Ketotifen - mast cell membrane stabilizer; antiallergic agent.
Release form and composition
- Tablets - 10 pcs. in blisters, in a carton pack of 1, 2, 3, 4, or 5 packs;
- Syrup for oral administration - 100 ml vials of dark glass, in a cardboard box 1 bottle complete with a measuring cup.
The active ingredient of the drug is ketotifen (in the form of fumarate): in 1 tablet and 5 ml of syrup - 1 mg.
Indications for use
Ketotifen is intended for long-term treatment and prevention of exacerbations of the following diseases:
- Allergic bronchitis;
- Atopic bronchial asthma;
- Allergic dermatitis;
- Allergic conjunctivitis;
- Allergic rhinitis;
- Acute and chronic urticaria;
- Hay fever (pollinosis) and its asthmatic complications.
- Children under 3 years old - for tablets, up to 6 months - for syrup;
- Lactation (or breastfeeding should be stopped);
- Taking sedatives;
- Hypersensitivity to the drug.
Patients with hepatic insufficiency and epilepsy should be under special observation during the treatment period.
Although in animal studies, no effect of Ketotifen on pregnancy, peri-and postnatal development was noted, the safety of its use in humans has not been established. For this reason, pregnant women, especially in the first trimester, are prescribed the drug only in cases of emergency, after careful assessment of the ratio of the expected benefits to the mother and the potential risks to the fetus.
Dosing and Administration
The drug should be taken orally during meals.
Adults are prescribed 1 mg of ketotifen — 1 tablet or 5 ml of syrup — 2 times a day (during breakfast and dinner). If necessary, increase the daily dose to 4 mg (2 tab. Or 10 ml of syrup twice a day). Patients who are prone to developing a sedative effect should start taking the drug with a dose of 0.5 mg (1/2 tablet or 2.5 ml of syrup) 2 times a day, gradually increasing it to the recommended therapeutic dose.
Children over 3 years old are prescribed 1 tablet or 5 ml of syrup twice a day.
Children 1-3 years of age give Ketotifen only in the form of syrup. A single dose of 0.25 ml (0.05 mg) per kilogram of body weight, the number of doses - 2 times a day.
The minimum duration of treatment is 3 months. The abolition of the drug is carried out gradually - reducing the dose within 2-4 weeks.
- Nervous system: dizziness, drowsiness, slowing down of the reaction rate (as a rule, these symptoms disappear after a few days of treatment), feeling of fatigue, sedation; rarely - sleep disturbance, anxiety, nervousness (especially in children);
- Digestive system: increased appetite, dry mouth, nausea, vomiting, constipation, gastralgia;
- Urinary system: cystitis, dysuria;
- Other: weight gain, thrombocytopenia, skin allergic reactions.
Symptoms of acute overdose: disorientation, confusion, drowsiness, up to depression of consciousness, arterial hypotension, tachycardia, more often in children - anxiety and convulsions. Possible coma.
If it has not been long since taking a high dose of the drug, you should do a gastric lavage and take activated carbon. Further treatment is symptomatic, under the control of the functional parameters of the cardiovascular system. With the development of convulsive syndrome, anticonvulsants are prescribed - benzodiazepines or barbiturates. Dialysis is ineffective.
When prescribing ketotifen to patients with bronchial asthma, it should be borne in mind that it may take several weeks to reach the full therapeutic effect. If an adequate response to the therapy is given after this time has not yet appeared, it is not necessary to interrupt the treatment, it is recommended to continue taking the drug for another 2-3 months.
Anti-asthma therapy should be continued for at least 2 weeks after starting ketotifen.
In the case of previous treatment with glucocorticosteroids, beta-adrenostimulants or adrenocorticotropic hormone in patients with bronchial asthma and bronchospastic syndrome after starting ketotifen, they should be discontinued within 2 weeks - gradually reducing the dose. A recurrence of asthmatic symptoms is possible within 2–4 weeks.
The drug is not intended for the relief of asthma attacks.
Ketotifen can reduce the dose taken at the same time bronchodilators.
According to pharmacokinetic data and clinical observations, children may need higher doses for optimal results than adults. Tolerability of the drug in this case does not deteriorate.
During the period of treatment, one should refrain from the use of alcoholic beverages, occupations with potentially dangerous types of activities for which performance requires a reaction speed and / or increased concentration of attention (including driving a car).
Ketotifen enhances the action of ethanol, sleeping pills, sedatives and antihistamines.
In combination with oral hypoglycemic agents, there is a risk of thrombocytopenia, therefore during the treatment period the number of platelets in the blood should be controlled.
Ketotifen can reduce the need of patients for sympathomimetics and anti-inflammatory drugs (glucocorticosteroids, sodium cromoglycate, nedocromil sodium).
Terms and conditions of storage
Store in a dry place (tablets), dark and out of reach of children at temperature: tablets - up to 25 ºС, syrup - 5-15 ºС.
Shelf life - 3 years.