using the medicine 24 hours after surgery, and keep using it for the first 2 weeks, followed by 2 times a day for one week. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- For endogenous anterior uveitis:
- Adults—One drop in the affected eye(s) 4 times a day for 14 days. Your doctor may adjust your dose if needed.
- Children—Use and dose must be determined by your doctor.
- For eye pain, redness, and swelling caused by eye surgery:
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.
Precautions
Your eye doctor will want to examine your eye(s) at regular visits to make sure the medicine is working properly and to check for unwanted effects, especially if you will be using this medicine for 10 days or longer.
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 this medicine 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 after 2 days or if they become worse, check with your eye doctor (ophthalmologist) right away.
Side Effects
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.
DRG-20072011
