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
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
ActionsActions
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.
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 03/2011. 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 & LOMB CONS): 10/$18.99 or 30/$35.97
Zaditor 0.025% Solution (NOVARTIS): 5/$25.99 or 15/$49.97
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions March 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.
More Ketotifen Fumarate resources
- Ketotifen Fumarate Side Effects (in more detail)
- Ketotifen Fumarate Dosage
- Ketotifen Fumarate Use in Pregnancy & Breastfeeding
- Ketotifen Fumarate Support Group
- 4 Reviews for Ketotifen Fumarate - Add your own review/rating
Compare Ketotifen Fumarate with other medications
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