Preventive treatment of ba, mainly of atopic form.
For the symptomatic treatment of allergic conditions, including allergic rhinitis and conjunctivitis.
The tablets are taken orally during meals with water.
Termination of therapy. Discontinue treatment with ketotifen gradually, over 2-4 weeks, in order to avoid the risk of recurrence of asthmatic symptoms.
There are no special requirements for the elderly.
Hypersensitivity to the active or auxiliary substances of the preparation.
Breastfeeding period.
Uncommon - cystitis.
Very rarely - severe skin reactions, erythema multiforme, Stevens-Johnson syndrome.
Metabolic and nutritional disorders.
Rarely - an increase in body weight due to increased appetite.
Mental disorders
Often - psychomotor agitation, irritability, insomnia, anxiety, nervousness.
From the side of the central nervous system
Infrequently - dizziness, rarely - sedation, very rarely - convulsions.
From the gastrointestinal tract
Uncommon - dry mouth.
Hepatobiliary Disorders
Very rarely - an increase in the level of liver enzymes, hepatitis.
Dry mouth and dizziness may appear early on in treatment, but these usually resolve spontaneously with therapy. In rare cases, symptoms of CNS stimulation such as agitation, irritability, insomnia, and anxiety are observed, especially in children.
Special instructions
The preparation is ineffective in the treatment of acute allergic reactions and asthma attacks with BA.
The maximum therapeutic effect of the preparation occurs after several weeks of systematic administration.
Normalization of the function of the pituitary-adrenal system can last up to 1 year. Therefore, in the first weeks of using ketotifen, it is recommended to continue the previous treatment and to cancel it gradually for a long time.
At the beginning of long-term therapy with ketotifen, treatment with other anti-asthma preparations, especially corticosteroids, should not be abruptly stopped. In patients with steroid dependence, adrenocortical insufficiency may develop.
In the case of intercurrent infection, specific antibiotic therapy is necessary.
During the use of the preparation, medical supervision is required, given the possibility of seizures.
Ketotifen should be used with caution in patients with a history of epilepsy due to the possibility of lowering the seizure threshold during preparation treatment.
During therapy with ketotifen, alcohol should not be consumed, because it enhances the depressive effect of ketotifen on the central nervous system.
You should stop taking the preparation 10-14 days before performing skin tests for allergies.
If it is necessary to discontinue treatment with ketotifen, the dose is gradually reduced over 2–4 weeks to avoid recurrence of AD symptoms.
Caution should be exercised when using ketotifen in patients with impaired liver function. Considering that concomitant use with oral hypoglycemic preparations can cause thrombocytopenia, this combination should be avoided or platelet counts should be closely monitored if such treatment is recommended.
Wheat starch in the tablet contains only traces of gluten and is considered safe for celiac patients.
Application during pregnancy or lactation. During animal studies, no embryotoxic and teratogenic effects of ketotifen were established. No controlled clinical trials involving pregnant women have been conducted. During pregnancy, ketotifen should be prescribed only after a strict assessment of the availability of direct indications, in cases where the expected benefit from treatment outweighs the potential risk to the fetus.
Ketotifen passes into breast milk. Therefore, during the period of treatment, breastfeeding should be stopped.
Children. Clinical observations support the pharmacokinetic features and indicate that children may need a higher dose (in mg / kg) than adults for optimal results. Higher doses are just as well tolerated as lower doses.
The ability to influence the reaction rate when driving or operating other mechanisms. At the beginning of treatment, the preparation Ketotifen Sopharma can slow down the rate of reactions, which requires increased caution from the patient while driving and working with automated mechanisms.
Interactions
With the simultaneous use of ketotifen and oral antidiabetic agents, there is a risk of reversible thrombocytopenia. in patients, the number of platelets should be monitored.
With the combined use of atropine, agents with atropine-like action and ketotifen, the risk of adverse reactions, such as urinary retention, constipation, and dry mouth, increases.
Ketotifen can potentiate the effects of other preparations (sedatives, hypnotics) that depress the central nervous system.
The simultaneous use of ketotifen with other antihistamines can lead to the mutual potentiation of their effects.
Overdose
Symptoms: possible significant disturbances in the psychomotor reaction, drowsiness before severe sedation, headache, disorientation, tachycardia, decreased blood pressure, coma (especially in children), symptoms of excitation of the central nervous system, including convulsions.
Bradycardia, arrhythmia, depression of the respiratory center, nystagmus are also noted.
In the event of the above symptoms, the patient should be carefully examined.
Treatment: general measures to remove the unresorbed amount of the preparation from the gastrointestinal tract: rinse the stomach, artificially induce vomiting. Taking activated charcoal can have positive effects. If necessary, symptomatic treatment and monitoring of the cardiovascular and respiratory systems are recommended. In states of arousal, short-acting barbiturates or benzodiazepines can be used.
Storage conditions
In a dry, dark place at a temperature not exceeding 25 ° C.