Indication

XIPERE^® (triamcinolone acetonide injectable suspension) is a corticosteroid used to treat macular edema associated with an eye disease called uveitis.

Important Safety Information

• Your eye doctor will monitor you for elevated eye pressure following treatment and manage it with medication or surgery if required.
• See your eye doctor right away if your eyes become red, sensitive to light or painful, or if you notice changes in vision.
• XIPERE is not appropriate for use in patients with eye infections. It should be used with caution in patients with a history of herpes simplex in the eye.
• XIPERE is not appropriate for use in patients with a known allergy to triamcinolone acetonide or any other components of this product.
• Use of corticosteroids such as XIPERE may produce cataracts, increased eye pressure and glaucoma, and may increase the likelihood of eye infections.
• Patients being treated with XIPERE for extended periods of time will be monitored for problems with the body’s hormonal system, which controls the ability to respond to stress.
• In clinical studies, the most common eye-related side effects were increased eye pressure and eye pain. Other side effects included cataract, floaters or flashes of light, injection site pain, burst blood vessels, reduced or blurred vision, dry eye, light sensitivity, redness, infection, swelling, watery eyes, eye or eyelid irritation, bumps on the eyelid, itchy eyes, and drooping eyelid.

The most common non-eye-related side effect was headache.

• Corticosteroids should be used during pregnancy or nursing only if the potential benefit justifies the potential risk to the fetus or nursing infant. Talk to your eye doctor.

To report SUSPECTED ADVERSE REACTIONS, contact Bausch + Lomb at 1-800-321-4576 or FDA at 1-800-FDA 1088 or visit www.fda.gov/medwatch.

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