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|Fluocinolone Acetonide Implant Fluocinolone Acetonide

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Fluocinolone Acetonide Implant

Generic Name: Fluocinolone Acetonide Eye Implant (floo-oh-SIN-oh-lone)
Brand Name: Retisert

Fluocinolone Acetonide Implant is used for:

Treating a certain type of inflammation of the eye (chronic noninfectious uveitis).

Fluocinolone Acetonide Implant is a corticosteroid. Exactly how it works is unknown. It may decrease the production of certain substances that cause inflammation. Fluocinolone Acetonide Implant releases slowly over 30 months through a surgical implant in the eye.

Do NOT use Fluocinolone Acetonide Implant if:

you are allergic to any ingredient in Fluocinolone Acetonide Implant or other corticosteroids (eg, prednisone)
you have certain viral, bacterial, or fungal eye infections (eg, herpes simplex, mycobacterial infection)
you have chickenpox or a certain infection due to smallpox vaccination (vaccinia)

Contact your doctor or health care provider right away if any of these apply to you.

Before using Fluocinolone Acetonide Implant:

Some medical conditions may interact with Fluocinolone Acetonide Implant. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have other eye problems (eg, glaucoma, increased pressure in the eyes)

Some MEDICINES MAY INTERACT with Fluocinolone Acetonide Implant. Because little, if any, of Fluocinolone Acetonide Implant is absorbed into the blood, the risk of it interacting with another medicine is low.

Ask your health care provider if Fluocinolone Acetonide Implant may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Fluocinolone Acetonide Implant:

Use Fluocinolone Acetonide Implant as directed by your doctor. Check the label on the medicine for exact dosing instructions.

Fluocinolone Acetonide Implant will be surgically implanted into the eye at your doctor"s office, hospital, or clinic.
If you miss a dose of Fluocinolone Acetonide Implant, contact your doctor right away.

Ask your health care provider any questions you may have about how to use Fluocinolone Acetonide Implant.

Important safety information:

After implantation of Fluocinolone Acetonide Implant, follow-up eye exams will be required. Be sure to keep all doctor and lab appointments.
Most patients experience an immediate and temporary decrease in vision in the implanted eye for about 1 to 4 weeks after surgery. Do not drive or perform other possibly unsafe tasks until you know how you react to Fluocinolone Acetonide Implant. Contact your doctor if your vision does not return to normal after 4 weeks.
Fluocinolone Acetonide Implant treats inflammation in the eye, but it may not treat the disease that caused the inflammation. You may need to use other medicines along with this one. Carefully follow your doctor"s instructions for other eye medicines.
Fluocinolone Acetonide Implant may increase pressure in your eyes. You may need to use medicines or have procedures to control the pressure in your eyes. Carefully follow your doctor"s instructions for other eye medicines.
Fluocinolone Acetonide Implant may cause cataracts. It may also decrease the ability of your eyes to heal after cataract surgery. Discuss any concerns with your doctor.
Fluocinolone Acetonide Implant may increase the severity of eye infections and mask symptoms of eye infections. Contact your doctor if you suspect you have an eye infection.
Lab tests, including eye exams, may be performed while you use Fluocinolone Acetonide Implant. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Fluocinolone Acetonide Implant should not be used in CHILDREN younger than 12 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Fluocinolone Acetonide Implant while you are pregnant. It is not known if Fluocinolone Acetonide Implant is found in breast milk. If you are or will be breast-feeding while you use Fluocinolone Acetonide Implant, check with your doctor. Discuss any possible risks to your baby.

Possible side effects of Fluocinolone Acetonide Implant:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Abnormal sensation in the eye; back or limb pain; blurred vision; cough; dizziness; drooping eyelids; dry eye; eye irritation, itching, or redness; eye pain; fever; flu-like symptoms; headache; increased tearing; joint pain; nausea; nose and throat irritation; reduced vision; sinus inflammation; swelling of the eye or eyelid; upper respiratory tract infection; vomiting.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bleeding of the eye; eye discharge; eye infection; eye pain; implant problems; vision changes.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately.

Proper storage of Fluocinolone Acetonide Implant:

Fluocinolone Acetonide Implant is usually handled and stored by a health care provider. If you are using Fluocinolone Acetonide Implant at home, store Fluocinolone Acetonide Implant as directed by your pharmacist or health care provider. Keep Fluocinolone Acetonide Implant out of the reach of children and away from pets.

General information:

If you have any questions about Fluocinolone Acetonide Implant, please talk with your doctor, pharmacist, or other health care provider.
Fluocinolone Acetonide Implant is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Fluocinolone Acetonide Implant. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: November 1, 2006

Database Edition 06.4.1.002

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