Ketotifen tablets 1 mg, 30 pcs.

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Product Description


1 tablet contains:

active substance:

ketotifen hydrofumarate 1.38 mg

(corresponds to 1 mg of ketotifen)

auxiliary substances :


calcium hydrogen phosphate;

wheat starch;

magnesium stearate

pharmachologic effect

Ketotifen has a pronounced antihistamine, weak antiserotonin effect, without an anticholinergic effect. At higher doses, it has a slightly depressing effect on the central nervous system.


The mechanism of action of Ketotifen is associated with the ability to inhibit the release of histamine and other inflammatory mediators from mast cells due to membrane stabilization, as well as due to blockade of histamine H1 receptors. Ketotifen inhibits the enzyme phosphodiesterase, resulting in increased levels of cyclic adenosine monophosphate in mast cells.

The drug 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, bronchodilators, etc.


The drug is characterized by good and fast resorption, without the danger of accumulation in the body. Bioavailability is approximately 50%, which is associated with metabolism during the "first pass" through the liver.

The time to reach the maximum plasma concentration is 2-4 hours, and the binding to plasma proteins is 75%. Excretion from the body takes place in two phases, and within 48 hours the main part of the taken single dose is excreted in the urine. The therapeutic effect develops after 2 weeks of a course of taking the drug.


  • atopic bronchial asthma, allergic rhinitis,
  • allergic conjunctivitis, hay fever (hay fever)
  • Ketotifen Sopharma effectively prevents attacks of bronchial asthma, other manifestations of immediate allergic reactions


There are no absolute contraindications.

You should not take the drug during pregnancy, while taking oral antidiabetic drugs, which can lead to thrombocytopenia; with sedatives and alcohol.

Hypersensitivity to the components of the drug.

Side effects

In the first days, drowsiness, dry mouth, slight dizziness, fatigue, slowing down of mental reactions may appear, which usually disappear after a few days. A lower dose (5 ml per day) is recommended for the first week. Less commonly, there is an increase in appetite and a related increase in body weight.

Patients taking ketotifen should refrain from potentially hazardous activities associated with increased attention (for example, driving a car).

The drug can be used during lactation only if necessary, since it passes into breast milk.


The use of ketotifen in patients who have systematically taken corticosteroids requires a gradual decrease in previous corticosteroid therapy, since there is a risk of developing adrenal insufficiency.

The combination with oral antidiabetic agents sometimes leads to the development of thrombocytopenia.

The simultaneous intake of Ketotifen and sedatives, hypnotics, antihistamines and alcohol can lead to an increase in their effect.

How to take, course of administration and dosage

Inside, during meals.

Adults - 1 tablet (1 mg) 2 times a day (morning and evening). For patients who experience significant sedation, it is recommended to slowly increase the dose during the first week, starting with 0.5 mg in the evening before bedtime, until the therapeutic dose is gradually reached.

Children over 3 years old - 1 tablet (1 mg) 2 times a day (morning and evening).

Duration of treatment. The treatment is long-term, the therapeutic effect is achieved after several weeks of therapy. Treatment should be carried out for at least 2-3 months, especially in patients who did not experience an effect in the first weeks. Discontinue treatment with ketotifen gradually, within 2-4 weeks.


When the dose is increased, slight tremors of the extremities, restlessness and tachycardia may occur, which disappear after the dose is reduced.

Special instructions

Patients taking ketotifen should refrain from potentially hazardous activities associated with increased attention (for example, driving a car).

The drug can be used during lactation only if necessary, since it passes into breast milk.

Release form


Storage conditions

In a dark place, at a temperature not exceeding 25 ° C

Shelf life

4 years

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