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Anti-allergic & Antihistaminic drugs
Код АТХ: D04AA 0; R06AX 17
One tablet contains 1.38 mg ketotifen hydrogen fumarate, equivalent to 1 mg ketotifen. 5 ml syrup contains 138 mg ketotifen hydrogen fumarate, equivalent to 1 mg ketotifen. 1 g gel contains 10 mg ketotifen hydrogen fumarate.
For prophylactic of all forms of bronchial asthma, allergic bronchitis and asthmatic symptoms in hay fever. Prophylactic and treatment of other allergic diseases: acute and chronic urticaria, atopic dermatitis, allergic rhinitis and conjunctivitis.
Dosage and administration:
Tablets: adults – 1 tablet twice daily during meals. In insufficient therapeutic effect after a treatment course of 4 weeks, the dose can be increased to 2 tablets twice daily. Children up to 35 kg body mass - Ѕ tablet twice daily during meals, above 35 kg - 1 tablet twice daily. The therapy duration is prescribed by the doctor. Syrup: adults – 5 ml syrup peroral by a measuring cup twice daily, usually in the morning and evening during meals. In insufficient therapeutic effect after a treatment course of 4 weeks, the dose can be increased to 10 ml syrup twice daily.
Children above 3 years – 0.125 ml syrup per kg body mass twice daily; 12-18 kg – 2 ml; 19-25 kg – 3 ml; 26-35 kg – 4 ml; above 35 kg – 5 ml. Normally, well manifested therapeutic effect is reached after 10-weeks period of treatment. Gel: it is applied locally, 2-3 times daily on the affected area. When allergen is known and there will be a contact with it, gel may be applied prophylactically.
Hypersensitivity to the product; pregnancy, lactation. Ketotifen gel is applied in impetigo and exudative eczema. To be applied with caution to motor vehicle drivers.
Concomitant treatment with oral antidiabetics enhances a risk of reversible thrombocytopenia. It is possible to potentiate the effect of sedatives, hypnotics, antihistamines and alcohol (tablets and syrup). Ketotifen gel can be applied alone or in a combination with peroral forms of the product – tablets and syrup.
In the beginning of the treatment may appear xerostomia, drowsiness, light vertigo, fatigue, which disappear spontaneously within several days. Sometimes body mass gain is noticed due to increased appetite. Rarely: abdominal pains, nausea or vomiting; excitation, irritation, insomnia and anxiety, especially in children; cystitis, dark urine; elevation of hepatic enzymes; skin reactions - itching, erythema and skin desquamation, rashes; muscular spasms of extremities. Rarely hypersensitivity to the active substance and photosensibilization effect.
30 tablets (1 mg)
Vial of 100 or 125 ml syrup
Tube of 40 g gel (1%)
On doctor’s prescription.