Generic

ketotifen Fumarate

Indications

Prophylactic management or treatment of bronchial asthma and symptomatic treatment of allergic conditions including rhinitis and conjunctivitis.

Pharmacology

Ketifen is approved as an add-on drug in the chronic treatment of mild atopic asthma in children when administered orally. 7 It is also available as an over-the-counter ophthalmic solution for the brief relief of eye irritation caused by allergic conjunctivitis.

Dosage & Administration

Adult: 1mg (1 tablet or 1 teaspoonful) of ketotifen twice daily with food. In severe cases, the dose may be doubled. 0.5 mg to 1 mg at night may be preferable for the first few days of treatment if drowsiness is likely to be a problem.
Children (6 months t 3 years): 0.05 mg (0.25ml Syrup) per kg body weight given twice daily. Use in elderly: Same as adult dose or as advised by the physician.

Interaction

Sedatives, hypnotics, antihistamines, and alcohol may be enhanced by ketotifen. A reversible decrease in platelet count has been observed in a few patients receiving Tifen concurrently with oral antidiabetic agents, leading to the suggestion that this combination is avoided.

Contraindications

A reversible fall in the platelet count has been observed in a few patients receiving ketotifen concomitantly with oral antidiabetic agents and it has been suggested that this combination should therefore be avoided. Although there is no evidence of any teratogenic effect, recommendations for ketotifen in pregnancy or when breastfeeding can not be given.

Side Effects

Sedation, drowsiness associated with occasional dry mouth, and slight dizziness may occur at the beginning of treatment but usually disappears with continuous use. CNS stimulation and weight gain were also reported.

Pregnancy & Lactation

Despite the lack of evidence of teratogenicity, Ketotifen should not be used during pregnancy or breastfeeding.

Precautions & Warnings

Treatment with existing antiasthmatic treatment should be continued for at least 2 weeks after initiation of ketotifen treatment due to the risk of exacerbation of asthma. For the same reason, ketotifen should be discontinued gradually over a period of 2-4 weeks. Drowsiness may occur, particularly during the first days of treatment. Patients should be warned not to drive or operate machinery until the effect of treatment on the individual is known. Ketotifen may also potentiate the effect of sedatives, hypnotics, antihistamines, and alcohol. For this reason, patients should be advised to avoid alcoholic drinks.

Therapeutic Class

Cromoglycate and related medications

Storage Conditions

Keep cool and dry, and keep away from direct sunlight. Keep out of children’s reach.

Pharmaceutical Name

Ibn Sina Pharmaceuticals Ltd.