Fluocinolone (Ophthalmic)

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.

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.

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.

• If you have an allergy to fluocinolone (ophthalmic) or any part of this medicine.
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.
• If you have glaucoma.
• If you have any kind of eye infection.
• If you have ever had a herpes infection of the eye.

This is not a list of all drugs or health problems that interact with fluocinolone.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in eyesight, eye pain, or very bad eye irritation.
• Eye redness.
• Not able to pass urine or change in how much urine is passed.
• If bright lights bother your eyes.
• Feeling very tired or weak.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Inhibit phospholipase A2 via lipocortin induction Lipocortins may control biosynthesis of prostaglandins and leukotrienes by inhibiting arachidonic acid. Arachidonic acid is released by membrane phospholipids by phospholipase A2.

Absorption

Systemic absorption is negligible

Distribution

Retisert: Aqueous and vitreous humor

Diabetic macular edema: Ocular implant (Iluvien): Intravitreal injection: One implant (0.19 mg) injected in affected eye. Note: Implant is designed to release fluocinolone at an initial rate of 0.25 mcg daily lasting 36 months.

Uveitis (chronic): Ocular implant (Retisert): Intravitreal injection: One silicone-encased tablet (0.59 mg) surgically implanted into the posterior segment of the affected eye. Note: Implant is designed to initially release 0.6 mcg/day, decreasing over 30 days to a steady-state release rate of 0.3 to 0.4 mcg daily for 30 months. Recurrence of uveitis denotes depletion of tablet, requiring reimplantation.

Ophthalmic implant (intravitreal injection): Administer under controlled aseptic conditions (eg, sterile gloves, sterile drape, sterile eyelid speculum). Administer adequate anesthesia and a broad-spectrum bactericidal to the periocular skin, eyelid, and ocular surfaces prior to injection. Refer to manufacturer’s prescribing information for administration technique.

Iluvien: Visually inspect preloaded applicator to ensure that it contains a drug implant. Optimal placement is inferior to optic disc and posterior to the equator of the eye

Retisert: Handle only by suture tab to avoid damaging the tablet integrity and adversely affecting release characteristics. Do not resterilize.

Store at 15°C to 25°C (59°F to 77°F). Retisert: Protect from freezing.