Flarex

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

Fluorometholone ophthalmic (for the eyes) is used to treat eye swelling caused by infections, injury, surgery, or other conditions.

Fluorometholone ophthalmic may also be used for purposes not listed in this medication guide.

You should not use this medicine if you have any type of infection, especially a fungal or viral eye infection (such as ocular herpes), tuberculosis, or an untreated infection such as chickenpox in your eye or elsewhere.

You should not use this medicine if you are allergic to fluorometholone or other steroid medications, or if you have any type of infection, especially:

• a fungal eye infection;

• any type of viral eye infection, such as ocular herpes;

• tuberculosis; or

• an untreated infection in your eye or elsewhere, including chickenpox.

To make sure fluorometholone ophthalmic is safe for you, tell your doctor if you have:

• a history of cataracts; or

• a history of glaucoma or increased pressure inside your eyes.

It is not known whether this medicine will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant.

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

Fluorometholone ophthalmic should not be given to a child younger than 2 years old.

Follow all directions on your prescription label. Do not use this medicine in larger or smaller amounts or for longer than recommended.

Do not use this medicine while wearing contact lenses. Fluorometholone ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 15 minutes after using this medicine before putting in your contact lenses.

Wash your hands before using eye medication.

Shake the eye drops well just before each use.

To apply the eye drops:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.

• Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.

• Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.

• Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

To apply the ointment:

• Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the ointment tube with the tip pointing toward this pocket. Look up and away from the tip.

• Squeeze out a ribbon of ointment into the lower eyelid pocket without touching the tip of the tube to your eye. Blink your eye gently and then keep it closed for 1 or 2 minutes.

• Use a tissue to wipe excess ointment from your eyelashes.

• After opening your eyes, you may have blurred vision for a short time. Avoid driving or doing anything that requires you to be able to see clearly.

Do not touch the tip of the eye dropper or ointment tube or place it directly on your eye. A contaminated applicator tip can infect your eye, which could lead to serious vision problems.

Call your doctor if your symptoms do not improve after 2 days of treatment with fluorometholone ophthalmic.

If you use fluorometholone ophthalmic for 10 days or longer, you may need frequent eye tests at your doctor's office.

Store at room temperature away from moisture and heat. Do not freeze. Store eye drops with the bottle upright. Keep the tube or bottle tightly closed when not in use.

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

Stop using fluorometholone ophthalmic and call your doctor at once if you have:

• worsening or no improvement in your symptoms after 48 hours of use;

• pain behind your eyes, sudden vision changes, severe headache;

• sudden eye irritation;

• severe burning, redness, or irritation of your eyes;

• blurred vision, tunnel vision, eye pain, or seeing halos around lights; or

• signs of new eye infection, such as pain, itching, swelling, draining, or crusting of your eyes.

Although the risk of serious side effects is low when fluorometholone is used in the eyes, side effects can occur if the medicine is absorbed into your bloodstream. Tell your doctor if you develop any of the following symptoms of steroid absorption:

• weight gain (especially in your face or your upper back and torso);

• slow wound healing, thinning skin, increased body hair;

• irregular menstrual periods, changes in sexual function; or

• muscle weakness, tired feeling, depression, anxiety, feeling irritable.

Common side effects may include:

• mild stinging, burning, redness, or irritation in your eyes;

• feeling like something is in your eye;

• red or puffy eyelids;

• blurred vision; or

• drooping eyelids.

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.

Tell your doctor about all your current medicines and any you start or stop using, especially an oral, nasal, inhaled, or injectable steroid medicine.

It is not likely that other drugs you take orally or inject will have an effect on fluorometholone used 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. Not all possible interactions are listed in this medication guide.

This section provides information on the proper use of a number of products that contain fluorometholone. It may not be specific to Flarex. Please read with care.

Your eye doctor will tell you how much of this medicine to use and how often. Do not use more medicine or use it more often than your doctor tells you to. This medicine is not for long-term use.

Wash your hands with soap and water before and after using this medicine.

Lie down or tilt your head back. With your index finger, pull down the lower lid of your eye to form a pocket.

To use the eye drops:

• Shake the bottle well just before each use.
• Hold the dropper close to your eye with the other hand.
• Drop the correct number of drops into the pocket made between your lower lid and eyeball. Gently close your eyes.
• Place your index finger over the inner corner of your eye for 1 minute.
• Do not rinse or wipe the dropper or allow it to touch anything, including your eye.
• Put the cap on the bottle right away. Keep the bottle upright when you are not using it.

The preservative used in the eye drops may be absorbed by soft contact lenses and cause irritation of your eyes. Contact lenses should be taken out before you use fluorometholone. Lenses may be put back in the eyes 15 minutes after you have used the medicine.

To use the eye ointment:

• Hold the tip of the tube close to your eye with the other hand. Avoid touching the tip of the tube to your eye or finger.
• Squeeze a small amount (1/2 inch ribbon) of ointment into the pocket between your lower lid and eyeball.
• Close your eyes for 1 to 2 minutes.
• Wipe the tip with a clean tissue and close the tube tightly. Keep the tube tightly closed when you are not using it.

Dosing

The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

• For eye conditions caused by swelling:
  • For ophthalmic dosage form (eye drops):
    • Adults—Use one drop in the affected eye two to four times a day. During the first 24 to 48 hours, you may use this medicine every 4 hours, as directed by your doctor.
    • Children 2 years of age and older—Dose must be determined by your doctor.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.
  • For ophthalmic dosage form (eye ointment):
    • Adults—Use a small amount (1/2 inch ribbon) in the affected eye one to three times a day. During the first 24 to 48 hours, you may use this medicine every 4 hours, as directed by your doctor.
    • Children 2 years of age and older—Dose must be determined by your doctor.
    • Children younger than 2 years of age—Use and dose must be determined by your doctor.

Missed Dose

If you miss a dose of this medicine, apply it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule.

Storage

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Fluorometholone eye drops may be refrigerated. Keep from freezing.

General: Fungal infections of the cornea are particularly prone to develop coincidentally with long-term local steroid application. Fungus invasion must be considered in any persistent corneal ulceration where a steroid has been used or is in use.

Information for Patients: Do not touch dropper tip to any surface, as this may contaminate the suspension. The preservative in Flarex® (fluorometholone acetate ophthalmic suspension), benzalkonium chloride, may be absorbed by soft contact lenses. Contact lenses should be removed during instillation of Flarex (fluorometholone acetate ophthalmic suspension) but may be reinserted 15 minutes after instillation.

Patients should be advised that their vision may be temporarily blurred following dosing with Flarex (fluorometholone acetate ophthalmic suspension). Care should be exercised in operating machinery or driving a motor vehicle.

Carcinogenesis, Mutagenesis, Impairment of Fertility: No studies have been conducted in animals or in humans to evaluate the possibility of these effects with fluorometholone.

Pregnancy: Fluorometholone has been shown to be embryocidal and teratogenic in rabbits when administered at low multiples of the human ocular dose. Fluorometholone was applied ocularly to rabbits daily on days 6-18 of gestation, and dose-related fetal loss and fetal abnormalities including cleft palate, deformed rib cage, anomalous limbs and neural abnormalities such as encephalocele, craniorachischisis, and spina bifida were observed. There are no adequate and well controlled studies of fluorometholone in pregnant women, and it is not known whether fluorometholone can cause fetal harm when administered to a pregnant woman. Fluorometholone should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers: Systemically administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other untoward effects. It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in human milk. Because many drugs are excreted in human milk, caution should be exercised when Flarex (fluorometholone acetate ophthalmic suspension), is administered to a nursing woman.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: No overall differences in safety or effectiveness have been observed between elderly and younger patients.

ADVERSE REACTIONS: Glaucoma with optic nerve damage, visual acuity and field defects, cataract formation, secondary ocular infection following suppression of host response, and perforation of the globe may occur.

Postmarketing Experience: The following reaction has been identified during post-marketing use of Flarex® (fluorometholone acetate ophthalmic suspension) in clinical practice. Because reactions are reported voluntarily from a population of unknown size, estimates of frequency cannot be made. The reaction, which has been chosen for inclusion due to either its seriousness, frequency of reporting, possible causal connection to Flarex, or a combination of these factors, includes: dysgeusia.

DOSAGE AND ADMINISTRATION: Shake Well Before Using. One to two drops instilled into the conjunctival sac(s) four times daily. During the initial 24 to 48 hours the dosage may be safely increased to two drops every two hours. If no improvement after two weeks, consult physician. Care should be taken not to discontinue therapy prematurely.

HOW SUPPLIED: Flarex (fluorometholone acetate ophthalmic suspension) is supplied in white low density polyethylene (LDPE) bottles, with natural LDPE dispensing plugs and pink polypropylene closures. The product is supplied as 5mL in an 8 mL bottle.

5 mL: NDC 0065-0096-05

STORAGE: Store upright between 2°C -25°C (36°F -77°F).

Protect from freezing.

© 2002, 2004, 2006, 2016 Novartis

Distributed by:
ALCON LABORATORIES, INC.
Fort Worth, Texas 76134 USA

ALCON®

A Novartis company

T2017-30
March 2017

Applies to fluorometholone ophthalmic: ophthalmic ointment, ophthalmic suspension

Along with its needed effects, fluorometholone ophthalmic (the active ingredient contained in Flarex) may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking fluorometholone ophthalmic:

• Bigger, dilated, or enlarged pupils (black part of the eye)
• blurred vision or other change in vision
• burning, dry, or itching eyes
• decreased vision
• delayed wound healing
• discharge from eye
• headache
• increased sensitivity of the eyes to light
• nausea or vomiting
• redness, pain, swelling of the eye, eyelid, or inner lining of the eyelid
• tearing

Some side effects of fluorometholone ophthalmic may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

• Burning and stinging sensation when medicine is applied
• drooping upper eyelids
• feeling of having something in the eye

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother. Excreted into human milk: Unknown Excreted into animal milk: Data not available Comments: -Systemically-administered corticosteroids appear in human milk and could suppress growth, interfere with endogenous corticosteroid production, or cause other effects.