Fluorometholone Ophthalmic

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.

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.

In the U.S.

• Flarex
• Fluor-OP
• FML Forte Liquifilm
• FML Liquifilm
• FML S.O.P.

In Canada

• Fml Forte
• Fml Liquifilm
• Pms-Fluorometholone

Available Dosage Forms:

• Suspension
• Ointment

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Adrenal Glucocorticoid

Along with its needed effects, a medicine 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:

• 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 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

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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.

This medication is used to treat certain eye conditions due to inflammation or injury. Fluorometholone works by relieving symptoms such as swelling, redness, and itching. It belongs to a class of drugs known as corticosteroids.

How to use Fluorometholone Ointment

Do not wear contact lenses while you are using this medicine. Sterilize contact lenses according to the manufacturer's directions, and check with your doctor before you begin using them again.

To apply the eye ointment, wash your hands first. To avoid contamination, do not touch the tube tip or let it touch your eye or any other surface. Gently pull down the lower eyelid to make a pouch. Place a 1/2 inch (1.5 centimeters) strip of ointment into the pouch. Gently close the eye and roll the eyeball in all directions to spread the medication. Try not to blink and do not rub the eye.

Repeat these steps for your other eye if so directed. Apply as often as directed by your doctor. Wipe the tip of the ointment tube with a clean tissue to remove extra medication before recapping it.

If you are using another kind of eye medication (for example, other drops or ointments), apply the eye drops first and wait at least 5 to 10 minutes before applying this eye ointment. Use eye drops before eye ointments to allow the drops to enter the eye.

Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time(s) each day.

The dosage and length of treatment are based on your medical condition and response to treatment. Do not use this medication more often or for longer than prescribed because doing so may increase your risk of side effects.

Continue to use this medication for the full time prescribed. Do not stop using this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Do not use this product if it becomes contaminated (for example, the ointment turns a dark color or develops particles in it). Use of contaminated eye medication can cause infection, serious damage to the eye, and loss of vision. Contact your doctor or pharmacist for more information.

Tell your doctor if your condition does not improve after 2 days or if it worsens.

Before using fluorometholone, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye infections, recent eye surgery, cataracts, glaucoma (open-angle type), severe nearsightedness (myopia), diabetes.

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

If you develop a new eye infection or injury, or require eye surgery, ask your doctor if you should continue to use your current tube of fluorometholone eye ointment or start a new tube.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known if the medication in this product passes into breast milk. Consult your doctor before breast-feeding.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

This medication has been prescribed for your current condition only. Do not use it later for another eye condition unless told to do so by your doctor. A different medication may be necessary in that case.

Laboratory and/or medical tests (such as eye exams, measurement of the pressure inside the eyes) may be performed periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Missed Dose

If you miss a dose, apply it as soon as you remember. If it is near the time of the next dose, skip themissed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store at room temperature at or below 77 degrees F (25 degrees C) away from light and moisture. Avoid exposure to temperatures above 104 degrees F (40 degrees C). Do not store in the bathroom. Keep the tube tightly closed when not in use. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.