Ketotifenum

General characteristics. Structure:

Active ingredient: 1 mg of Ketotifenum (in the form of Ketotifenum of a fumarat) in 1 tablet.

Excipients: potato starch, calcium hydrophosphate dihydrate, magnesium stearate.

Pharmacological properties:

Pharmacodynamics. Antiallergic means. The mechanism of action is connected with stabilization of membranes of mast cells and reduction of release from them of a histamine, leukotrienes and other biologically active agents. Suppresses the accumulation of eosinophils in respiratory tracts caused by a factor of activation of thrombocytes. Prevents development of a bronchospasm, some other manifestations of allergic reactions of immediate type. Blocks histamine H1 receptors.

Pharmacokinetics. After intake it is almost completely absorbed from digestive tract. The concomitant use of food does not influence extent of absorption of Ketotifenum. It is metabolized for 50% at "the first passing" through a liver. Cmax in a blood plasma is reached during 2 - 4 h. Linkng with proteins of plasma makes 75%.

It is removed dvukhfazno. Initial T1/2 makes 3 - 5 h, final - 21 h. 60 - 70% in the form of metabolites, 1% - in not changed look are removed by kidneys.

Indications to use:

Prevention of allergic diseases, including atopic bronchial asthma, allergic bronchitis, hay fever, allergic rhinitis, allergic dermatitis, small tortoiseshell, allergic conjunctivitis.

Route of administration and doses:

Inside, during food, the adult - on 1 mg of 2 times/days (in the morning and in the evening). If necessary it is possible to increase a daily dose to 4 mg. The maximum dose for adults - 4 mg/days.

To patients at whom the expressed sedation is supposed Ketotifenum is appointed on 0,5 - 1 mg to night the first few days.

To children 3 years are more senior: at body weight to 25 kg - on 0,5 mg (1/2 tablets) twice a day (in the morning and in the evening); at body weight more than 25 kg - on 1 mg (1 tablet) twice a day. At insufficient therapeutic effect after 4 weeks treatment of children with body weight a drug dose it is possible to increase less than 25 kg to 1 mg (1 tablet) twice a day.

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

Features of use:

The therapeutic effect of Ketotifenum develops slowly, within 1 - 2 months.

The carried-out antiasthmatic therapy should be continued, at least, within 2 weeks after the beginning of use of Ketotifenum, gradually reducing doses. Treatment is stopped gradually, within 2 - 4 weeks (the recurrence of "asthmatic symptoms" is possible).

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

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

At simultaneous use of Ketotifenum and bronchodilators the dose of the last can be sometimes reduced.

Influence on ability to driving of motor transport and to control of mechanisms. The patients accepting Ketotifenum have to abstain from potentially dangerous types of activity connected with need of special attention and bystry psychomotor reactions.

Pregnancy and lactation. At pregnancy, especially in the I trimester, use is possible only if the potential advantage for mother surpasses possible risk for a fruit.

Ketotifenum gets into breast milk therefore in need of its use in the period of a lactation it is necessary to resolve an issue of the breastfeeding termination.

Side effects:

From the central nervous system: drowsiness, slight dizziness, delay of mental reactions (usually disappearing in several days after an initiation of treatment), sedation, feeling of fatigue, it is rare – concern, sleep disorders, nervousness (especially at children).

From the alimentary system: increase in appetite is possible; seldom - the dispeptic phenomena, dryness in a mouth.

From system of a hemopoiesis: thrombocytopenia.

From an urinary system: dysuria, cystitis.

From a metabolism: increase in body weight.

Others: very seldom – hepatitis, increase in level of liver enzymes, Stephen-Jones's syndrome.

Interaction with other medicines:

Ketotifenum can strengthen effects sedative, hypnotic drugs, antihistamines and ethanol.

At reception of Ketotifenum along with peroral hypoglycemic medicines the probability of development of thrombocytopenia increases.

Contraindications:

Hypersensitivity to Ketotifenum, pregnancy, the lactation period, children's age up to 3 years.

With care. Epilepsy, liver failure.

Overdose:

Symptoms: drowsiness, up to consciousness oppression; confusion of consciousness and disorientation; bradi-or tachycardia, lowering of arterial pressure; especially children have a hyperexcitability, spasms; reversible coma.

Treatment: a gastric lavage (if there passed a little time from the moment of reception), absorbent carbon, a symptomatic treatment, if necessary - monitoring of functional parameters of cardiovascular system; at development of a convulsive syndrome - barbiturates of short action and benzodiazepines. Dialysis is inefficient.

Storage conditions:

In the place protected from moisture, at a temperature not over 25 ºС. To store in the place, unavailable to children. A period of validity - 3 years. Not to use medicine after the termination of a period of validity.

Issue conditions:

According to the recipe

Packaging:

On 10 tablets in a blister strip packaging. 3 planimetric packagings with a leaf insert in a pack from a cardboard.