Fluorometholone (Ophthalmic)

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

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

Your eye doctor will want to check your eye(s) regularly to ensure the medicine is working well and not causing any unwanted side effects.

This medicine may increase the pressure in your eye or lead to other eye issues, including glaucoma or cataracts. You might also experience slow or delayed healing while using this medicine after cataract surgery. It is important to have regular eye exams with your doctor to monitor for these issues.

If you injure your eye or get an eye infection, contact your doctor immediately. You may need to change your medicine or stop using it.

If your symptoms do not get better within two days or if they get worse, consult your doctor.

In deciding to use a medicine, you need to consider the risks versus the benefits. This is a choice you will make with your doctor. For this medicine, keep the following in mind:

Allergies

Inform your doctor if you have ever had any unusual or allergic reactions to this medicine or any other medicines. Also, let your healthcare professional know if you have any other allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric

There have been no appropriate studies on how age affects the effects of fluorometholone in children. Safety and effectiveness have not been established for children younger than 2 years old.

Geriatric

Current studies have not shown any specific problems in older adults that would limit the usefulness of fluorometholone.

Breast Feeding

There are no adequate studies in women to determine the risk to infants when using this medication during breastfeeding. Consider the potential benefits against the potential risks before using this medication while breastfeeding.

Interactions with Medicines

Some medicines should not be used together. In other cases, two different medicines may be used at the same time even if an interaction might happen. In these situations, your doctor may adjust the dose or take other precautions. Inform your healthcare professional if you are taking any other prescription or nonprescription (over-the-counter [OTC]) medicine.

Interactions with Food/Tobacco/Alcohol

Certain medicines should not be taken around the time of eating certain foods due to possible interactions. Drinking alcohol or using tobacco with certain medicines may also lead to interactions. Talk with your healthcare professional about how to use your medicine with food, alcohol, or tobacco.

Other Medical Problems

Having other medical issues may affect the use of this medicine. Be sure to tell your doctor if you have any other medical problems, especially:

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

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

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

• Eye infection caused by a virus (e.g., herpes simplex), history of or
• Glaucoma—Use with caution. May worsen these conditions.

Along with its necessary effects, a medicine may cause some unwanted effects. Not all of these side effects may happen, but if they do, they may need medical attention.

Check with your doctor right away if any of the following side effects occur:

Incidence not known

• Bigger, dilated, or enlarged pupils (the black part of the eye)
• Blurred vision or other changes in vision
• Burning, dry, or itchy eyes
• Decreased vision
• Delayed wound healing
• Discharge from the eye
• Headache
• Increased sensitivity of the eyes to light
• Nausea or vomiting
• Redness, pain, or 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 gets used to the medicine. Also, your healthcare professional may be able to tell you how to prevent or reduce some of these side effects. Check with your healthcare professional if any of the following side effects continue, are bothersome, or if you have any questions about them:

Incidence not known

• Burning and stinging sensation when the 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.

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

Therapeutic Class: Ophthalmologic Agent

Pharmacologic Class: Adrenal Glucocorticoid

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.