Kombitropil

General characteristics. Structure:

Active ingredient: 1 капс. piracetam of 400 mg; cinnarizine of 25 mg;

Excipients: cellulose microcrystallic, lactose, magnesium stearate, talc.

Structure of gelatin capsules: titanium dioxide, methylparahydroxybenzoate, пропилпарагидроксибензоат, acetic acid, gelatin.

Description: Gelatin capsules, size No. 0, white color; contents of capsules - powder of white or almost white color.

Pharmacological properties:

The combined drug with the expressed anti-hypoxemic, nootropic and vasodilating effect.

Both components mutually exponentiate own antihypoxemic action and have vasodilating effect. The combined drug also promotes substantial increase of a blood-groove in a brain. Toxicity of a combination does not exceed toxicity of separate components of drug.

Piracetam - nootropic means. Exerts positive impact on exchange processes of a brain: increases concentration of ATP in brain fabric, strengthens synthesis of RNA and phospholipids, stimulates glycoclastic processes, strengthens glucose utilization.

Improves integrative activity of a brain, promotes memory consolidation, facilitates training process.

Changes the speed of spread of activation in a brain, improves microcirculation, without having at the same time vasodilating effect, suppresses aggregation of the activated thrombocytes.

Has protective action at the injuries of a brain caused by a hypoxia, intoxications, an electroshock; strengthens α-and β-activity, reduces δ-activity on EEG, reduces expressiveness of a vestibular nystagmus.

Improves mezhneyronalny transfer and synaptic conduction in neocortical structures, increases intellectual working capacity, improves a brain blood stream.

The effect develops gradually. Practically has no sedative and psychogogic influence.

The therapeutic effect of piracetam is shown in 1-6 h.

Cinnarizine - the selection blocker of slow calcium channels, reduces receipt in cells of calcium ions and reduces its keeping in depot of a plasmolemma, reduces a tone of smooth muscles of arterioles, reduces their reaction to biogenic vasoconstrictive substances (including Epinephrinum, Norepinephrinum, dopamine, angiotensin, vasopressin, serotonin).

Possesses vasodilating action (especially concerning brain vessels, strengthening anti-hypoxemic effect of piracetam), without having significant effect on the ABP.

Shows moderate antihistaminic activity, reduces excitability of a vestibular mechanism, lowers a tone of a sympathetic nervous system.

At patients with disturbance of peripheric circulation improves blood supply of bodies and fabrics (including a myocardium), strengthens post-ischemic vasodilatation.

Increases elasticity of membranes of erythrocytes, their deformability, reduces viscosity of blood.

 

Pharmacokinetics. Drug is quickly and completely soaked up from a GIT.

Piracetam

Absorption

Bioavailability of piracetam - 95%. Cmax of piracetam is reached in 2-6 h.

Distribution

Piracetam gets through GEB, a placental barrier. Collects in brain fabric in 1-4 h after intake. Out of cerebrospinal fluid it is brought much more slowly, than out of other fabrics.

Metabolism and removal

Piracetam is practically not metabolized. Piracetam T1/2 makes 4.5 h of a blood plasma, T1/2 from a brain is on average 7.7 h. It is removed preferential by kidneys (2/3 in not changed look during 30 h).

Cinnarizine

Absorption

Cmax of cinnarizine is reached in 1-4 h.

Distribution

Cmax of cinnarizine in 1-4 h note not only in blood, and also in a liver, kidneys, heart, lungs, a spleen and in a brain. Linkng with proteins of a blood plasma - 91%.

Metabolism and removal

Cinnarizine is completely metabolized in a liver (by dealkylation).

60% of cinnarizine in not changed look are removed with a stake, other quantity with urine in the form of metabolites approximately for 5 h.

Indications to use:

— disturbances of cerebral circulation (at atherosclerosis of vessels of a brain, an ischemic stroke, the aftercare period after a hemorrhagic stroke, after craniocereberal injuries);

— encephalopathies of various genesis;

— coma and subcomas after intoxications and brain injuries;

— TsNS diseases which are followed by decrease intellectual мнестических functions;

— the labyrinthopathies of various genesis (which are followed by dizziness, a sonitus, a nystagmus, nausea and vomiting), Menyer's syndrome;

— depression;

— a psychoorganic syndrome with dominance of signs of an adynamy and adynamia;

— adynamy of a psychogenic origin;

— prevention of migraine and kinetoz;

— disturbance of memory, cogitative function and concentration of attention;

— lag of intellectual development at children.

Route of administration and doses:

Drug should be accepted inside.

The adult - on 1-2 капс. 3 within 1-3 months depending on disease severity.

To children since 5 years - on 1-2 капс. 1-2 within 1-3 months.

2-3 times a year treat.

At a chronic renal failure (KK <60 ml/min.) is necessary a dose decline or increase in an interval between administrations of drug.

Features of use:

During treatment it is necessary to control function of a liver.

In an initiation of treatment the patient should abstain from alcohol intake.

In view of the content of cinnarizine drug can cause positive reaction in athletes when carrying out a doping test.

Drug should be used with care with the increased intraocular pressure.

Influence on ability to driving of motor transport and to control of mechanisms

During treatment it is necessary to be careful during the driving of the car and occupations the types of activity demanding the increased concentration of attention and speed of psychomotor reactions.

Side effects:

From a nervous system: irritability, sleep disorder, headache, tremor of extremities.

From the alimentary system: dyspepsia, pains in epigastriums, dryness in a mouth.

Allergic reactions: skin rash.

Interaction with other medicines:

Комбитропил® strengthens effects of medicines, the oppressing TsNS, ethanol, and also nootropic and antihypertensives.

Improves portability of antipsychotic medicines (neuroleptics) and tricyclic antidepressants.

Vazodilatiruyushchy medicines strengthen Kombitropil's action.

Contraindications:

— liver failure of heavy degree;

— renal failure of heavy degree;

— parkinsonism;

— pregnancy;

— lactation period;

— children's age up to 5 years;

— hypersensitivity to drug components.

With care it is necessary to use drug at Parkinson's disease, a renal or liver failure.

 

Use of the drug KOMBITROPIL® at pregnancy and feeding by a breast
Use of drug at pregnancy and during breastfeeding is contraindicated.

 

Use at abnormal liver functions
Use of drug at a liver failure of heavy degree is contraindicated.

 

Use at renal failures
Use of drug at a renal failure of heavy degree is contraindicated.

 

Use for children
Contraindication: children's age (up to 5 years). To children 5 years on 1-2 капс are aged more senior. 1-2 within 1-3 months.

Overdose:

There are no data on overdose of drug.

Storage conditions:

List B. Drug should be stored in the unavailable to children, dry, protected from light place at a temperature not above 25 °C. A period of validity - 2 years.

Issue conditions:

According to the recipe

Packaging:

10 - planimetric strip packagings (3) - packs cardboard.
10 - planimetric strip packagings (6) - packs cardboard.