Omarone® (Omaron)

Composition Pharmacodynamics Indications Carefully Contraindications Dosing and Administration Side effects Form release / dosage
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Active substancePiracetam + CinnarizinePiracetam + Cinnarizine
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    • Dosage form: & nbsppills
    Composition:

    Composition per 1 tablet

    Active substances: piracetam 400 mg; cinnarizine 25 mg;

    Excipients: lactose monohydrate 23.5 mg; magnesium hydroxycarbonate pentahydrate 46.8 mg; Povidone (Kollidone 30) 3.9 mg; silicon dioxide colloid (aerosil A-380) 5.2 mg; calcium stearate monohydrate 5.2 mg; crospovidone (collidone CL-M) 10.4 mg

    Description:

    Tablets of flat-cylindrical form with a risk, white. Marble surface is allowed.

    Pharmacotherapeutic group:Nootropic remedy
    ATX: & nbsp

    N.06.B.X   Other psychostimulants and nootropic drugs

    Pharmacodynamics:

    Combined drug with 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 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 (epinephrine, norepinephrine, dopamine, angiotensin II, 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. Increases the elasticity of erythrocyte membranes, their ability to deform, reduces the viscosity of the blood.

    Pharmacokinetics:

    Suction. After oral administration piracetam and cinnarizine quickly and almost completely absorbed in the gastrointestinal tract. The bioavailability of piracetam is about 100 %. The maximum concentration (Cmax) of piracetam is achieved 0.5-1 hour after taking. The maximum concentration of cinnarizine in plasma is reached in 1-3 hours.Bioavailability of cinnarizine increases in an acidic environment.

    Distribution. Pyracetam does not bind to blood plasma proteins. The volume of distribution is about 0.6 l / kg. Penetrates through the blood-brain and placental barriers, to all organs and tissues, and through the filter 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, the cerebellum and basal ganglia.

    Cinnarizine. The connection with plasma proteins is 91%. 1-4 hours after ingestion, it is found in the liver, kidneys, heart, lungs, spleen and brain.

    Metabolism. Pyracetam practically not metabolized in the body.

    Cinnarizine is actively and completely metabolized by dealkylation; the process of metabolism begins 30 minutes after ingestion.

    Excretion. Pyracetam. More than 95% of the ingested 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) - 4-5 hours from the blood plasma and 8.5 hours from the cerebrospinal fluid. In patients with renal insufficiency T1/2 lengthens. In patients with hepatic insufficiency, the pharmacokinetics of piracetam does not change.

    Cinnarizine is excreted from the body in the form of metabolites (1/3 - kidney, 2/3 - through the intestine), T1/2 -About 4 hours.

    Indications:

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

    As part of complex therapy: cerebral circulatory insufficiency (cerebral arteriosclerosis, recovery period after ischemic and hemorrhagic stroke); encephalopathy post-toxication or post-traumatic; depression; psychoorganic syndrome with predominance of asthenia and adynamia; vestibular disorders; Meniere's syndrome; the backwardness of intellectual development in children; prevention of migraine; prevention of kinetosis in adults and children.

    Contraindications:

    Hypersensitivity to the main and / or auxiliary components of the drug; severe hepatic impairment; severe renal failure (creatinine clearance less than 20 ml / min); hemorrhagic stroke; Parkinsonism (incl.Parkinson's disease); psychomotor agitation; Huntington's disease; pregnancy; lactation period; children under 5 years; lactose intolerance, lactase insufficiency, glucose-galactose malabsorption syndrome (the preparation contains lactose).

    Carefully:

    Diseases of the liver and / or kidney, 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 cerebral vessels; propensity to neurotic reactions.

    Dosing and Administration:

    Inside, during or after a meal.

    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 older than 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 - ½ tablets 30 minutes before the start of travel; with repeated reception (if necessary) every 6-8 hours.

    Patients with impaired renal function: with chronic renal failure (creatinine clearance 20-80 ml / min) - 1 tablet 2 times a day.

    Side effects:

    From the central and peripheral nervous system: motor disinhibition, irritability, drowsiness, depression, asthenia, headache. In isolated cases there is dizziness, ataxia, exacerbation of epilepsy; extrapyramidal disorders, tremor, imbalance, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased sexuality.

    From the side of the cardiovascular system: decrease or increase in blood pressure.

    From the digestive system: dyspeptic phenomena, a feeling of dryness in the 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: increase in body weight.

    Allergic reactions: angioedema.

    Other: increased sweating; in isolated cases - lupus-like syndrome, red flat lichen.

    Overdose:

    Symptoms overdoses due mainly to m-cholinoblocking activity of cinnarizine include: impaired consciousness, vomiting, extrapyramidal symptoms, lowering 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, it is necessary to wash the stomach and take activated charcoal, conduct symptomatic and maintenance therapy. The efficacy of hemodialysis for piracetam is 50-60%.
    Interaction:

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

    Vasodilating agents enhance the effect of the drug.

    Improves tolerability of antipsychotic drugs and tricyclic antidepressants.

    With simultaneous application piracetam strengthens the central effects of thyroid hormones (possible tremors, anxiety, irritability, sleep disturbances); can enhance the effect of oral anticoagulants.

    Special instructions:

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

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

    It is not recommended to drink alcohol during treatment.

    Distortion of the results of the doping test and allergic skin tests is possible; 4 days before the test, the drug should be withdrawn.

    Effect on the ability to drive transp. cf. and fur:

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

    Form release / dosage:

    Tablets 400 mg + 25 mg.

    Packaging:

    For 10 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

    3, 6 or 9 contour mesh packages together with instructions for medical use of the drug are placed in a pack of cardboard.

    Storage conditions:

    In a dry, protected from light place at a temperature of no higher than 25 ° C.

    Keep out of the reach of children.

    Shelf life:

    3 years.Do not use after the expiration date printed on the package.

    Terms of leave from pharmacies:On prescription
    Registration number:LS-001014
    Date of registration:30.05.2011 / 27.05.2015
    Expiration Date:Unlimited
    The owner of the registration certificate:NIZHFARM, JSC NIZHFARM, JSC Russia
    Manufacturer: & nbsp
    Information update date: & nbsp06.06.2017
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