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Ketotifen (Monograph)

Brand name: Zaditor
Drug class: Antiallergic Agents
- Histamine H1-receptor Antagonists
- Mast-cell Stabilizers
ATC class: S01GX08
VA class: OP900
Chemical name: 10H-Benzo(4,5)cyclohepta(1,2-b)thiophen-10-one,4,9-dihydro-4-(1-methyl-4-piperidinylidene)
Molecular formula: C19H19NOS
CAS number: 34580-13-7

Medically reviewed by Drugs.com on Feb 20, 2024. Written by ASHP.

Introduction

Relatively selective histamine H1-receptor antagonist and mast-cell stabilizer.

Uses for Ketotifen

Allergic Conjunctivitis

Self-medication for temporary relief of ocular itching associated with allergic conjunctivitis (i.e., conjunctivitis due to pollen, grass, ragweed, or animal hair or dander).

Ketotifen Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.

Dosage

Available as ketotifen fumarate; dosage expressed in terms of ketotifen.

Pediatric Patients

Allergic Conjunctivitis
Ophthalmic

One drop of a 0.025% solution in the affected eye(s) twice daily (at an interval of 8–12 hours) for those ≥3 years of age.

Adults

Allergic Conjunctivitis
Ophthalmic

One drop of a 0.025% solution in the affected eye(s) twice daily (at an interval of 8–12 hours).

Prescribing Limits

Pediatric Patients

Allergic Conjunctivitis
Ophthalmic

Do not administer more frequently than twice daily.

Adults

Allergic Conjunctivitis
Ophthalmic

Do not administer more frequently than twice daily.

Cautions for Ketotifen

Contraindications

Warnings/Precautions

Specific Populations

Pregnancy

Category C.

Lactation

Distributed into milk in rats following oral administration. Cautious use is recommended.

Pediatric Use

Safety and efficacy not established in children <3 years of age.

Should not be used in children <3 years of age unless otherwise directed by a clinician.

Common Adverse Effects

Conjunctival injection, headaches, rhinitis. Some events may be related to the underlying ocular disease.

Ketotifen Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed following topical application to the eye.

Onset

Within minutes after topical application to the eye.

Stability

Storage

Ophthalmic

Solution

4–25°C.

Do not use if solution changes color or becomes cloudy.

Actions

Advice to Patients

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Ketotifen Fumarate

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Ophthalmic

Solution

0.025% (of ketotifen)

Alaway (with benzalkonium chloride)

Bausch & Lomb

Zaditor (with benzalkonium chloride)

Novartis

AHFS DI Essentials™. © Copyright 2024, Selected Revisions March 1, 2008. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.

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