Ketotifen Fumarate Ophthalmic Solution

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.

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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

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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

SLIDESHOW

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.

What is the difference between Zaditor (ketotifen fumarate) and leading OTC antihistamine eye drops?
With Zaditor (ketotifen fumarate) , 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 (ketotifen fumarate) 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 (ketotifen fumarate) , you don’t have to worry about worsening your symptoms as a result of the “rebound effect.”

Why did Novartis Ophthalmics apply to the FDA to change Zaditor (ketotifen fumarate) from prescription to OTC?
Since its introduction in the U.S. in 1999, Zaditor (ketotifen fumarate) has been safely used by millions for the temporary prevention of itchy eyes due to allergic conjunctivitis. By making Zaditor (ketotifen fumarate) available OTC, itchy eye sufferers can experience fast, long-lasting relief from itchy eyes without a prescription.

Is OTC Zaditor (ketotifen fumarate) the same strength as original prescription-strength Zaditor (ketotifen fumarate) ?
Yes. You can now benefit from the same prescription-strength Zaditor (ketotifen fumarate) without a prescription.