Ketotifen ophthalmic (for the eyes) is used in adults and children at least 3 years old to temporarily treat itching of the eyes caused by allergy to dust, pollen, grass, animals, or other allergens.

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

Follow all directions on the label and package. Use exactly as directed.

Use exactly as directed on the label, or as prescribed by your doctor.

Do not use while wearing soft contact lenses. Ketotifen ophthalmic may contain a preservative that can permanently stain the lenses. Wait at least 10 minutes before inserting your contact lenses.

Wash your hands before using eye medication.

To apply the eye drops: Pull down your lower eyelid to create a small pocket and squeeze a drop into this pocket. Close your eyes for 1 or 2 minutes.

Use only the prescribed number of drops.

Wait at least 5 minutes before using any other eye drops.

Do not touch the dropper tip or place it directly on your eye. A contaminated dropper can infect your eye and lead to serious vision problems.

Call your pharmacist if the medicine looks cloudy, has changed colors or has particles in it.

Each single-use vial is for one use only (in both eyes). Store the unused vials in the original foil pouch and protect from light. Throw the vial away after one use, even if there is still medicine left inside.

Store at room temperature, in an upright position and tightly closed. Do not freeze.

Usual Adult Dose for Allergic Conjunctivitis:

Instill 1 drop in the affected eye(s) 2 times a day

Comments: May administer eye drops every 8 to 12 hours, but should not administer more than twice a day.

Use: For the treatment of itching related to pollen, ragweed, grass, animal hair and dander.

Usual Pediatric Dose for Allergic Conjunctivitis:

Age: 3 years and older
Instill 1 drop in the affected eye(s) 2 times a day

Comments: May administer eye drops every 8 to 12 hours, but should not administer more than twice a day.

Use: For the treatment of itching related to pollen, ragweed, grass, animal hair and dander.

You should not use ketotifen ophthalmic if you are allergic to it, or if you have:

• eye irritation caused by wearing contact lenses.

Ask a doctor before using ketotifen ophthalmic if you are pregnant or breastfeeding.

Do not allow a young child to use ketotifen ophthalmic without help from an adult.

Use the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not use two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medicine.

Do not use other eye medications unless your doctor tells you to.

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

Ketotifen ophthalmic may cause serious side effects. Stop using ketotifen ophthalmic and call your doctor at once if you have:

• eye pain or changes in vision;

• eye itching that gets worse or lasts longer than 72 hours;

• severe burning, stinging, or eye irritation after using the eye drops; or

• signs of eye infection--swelling, redness, severe discomfort, crusting or drainage.

Less serious side effects may be more likely, and you may have none at all.

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.