Zaditor

— THERAPEUTIC CATEGORIES —
  • Ocular allergy/inflammation

Zaditor Generic Name & Formulations

General Description

Ketotifen (as fumarate) 0.025%; oph soln; contains benzalkonium chloride.

Pharmacological Class

Antihistamine.

How Supplied

Soln—5mL

Storage

Store at 4°-25°C (39°-77°F).

Zaditor Indications

Indications

Temporary prevention of ocular itching due to allergic conjunctivitis.

Zaditor Dosage and Administration

Adults and Children

<3yrs: not recommended. ≥3yrs: 1 drop in affected eye(s) every 8–12hrs. Max 2 doses/day.

Zaditor Contraindications

Not Applicable

Zaditor Boxed Warnings

Not Applicable

Zaditor Warnings/Precautions

Warnings/Precautions

Contact lenses (remove; may reinsert 10 minutes after administration, if eye is not red). Reevaluate if irritation, eye pain, or visual changes persist beyond 72 hours or worsen.

Nursing Mother Considerations

Caution should be used when ketotifen fumarate is administered to a nursing mother. It is unknown whether ocular administration could result in sufficient systemic absorption.

Pediatric Considerations

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

Zaditor Pharmacokinetics

See Literature

Zaditor Interactions

Not Applicable

Zaditor Adverse Reactions

Not Applicable

Zaditor Clinical Trials

Clinical Trials

Ketotifen fumarate ophthalmic solution was found to be significantly more effective than placebo in preventing ocular itching associated with allergic conjunctivitis. The effect of ketotifen was seen within minutes after administration.

Zaditor Note

Not Applicable

Zaditor Patient Counseling

Patient Counseling

Care should be taken not to touch the eyelids or surrounding areas with the dropper tip of the bottle.

Do not use to treat contact lens related irritation.

Benzalkonium chloride, the preservative in Zaditor, may be absorbed by soft contact lenses. Wait at least 10 minutes after instilling drops before inserting contact lenses.

Cost Savings Program