Ketotifen tablets 1mg, No. 30
Expiration Date: 05/2027
Russian Pharmacy name:
Кетотифен таблетки 1мг, №30
Adults. Ketotifen is prescribed 1 tablet (1 mg) 2 times a day (with morning and evening meals) or 5 ml of syrup twice a day with meals. If the patient is prone to the development of a sedative effect, it is recommended to slowly increase the dose during the first week of treatment - the initial dose is 1/2 tablet 2 times a day, followed by its increase to the full therapeutic dose. If necessary, it is possible to increase the daily dose to 4 mg, that is, 2 tablets 2 times a day or 20 ml of syrup in two steps. When using a higher dose, a more rapid onset of the effect can be expected. When prescribing Ketotifen to patients with bronchial asthma, it should be borne in mind that it may take several weeks to achieve the full therapeutic effect.In the absence of an adequate effect from the use of Ketotifen after several weeks of treatment, it is recommended to continue taking the drug for at least 2-3 months.
1 tab. contains ketotifen fumarate 1 mg.
Hypersensitivity to ketotifen or any other component of the drug. Children under 3 years old. You should not take the drug during pregnancy, while taking oral antidiabetic drugs, which can lead to thrombocytopenia; with sedatives and alcohol.
pharmachologic effect
Ketotifen has antiallergic and anti-inflammatory effect, in the implementation of which the following mechanisms play a role:
stabilization of mast cell membranes and suppression of the release of mediators of allergy and inflammation from them, such as histamine, platelet activating factor, etc. (inhibits the enzyme phosphodiesterase, resulting in an increase in the level of cyclic adenosine monophosphate in mast cells);
suppression of the primary effect of the antigen on eosinophils and, therefore, suppression of the accumulation of eosinophils in the areas of inflammation in the airways;
suppression of the development of airway hyperresponsiveness associated with platelet activation under the influence of PAF (platelet activating factor), or caused by contact with an allergen.
Ketotifen blocks histamine H1 receptors, so it can also be used in place of the classic histamine H1 blockers. Ketotifen reduces or suppresses the reactions of the skin and bronchi caused by the antigen, which leads to its use for prophylactic purposes. When used as monotherapy, it does not relieve asthma attacks, but leads to a decrease in the number, duration and intensity of these attacks, and in some cases they completely disappear. Reduces eosinophilia, reduces the need and frequency of use of anti-asthma drugs: corticosteroids (beclomethasone, fluticasone, budesonide), bronchodilators (ventolin, berotek, salmeterol), etc. The preventive effect of Ketotifen develops after 2Ц4 weeks of its constant use.
Indications
Bronchial asthma (all forms). Pollinosis and its asthmatic complications. Urticaria (acute and chronic). Atopic dermatitis. Allergic rhinitis. Allergic conjunctivitis. Ketotifen is used for long-term treatment of the above-mentioned diseases, including for the prevention of exacerbations.
Contraindications
Hypersensitivity to ketotifen or any other component of the drug. Children under 3 years old. You should not take the drug during pregnancy, while taking oral antidiabetic drugs, which can lead to thrombocytopenia; with sedatives and alcohol.
Application during pregnancy and lactation
Although in experiments on animals, no effect on pregnancy and peri- and postnatal development was noted when using Ketotifen in doses that were tolerated by animals, its safety during pregnancy in humans has not been established. Therefore, during pregnancy, Ketotifen can be prescribed only in cases of extreme necessity. It is believed that ketotifen is also excreted in human breast milk, so mothers taking ketotifen should not breastfeed.
special instructions
With a pronounced sedative effect, in the first two weeks, 0.5 mg is prescribed 2 times a day. Ketotifen is not intended to relieve an attack of bronchial asthma. At the beginning of long-term treatment with Ketotifen, anti-asthmatic symptomatic and prophylactic agents used by the patient should not be immediately canceled: previous therapy with beta-adrenergic agonists, glucocorticoids, ACTH. Treatment with Ketotifen is stopped gradually, within 2-4 weeks (relapse of asthmatic symptoms is possible). This is especially true for systemic glucocorticoids (prednisolone, polcortolone, dexamethasone) due to the possible presence of adrenal insufficiency in steroid-dependent patients, since it may take up to 1 year to restore the function of the pituitary-adrenal system and its normal response to stress. In patientstaking ketotifen and oral antidiabetic drugs, the number of platelets in the peripheral blood should be monitored. Given that Ketotifen can cause a decrease in the seizure threshold, caution should be exercised when prescribing it to patients with a history of epilepsy.
Composition
1 tab. contains ketotifen fumarate 1 mg.
Method of administration and dosage
Adults. Ketotifen is prescribed 1 tablet (1 mg) 2 times a day (with morning and evening meals) or 5 ml of syrup twice a day with meals. If the patient is prone to the development of a sedative effect, it is recommended to slowly increase the dose during the first week of treatment - the initial dose is 1/2 tablet 2 times a day, followed by its increase to the full therapeutic dose. If necessary, it is possible to increase the daily dose to 4 mg, that is, 2 tablets 2 times a day or 20 ml of syrup in two steps. When using a higher dose, a more rapid onset of the effect can be expected. When prescribing Ketotifen to patients with bronchial asthma, it should be borne in mind that it may take several weeks to achieve the full therapeutic effect.In the absence of an adequate effect from the use of Ketotifen after several weeks of treatment, it is recommended to continue taking the drug for at least 2-3 months.
Side effects
At the beginning of treatment, a sedative effect is possible, less often - dry mouth and light dizziness, but, as a rule, these phenomena disappear on their own with continued treatment. Sometimes, especially in children, symptoms of irritation of the central nervous system were noted, such as agitation, increased irritability, insomnia, and increased excitability. There are very rare reports of seizures during treatment with Ketotifen. Weight gain has been reported (may increase appetite). There are rare reports of cystitis noted with the use of Ketotifen. In very rare cases, an increase in the activity of liver enzymes and the development of hepatitis are possible. There are reports of isolated cases of severe skin reactions (erythema multiforme, Stevens-Johnson syndrome); the approximate frequency of occurrence is 1 case per 2 million patients who received Ketotifen.
Drug interactions
Ketotifen can enhance the effects of drugs that have a depressing effect on the central nervous system - sedatives, hypnotics, as well as antihistamines (suprastin, tavegil) and alcohol. There have been rare cases of a reversible decrease in the number of platelets with the simultaneous use of Ketotifen and oral antidiabetic drugs. Against the background of the use of Ketotifen, the patient's need for sympathomimetics and anti-inflammatory drugs (GCS, sodium cromoglycate, sodium nedocromil) may decrease.
Overdose
The main symptoms of acute overdose: drowsiness, up to depression of consciousness; confusion and disorientation; tachycardia and arterial hypotension; especially in children - hyperexcitability, convulsions; reversible coma. Treatment is symptomatic. If the drug has been taken recently, gastric lavage is indicated. The appointment of activated carbon may be beneficial. If necessary, symptomatic treatment and monitoring of the functional parameters of the cardiovascular system are carried out. In the case of seizures, the appointment of anticonvulsants (in particular, benzodiazepine derivatives) is indicated. Dialysis is ineffective.