What Zaditor is used for and how to use it
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Zaditor - Consumer Medicine Information

Manufacture: Alcon
Country: Canada
Condition: Conjunctivitis, Allergic
Class: Ophthalmic antihistamines and decongestants
Form: Liquid solution, Eye drops (ophthalmic)
Ingredients: Ketotifen fumarate, glycerol, water for injection, sodium hydroxide, benzalkonium chloride, glycerol, hydrochloric acid/sodium hydroxide, purified water

Ketotifen Fumarate Ophthalmic Solution

Single dose container and Multi dose container

About this medication

What the medication is used for

Single dose container

  • Treatment of seasonal allergic conjunctivitis (itchy, watery, red or swollen eyes and/or eyelids) for adults and children over 3 years old.

Multi dose container

Treatment of seasonal allergic conjunctivitis (itchy, watery, red or swollen eyes and/or eyelids).

What it does

ZADITOR is an anti-allergy agent.

When it should not be used

Do not use ZADITOR if you are allergic to ketotifen or any of the nonmedicinal ingredients or any component of the container.

What the medicinal ingredient is

Ketotifen fumarate

What the important nonmedicinal ingredients are

Single dose container

Glycerol, water for injection, sodium hydroxide.

Multi dose container

Benzalkonium chloride, glycerol, hydrochloric acid/sodium hydroxide, purified water.

What dosage forms it comes in

Single dose container

Transparent plastic containers containing 0.4mL of clear 0.025% ketotifen solution. Blocks of 5 single dose containers are each packed in a blister. The blisters are packed in carton boxes of 30 containers.

Multi dose container

White plastic bottles with controlled dropper tips, containing 5 mL of clear 0.025% ketotifen solution.

Warnings and precautions

Before using ZADITOR, tell your doctor if:

  • you are pregnant or breastfeeding
  • you wear contact lenses

Interactions with this medication

If you are using ZADITOR with any other eye medications, you must wait at least 5 minutes between the use of each medication

Proper use of this medication

Single dose container

For topical use only.

Usual dose

The usual dose is one drop of ZADITOR in the affected eye every 8 to 12 hours.

  • The contents of the container remain sterile until the original closure is broken. You must use the contents immediately after the container has been opened.
  • Discard the container after use. This is to avoid the risk of microbial contamination of the product.
  • After opening a blister, any unused single-dose containers should be discarded after 4 weeks unless they have been stored in the outer carton, in which case they should be discarded after 3 months.

How to use your medication

  • In order to receive the optimum benefits from ZADITOR, it is essential to use the eye drops regularly (usually 2 to 3 times a day) as directed by your physician.
  • Cut pouch along dotted line and remove the strip of single use units. Tear off one single dose unit from the strip (figure 1).
  • Hold it by the tab with the nozzle pointing downwards and tap the unit gently until all the air bubbles are above the solution.
  • Twist the tab off the single dose unit (figure 2). Make sure that the tip of the unit does not touch anything.
  • Hold the single dose unit in one hand between the thumb and forefinger. With your head tilted back (figure 3), use the fore- finger of your other hand to pull down the lower lid of your eye.
  • Place the single dose unit tip close to your eye, but without touching your eye or lid, and gently squeeze the unit to allow one drop to be applied (figure 4).
  • Close your eyelid and gently press the inner corner of your eye with your forefinger for one minute (figure 5).
  • Discard the single dose unit and the remaining solution.

Missed Dose

If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular schedule. Do not double doses.

Multi dose container

Usual dose

The usual dose is one drop of ZADITOR in the affected eye every 8 to 12 hours.

  • If you wear contact lenses, you should remove your lenses before using ZADITOR. Before you put your contact lenses back in, you should wait at least 10 minutes after using ZADITOR.
  • To avoid contamination, do not touch any surface with the tip of the container.

Missed Dose

If a dose of this medication has been missed, it should be taken as soon as possible. However, if it is almost time for the next dose, skip the missed dose and go back to the regular schedule. Do not double doses.

Side effects and what to do about them

The most common side effects are red eyes and headache.

Other side effects are itching, dry eyes, burning or stinging in the eyes, sore eyelids and discharge from the eyes.

This is not a complete list of side effects. For any unexpected effects while taking ZADITOR, contact your doctor or pharmacist.

How to store it

Store between 4°C and 25°C.

After opening a blister pack, unused containers may be stored for 4 weeks. Single dose containers may be stored outside the blister in the carton box for 3 months.

REPORTING SUSPECTED SIDE EFFECTS

To monitor drug safety, Health Canada collects information on serious and unexpected effects of drugs . If you suspect you have had a serious or unexpected reaction to this drug you may notify Health Canada by:

toll-free telephone: 866-234-2345
toll-free fax 866-678-6789
By email: cadrmp@hc-sc.gc.ca


By regular mail:
National AR Centre
Marketed Health Products Safety and Effectiveness
Information Division
Marketed Health Products Directorate
Tunney’s Pasture, AL 0701C
Ottawa ON K1A 0K9


NOTE: Before contacting Health Canada, you should contact your physician or pharmacist.

More information

This document plus the full product monograph, prepared for health professionals can be obtained by contacting the sponsor, Novartis Pharmaceuticals Canada Inc., at:


1-866-393-6337