Availability of Oral Ketotifen in the USA
Oral ketotifen is not available in the United States, though it is available in other countries around the world. 1
Current Status in the USA
Ketotifen is only available in the United States as an ophthalmic (eye drop) formulation, marketed under brand names such as Alaway and Zaditor for the treatment of allergic conjunctivitis. 1 The ophthalmic formulation is classified as a dual-action agent with both antihistamine and mast cell stabilizing properties.
Available Formulations in the USA
- Ophthalmic solution: Ketotifen fumarate 0.025% is FDA-approved and available over-the-counter for the temporary relief of itching due to allergic conjunctivitis 1, 2
- Oral formulation: Not available in the United States 1
International Availability
Oral ketotifen is available in many countries outside the United States for the treatment of:
- Allergic disorders
- Bronchial asthma
- Atopic dermatitis
- Seasonal or perennial rhinitis
- Allergic conjunctivitis
- Chronic or acute urticaria
- Food allergy 3
Clinical Efficacy of Available Ketotifen Products
The ophthalmic formulation of ketotifen available in the USA:
- Has a rapid onset of action (within 15 minutes)
- Provides extended duration of action (at least 8 hours)
- Effectively reduces ocular itching and hyperemia associated with allergic conjunctivitis 2
- Is safe and well-tolerated in both adult and pediatric populations 4, 5
Alternative Medications Available in the USA
For patients seeking oral medications with similar properties to ketotifen, the following alternatives are available in the USA:
Cyproheptadine: A first-generation antihistamine with similar dual function as both an H1 antihistamine and serotonin receptor antagonist. It can be used to treat dermatologic, gastrointestinal, and neuropsychiatric symptoms. 1, 6
Other oral antihistamines: For allergic conditions, various oral antihistamines are available in the USA, though they may not have the same mast cell stabilizing properties as ketotifen. 1
Important Considerations
If you are seeking an oral medication with similar properties to ketotifen for allergic conditions, consult with your healthcare provider about appropriate alternatives available in the United States. The specific alternative recommended will depend on your condition and symptoms.