Ketotifen tablets 1 mg 30 pcs. (Ketotifen)

Release form

Tablets.

Packing

30 pcs.

Pharmacological action of

Ketotifen has an anti-allergic 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, and others (inhibits enzyme enzyme phosphodies resulting in increased levels of cyclic adenosine monophosphate in mast cells)

suppression of the primary effect of antigen on eosinophils and, therefore, suppressing the accumulation of eosinophils in areas of inflammation in the airways

suppressing the development of airway hyperreactivity associated with platelet activation under the influence of PAT (platelet activating factor), or caused by contact with an allergen.

Ketotifen blocks histamine H1 receptors, so it can also be used instead of the classic histamine H1 receptor blockers.

Ketotifen reduces or suppresses the reaction of the skin and bronchi caused by the antigen, which leads to its use for prophylactic purposes. When used as monotherapy does not stop 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 prophylactic effect of Ketotifen develops after 2–4 weeks of continuous 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 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.

Use in pregnancy and lactation

Although no effects on pregnancy and peri- and postnatal development have been observed in animal studies in the use of ketotifen in doses tolerated by animals, its safety during pregnancy in humans has not been established. Therefore, during pregnancy, Ketotifen can be prescribed only in cases of emergency.

It is believed that ketotifen is also excreted in human breast milk, so mothers taking Ketotifen should not breast-feed.

Special instructions

With pronounced sedative effect, 0.5 mg 2 times a day is prescribed in the first two weeks.

Ketotifen is not intended to relieve an attack of bronchial asthma. At the beginning of long-term treatment with ketotifen, the anti-asthmatic symptomatic and prophylactic drugs used by patients should not be immediately abolished: previous therapy with beta-adrenergic agonists, glucocorticoids, ACTH. Treatment with Ketotifen is stopped gradually, within 2-4 weeks (a relapse of asthmatic symptoms is possible). This is especially true for systemic glucocorticoids (prednisone, 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 patients taking ketotifen and oral antidiabetic drugs, platelet count in the peripheral blood should be monitored.

Considering that Ketotifen may cause a decrease in the threshold of convulsive readiness, caution should be exercised when prescribing it to patients with a history of epilepsy.

Composition

1 tab. contains ketotifen fumarate 1 mg.

Dosage and Administration

Adults.

Ketotifen is prescribed 1 tablet (1 mg) 2 times a day (with morning and evening meals) or twice a day, 5 ml of syrup with meals.

If the patient is prone to develop a sedative effect, Slow dose increase is recommended during the first week of treatment - the initial dose is 1/2 tablet 2 times a day, followed by its increase to a full therapeutic. 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 divided doses. When using an increased dose, a faster onset of 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 another 2-3 months.

Side effects

At the beginning of treatment, sedation is possible, less often - dry mouth and slight dizziness, but, as a rule, these phenomena disappear on their own with continued treatment. Sometimes, especially in children, symptoms of CNS irritation were noted, such as agitation, increased irritability, insomnia, and irritability. There are very rare reports of seizures during treatment with ketotifen. There are reports of weight gain (may increase appetite).

There are rare reports of cystitis observed with Ketotifen. In very rare cases, an increase in the activity of liver enzymes and the development of hepatitis are possible. There are reports of individual cases of severe skin reactions (erythema multiforme, Stevens-Johnson syndrome), the approximate frequency of occurrence - 1 case in 2 million patients receiving Ketotifen.

Drug interactions

Ketotifen may 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.

Rare cases of a reversible decrease in platelet count with the simultaneous use of Ketotifen and oral antidiabetic drugs have been noted.

Against the background of the use of Ketotifen, the patient's need for sympathomimetics and anti-inflammatory drugs (GCS, cromolyn sodium, nedocromil sodium) may decrease.

Overdose

The main symptoms of an acute overdose: drowsiness, down to depression of consciousness confusion and disorientation of tachycardia and arterial hypotension especially in children - increased excitability, convulsions reversible coma.

Treatment is symptomatic. If taken recently, gastric lavage is indicated. Activated charcoal may be useful. If necessary, symptomatic treatment and monitoring of the functional parameters of the cardiovascular system is performed. In the case of seizures, the use of anticonvulsants (in particular, benzodiazepine derivatives) is indicated. Dialysis is ineffective.

Storage conditions

Store at a temperature not exceeding 25 C.

active substance

ketotifen

Terms leave through pharmacies

In retseptu

lekarstvennaja form

tablets

Indications

Indications

bronchial asthma, dermatitis, allergic conjunctivitis, allergic rhinitis, urticaria, allergy, hay fever



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