Omaron tablets 400mg + 25mg, No. 90

Diseases of the central nervous system, accompanied by a decrease in intellectual and mnestic functions.

As part of complex therapy:

• insufficiency of cerebral circulation (atherosclerosis of the vessels of the brain, the recovery period after ischemic and hemorrhagic stroke);

• post-intoxication or post-traumatic encephalopathy;

• depression;

• psychoorganic syndrome with a predominance of signs of asthenia and adynamia;

• vestibular disorders;

• Meniere's syndrome;

• lag in intellectual development in children;

• prevention of migraine;

• prevention of kinetosis in adults and children.

Inside, during or after meals.

Adults - 1-2 tab. 3 times / day for 1-3 months, depending on the severity of the disease. It is possible to carry out repeated courses of treatment - 2-3 times a year.

Children over 5 years old - 1-2 tab. 1-2 times / day Do not use for more than 3 months.

For the prevention of kinetosis : adults - 1 tab., Children over 5 years old - 1/2 tab. 30 minutes before the start of the trip, with a second appointment (if necessary) every 6-8 hours.

In chronic renal failure (creatinine clearance 20-80 ml / min) - 1 tab. 2 times / day

Tablets are white, round, flat-cylindrical, with a line on one side and beveled on both sides; marbling of the surface is allowed.

piracetam 400 mg

cinnarizine 25 mg

Excipients : lactose monohydrate, heavy magnesium carbonate, povidone K30, colloidal silicon dioxide (Aerosil A-380), calcium stearate, crospovidone (Kollidone CL-M).

• 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 of age;

• lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (the drug contains lactose);

• hypersensitivity to the main and / or auxiliary components of the drug.

With care: liver and / or kidney disease, chronic renal failure (creatinine clearance 20-80 ml / min); increased intraocular pressure; porphyria; violation of hemostasis; extensive surgical interventions; heavy bleeding; hyperthyroidism; epilepsy; pronounced atherosclerosis of the vessels of the brain; a tendency to neurotic reactions.

pharmachologic effect

Combined drug with 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, and improves regional blood flow in the ischemic zone.

Cinnarizine is a selective blocker of slow calcium channels, inhibits the entry of calcium ions into cells and reduces their content in the plasmolemma depot, reduces the tone of smooth muscles of arterioles, reduces their response to biogenic vasoconstrictor substances (epinephrine, norepinephrine, dopamine, angiotensin, vasopressin). It has a vasodilating effect (especially in relation to cerebral vessels, enhancing the antihypoxic effect of piracetam), without significantly affecting blood pressure. Shows moderate antihistamine activity, reduces the excitability of the vestibular apparatus, lowers the tone of the sympathetic nervous system. Increases the elasticity of erythrocyte membranes, their ability to deform, reduces blood viscosity.

Pharmacokinetics

Suction

After oral administration, piracetam and cinnarizine are rapidly and almost completely absorbed in the gastrointestinal tract. The bioavailability of piracetam is about 100%. Cmax of piracetam is achieved within 0.5-1 hours after administration. Cmax 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 blood plasma proteins. Vd is about 0.6 l / kg. Penetrates through the BBB 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.

Plasma protein binding of cinnarizine is 91%. After 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.

Withdrawal

More than 95% of an oral dose of piracetam is excreted unchanged by the kidneys by renal filtration within 30 hours. The renal clearance of piracetam in healthy volunteers is 86 ml / min. T1 / 2 - 4-5 hours from blood plasma and 8.5 hours from cerebrospinal fluid. In patients with renal insufficiency, T1 / 2 is lengthened. In patients with hepatic impairment, the pharmacokinetics of piracetam does not change.

Cinnarizine is excreted from the body in the form of metabolites (1/3 - by the kidneys, 2/3 - through the intestines), T1 / 2 - about 4 hours.

Indications of the drug OmaronЃ

Diseases of the central nervous system, accompanied by a decrease in intellectual and mnestic functions.

As part of complex therapy:

• insufficiency of cerebral circulation (atherosclerosis of the vessels of the brain, the recovery period after ischemic and hemorrhagic stroke);

• post-intoxication or post-traumatic encephalopathy;

• depression;

• psychoorganic syndrome with a predominance of signs of asthenia and adynamia;

• vestibular disorders;

• Meniere's syndrome;

• lag in intellectual development in children;

• prevention of migraine;

• prevention of kinetosis in adults and children.

  Side effect

  From the side of the central and peripheral nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia, headache. In isolated cases, dizziness, ataxia, exacerbation of epilepsy, extrapyramidal disturbances, tremors, imbalance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased sexuality are noted.

  From the side of 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.

  On the part of the skin: in isolated cases, dermatitis, itching, skin rash.

  From the side of metabolism: an increase in body weight.

  Allergic reactions: angioedema.

  Others: increased sweating; in isolated cases - lupus-like syndrome, lichen planus.

  Contraindications for use

  • 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 of age;

  • lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (the drug contains lactose);

  • hypersensitivity to the main and / or auxiliary components of the drug.

  With care: liver and / or kidney disease, chronic renal failure (creatinine clearance 20-80 ml / min); increased intraocular pressure; porphyria; violation of hemostasis; extensive surgical interventions; heavy bleeding; hyperthyroidism; epilepsy; pronounced atherosclerosis of the vessels of the brain; a tendency to neurotic reactions.

  Application during pregnancy and lactation

  The drug is contraindicated for use during pregnancy and lactation (breastfeeding).

  Application for violations of liver function

  Contraindicated in severe hepatic impairment.

  Application for impaired renal function

  Contraindicated in severe renal failure (creatinine clearance less than 20 ml / min).

  In chronic renal failure (creatinine clearance 20-80 ml / min) - 1 tab. 2 times / day

  Application in children

  Children over 5 years old - 1-2 tab. 1-2 times / day Do not use for more than 3 months.

  For the prevention of kinetosis : children over 5 years old - 1/2 tab. 30 minutes before the start of the trip, with a second appointment (if necessary) every 6-8 hours.

  Contraindicated in children under 5 years of age.

  special instructions

  With prolonged use, it is recommended to monitor liver and kidney function (especially in patients with chronic renal failure).

  During the period of treatment in patients with arterial hypotension, a more significant decrease in blood pressure is possible.

  Drinking alcohol during treatment is not recommended.

  Possible distortion of the results of doping tests and allergic skin tests; the drug should be discontinued 4 days before the study.

  Influence on the ability to drive vehicles and use mechanisms

  During the period of treatment, care must be taken when driving vehicles and engaging in other potentially hazardous activities that require increased concentration of attention and speed of psychomotor reactions.

  Overdose

  Overdose symptoms , mainly due 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, bloody diarrhea and abdominal pain were observed.

  Treatment: there is no specific antidote. In case of an overdose, it is necessary to wash the stomach and take activated charcoal, conduct symptomatic and supportive therapy. The effectiveness of hemodialysis for piracetam is 50-60%.

  Drug interactions

  With the simultaneous use, it is possible to enhance the sedative effect of drugs that depress the activity of the central nervous system, as well as ethanol, nootropic and antihypertensive drugs.

  Vasodilating agents enhance the effect of the drug.

  Improves the tolerance of antipsychotic drugs and tricyclic antidepressants.

  With the simultaneous use of piracetam, it enhances the central effects of thyroid hormones (tremors, anxiety, irritability, sleep disturbances are possible).

  May enhance the effect of oral anticoagulants.