Difluprednate Opthalmic Emulsion

Risk of Contamination

This product is sterile when packaged. Advise patients not to allow the dropper tip to touch any surface, as this may contaminate the emulsion.

Use of the same bottle for both eyes is not recommended with topical eye drops that are used in association with surgery.

Risk of Secondary Infection

If pain develops, or if redness, itching, or inflammation becomes aggravated, advise patients to consult a physician.

Contact Lens Wear

DUREZOL should not be instilled while wearing contact lenses. Advise patients to remove contact lenses prior to instillation of DUREZOL. The preservative in DUREZOL may be absorbed by soft contact lenses. Lenses may be reinserted after 10 minutes following administration of DUREZOL.

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.