Product Overview
Composition
Active substances :
Piracetam 400 mg;
Cinnarizine 25 mg;
Excipients :
Lactose Monohydrate 23.5 mg;
Magnesium hydroxycarbonate pentahydrate 46.8 mg;
Povidone (Collidone 30) 3.9 mg;
Silicon dioxide colloidal (Aerosil A-380) 5.2 mg,
Calcium stearate monohydrate 5.2 mg;
Crospovidone (Collidone CL-M) 10.4 mg.
pharmachologic effect
Combined drug with a pronounced antihypoxic, nootropic and vasodilating effect.
Piracetam activates metabolic processes in the brain by enhancing energy and protein metabolism, accelerating the utilization of glucose by cells and increasing their resistance to hypoxia;
improves interneuronal transmission in the central nervous system, improves regional blood flow in the ischemic zone.
Cinnarizine is a selective blocker of "slow" calcium channels, reduces the intake of calcium ions in cells and reduces its content in the plasma membrane depot, reduces the smooth muscle tone of arterioles,
reduces their response to biogenic vasoconstrictors (adrenaline, norepinephrine, dopamine, angiotensin II, vasopressin, serotonin )
It has a vasodilating effect (especially in relation to cerebral vessels, enhancing the antihypoxic effect of piracetam), without having a significant effect on blood pressure.
It exhibits moderate antihistamine activity, reduces the excitability of the vestibular apparatus, and lowers the tone of the sympathetic nervous system.
Increases the elasticity of erythrocyte membranes, their ability to deform, reduces blood viscosity.
Suction. After oral administration, piracetam and cinnarizine are rapidly and almost completely absorbed in the gastrointestinal tract. The bioavailability of piracetam is about 100%.
The maximum concentration (Cmax) of piracetam is reached in 0.5-1 hours after administration. The maximum concentration of cinnarizine in plasma is achieved after 1-3 hours. The bioavailability of cinnarizine increases in an acidic environment.
Distribution. Piracetam does not bind to plasma proteins. The volume of distribution is about 0.6 l / kg.
It penetrates the blood-brain and placental barriers, into all organs and tissues, as well as through the filtering membranes used in hemodialysis.
In animal studies, it was found that piracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, cerebellum and basal ganglia.
Cinnarizine. Communication with plasma proteins is 91%. 1-4 hours after ingestion, it is found in the liver, kidneys, heart, lungs, spleen and brain.
Metabolism. Piracetam is practically not metabolized in the body.
Cinnarizine is actively and completely metabolized by dealkylation; the metabolic process begins 30 minutes after ingestion.
Breeding. Piracetam More than 95% of the oral dose is excreted by the kidneys unchanged by renal filtration for 30 hours.
The renal clearance of piracetam in healthy volunteers is 86 ml / min.
The half-life (T1 / 2) is 4-5 hours from blood plasma and 8.5 hours from cerebrospinal fluid.
In patients with renal failure, T1 / 2 lengthens. In patients with hepatic insufficiency, the pharmacokinetics of piracetam does not change.
Cinnarizine is excreted in the form of metabolites (1/3 - by the kidneys, 2/3 - through the intestines), T1 / 2 - about 4 hours.
Active components
Indications
Diseases of the central nervous system, accompanied by a decrease in intellectual-mnestic functions.
As part of complex therapy: cerebrovascular insufficiency (cerebral arteriosclerosis, recovery period after ischemic and hemorrhagic stroke);
encephalopathy post-toxic or post-traumatic; depression; psycho-organic syndrome with a predominance of signs of asthenia and adynamia; vestibular disorders;
Meniere's syndrome; lag of intellectual development in children; migraine prophylaxis; prevention of kinetosis in adults and children.
Pregnancy and lactation
The drug is contraindicated for use during pregnancy and lactation.
Recommendations for use
Inside, during or after meals.
Adults: 1-2 tablets 3 times a day for 1-3 months, depending on the severity of the disease. It is possible to conduct repeated courses of treatment - 2-3 times a year.
Children over 5 years: 1-2 tablets 1-2 times a day. Do not use for more than 3 months.
For the prevention of kinetosis: in adults - 1 tablet, in children over 5 years - 1/2 tablet 30 minutes before the start of the trip, with a second dose (if necessary) every 6-8 hours.
Patients with impaired renal function: for chronic renal failure (creatinine clearance of 20-80 ml / min) - 1 tablet 2 times a day.
Contraindications
Hypersensitivity to the main and / or auxiliary components of the drug; severe liver failure; severe renal failure (creatinine clearance less than 20 ml / min); hemorrhagic stroke;
parkinsonism (including Parkinson's disease); psychomotor agitation; Huntington's disease; pregnancy; lactation period; children under 5 years old; lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (the drug contains lactose).
With caution
Diseases of the liver and / or kidneys, chronic renal failure (creatinine clearance 20-80 ml / min); increased intraocular pressure; porphyria; violation of hemostasis; extensive surgical interventions;
heavy bleeding; hyperthyroidism; epilepsy; severe cerebral arteriosclerosis; tendency to neurotic reactions.
Side effects
From the central and peripheral nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia, headache. In isolated cases, dizziness, ataxia,
exacerbation of epilepsy, extrapyramidal disorders, tremor, imbalance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased sexuality.
From the cardiovascular system: decrease or increase in blood pressure.
From the digestive system: dyspeptic symptoms, a feeling of dry mouth; in isolated cases - nausea, vomiting, diarrhea, abdominal pain, cholestatic jaundice.
From the skin: in isolated cases, dermatitis, itching, skin rash.
From the side of metabolism: weight gain.
Allergic reactions: angioedema.
Other: increased sweating; in isolated cases - lupus-like syndrome, lichen planus.
Interaction
With simultaneous use, it is possible to enhance the sedative effect of drugs that inhibit the activity of the central nervous system, as well as ethanol, nootropic and antihypertensive drugs.
Vasodilating agents enhance the effect of the drug.
Improves tolerance to antipsychotic drugs and tricyclic antidepressants.
With the simultaneous use of piracetam enhances the central effects of thyroid hormones (tremors, anxiety, irritability, sleep disturbances are possible); may enhance the effects of oral anticoagulants.
How to take, course of administration and dosage
Adults are prescribed 1-2 tablets. 3 times / day for 1-3 months, depending on the severity of the disease;
children - 1-2 tablets. 1-2 times / day. Do not use the drug for more than 3 months.
Overdose
Symptoms of an overdose due mainly to the m-anticholinergic activity of cinnarizine include: impaired consciousness, vomiting, extrapyramidal symptoms, decreased blood pressure. After oral administration of piracetam at a dose of 75 g, diarrhea with blood and abdominal pain were observed.
Treatment: there is no specific antidote. In case of an overdose, gastric lavage and the use of activated carbon, symptomatic and supportive therapy are necessary. The effectiveness of hemodialysis for piracetam is 50-60%.
Appointment
Description
Special instructions
With prolonged use, it is recommended to monitor liver and kidney function (especially in patients with chronic renal failure).
During treatment, patients with arterial hypotension may experience a more significant decrease in blood pressure.
Alcohol is not recommended during treatment.
Possible distortion of the results of a doping test and allergic skin tests; 4 days before the study, the drug should be discontinued.
Impact on the ability to drive vehicles and work with mechanisms
During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require an increased concentration of attention and speed of psychomotor reactions.
Release form
Tablets 400 mg + 25 mg.
On 10 tablets in a blister strip packaging from a film of polyvinyl chloride and foil printed aluminum varnished.
3, 6 or 9 blister packs along with instructions for medical use of the drug are placed in a pack of cardboard.
Storage conditions
In a dry, dark place at a temperature of no higher than 25 ° C.
Keep out of the reach of children.
