Zaditor

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Zaditor is a prescription eye drop indicated for the temporary prevention of itching of the eye due to allergic conjunctivitis.

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

Zaditor begins to work within minutes after administration and lasts up to 12 hours. 

Dosing and Formulation
The recommended dose is 1 drop in the affected eye(s) twice daily. Patients who wear contact lenses should remove them before using Zaditor and should not reinsert them for at least 10 minutes.

Zaditor is available by prescription in 7.5 mL plastic bottles.

Pronounced: ZA-di-tor
Active Ingredient: Ketotifen fumarate
Brand name(s): Zaditor
Strength(s):  0.025%
Dosage Form(s): Ophthalmic solution
Company Name:  Ciba Vision, A Novartis Company
Availability:  Prescription only
Date Approved by the FDA: July 7, 1999
Established Name: Ketotifen Fumarate Ophthalmic Solution
Category:

• Antihistamine, H 1 - receptor, ophthalmic
• mast cell stabilizer, ophthalmic
• antiallergic, ophthalmic

Description
ZADITOR ™ 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.

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.

In human conjunctival allergen challenge studies, ZADITOR ™ was significantly more effective than placebo in preventing ocular itching associated with allergic conjunctivitis. The action of ketotifen occurs rapidly with an effect seen within minutes after administration.

Possible side effects of Zaditor
(This is NOT a complete list of side effects reported with Zaditor. Your health care provider can discuss with you a more complete list of side effects.)

The side effects of Zaditor are generally mild. Some possible side effects are:

• Redness
  
• Headache
  
• Runny nose
  
• Temporary burning or stinging of the eye

Less common side effects may include:
Allergic reactions, burning or stinging, dilated pupils, discharge, dry eyes, eye pain, eyelid disorder, flu syndrome, itching, inflamed eyelids or corneas, light sensitivity, rash, sore throat, tearing

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

Contraindications
ZADITOR™ is contraindicated in persons with a known hypersensitivity to any component of this product.

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

Precautions
Information for Patients: To prevent contaminating the dropper tip and solution, care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle. Keep the bottle tightly closed when not in use. Patients should be advised not to wear a contact lens if their eye is red.

ZADITOR™ should not be used to treat contact lens related irritation. The preservative in ZADITOR™, benzalkonium chloride, may be absorbed by soft contact lenses. Patients who wear soft contact lenses and whose eyes are not red, should be instructed to wait at least ten minutes after instilling ZADITOR™ before they insert their contact lenses.

Adverse reactions
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.

Overdosage
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.

Dosage
The recommended dose is one drop in the affected eye(s) every 8 to 12 hours.

How supplied
ZADITOR™ is supplied as 5 mL solution in white 7.5 mL LDPE plastic bottles with controlled plastic dropper tips and white plastic caps.
NDC 58768-102-05

Storage
Store at 4°-25°C(39°-77°F).

Pregnancy: Pregnancy Category C
Oral treatment of pregnant rabbits during organogenesis with 45 mg/kg/day of ketotifen (30,000 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.

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