Ketotifen is a second-generation antihistamine and mast cell stabilizer, widely recognized in clinical practice for its dual mechanism of action in managing allergic conditions. It functions by inhibiting the release of histamine and other inflammatory mediators from mast cells, while also competitively blocking H1-histamine receptors. Primarily indicated for the prophylaxis and long-term management of allergic disorders such as asthma, allergic rhinitis, conjunctivitis, and atopic dermatitis, ketotifen offers a preventive approach rather than immediate symptomatic relief. Its efficacy, favorable safety profile, and availability in various formulations—including oral tablets, syrups, and ophthalmic solutions—make it a versatile option in both pediatric and adult populations. This agent is particularly valued for its role in reducing the frequency and severity of allergic exacerbations when used consistently.

Features

• Contains ketotifen fumarate as the active pharmaceutical ingredient
• Available in oral formulations (tablets, syrup) and ophthalmic solution
• Exhibits mast cell stabilizing and H1-antihistaminic properties
• Long half-life allowing for twice-daily dosing in most cases
• Suitable for chronic use with established safety data
• Often prescribed as a prophylactic agent rather for acute relief

Benefits

• Reduces frequency and severity of allergic asthma attacks through mast cell stabilization
• Alleviates symptoms of allergic conjunctivitis such as itching, redness, and watering
• Decreases nasal symptoms in allergic rhinitis, including sneezing and rhinorrhea
• Provides long-term control of chronic urticaria and atopic dermatitis
• Minimizes reliance on rescue medications like short-acting bronchodilators or antihistamines
• Offers a well-tolerated option for pediatric patients aged 3 years and above

Common use

Ketotifen is commonly used for the prophylaxis and management of bronchial asthma, particularly in cases with a significant allergic component. It is also indicated for allergic rhinitis, allergic conjunctivitis, chronic urticaria, and atopic dermatitis. In ophthalmology, ketotifen eye drops are employed to treat itching associated with allergic conjunctivitis. Its use is generally chronic and preventive, rather than for immediate relief of acute symptoms.

Dosage and direction

Adults and adolescents (12 years and older):
Oral: 1 mg twice daily, taken with morning and evening meals.
Ophthalmic solution: Instill one drop into the affected eye(s) twice daily, approximately 12 hours apart.

Children (3–12 years):
Oral: 0.5 mg (½ tablet or measured syrup) twice daily.
Ophthalmic use should be under medical supervision.

Dosage may be adjusted based on clinical response and tolerability. Consistent use is necessary for optimal prophylactic effect. Tablets should be swallowed whole with water; syrup must be measured using the provided dosing device.

Precautions

Use with caution in patients with renal or hepatic impairment; dosage adjustment may be necessary. Sedation may occur, especially at therapy initiation; patients should avoid driving or operating machinery until response is known. Alcohol and other CNS depressants may enhance sedative effects. Not recommended during pregnancy unless clearly needed; caution advised in breastfeeding. Periodic monitoring of weight and growth in pediatric patients is recommended during long-term therapy.

Contraindications

Hypersensitivity to ketotifen or any component of the formulation. Avoid use in patients with acute asthma attacks or status asthmaticus, as it is not a bronchodilator. Contraindicated in individuals with a history of bone marrow suppression or blood dyscrasias. Not recommended in children under 3 years of age.

Possible side effect

Common: Drowsiness, dry mouth, dizziness, weight gain.
Less common: Headache, nausea, irritability, nasal dryness.
Rare: Thrombocytopenia, hepatitis, seizures, hypersensitivity reactions.
Ophthalmic use may cause transient burning, stinging, or conjunctival hyperemia.

Drug interaction

Potentiates effects of alcohol, sedatives, hypnotics, and other CNS depressants. Concurrent use with MAO inhibitors may increase anticholinergic and sedative effects. Ketotifen may interact with oral antidiabetic drugs; monitor blood glucose levels. Use with other antihistamines may enhance sedative properties.

Missed dose

If a dose is missed, take it as soon as remembered unless it is nearly time for the next dose. Do not double the dose. Resume regular dosing schedule.

Overdose

Symptoms may include severe drowsiness, confusion, tachycardia, hypotension, or coma. Management is supportive; gastric lavage may be considered if ingestion was recent. There is no specific antidote. Symptomatic treatment and monitoring of vital functions are advised.

Storage

Store at room temperature (15–30°C), protected from light and moisture. Keep out of reach of children. Do not use after the expiration date. Oral syrup should not be refrigerated to avoid crystallization.

Disclaimer

This information is for educational purposes and does not replace professional medical advice. Always consult a healthcare provider for diagnosis, treatment decisions, and personalized dosage recommendations. Do not discontinue or modify therapy without medical supervision.

Reviews

“Ketotifen has significantly reduced my son’s nighttime asthma symptoms. It took about 4–6 weeks to see full effect, but the improvement has been sustained.” — Parent of pediatric patient
“As an allergist, I find ketotifen particularly useful in patients with multiple allergic triggers. Its mast cell stabilizing action provides a foundation for long-term control.” — Specialist Physician
“Effective for allergic conjunctivitis with minimal stinging compared to other eye drops. The twice-daily dosing is convenient.” — Adult user