Ketotifen Sopharma 1 mg, 2p x 30 tablets — Made in Ukraine — Free Delivery
(Ketotifen Sopharma)
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Description Ketotifen Sopharma 1 mg, 2p x 30 tablets — Made in Ukraine — Free Delivery
Pharmacological properties
Pharmacodynamics. Ketotifen belongs to the group of cycloheptathiophenones and has a pronounced antihistamine effect. It belongs to the group of non-bronchodilating anti-asthma preparations. the mechanism of its action is associated with inhibition of the release of histamine and other mediators from mast cells, blocking histamine H1-receptors and inhibition of the enzyme pde, as a result of which the level of cAMP in mast cells increases. suppresses the effects of platelet-activating factor. when used independently, it does not stop attacks of ba, but prevents their appearance and leads to a decrease in their duration and intensity, and in some cases they completely disappear.
Pharmacokinetics. Resorption: characterized by almost complete resorption in the gastrointestinal tract. Cmax in blood plasma is reached after 2–4 hours. The equilibrium state is achieved after taking a minimum daily dose of 2 mg.
Distribution: binds to blood plasma proteins by about 75%. The volume of distribution is 2.7 l / kg of body weight.
Metabolism: about 60% of the dose taken is metabolized in the liver in three ways: demethylation, N-oxidation, N-glucuroconjugation, to such metabolites: ketotifen-N-glucuronide (pharmacologically inactive), nor-ketotifen (with pharmacological activity similar to that of unchanged ketotifen) , Ketotifen N-oxide and 10-hydroxy ketotifen (pharmacological activity unknown).
Excretion: excreted biphasic, with a short T1 / 2 (3-5 hours) and longer - 21 hours. About 1% of the substance is excreted unchanged in the urine within 48 hours, and 60-70% - in the form of metabolites.
Indications
Preventive treatment of ba, mainly of atopic form.
For the symptomatic treatment of allergic conditions, including allergic rhinitis and conjunctivitis.
Application
The tablets are taken orally during meals with water.
Adults: 1 tablet (1 mg) 2 times a day in the morning and in the evening with meals. For patients who have a pronounced sedative effect, it is recommended to slowly increase the dose over the 1st week, starting from 0.5 mg 2 times a day until the therapeutic dose is gradually reached. If necessary, the daily dose can be increased to 4 mg (4 tablets) 2 times a day. When using the preparation at a higher dose, a more rapid onset of the therapeutic effect can be expected.
Children over the age of 3 years: 1 tablet (1 mg) 2 times a day in the morning and in the evening with meals.
Duration of treatment. The treatment is long-term, and the therapeutic effect is achieved after several weeks of therapy. Treatment should last at least 2-3 months, especially in patients who did not experience an improvement in their well-being in the first weeks of therapy. Concomitant bronchodilator therapy: Concomitant use of ketotifen with bronchodilators may reduce the frequency of bronchodilator use.
Termination of therapy. Discontinue treatment with ketotifen gradually, over 2-4 weeks, in order to avoid the risk of recurrence of asthmatic symptoms.
Elderly patients.
There are no special requirements for the elderly.
Contraindications
Hypersensitivity to the active or auxiliary substances of the preparation.
Breastfeeding period.
Side effects
Infections and invasions
Uncommon - cystitis.
From the immune system
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.
Tags: Ketotifen
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