Composition, form of production and packaging
Capsules gelatinous, the size в„–0, white color; the contents of the capsules are white or almost white powder.
1 caps.
piracetam 400 mg
cinnarizine 25 mg
Excipients: microcrystalline cellulose, lactose, magnesium stearate, talc.
The composition of gelatin capsules: titanium dioxide, methyl parahydroxybenzoate, propyl parahydroxybenzoate, acetic acid, gelatin.
10 pieces. - packings cellular planimetric (3) - packs cardboard.
10 pieces. - packings cellular planimetric (6) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2013.
PHARMACHOLOGIC EFFECT
Combined drug with pronounced antihypoxic, nootropic and vasodilating effect.
Both components mutually potentiate their own antihypoxic effect and have a vasodilating effect. Combined drug also contributes to a significant increase in blood flow in the brain. The toxicity of the combination does not exceed the toxicity of the individual constituents of the preparation.
Pyracetam is a nootropic agent. Has a positive effect on brain metabolic processes: increases the concentration of ATP in the brain tissue, enhances the synthesis of RNA and phospholipids, stimulates glycolytic processes, increases the utilization of glucose.
It improves the integrative activity of the brain, facilitates the consolidation of memory, facilitates the learning process.
Changes the speed of propagation of excitation in the brain, improves microcirculation, without providing a vasodilating action, suppresses the aggregation of activated platelets.
Has a protective effect on brain damage caused by hypoxia, intoxication, electric shock; enhances? - and? -activity, reduces? -activity on the EEG, reduces the severity of the vestibular nystagmus.
Improves interneuronal transmission and synaptic conductivity in neocortical structures, increases mental performance, improves cerebral blood flow.
The effect develops gradually. Practically does not have sedative and psycho-stimulating effect.
The therapeutic effect of piracetam appears after 1-6 h.
Cinnarizin is a selective blocker of slow calcium channels, reduces the entry of calcium ions into cells and reduces its content in the depot of the plasmolemma, reduces the tone of the smooth muscles of arterioles, reduces their response to biogenic vasoconstrictors (including epinephrine, norepinephrine, dopamine, angiotensin, vasopressin , serotonin).
Has a vasodilating effect (especially with respect to cerebral vessels, enhancing the antihypoxic effect of piracetam), without having a significant effect on blood pressure.
It shows moderate antihistamine activity, reduces the excitability of the vestibular apparatus, lowers the tone of the sympathetic nervous system.
In patients with impaired peripheral circulation improves blood supply to organs and tissues (including myocardium), enhances postischemic vasodilation.
Increases the elasticity of erythrocyte membranes, their ability to deform, reduces the viscosity of the blood.
PHARMACOKINETICS
The drug is quickly and completely absorbed from the digestive tract.
Pyracetam
Suction
Bioavailability of piracetam is 95%. C max of piracetam is achieved in 2-6 h.
Distribution
Piracetam penetrates the BBB, the placental barrier. It accumulates in the brain tissue 1-4 h after ingestion. From the cerebrospinal fluid is derived much more slowly than from other tissues.
Metabolism and excretion
Piracetam is practically not metabolized. T 1/2 pyracetam from the blood plasma is 4.5 h, T 1/2 from the brain - an average of 7.7 h. It is excreted mainly by the kidneys (2/3 unchanged for 30 h).
Cinnarizine
Suction
C max of cinnarizine is reached after 1-4 hours.
Distribution
C max cinnarizine after 1-4 hours not only in the blood, but also in the liver, kidneys, heart, lungs, spleen and in the brain. Binding to blood plasma proteins - 91%.
Metabolism and excretion
Cinnarizine is completely metabolized in the liver (by dealkylation).
60% of cinnarizine in unchanged form is excreted with feces, the rest with urine in the form of metabolites in about 5 hours.
INDICATIONS
- disorders of cerebral circulation (with atherosclerosis of cerebral vessels, ischemic stroke, the period of post-treatment after hemorrhagic stroke, after craniocerebral injuries);
- encephalopathy of different genesis;
- comatose and subcomatous states after intoxications and brain injuries;
- CNS diseases, accompanied by a decrease in intellectual-mnestic functions;
- labyrinthopathies of various genesis (accompanied by dizziness, noise in the ears, nystagmus, nausea and vomiting), Meniere's syndrome;
- Depression;
- Psycho-organic syndrome with predominance of signs of asthenia and adynamia;
- asthenia of psychogenic origin;
- prevention of migraine and kinetosis;
- impaired memory, mental function and concentration of attention;
- lagging behind the intellectual development of children.
DOSING MODE
The drug should be taken orally.
Adults - 1-2 caps. 3 times / day for 1-3 months depending on the severity of the disease.
Children from 5 years - 1-2 caps. 1-2 times / day for 1-3 months.
The treatment course is 2-3 times a year.
In chronic renal failure (CK <60 ml / min) , a dose reduction or an increase in the interval between doses of the drug is necessary.
SIDE EFFECT
From the nervous system: irritability, sleep disturbance, headache, limb tremor.
On the part of the digestive system: dyspepsia, epigastric pain, dry mouth.
Allergic reactions: skin rash.
CONTRAINDICATIONS
hepatic failure of severe degree;
- severe renal failure;
- Parkinsonism;
- Pregnancy;
- lactation period;
- Children's age till 5 years;
- Hypersensitivity to the components of the drug.
Caution should be applied to the drug in Parkinson's disease, renal or hepatic insufficiency.
PREGNANCY AND LACTATION
Contraindicated use of the drug during pregnancy and during breastfeeding.
APPLICATION FOR FUNCTIONS OF THE LIVER
Contraindicated use of the drug for severe renal failure.
APPLICATION FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS
Contraindicated use of the drug for severe hepatic failure.
APPLICATION FOR CHILDREN
Contraindication: children's age (up to 5 years). For children over the age of 5 years , 1-2 caps. 1-2 times / day for 1-3 months.
SPECIAL INSTRUCTIONS
During the treatment should be monitored liver function.
At the beginning of treatment, the patient should refrain from drinking alcohol.
Due to the content of cinnarizine, the drug can cause a positive reaction in athletes during the doping test.
The drug should be used with caution at increased intraocular pressure.
Impact on the ability to drive vehicles and manage mechanisms
During the treatment period, care must be taken when driving a car and engaging in activities that require a high concentration of attention and speed of psychomotor reactions.
OVERDOSE
There is no evidence of an overdose of the drug.
DRUG INTERACTION
Combbitropil В® enhances the effects of drugs, oppressive central nervous system, ethanol, as well as nootropic and antihypertensive agents.
Improves the tolerability of antipsychotic drugs (neuroleptics) and tricyclic antidepressants.
Vasodilating drugs enhance the action of Combbitropyl.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
List B. The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 В° C. Shelf life - 2 years.
