Pronunciation:

flure-oh-METH-oh-lone

Brand Names:

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

Dosage Forms:

• Suspension

Classifications:

Therapeutic—

Ophthalmologic Agent

Pharmacologic—

Adrenal Glucocorticoid

Uses of This Medicine:

Fluorometholone is used to treat eye conditions caused by inflammation (swelling). This medicine is a corticosteroid (steroid medicine) that helps reduce the swelling in the eye.

This medicine is available only with your doctor's prescription.

Before Using This Medicine:

In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Children—

Appropriate studies have not been performed on the relationship of age to the effects of fluorometholone in the pediatric population. Safety and efficacy have not been established in children younger than 2 years of age.

Older adults—

Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of fluorometholone in the elderly.

Breast-feeding—

There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Other medicines—

Although certain medicines should not be used together at all, in other cases two different medicines may be used together even if an interaction might occur. In these cases, your doctor may want to change the dose, or other precautions may be necessary. Tell your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Other interactions—

Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other medical problems—

The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataract surgery—Use with caution. May cause delayed healing.

• Certain eye diseases that cause the cornea or sclera to get thin—Use could cause a hole to form (perforation).

• Eye infection caused by fungus, mycobacteria or
• Eye infection caused by virus (eg, epithelial herpes simplex keratitis)—Should not be used in patients with these conditions.

• Eye infection caused by virus (eg, herpes simplex), history of or
• Glaucoma—Use with caution. May make these conditions worse.

Proper Use of This Medicine:

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.

Precautions While Using This Medicine:

Your eye doctor will want to examine your eye(s) at regular visits to make sure the medicine is working properly and is not causing unwanted effects.

This medicine may increase the pressure inside your eye or cause other eye problems, including glaucoma or cataracts. Slow or delayed healing may also occur while you are using this medicine after cataract surgery. You will need to have regular eye exams with your doctor to check for these problems.

If you hurt your eye or develop an eye infection, talk with your doctor right away. You may need to change your medicine or stop using it.

If your symptoms do not improve within two days or if they becomes worse, check with your doctor.

Side Effects of This Medicine:

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:

Incidence not known

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:

Incidence not known

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.