Ketotifen Solution is used for:

Temporary prevention of itching of the eye due to allergies.

Ketotifen Solution is an antihistamine and mast cell stabilizer. It works by blocking the release of chemicals from cells involved in allergic reactions.

Special warnings about Ketotifen fumarate

Do not wear contact lenses if your eyes are red or irritated, and do not use Zaditor to treat irritation from contact lenses. If you wear soft contact lenses, wait at least 10 minutes after applying Zaditor before inserting them.

The safety and effectiveness of Zaditor in children below the age of 3 years have not been established.

How to use Ketotifen Solution:

Use Ketotifen Solution as directed by your doctor. Check the label on the medicine for exact dosing instructions.

• To use Ketotifen Solution in the eye, first, wash your hands. Tilt your head back. Using your index finger, pull the lower eyelid away from the eye to form a pouch. Drop the medicine into the pouch and gently close your eyes. Immediately use your finger to apply pressure to the inside corner of the eyelid for 1 to 2 minutes. Do not blink. Remove excess medicine around your eye with a clean, dry tissue, being careful not to touch your eye. Wash your hands to remove any medicine that may be on them.
• To prevent germs from contaminating your medicine, do not touch the applicator tip to any surface, including the eye. Keep the container tightly closed.
• Ketotifen Solution is only for the eye. Do not get it in your nose or mouth.
• Do not wear contact lenses if your eye is red.
• Do not use Ketotifen Solution to treat irritation caused by contact lenses.
• Remove contact lenses before you use Ketotifen Solution; soft contact lenses may be placed back in the eyes 10 minutes after use of Ketotifen Solution if your eyes are not red.
• If you miss a dose of Ketotifen Solution, use it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not use 2 doses at once.

Ask your health care provider any questions you may have about how to use Ketotifen Solution.

Possible side effects of Ketotifen Solution:

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Burning; stinging; sore throat; sensitivity to light; runny nose; red eyes; nasal congestion; itching; inflammation of the cornea; infection of the mucous membrane around the eye; headache; flu-like syndrome; eyelid disorder; eye discharge; dry eyes; tearing.

Severe allergic reactions (rash; eye pain or swelling; swelling of the mouth, lips, face, or tongue); tightness in the chest; difficulty breathing; itching; hives; trouble breathing.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch .

Important safety information:

• Ketotifen Solution may cause mild stinging when you first put it in your eye. Contact your doctor if the stinging continues.
• Do not use Ketotifen Solution for future eye problems without first checking with your doctor.
• Ketotifen Solution may cause harm if it is swallowed. If you may have taken it by mouth, contact your poison control center or emergency room right away.
• Ketotifen Solution should not be used in CHILDREN younger than 3 years old; safety and effectiveness in these children have not been confirmed.
• PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Ketotifen Solution while you are pregnant. It is not known if Ketotifen Solution is found in breast milk. If you are or will be breast-feeding while you use Ketotifen Solution, check with your doctor. Discuss any possible risks to your baby.