Generic Name: fluocinolone ophthalmic implant (floo oh SIN oh lone off THAL mik IM plant)Brand Names: Retisert
Fluocinolone is in a group of drugs called corticosteroids. 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 may be caused by a variety of diseases or infections. The implant slowly releases fluocinolone into the eye over a period of approximately 30 months. Fluocinolone 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?
The fluocinolone ophthalmic implant is surgically placed into the eye. If both eyes will be treated, the implants will most likely be placed at two separate times, to decrease your risk of infection in both eyes at the same time.
Before receiving the implant, tell your doctor if you are allergic to any drugs, or if you have glaucoma, herpes simplex or other eye infection, or if you have recently had cataract surgery.Do not use any eye medications that your doctor has not prescribed. Fluocinolone ophthalmic implant can cause dizziness or blurred vision. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
For the first 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 after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.
The placement of the 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.What should I discuss with my healthcare provider before receiving a fluocinolone ophthalmic implant?You should not receive this medication if you are allergic to fluocinolone, or if you have:
a viral, bacterial, or fungal infection of your eye; or
a history of allergy to a steroid medicine.
If you have certain conditions, you may need special tests or other medications after receiving a fluocinolone implant. Tell your doctor if you are allergic to any drugs, or if you have:
herpes simplex or other eye infection; or
if you have recently had cataract surgery.
The placement of the 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.FDA pregnancy category C. 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 if you are pregnant or plan to become pregnant during the 30 months after you receive the implant. It is not known whether fluocinolone from the ophthalmic implant passes into breast milk or if it could harm a nursing baby. Do not receive this implant without telling your doctor if you are breast-feeding a baby.
This implant is surgically placed into the eye. If both eyes will be treated, the 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.
You may need to use the medications to control pressure inside your eyes for several weeks after receiving the fluocinolone ophthalmic implant. Be sure to use this medication as directed by your doctor to avoid complications or needing further surgical procedures to control ocular hypertension.
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. Do not miss any scheduled visits to your doctor.
Since the fluocinolone ophthalmic implant is surgically put into place, you will not be on a dosing schedule for this medication.
If you are taking medication to control pressure inside your eyes and you miss a dose, take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at your next regularly scheduled time. Do not take extra medicine to make up the missed dose.
An overdose of fluocinolone is unlikely to occur with the ophthalmic implant.
Avoid wearing contact lenses after receiving the fluocinolone ophthalmic implant unless your doctor has told you to.
For the first 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 after 4 weeks. Fluocinolone ophthalmic implant will not correct vision problems (such as near-sightedness or far-sightedness) that you had before receiving the implant.Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
sudden vision loss, eye pain or redness;
bleeding, oozing, or crusting of your eyes;
cloudiness in the pupils or iris of your eyes;
seeing flashes of light, halos around lights, or "floaters" in your vision; or
tunnel vision, problems with peripheral (side) vision.
Less serious side effects may include:
swelling of the eyelids;
mild eye irritation;
dry or watery eyes;
itching, mild skin rash;
the feeling that something is in your eye;
runny or stuffy nose, sore throat, fever, cough;
nausea, vomiting; or
back pain, joint or muscle pain.
This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.
Usual Adult Dose for Uveitis:
Initial dose: 1 implant, containing one tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye.
Usual Pediatric Dose for Uveitis:
12 years to 18 years:Initial dose: 1 implant, containing one tablet of 0.59 mg of fluocinolone acetonide, to be surgically implanted into the posterior segment of the affected eye.
Before using this medication, tell your doctor if you are using any other steroid medications, including:
nasal or inhaled steroids such as budesonide (Pulmicort, Rhinocort, Symbicort), flunisolide (AeroBid, Nasarel), fluticasone (Advair, Flonase, Flovent), mometasone (Asmanex, Nasonex), or triamcinolone (Azmacort); or
steroid medication taken by mouth such as betamethasone (Celestone), budesonide (Entocort), dexamethasone (Decadron, Hexadrol), fludrocortisone (Florinef), hydrocortisone (Cortef, Hydrocortone), prednisone (Deltasone, Meticorten, Orasone, others), methylprednisolone (Medrol), triamcinolone (Aristocort).
There may be other drugs that can affect fluocinolone ophthalmic implant. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.