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Ketotifen Fumarate

Class: Antiallergic Agents
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
Brands: Zaditor

Introduction

Relatively selective histamine H1-receptor antagonist and mast-cell stabilizer.1

Uses for Ketotifen Fumarate

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).6 7

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Ketotifen Fumarate Dosage and Administration

Administration

Ophthalmic Administration

Apply topically to the eye as an ophthalmic solution.6 7

Dosage

Available as ketotifen fumarate; dosage expressed in terms of ketotifen.6 7

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.6 7

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).6 7

Prescribing Limits

Pediatric Patients

Allergic Conjunctivitis
Ophthalmic

Do not administer more frequently than twice daily.6 7

Adults

Allergic Conjunctivitis
Ophthalmic

Do not administer more frequently than twice daily.6 7

Cautions for Ketotifen Fumarate

Contraindications

  • Known hypersensitivity to ketotifen or any ingredient in the formulation.6 7

Warnings/Precautions

Specific Populations

Pregnancy

Category C.1

Lactation

Distributed into milk in rats following oral administration.1 Cautious use is recommended.1

Pediatric Use

Safety and efficacy not established in children <3 years of age.6 7

Should not be used in children <3 years of age unless otherwise directed by a clinician.6 7

Common Adverse Effects

Conjunctival injection, headaches, rhinitis.1 Some events may be related to the underlying ocular disease.1

Ketotifen Fumarate Pharmacokinetics

Absorption

Bioavailability

Minimally absorbed following topical application to the eye.1

Onset

Within minutes after topical application to the eye.1

Stability

Storage

Ophthalmic

Solution

4–25°C.6 7

Do not use if solution changes color or becomes cloudy.6 7

Actions

  • Suppresses the release of mediators from cells involved in hypersensitivity reactions and decreases chemotaxis and activation of eosinophils.1

Advice to Patients

  • Importance of learning and adhering to proper administration techniques to avoid contamination of the product.6 7

  • Importance of delaying insertion of contact lenses for at least 10 minutes after ketotifen instillation to prevent absorption of benzalkonium chloride by contact lenses.1 6 7

  • Not indicated for contact lens-related irritation.6 7

  • Importance of reporting new-onset eye pain or discomfort, visual disturbances, eye redness, worsening of itching, or itching lasting >72 hours.6 7

  • Importance of seeking quick medical attention if preparation is ingested orally.6 7

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs, as well as any other concomitant illnesses.6 7

  • Importance of informing patient of other important precautionary information.6 7 (See Cautions.)

Preparations

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

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

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 02/2014. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

Alaway 0.025% Solution (BAUSCH &amp; LOMB CONS): 10/$19.99 or 30/$38.97

Refresh Eye Itch Relief 0.025% Solution (ALLERGAN OPTICAL): 5/$21.99 or 15/$45.97

Zaditor 0.025% Solution (ALCON VISION): 5/$25.99 or 15/$49.97

AHFS DI Essentials. © Copyright, 2004-2014, Selected Revisions March 1, 2008. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

References

1. Novartis Opthalmics. Zaditor (ketotifen fumarate) ophthalmic solution prescribing information. Duluth, GA; 2002 Oct.

2. Ciprandi G, Buscaglia S, Cerqueti PM et al. Drug treatment of allergic conjunctivitis: a review of the evidence. Drugs. 1992; 43:154-76. [IDIS 360840] [PubMed 1372215]

3. Morrow GL, Abbott RL. Conjunctivitis. Am Fam Physician. 1998; 57:735-46. [IDIS 418448] [PubMed 9490996]

4. Titi MJ. A critical look at ocular allergy drugs. Am Fam Physician. 1996; 53:2637-42. [IDIS 367250] [PubMed 8644576]

5. Galindez OA, Kaufman HE. Coping with the itchy-burnies: the management of allergic conjunctivitis. Ophthalmology. 1996; 103:1335-6. [IDIS 373485] [PubMed 8841290]

6. Novartis. Zaditor (ketotifen fumarate) drug facts. 2007. From Zaditor website (). Accessed 2007 Sep 26.

7. Bausch & Lomb. Alaway (ketotifen fumarate ) ophthalmic solution 0.025%: antihistamine eye drops. From Bausch & Lomb website (). Accessed 2007 Sep 27.

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