Ketotifen has a membrane stabilizing, antiallergic, antihistamine effect. The mechanism of action of ketotifen is due to the suppression of the release of biologically active substances by mast cells and basophilic granulocytes (histamine, leukotrienes, etc.), suppression of sensitization of eosinophilic granulocytes by cytokines, blocking their migration to the foci of inflammation. the preparation inhibits the development of airway hyperresponsiveness due to platelet activation under the influence of platelet activating factor (FAT) or allergens. the preparation inhibits phosphodiesterase, increases the level of camp in cells. ketotifen induces a noncompetitive blockade of histamine H1 receptors. effectively prevents bronchospasm, reduces the need for the use of corticosteroids, bronchodilators. has no bronchodilator effect. the therapeutic effect after taking the preparation develops slowly, within 1–2 months.
When taken orally, ketotifen is almost completely absorbed. The main metabolite of ketotifen, N-gluronide, is practically non-toxic. The maximum concentration in blood plasma is reached after 2–4 hours. Protein binding is about 75%. The elimination of ketotifen from the body is biphasic: the first half-life is 3-5 hours, the second is 21 hours. Approximately 60-70% of the preparation is excreted by the kidneys and 30-20% - by the liver in the form of metabolites, 10% of the preparation is excreted unchanged. Within 48 hours, the main part of the taken single dose of the preparation is excreted in the urine. The metabolic pattern in children is the same as in adults, but the clearance is higher. Therefore, children over 3 years old require the same daily dose as adults.
Prevention of BA attacks, allergic bronchitis, asthmatic complications in hay fever, allergic dermatoses, allergic rhinitis and conjunctivitis, urticaria.
Assign to adults and children over 14 years of age 1-2 mg of ketotifen (5-10 ml of syrup) 2 times a day. for children aged 6 months to 3 years, the preparation is prescribed 2 times a day at 0.0125 mg of ketotifen per 1 kg of body weight. for children over 3 years old, the preparation is prescribed 2 times a day at 0.025 mg of ketotifen per 1 kg of body weight. the required dose is measured using a dosing device with a graduation of 0.1 ml.
Hypersensitivity to the components of the preparation, the period of pregnancy and lactation, age up to 6 months.
Drowsiness, a feeling of dry mouth, slight dizziness, slowing down of mental reactions, usually disappearing after several days of administration, are possible. sometimes dyspeptic disorders, thrombocytopenia, dysuria, cystitis are noted. in rare cases - an increase in body weight due to increased appetite.
Patients taking ketotifen should refrain from potentially hazardous activities that require increased attention. at the beginning of treatment with ketotifen, anti-asthma preparations should not be abruptly canceled, especially corticosteroids for systemic use, due to the possible development of adrenal insufficiency.
Alcohol intake should be avoided while using the preparation.
When taken simultaneously, it enhances the effect of sleeping pills, antihistamines, alcohol. when taking ketotifen, the need for corticosteroids and bronchodilators in patients with BA may decrease. in combination with antidiabetic preparations increases the likelihood of thrombocytopenia.
It is characterized by drowsiness, confusion, disorientation, tachycardia, arterial hypotension, increased excitability, convulsions (especially in children), coma. in case of an overdose, the appointment of emetics, gastric lavage, the appointment of activated carbon, saline laxatives are recommended; if necessary, symptomatic treatment is carried out, the state of the cardiovascular system is monitored, short-acting barbiturates or benzodiazepines are prescribed when agitated or convulsions.
In a dry, dark place at a temperature of 15-25 ° C. shelf life - 3 years.
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