Ketotifenum

General characteristics. Structure:

Active ingredient: 1,3 mg of Ketotifenum of a fumarat that corresponds to 1 mg of Ketotifenum.

Excipients: potato starch, lactoses monohydrate (sugar milk), magnesium stearate.

Antiallergic and antiasthmatic means. At penetration into an organism of the causative agent of an allergy, Ketotifenum reduces or completely prevents response negative reaction of bodies and systems, without allowing a rupture of mast cells under the influence of allergen.

Therefore, prevents emergence of attacks of bronchial asthma, leads to reduction of their number, duration and intensity, prevents progressing of allergic pathologies.

Warning a spasm of bronchial tubes, medicine does not cause relaxation of their smooth muscles and does not expand bronchial tubes. Reduces quantity of eosinophilic granulocytes in blood, characteristic of allergic diseases.

Pharmacological properties:

Pharmacodynamics. The stabilizer of membranes of mast cells, has the activity moderated H1-gistaminoblokiruyushchey, inhibits allocation of a histamine, leukotrienes from basophiles and neutrophils, reduces accumulation of eosinophils in respiratory tracts and reaction to a histamine, suppresses early and late asthmatic reactions to allergen. Prevents development of a bronchospasm, does not render bronkhodilatiruyushchy effect. Inhibits phosphodiesterase therefore the maintenance of tsAMF in cells of fatty tissue increases.

Therapeutic action is fully shown in 1,5-2 months from the beginning of therapy.

Pharmacokinetics. Absorbability - almost full, bioavailability - about 50% (because of existence of effect of "the first passing" through a liver). Time of achievement of the maximum concentration (Tcmax) - 2-4 h, communication with proteins of plasma - 75%. Passes through a blood-brain barrier. Gets into breast milk.

It is metabolized in a liver. It is removed by kidneys in the form of metabolites (the main metabolite - Ketotifenum a N-glucuronide pharmacological is inactive). During 48 h kidneys remove the main part of the accepted dose (1% - in not changed look and 60-70% - in the form of metabolites). Removal - two-phase: an elimination half-life of the first phase - 3-5 h, the second - 21 h.

The pharmacokinetics at children is more senior than 3 years does not differ from adults.

Indications to use:

Atopic bronchial asthma, pollinosis (hay fever), allergic rhinitis, allergic conjunctivitis, atopic dermatitis, small tortoiseshell.

Route of administration and doses:

Inside, during food, the adult - on 1 mg 2 times a day in the morning and in the evening. If necessary the dose is increased to 2 mg by 2 times a day. To children of 3 years is also more senior - 1 mg 2 times a day.

Treatment duration - not less than 3 months. Cancellation of therapy is carried out gradually, within 2-4 weeks.

Features of use:

During treatment it is necessary to abstain from driving of motor transport and occupations potentially dangerous types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Sharp cancellation of the previous treatment beta адреностимуляторами, glucocorticosteroids, adrenocorticotropic hormone (AKTG) at patients with bronchial asthma and a bronkhospastichesky syndrome after accession to therapy of Ketotifenum is undesirable, cancellation is carried out within at least 2 weeks, gradually reducing doses. Treatment is stopped gradually, within 2-4 weeks (the recurrence of asthmatic symptoms is possible).

To the persons sensitive to sedative action, in the first 2 weeks drug is appointed small doses.

It is not intended for stopping of an attack of bronchial asthma.

At the patients who are at the same time receiving peroral hypoglycemic means it is necessary to control number of thrombocytes in peripheral blood.

Side effects:

From a nervous system: drowsiness, dizziness, delay of speed of response (disappear in several days of therapy), sedation, feeling of fatigue; seldom - concern, sleep disorders, nervousness (especially at children).

From the alimentary system: dryness in a mouth, increase in appetite, nausea, vomiting, a gastralgia, a lock.

From urination: dysuria, cystitis.

Others: thrombocytopenia, increase in body weight, allergic skin reactions.

Interaction with other medicines:

Strengthens effect of somnolent, antihistaminic drugs, ethanol.

In combination with hypoglycemic drugs the probability of development of thrombocytopenia increases.

Contraindications:

Hypersensitivity, pregnancy, the lactation period, children's age up to 3 years. With care - epilepsy, a liver failure.

Overdose:

Symptoms: drowsiness, confusion of consciousness, disorientation, bradi-or tachycardia, lowering of arterial pressure, short wind, cyanosis, spasms, hyperexcitability, coma. Treatment: a gastric lavage (if there passed a little time from the moment of reception), a symptomatic treatment, at development of a convulsive syndrome - barbiturates or benzodiazepines. Dialysis is inefficient.

Storage conditions:

In the dry place protected from light at a temperature not above 25 °C. To store in places, unavailable to children. Period of validity 3 years. Not to apply after the period of validity specified on packaging.

Issue conditions:

According to the recipe

Packaging:

Tablets of 1 mg, on 10 tablets in a blister strip packaging. 1, 2, 3, 4, 5 blister strip packagings together with the instruction place in a pack cardboard.