Brand Names:

• AK-Pred
• Alrex
• Dextenza
• Durezol
• Econopred Plus
• Flarex
• FML Forte Liquifilm
• FML Liquifilm
• FML S.O.P.
• HMS
• Inflamase
• Inveltys
• Lotemax
• Omnipred
• Pred Forte
• Pred Mild
• Prednisol
• Vexol
• Ak-Dex
• Ak-Tate
• Decadron
• Fml Forte
• Fml Liquifilm
• Inflamase Forte
• Inflamase Mild
• Maxidex
• Ophtho-Tate
• Pms-dexAMETHasone Sodium Phosphate
• Pms-Fluorometholone

Dosage Forms:

• Emulsion
• Suspension
• Insert, Extended Release
• Solution
• Ointment
• Gel/Jelly

Uses of This Medicine:

Ophthalmic corticosteroids (cortisone-like medicines) are used to prevent permanent damage to the eye, which may occur with certain eye problems. They also provide relief from redness, irritation, and other discomfort.

Corticosteroids for use in the eye are available only with your doctor's prescription.

Before Using This Medicine:

Allergies—

Tell your doctor if you have ever had any unusual or allergic reaction to medicines in this group 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—

Children less than 2 years of age may be especially sensitive to the effects of ophthalmic corticosteroids. This may increase the chance of side effects. If this medicine has been ordered for a young child, you should discuss its use with your child's doctor. Be sure you follow all of the doctor's instructions very carefully.

Older adults—

Although there is no specific information about the use of ophthalmic corticosteroids in the elderly, they are not expected to cause different side effects or problems in older people than they do in younger adults.

Pregnancy—

Although studies on birth defects with ophthalmic corticosteroids have not been done in humans, these medicines have not been reported to cause birth defects or other problems. However, in animal studies, dexamethasone, fluorometholone, hydrocortisone, and prednisolone caused birth defects when applied to the eyes of pregnant animals. Also, fluorometholone and medrysone caused other unwanted effects in the animal fetus.

Breast-feeding—

Ophthalmic corticosteroids have not been reported to cause problems in nursing babies.

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 medicines in this class. Make sure you tell your doctor if you have any other medical problems, especially:

• Cataracts—Corticosteroids may cause cataracts or make them worse.

• Type 2 diabetes mellitus—Patients with diabetes may be more likely to develop cataracts or glaucoma with the use of corticosteroids.

• Herpes infection of the eye or
• Tuberculosis of the eye (active or history of) or
• Any other eye infection—Ophthalmic corticosteroids may make existing infections worse or cause new infections.

Proper Use of This Medicine:

For patients who wear contact lenses:

• Use of ophthalmic corticosteroids while you are wearing contact lenses (either hard lenses or soft lenses) may increase the chance of infection. Therefore, do not apply this medicine while you are wearing contact lenses. Also, check with an ophthalmologist (eye doctor) for advice on how long to wait after applying this medicine before inserting your contact lenses. It is possible that you may be directed not to wear contact lenses at all during the entire time of treatment and for a day or two after treatment has been stopped.

For patients using an ophthalmic solution or suspension (eye drop) form of this medicine:

• If you are using a suspension form of this medicine, always shake the container very well just before applying the eye drops.
• To use:
  • First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Drop the medicine into this space. Let go of the eyelid and gently close the eyes. Do not blink. Keep the eyes closed and apply pressure to the inner corner of the eye with your finger for 1 or 2 minutes to allow the medicine to be absorbed by the eye.
  • If you think you did not get the drop of medicine into your eye properly, use another drop.
  • Immediately after using the eye drops, wash your hands to remove any medicine that may be on them.
  • To keep the medicine as germ-free as possible, do not touch the dropper or the applicator tip to any surface (including the eye). Always keep the container tightly closed.

For patients using an ointment form of this medicine:

• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1-cm (approximately ⅓ inch) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the irritation.
• First, wash your hands. Tilt the head back and, pressing your finger gently on the skin just beneath the lower eyelid, pull the lower eyelid away from the eye to make a space. Squeeze a thin strip of ointment into this space. A 1-cm (approximately 1/3 inch) strip of ointment is usually enough, unless you have been told by your doctor to use a different amount. Let go of the eyelid and gently close the eyes. Keep the eyes closed for 1 or 2 minutes to allow the medicine to come into contact with the irritation.
• To keep the medicine as germ-free as possible, do not touch the applicator tip to any surface (including the eye). After using the eye ointment, wipe the tip of the ointment tube with a clean tissue. Do not wash the tip with water. Always keep the tube tightly closed.

Do not use corticosteroids more often or for a longer time than your doctor ordered. To do so may increase the chance of side effects, especially in children 2 years of age or younger.

Do not use any leftover medicine for future eye problems without first checking with your doctor. This medicine should not be used if certain kinds of infections are present. To do so may make the infection worse and possibly lead to eye damage.

Dosing—

The dose medicines in this class 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 these medicines. 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 disorders:
  • For ophthalmic solution (eye drops) dosage form:
    • Adults and children—Use one or two drops in the eye every one or two hours, then space the doses further apart as the eye gets better.

• For eye disorders:
  • For ophthalmic ointment dosage form:
    • Adults and children—Use the ointment in the eye three or four times a day, then space the doses further apart as the eye gets better.
  • For ophthalmic suspension (eye drops) dosage form:
    • Adults and children—Use one or two drops in the eye up to six times a day.
  • For ophthalmic solution (eye drops) dosage form:
    • Adults and children—Use one or two drops in the eye four to six times a day.

• For eye disorders:
  • For ophthalmic ointment dosage form:
    • Adults and children—Use the ointment in the eye one to three times a day.
  • For ophthalmic suspension (eye drops) dosage form:
    • Adults and children—Use one or two drops in the eye two to four times a day.

• For eye disorders:
  • For ophthalmic ointment dosage form:
    • Adults and children—Use the ointment in the eye three or four times a day, then space the doses further apart as the eye gets better.

• For eye disorders:
  • For ophthalmic suspension (eye drops) dosage form:
    • Adults and children—Use one drop in the eye up to every four hours.

• For eye disorders:
  • For ophthalmic suspension (eye drops) dosage form:
    • Adults and children—Use one or two drops in the eye up to six times a day.
  • For ophthalmic solution (eye drops) dosage form:
    • Adults and children—Use one or two drops in the eye two to four times a day.

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.

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

Do not keep outdated medicine or medicine no longer needed.

Precautions While Using This Medicine:

If you will be using this medicine for more than a few weeks, an ophthalmologist (eye doctor) should examine your eyes at regular visits to make sure it does not cause unwanted effects.

If your eye condition does not improve after 5 to 7 days, or if it 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:

Check with your doctor as soon as possible if any of the following side effects occur:

Less common or rare

Decreased vision

eye infection

eye pain

gradual blurring or loss of vision

nausea

vomiting

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:

More common

Blurred vision (mild and temporary, occurs after use of ointments)

Less common or rare

Burning, stinging, redness, or watering of the eyes

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.