Zaditor (ketotifen fumarate) Antihistamine Eye Drops


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QUESTIONS & ANSWERS




What is Zaditor?
What is the difference between Zaditor and other OTC antihistamine eye drops?
Why did Novartis apply to the FDA to change Zaditor from prescription to OTC?
Is OTC Zaditor the same strength as original prescription-strength Zaditor?
How safe is Zaditor?
Is Zaditor safe for use in children?
Who should not use Zaditor?
Can Zaditor be used in both eyes?
How is Zaditor administered?
Can Zaditor be used with contact lenses?
Does Zaditor treat seasonal allergic conjunctivitis?
Does Zaditor treat perennial allergic conjunctivitis?
Does Zaditor treat pink eye?
When should I consult a doctor?
How much does Zaditor cost?
Is Zaditor covered by insurance?
What are some of the causes of itchy eyes?
When and where will Zaditor be available OTC?
What is the preservative in Zaditor?
How should Zaditor be stored?
What size is the Zaditor bottle?

What is Zaditor?

Zaditor (ketotifen fumarate ophthalmic solution 0.025%) is an over-the-counter (OTC) antihistamine eye drop that relieves itchy eyes due to allergens. It's the first OTC eye drop strong enough to last up to 12 hours with just one drop. Previously available only with a prescription, Zaditor is now available OTC in original prescription strength.

What is the difference between Zaditor and leading OTC antihistamine eye drops?

With Zaditor, you can expect fast, effective relief with just one drop that lasts up to 12 hours, whereas the leading OTC eye drops only provide relief for up to 4-6 hours. Some OTC itchy eye products also contain redness relievers (vasoconstrictors) that through repeated use can actually cause your eyes to become even redder after the effect of the vasoconstrictor wears off. This is called the "rebound effect." Zaditor works differently from these types of products. It stops the itch at the source by also blocking histamines (a chemical made by the body during an allergic reaction) that causes itchy eyes but does not directly constrict blood vessels. With Zaditor, you don't have to worry about worsening your symptoms as a result of the "rebound effect."

Why did Novartis apply to the FDA to change Zaditor from prescription to OTC?

Zaditor was approved by the FDA in 1999 for sale as a prescription medication. Since its introduction, Zaditor has been used by millions of patients for the temporary prevention of itchy eyes due to allergic conjunctivitis. In 2006 the FDA approved the sale of Zaditor as an OTC product. Because Zaditor is available OTC, patients are able to experience fast, long-lasting relief from itchy eyes without the need for a prescription.

Is OTC Zaditor the same strength as original prescription-strength Zaditor?

Yes. You can now benefit from the same prescription-strength Zaditor without a prescription.

How safe is Zaditor?

The FDA has determined that Zaditor is safe for OTC use based on the long-term use of the drug, as well as the controlled clinical studies that supported the original prescription-strength formula.

Is Zaditor safe for use in children?

Yes. Zaditor is safe for children aged 3 years and older.

Who should not use Zaditor?

Do not use if you are sensitive to any ingredients in Zaditor.

Can Zaditor be used in both eyes?

Zaditor should only be applied to the eye or eyes that are affected.

How is Zaditor administered?

The recommended dose is one drop in the affected eye(s) twice daily. Do not touch the tip of container to any surface to avoid contamination. Replace cap after use.

Can Zaditor be used with contact lenses?

Yes. However, contact lenses should be removed prior to applying Zaditor and not reinserted for at least 10 minutes following application.

Does Zaditor treat seasonal allergic conjunctivitis?

Zaditor relieves itchy eyes caused by seasonal allergic conjunctivitis.

Does Zaditor treat perennial allergic conjunctivitis?

Zaditor relieves itchy eyes caused by perennial allergic conjunctivitis.

Does Zaditor treat pink eye?

Zaditor relieves the symptoms of allergic conjunctivitis, which is a type of pink eye. Other causes of pink eye include infectious (viral, bacterial and fungal), inflammatory (rheumatoid arthritis, systemic lupus erythematosus, etc) and toxic (chemical and other irritants). Always consult your health-care professional for proper diagnosis and treatment.

When should I consult a doctor?

If you experience eye pain, changes in vision, redness of the eye or itching worsens or lasts for more than 72 hours, please see your doctor.

How much does Zaditor cost?

Suggested retail price for a 30-day supply is $14.99.

Is Zaditor covered by insurance?

Typically, OTC medications are not covered by health insurance. Patients should check with insurers to determine coverage.

What are some of the causes of itchy eyes?

Itchy eyes can be caused by seasonal or perennial allergens such as pollen, ragweed, grass, animal hair and pet dander.

When and where will Zaditor be available OTC?

Zaditor has been available OTC in retail stores since January 2007.

What is the preservative in Zaditor?

The preservative in Zaditor is benzalkonium chloride.

How should Zaditor be stored?

Zaditor should be stored at temperatures between 39° and 77° F (4° - 25° C). Replace cap after each use. Do not use if solution changes color or becomes cloudy.

What size is the Zaditor bottle?

Zaditor comes in a 5 ml bottle that contains a 30-day supply if dosed as directed.


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