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fluocinolone ophthalmic implant

Generic Name: fluocinolone ophthalmic implant (FLOO oh SIN oh lone off THAL mik IM plant)
Brand Name: Iluvien, Retisert

What is fluocinolone ophthalmic implant?

Fluocinolone is a steroid medicine. It prevents the release of substances in the body that cause inflammation.

Fluocinolone ophthalmic (for the eye) implant is used to treat inflammation within the eye that is caused by disease or infection. The implant slowly releases fluocinolone into the eye over a period of approximately 30 months.

Fluocinolone is not an antibiotic and will not treat an eye infection.

Fluocinolone ophthalmic implant may also be used for other purposes not listed in this medication guide.

What is the most important information I should know about fluocinolone ophthalmic implant?

You should not be treated with this medicine if you have glaucoma or any type of infection in or around your eye, or if you are allergic to steroid medicine.

What should I discuss with my healthcare provider before receiving a fluocinolone ophthalmic implant?

You should not be treated with this medicine if you are allergic to fluocinolone, or if you have:

  • glaucoma;

  • any type of infection in or around your eye; or

  • a history of allergy to a steroid medicine.

The use of fluocinolone ophthalmic implant may increase your risk of developing cataracts and eventually needing cataract surgery. Talk with your doctor if you have concerns about this risk.

To make sure the fluocinolone implant is safe for you, tell your doctor if you have ever had:

  • herpes simplex;

  • cataract surgery; or

  • a detached retina.

Tell your doctor if you are pregnant. It is not known whether the fluocinolone ophthalmic implant is harmful to an unborn baby if you receive the implant while you are pregnant. Tell your doctor right away if you become pregnant during the 30 months after you receive the implant.

It is not known whether fluocinolone passes into breast milk or if it could harm a nursing baby. Tell your doctor if you are breast-feeding a baby.

How is the fluocinolone ophthalmic implant put into place?

A healthcare provider will surgically place the fluocinolone ophthalmic implant in your eye. If both eyes will be treated, your implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.

Your doctor may prescribe other medications to help control the pressure inside your eyes. Increased pressure inside the eye (also called ocular hypertension) can damage the optic nerve and lead to permanent blindness.

Use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

You may need to continue using these other medications for several weeks after receiving the fluocinolone ophthalmic implant, to avoid complications or further surgeries.

For 1 to 4 weeks after receiving the implant, you may have a temporary decrease in vision. Call your doctor if your vision does not return to normal with 4 weeks after your implant was put in place.

To be sure the implant is helping your condition and is not causing harmful effects, your eyes will need to be checked on a regular basis.

Fluocinolone ophthalmic implant will not correct vision problems you had before receiving the implant, such as near-sightedness or far-sightedness.

What happens if I miss a dose?

Since the fluocinolone ophthalmic implant is surgically put into place, you will not be on a dosing schedule.

If you miss a dose of any medication you take to control pressure inside your eyes, take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Since the fluocinolone implant contains a specific amount of the medication, you are not likely to receive an overdose.

What should I avoid after receiving a fluocinolone ophthalmic implant?

Do not use other eye medications unless your doctor tells you to.

Ask your doctor before wearing contact lenses after receiving the fluocinolone ophthalmic implant.

This medicine may cause blurred vision and may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.

Fluocinolone ophthalmic implant side effects

Get emergency medical help if you have signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have:

  • blurred vision, tunnel vision, problems with peripheral (side) vision;

  • eye redness, eye pain or swelling;

  • bleeding, oozing, or crusting of your eyes;

  • cloudiness in your pupil or iris (colored part of your eyes);

  • seeing flashes of light or "floaters" in your vision;

  • seeing halos around lights; or

  • pale skin, feeling light-headed or short of breath.

Common side effects may include:

  • mild eye redness, dryness, itching, or irritation;

  • the feeling that something is in your eye;

  • headache, dizziness; or

  • your eyes being more sensitive to light.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

See also: Side effects (in more detail)

Fluocinolone ophthalmic implant dosing information

Usual Adult Dose for Uveitis:

1 implant, containing 1 tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye through a pars plana incision

Comments:
-Following depletion of this drug as evidenced by recurrence of uveitis, the implant may be replaced.
-Caution should be used in handling the implant to avoid damage, which may result in an increased rate of drug release from the implant.
-Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir from the suture tab.
-Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.
-The implant should not be resterilized by any method.

Use: Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye

Usual Adult Dose for Macular Edema:

1 implant, containing 0.19 mg of fluocinolone acetonide, to be surgically implanted inferior to the optic disc and posterior to the equator of the eye

Comments:
-For ophthalmic intravitreal injection.
-Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure. Consult the manufacturer product information for proper handling.
-Patients should be monitored for elevation in intraocular pressure and for endophthalmitis.
-Patients should be instructed to report any symptoms suggestive of endophthalmitis.

Use: Treatment of diabetic macular edema in patients who have been previously treated with a course of corticosteroids and did not have a clinically significant rise in intraocular pressure.

Usual Pediatric Dose for Uveitis:

12 years or older:
1 implant, containing 1 tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye through a pars plana incision

Comments:
-Following depletion of this drug as evidenced by recurrence of uveitis, the implant may be replaced.
-Caution should be used in handling the implant to avoid damage, which may result in an increased rate of drug release from the implant.
-Care should be taken during implantation and explantation to avoid sheer forces on the implant that could disengage the silicone cup reservoir from the suture tab.
-Aseptic technique should be maintained at all times prior to and during the surgical implantation procedure.
-The implant should not be resterilized by any method.

Use: Treatment of chronic non-infectious uveitis affecting the posterior segment of the eye

What other drugs will affect fluocinolone ophthalmic implant?

It is not likely that other drugs you take orally or inject will have an effect on fluocinolone implanted in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

  • Your doctor can provide more information about fluocinolone ophthalmic implant.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 4.02. Revision Date: 2016-01-25, 4:43:55 PM.

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