Zaditor

DRUG DESCRIPTION

Zaditor® (ketotifen fumarate) is an antihistamine eye drop to relieve itchy eyes due to allergens.

ZADITOR® (ketotifen fumarate) is a sterile ophthalmic solution containing ketotifen for topical administration to the eyes. Ketotifen fumarate is a finely crystalline powder with an empirical formula of C23H23NO5S and a molecular weight of 425.50.

ketotifen

Established Name: Ketotifen Fumarate Ophthalmic Solution

Chemical Name: 4-(1-Methyl-4-piperidylidene)-4H-benzo[4,5]cyclohepta[1,2-b] thiophen-10(9H)-one hydrogen fumarate

Each mL of ZADITOR (ketotifen fumarate) &reade; contains:

Active: 0.345 mg ketotifen fumarate equivalent to 0.25 mg ketotifen.

Inactives: glycerol, sodium hydroxide/hydrochloric acid (to adjust pH) and purified water.

Preservative: benzalkonium chloride 0.01%. It has a pH of 4.4 to 5.8 and an osmolality of 210-300 mOsm/kg.

What are the possible side effects of ketotifen ophthalmic (Alaway, Zaditor)?

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

Stop using ketotifen ophthalmic and call your doctor at once if you have any of these serious side effects:

  • redness, drainage, eyelid swelling, or other signs of infection;
  • eye pain;
  • vision changes; or
  • severe itching of the eyes worse than before using the medication.

Less serious side effects may...

Read All Potential Side Effects and See Pictures of Zaditor »

What are the precautions when taking ketotifen fumarate (Zaditor)?

Before using ketotifen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative benzalkonium chloride in the multi-dose container), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Do not use this medication in children younger than 3 years unless directed by the doctor.

During...

Read All Potential Precautions of Zaditor »


Zaditor Consumer (continued)

SIDE EFFECTS: Burning/stinging/irritation of the eye, headache, stuffy/runny nose, bad taste in your mouth, and increased sensitivity to light may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

If your doctor has directed you to use this medication, remember that he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: dry eyes, eye pain, increased redness/swelling of the eye, vision problems.

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using ketotifen, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients (such as the preservative benzalkonium chloride in the multi-dose container), which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: eye problems (e.g., glaucoma).

After you apply this drug, your vision may become temporarily blurred. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Do not use this medication in children younger than 3 years unless directed by the doctor.

During pregnancy, this medication should be used only when clearly needed. Discuss the risks and benefits with your doctor.

It is not known whether this drug passes into breast milk. Consult your doctor before breast-feeding.


Zaditor Patient Information Including Side Effects

Brand Names: Alaway, Zaditor

Generic Name: ketotifen ophthalmic (Pronunciation: kee toe TYE fen off THAL mik)

  • What is ketotifen ophthalmic (Zaditor)?
  • What are the possible side effects of ketotifen ophthalmic (Zaditor)?
  • What is the most important information I should know about ketotifen ophthalmic (Zaditor)?
  • What should I discuss with my healthcare provider before using ketotifen ophthalmic (Zaditor)?
  • How should I use ketotifen ophthalmic (Zaditor)?
  • What happens if I miss a dose (Zaditor)?
  • What happens if I overdose (Zaditor)?
  • What should I avoid while using ketotifen ophthalmic (Zaditor)?
  • What other drugs will affect ketotifen ophthalmic (Zaditor)?
  • Where can I get more information?

What is ketotifen ophthalmic (Zaditor)?

Ketotifen is an antihistamine that inhibits the body's release of a chemical called histamine. Histamine can produce allergy symptoms such as sneezing, runny nose, and watery eyes.

Ketotifen ophthalmic is used to treat itching of the eyes caused by allergy to dust, pollen, animals, or other allergens.

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

What are the possible side effects of ketotifen ophthalmic (Zaditor)?

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

Stop using ketotifen ophthalmic and call your doctor at once if you have any of these serious side effects:

  • redness, drainage, eyelid swelling, or other signs of infection;
  • eye pain;
  • vision changes; or
  • severe itching of the eyes worse than before using the medication.

Less serious side effects may include:

  • mild burning, stinging, or eye irritation;
  • dryness of the eyes; or
  • increased sensitivity to light.

This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about ketotifen ophthalmic (Zaditor)?

Do not use this medication if you are allergic to ketotifen, or if you have an untreated eye infection. Ketotifen ophthalmic should not be used to treat eye irritation caused by wearing contact lenses.

Use this medication exactly as directed on the label, or as it has been prescribed by your doctor. Do not use the medication in larger amounts, or use it for longer than recommended.

If you wear contact lenses, remove them before applying ketotifen ophthalmic. This medication may contain a preservative (benzalkonium chloride) that may cause discoloration of contact lenses. Wait at least 10 minutes after using in the eye drops before putting contact lenses into your eyes.

Do not allow the medicine dropper tip to touch any surface, including the eyes or hands. If the dropper becomes contaminated it could cause an infection in your eye, which can lead to vision loss or serious damage to the eye.

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