Prevention of bronchial asthma. Symptomatic treatment of allergic diseases: allergic rhinitis and allergic conjunctivitis.
Composition:
1 tabl or 5 ml of syrup contains 1 mg of Ketotifen in the form of hydrogen fumarate.
Action:
Antihistamine for general use, non-competitive blocker of H-receptors1, has anti-asthmatic and antiallergic effects. The drug does not expand the bronchi. After oral administration, almost completely absorbed from the gastrointestinal tract. 50% of the dose undergoes first pass, resulting in bioavailability of 50%. The maximum concentration in the blood occurs within 2-4 h. Food does not affect the bioavailability. With proteins, it is 75% bound. The main metabolite is practically inactive ketotifen N-glucuronate. Metabolism in children is the same as in adults, but the renal clearance is higher in children, therefore, in children> 3 years, it may be necessary to use the same daily doses as in adults. The drug elimination process is two-phase, with short T0,5 in the first phase of 3-5 h and the longer phase II - 21 h. The drug is excreted in the urine, 60-70% of the dose in the form of metabolites.
Contraindications:
Hypersensitivity to the components of the preparation.
Precautions:
The preparation is not effective in the treatment of acute allergic reactions and in interrupting dyspnoea attacks in the course of asthma. Caution in patients with a history of epilepsy, because cathotifen may lower the seizure threshold. In the first weeks of using the drug, the current anti-asthmatics should not be rapidly discontinued (especially corticosteroids due to the risk of adrenal insufficiency) and discontinued gradually over a longer period of time. The concomitant use of ketotifen and oral antidiabetic agents (thrombocytopenic risk) should be avoided, if such therapy should be required, the number of platelets should be monitored. The preparation in the form of a syrup contains esters of parahydroxybenzoic acid (preservatives), which can cause allergic reactions (also of the late type). The syrup contains sucrose and sorbitol - it should not be used in patients with rare inherited disorders associated with fructose intolerance, glucose-galactose malabsorption or sucrase-isomaltase deficiency.
Pregnancy and lactation:
The drug can be used during pregnancy only if absolutely necessary. Do not use during breast-feeding.
Side effects:
Common: psychomotor agitation, irritability, insomnia, nervousness (these symptoms were observed especially in children). Uncommon: dry mouth, dizziness, cystitis. Rare: calming, weight gain. Very rare: seizures, hepatitis, increased liver enzymes, erythema multiforme, Stevens-Johnson syndrome, severe skin reactions.
Dosage:
Orally.Adults: 1 tabl. or 5 ml of syrup twice a day. In patients susceptible to sedative effects of Ketotifen, it is recommended to slowly increase the dose for the first week of treatment, starting from 1/2 tabl. or 2.5 ml of syrup, followed by increasing the dose until the therapeutic dose is reached. If necessary, the dose can be increased to 2 tables. or 10 ml of syrup twice daily (4 mg ketotifen per day).Children over 3 years: 1 tabl. or 5 ml of syrup twice a day. It is recommended to use a syrup.Children from 6 months to 3 years (only syrup): 0.05 mg of ketotifen (0.25 ml of syrup) per kg body weight. 2 times a day. The preparation is taken every 12 hours, in the morning and in the evening, with meals. In the prevention of asthma, full therapeutic effect can be achieved after several weeks of therapy. If after a few weeks there is no desired response to the drug, it is recommended to continue treatment for a minimum of 2-3 months.
(C)
