Ketotifen Ophthalmic

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Unneeded medications should be disposed of in special ways to ensure that pets, children, and other people cannot consume them. However, you should not flush this medication down the toilet. Instead, the best way to dispose of your medication is through a medicine take-back program. Talk to your pharmacist or contact your local garbage/recycling department to learn about take-back programs in your community. See the FDA's Safe Disposal of Medicines website (http://goo.gl/c4Rm4p) for more information if you do not have access to a take-back program.

It is important to keep all medication out of sight and reach of children as many containers (such as weekly pill minders and those for eye drops, creams, patches, and inhalers) are not child-resistant and young children can open them easily. To protect young children from poisoning, always lock safety caps and immediately place the medication in a safe location – one that is up and away and out of their sight and reach. http://www.upandaway.org

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.

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

• Store at room temperature.
• Keep all drugs in a safe place. Keep all drugs out of the reach of children and pets.
• Check with your pharmacist about how to throw out unused drugs.

(kee toe TYE fen)

Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product

Solution, Ophthalmic:

Alaway: 0.025% (10 mL) [contains benzalkonium chloride]

Alaway Childrens Allergy: 0.025% (5 mL) [contains benzalkonium chloride]

Claritin Eye: 0.025% (5 mL) [contains benzalkonium chloride]

Eye Itch Relief: 0.025% (5 mL) [contains benzalkonium chloride]

GoodSense Itchy Eye: 0.025% (5 mL) [contains benzalkonium chloride]

TheraTears Allergy: 0.025% (10 mL) [contains benzalkonium chloride]

Zaditor: 0.025% (5 mL) [contains benzalkonium chloride]

ZyrTEC Itchy Eye: 0.025% (5 mL [DSC]) [contains benzalkonium chloride]

Generic: 0.025% (5 mL)

There are no dosage adjustments provided in the manufacturer’s labeling. However, dosage adjustment unlikely due to low systemic absorption.

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

• an untreated eye infection; or

• eye irritation caused by wearing contact lenses.

Ketotifen ophthalmic is not approved for use by anyone younger than 3 years old.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

This medicine may be harmful if swallowed. If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes

Do not share this medication with others.

Avoid allergens (e.g., pollen, animal dander) and other triggering factors (e.g., irritants). Cold compresses and lubricating eye drops may decrease eye irritation.

Missed Dose

If you are using this medication on a regular schedule and miss a dose, use it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Storage

Store between 39-77 degrees F (4-25 degrees C) away from light and moisture. If you are using the single-dose container, discard it after use. Discard unused single-dose containers 4 weeks after you first open the blister pack (or 3 months after opening if you store them in the original carton box). Do not store in the bathroom. Keep all medicines away from children and pets.

Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your product.Information last revised July 2016. Copyright(c) 2016 First Databank, Inc.