Ketotifen Fumarate Ophthalmic Solution

Contents

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

Zaditor

Zaditor is used to treat the symptoms of Allergic Conjunctivitis. Zaditor may be used alone or with other medications.

Zaditor belongs to a class of drugs called Antihistamines, Ophthalmic.

It is not known if Zaditor is safe and effective in children younger than 3 years of age.

What are the possible side effects of Zaditor?

Zaditor may cause serious side effects including:

redness in the eye,
drainage from the eye,
eyelid swelling,
other signs of infection,
eye pain,
vision changes, and
severe itching of the eyes worse than before using the medication

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Zaditor include:

mild burning, stinging, or eye irritation,
dryness of the eyes, and
increased sensitivity to light

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Zaditor. For more information, ask your doctor or pharmacist.

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

Now available Over-The-Counter (OTC); No prescription needed.

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.

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.

Indications & Dosage

INDICATIONS

ZADITOR® (ketotifen fumarate ophthalmic solution) is indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.

DOSAGE AND ADMINISTRATION

Adults and children 3 years of age and older: Put 1 drop in the affected eye(s) twice daily, every 8-12 hours, no more than twice per day.

Children under 3 years of age: Consult a doctor.

HOW SUPPLIED

ZADITOR (ketotifen fumarate) comes in a 5 ml bottle that contains a 30-day supply if dosed as directed.

Store at 4°- 25° C (39°- 77° F).

Novartis Pharmaceuticals Corporation
One Health Plaza
East Hanover, New Jersey 07936-1080

QUESTION

Side Effects & Drug Interactions

SIDE EFFECTS

In controlled clinical studies, conjunctival injection, headaches, and rhinitis were reported at an incidence of 10 to 25%. The occurrence of these side effects was generally mild. Some of these events were similar to the underlying ocular disease being studied.

The following ocular and non-ocular adverse reactions were reported at an incidence of less than 5%:

Ocular: Allergic reactions, burning or stinging, conjunctivitis, discharge, dry eyes, eye pain, eyelid disorder, itching, keratitis, lacrimation disorder, mydriasis, photophobia, and rash.

Non-Ocular: Flu syndrome, pharyngitis.

DRUG INTERACTIONS

No information provided.

Warnings & Precautions

WARNINGS

For topical ophthalmic use only. Not for injection or oral use.

PRECAUTIONS

Carcinogenesis, Mutagenesis, Impairment of Fertility

Ketotifen fumarate was determined to be non-mutagenic in a battery of in vitro and in vivo mutagenicity assays including: Ames test, in vitro chromosomal aberration test with V79 Chinese hamster cells, in vivo micronucleus assay in mouse, and mouse dominant lethal test.

Treatment of male rats with oral doses of ketotifen ³ 10 mg/kg/day orally [6,667 times the maximum recommended human ocular dose of 0.0015 mg/kg/day on a mg/kg basis (MRHOD)] for 70 days prior to mating resulted in mortality and a decrease in fertility. Treatment with ketotifen did not impair fertility in female rats receiving up to 50 mg/kg/day of ketotifen orally (33,333 times the MRHOD) for 15 days prior to mating.

Pregnancy Category C

Oral treatment of pregnant rabbits during organogenesis with 45 mg/kg/day of ketotifen (30,000 times the MRHOD) resulted in an increased incidence of retarded ossification of the sternebrae. However, no effects were observed in rabbits treated with up to 15 mg/kg/day (10,000 times the MRHOD). Similar treatment of rats during organogenesis with 100 mg/kg/day of ketotifen (66,667 times the MRHOD) did not reveal any biologically relevant effects.

Oral treatment of pregnant rats (up to 100 mg/kg/day or 66,667 times the MRHOD) and rabbits (up to 45 mg/kg/day or 30,000 times the MRHOD) during organogenesis did not result in any biologically relevant embryofetal toxicity. In the offspring of the rats that received ketotifen orally from day 15 of pregnancy to day 21 post partum at 50 mg/kg/day (33,333 times the MRHOD), a maternally toxic treatment protocol, the incidence of postnatal mortality was slightly increased, and body weight gain during the first four days post partum was slightly decreased.

Nursing Mothers

Ketotifen fumarate has been identified in breast milk in rats following oral administration. It is not known whether topical ocular administration could result in sufficient systemic absorption to produce detectable quantities in breast milk. Nevertheless, caution should be exercised when ketotifen fumarate is administered to a nursing mother.

Pediatric Use

Safety and effectiveness in pediatric patients below the age of 3 years have not been established.

Overdose & Contraindications

OVERDOSE

Oral ingestion of the contents of a 5 mL bottle would be equivalent to 1.725 mg of ketotifen fumarate. Clinical results have shown no serious signs or symptoms after the ingestion of up to 20 mg of ketotifen fumarate.

CONTRAINDICATIONS

ZADITOR® (ketotifen fumarate) is contraindicated in persons with a known hypersensitivity to any component of this product.

Clinical Pharmacology

CLINICAL PHARMACOLOGY

Ketotifen is a relatively selective, non-competitive histamine antagonist (H1-receptor) and mast cell stabilizer. Ketotifen inhibits the release of mediators from cells involved in hypersensitivity reactions. Decreased chemotaxis and activation of eosinophils has also been demonstrated.

Ketotifen has been shown to have little systemic exposure following topical ocular administration. A study conducted with 15 healthy volunteers dosed bilaterally with ketotifen fumarate ophthalmic solution twice daily for 14 days demonstrated plasma concentrations generally below the quantitation limit of assay (

Medication Guide

PATIENT INFORMATION

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 (ketotifen fumarate) is now available OTC in original prescription strength.

Ketotifen Ophthalmic

Ophthalmic ketotifen is used to relieve the itching of allergic pinkeye. Ketotifen is in a class of medications called antihistamines. It works by blocking histamine, a substance in the body that causes allergic symptoms.

How should this medicine be used?

Ophthalmic ketotifen comes as a solution (liquid) to instill in the eye. It is usually instilled in the affected eye(s) twice daily, 8 to 12 hours apart. Instill ketotifen eye drops at around the same times every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Use ketotifen exactly as directed. Do not use more or less of it or use it more often than prescribed by your doctor.

To instill the eye drops, follow these steps:

Wash your hands thoroughly with soap and water.
Check the dropper tip to make sure that it is not chipped or cracked.
Avoid touching the dropper tip against your eye or anything else; eye drops and droppers must be kept clean.
While tilting your head back, pull down the lower lid of your eye with your index finger to form a pocket.
Hold the dropper (tip down) with the other hand, as close to the eye as possible without touching it.
Brace the remaining fingers of that hand against your face.
While looking up, gently squeeze the dropper so that a single drop falls into the pocket made by the lower eyelid. Remove your index finger from the lower eyelid.
Close your eye for 2 to 3 minutes and tip your head down as though looking at the floor. Try not to blink or squeeze your eyelids.
Place a finger on the tear duct and apply gentle pressure.
Wipe any excess liquid from your face with a tissue.
If you are to use more than one drop in the same eye, wait at least 5 minutes before instilling the next drop.
Replace and tighten the cap on the dropper bottle. Do not wipe or rinse the dropper tip.
Wash your hands to remove any medication.

Other uses for this medicine

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

What special precautions should I follow?

Before using ketotifen eye drops,

tell your doctor and pharmacist if you are allergic to ketotifen or any other medications.
tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking.
tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while using ketotifen, call your doctor.
you should know that you should not wear contact lenses if your eye(s) is/are red. If your eyes are not red and you wear contact lenses, you should know that ketotifen solution contains benzalkonium chloride, which can be absorbed by soft contact lenses. Remove your contact lenses before instilling ketotifen and put them back in 10 minutes later.

What special dietary instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do if I forget a dose?

Instill the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not instill a double dose to make up for a missed one.

What side effects can this medication cause?

Ketotifen eye drops may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

headache
runny nose
burning or stinging of the eye
eye discharge
dry eyes
eye pain
eyelid problems
itching
problem with tear production
blurred vision
sensitivity to light
rash
flu-like symptoms
sore throat

Ketotifen eye drops may cause other side effects. Call your doctor if you have any unusual problems while using this medication.

What should I know about storage and disposal of this medication?

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

What other information should I know?

Keep all appointments with your doctor.

Do not let anyone else use your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Ketotifen ophthalmic

Generic name: ketotifen ophthalmic [ kee-toe-TYE-fen-off-THAL-mik ]
Brand names: Alaway, Claritin Eye, Refresh Eye Itch Relief, Zaditor, Eye Itch Relief, ZyrTEC Itchy Eye
Dosage form: ophthalmic solution (0.025%)
Drug class: Ophthalmic antihistamines and decongestants

Medically reviewed by Drugs.com on Apr 29, 2022. Written by Cerner Multum.

What is ketotifen ophthalmic?

Ketotifen is an antihistamine that reduces the effects of natural chemical histamine in the body. Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose.

Ketotifen ophthalmic (for use in the eyes) 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 purposes not listed in this medication guide.

Warnings

Follow all directions on your medicine label and package. Tell each of your healthcare providers about all your medical conditions, allergies, and all medicines you use.

Before taking this medicine

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.

How should I use ketotifen ophthalmic?

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

Do not use ketotifen ophthalmic while wearing contact lenses. Ketotifen ophthalmic may contain a preservative that can discolor soft contact lenses. Wait at least 10 minutes after using this medicine before putting in your contact lenses.

Wash your hands before using the eye drops.

To apply the eye drops:

Tilt your head back slightly and pull down your lower eyelid to create a small pocket. Hold the dropper above the eye with the tip down. Look up and away from the dropper and squeeze out a drop.
Close your eyes for 2 or 3 minutes with your head tipped down, without blinking or squinting. Gently press your finger to the inside corner of the eye for about 1 minute, to keep the liquid from draining into your tear duct.
Use only the number of drops your doctor has prescribed. If you use more than one drop, wait about 5 minutes between drops.
Wait at least 10 minutes before using any other eye drops your doctor has prescribed.

Do not touch the tip of the eye dropper or place it directly on your eye. A contaminated dropper can infect your eye, which could lead to serious vision problems.

Do not use the eye drops if the liquid has changed colors or has particles in it. Call your pharmacist for new medicine.

Call your doctor if your eye itching does not improve, or if it lasts longer than 72 hours.

Store at room temperature away from moisture and heat. Do not freeze. Keep the bottle tightly closed when not in use.

Related/similar drugs

What happens if I miss a dose?

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.

What happens if I overdose?

An overdose of ketotifen ophthalmic is not expected to be dangerous. Seek emergency medical attention or call the Poison Help line at 1-800-222-1222 if anyone has accidentally swallowed the medication.

What should I avoid while using ketotifen ophthalmic?

Do not use other eye medications unless your doctor tells you to.

Ketotifen ophthalmic side effects

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

Ketotifen ophthalmic may cause serious side effects. Stop using ketotifen ophthalmic and call your doctor at once if you have:

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.

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

Ketotifen ophthalmic dosing information

Usual Adult Dose for Allergic Conjunctivitis:

Instill 1 drop in the affected eye(s) 2 times a day

Comments: May administer eye drops every 8 to 12 hours, but should not administer more than twice a day.

Use: For the treatment of itching related to pollen, ragweed, grass, animal hair and dander.

Usual Pediatric Dose for Allergic Conjunctivitis:

Age: 3 years and older
Instill 1 drop in the affected eye(s) 2 times a day

Comments: May administer eye drops every 8 to 12 hours, but should not administer more than twice a day.

Use: For the treatment of itching related to pollen, ragweed, grass, animal hair and dander.

What other drugs will affect ketotifen ophthalmic?

It is not likely that other drugs you take orally or inject will have an effect on ketotifen used in the eyes. But many drugs can interact with each other. Tell each of your healthcare providers about all medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products.

Where can I get more information?

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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Drug class: ophthalmic antihistamines and decongestants
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Zaditor

What are the possible side effects of Zaditor?

DESCRIPTION

INDICATIONS

DOSAGE AND ADMINISTRATION

HOW SUPPLIED

QUESTION

SIDE EFFECTS

DRUG INTERACTIONS

WARNINGS

PRECAUTIONS

OVERDOSE

CONTRAINDICATIONS

CLINICAL PHARMACOLOGY

PATIENT INFORMATION

Ketotifen Ophthalmic

How should this medicine be used?

To instill the eye drops, follow these steps:

Other uses for this medicine

What special precautions should I follow?

Before using ketotifen eye drops,

What special dietary instructions should I follow?

What should I do if I forget a dose?

What side effects can this medication cause?

Ketotifen eye drops may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

What should I know about storage and disposal of this medication?

What other information should I know?

Ketotifen ophthalmic

What is ketotifen ophthalmic?

Warnings

Before taking this medicine

How should I use ketotifen ophthalmic?

Related/similar drugs

What happens if I miss a dose?

What happens if I overdose?

What should I avoid while using ketotifen ophthalmic?

Ketotifen ophthalmic side effects

Ketotifen ophthalmic dosing information

What other drugs will affect ketotifen ophthalmic?

Where can I get more information?

More about ketotifen ophthalmic

Patient resources

Other brands

Professional resources

Related treatment guides

Further information

About Us

Family Medicine

Children's Health

Women's Health

Men's Health

Alex Koliada, PhD

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