Omaron, tablets 60 pcs

OMARON is a combined drug with antihypoxic, nootropic and vasodilator effects.

Piracetam activates metabolic processes in the brain by enhancing energy and protein metabolism, accelerating glucose utilization by cells and increasing their resistance to hypoxia, improves inter-neuronal transmission in the CNS, improves regional blood flow in the ischemic area.

Cinnarizine is a selective blocker of slow calcium channels, it inhibits entry of calcium ions into cells and reduces their content in the plasma membrane depot, reduces the tone of arteriolar smooth muscle, reduces

their response to biogenic vasoconstrictors (epinephrine, norepinephrine, dopamine, angiotensin, vasopressin).

It has a vasodilator effect (especially in relation to cerebral vessels, increasing the antihypoxic effect of piracetam) without having a significant effect on BP.

It has moderate antihistamine activity, reduces the excitability of the vestibular apparatus, reduces the tone of the sympathetic nervous system.

Enhances elasticity of erythrocyte membranes and their ability to deform, reduces blood viscosity.

Indications

Attention and memory impairment, Tinnitus, Dizziness, Stroke sequelae, Impaired cerebral circulation, Asthenia, Prevention of heart attacks and strokes, Concussion and other brain injuries, Meniere’s disease, Atherosclerosis

• Applications for use of Omaron: cerebral circulatory insufficiency (atherosclerosis of brain vessels, recovery period of ischemic and hemorrhagic strokes, craniocerebral injuries, encephalopathies of various genesis), intoxications
• Other diseases of the central nervous system, accompanied by decreased intellectual and mental functions (memory, attention, mood), psycho-organic syndrome with predominant signs of asthenia and adynamic, asthenic syndrome
• labyrinthopathies, Meniere’s syndrome
• delay of intellectual development in children, prevention of migraine and kinetosis.

Active ingredient

Piracetam, Cinnarizin

Composition

Active substances:

Piracetam 400 mg;

Cinnarizine 25 mg;

Supplementary substances:

Lactose monohydrate 23.5 mg;

Magnesium hydroxycarbonate pentahydrate 46.8 mg;

Povidone (collidon 30) 3.9 mg;

Colloidal silicon dioxide (aerosil A-380) 5.2 mg,

Calcium stearate monohydrate 5.2 mg;

Crospovidone (collidon SL-M) 10.4 mg.

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How to take, the dosage

Orally, 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 have repeated courses of treatment 2-3 times a year.

Children over 5 years: 1-2 tablets 1-2 times a day. Not to be used more than 3 months.

For prevention of motion sickness: in adults – 1 tablet, in children over 5 years old – 1/2 tablet 30 minutes before the trip, with repeated administration (if necessary) every 6-8 hours.

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

Interaction

In concomitant use of Omaron® the sedative effect of CNS depressants, as well as nootropics, antihypertensives and ethanol may be enhanced.

Vasodilators increase the effect of the drug.

Omaron® improves the tolerability of antipsychotic drugs and tricyclic antidepressants.

Special Instructions

Central and peripheral nervous system disorders: motor disinhibition, irritability, somnolence, depression, asthenia, headache.

In single cases dizziness, ataxia, worsening of epilepsy, extrapyramidal disorders, tremor, unsteadiness, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased sexuality have been reported.

Cardiovascular system: decreased or increased blood pressure.

Digestive system disorders: dyspeptic phenomena, feeling of dry mouth; in single cases – nausea, vomiting, diarrhea, abdominal pain, cholestatic jaundice.

Skin disorders: dermatitis, itching, skin rash in single cases.

Metabolism: weight gain.

Allergic reactions: angioedema.

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

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Synopsis

Tablets are flat-cylindrical shape with a ridge, white. Marbling of the surface is allowed.

Features

Absorption. After oral administration piracetam and cinnarizine are quickly and almost completely absorbed in the gastrointestinal tract. Bioavailability of piracetam is about 100%.

Maximum concentration (Cmax) of piracetam is reached 0.5-1 hour after intake. The maximum concentration of cinnarizine in plasma is reached after 1-3 hours. Bioavailability of cinnarizine increases in acidic environment.

Distribution. Piracetam does not bind with blood plasma proteins. The volume of distribution is about 0.6 l/kg.

Passes through the blood-brain and placental barriers, to all organs and tissues, as well as through filter membranes used in hemodialysis.

In animal studies it was found that piracetam selectively accumulates in cortical tissues, mainly in the frontal, parietal and occipital lobes, cerebellum and basal ganglia.

Cinnarizine. Binding with plasma proteins is 91%. In 1-4 hours after oral administration it is found in liver, kidneys, heart, lungs, spleen and brain.

Metabolism. Piracetam is virtually unmetabolized in the body.

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

Excretion. Piracetam.

Over 95% of the ingested dose is excreted unchanged by the kidneys by renal filtration within 30 hours.

Renal clearance of piracetam in healthy volunteers is 86 ml/min. Half-life (T1/2) is 4-5 hours from blood plasma and 8.5 hours from cerebrospinal fluid.

In patients with renal insufficiency T1/2 is prolonged. In patients with hepatic insufficiency pharmacokinetics of piracetam does not change.

Cinnarizine is excreted from the body as metabolites (1/3 – by kidneys, 2/3 – through intestine), T1/2 – about 4 hours.

Contraindications

Hypersensitivity to the main and/or auxiliary components of the drug; severe hepatic insufficiency; severe renal insufficiency (creatinine clearance less than 20 ml/min);

hemorrhagic stroke; parkinsonism (including Parkinson’s disease); psychomotor agitation; Huntington’s disease; pregnancy; lactation; children under 5 years old; lactose intolerance, lactase deficiency, glucose-galactose malabsorption syndrome (this medicine contains lactose).

With caution

Hepatic and/or renal diseases, chronic renal insufficiency (creatinine clearance 20-80 ml/min);

elevated intraocular pressure; porphyria; Haemostasis disorder; extensive surgical interventions;

severe bleeding; hyperthyroidism; epilepsy; pronounced atherosclerosis of cerebral vessels; susceptibility to neurotic reactions.

Side effects

Central and peripheral nervous system disorders: motor disinhibition, irritability, somnolence, depression, asthenia, headache.

In single cases dizziness, ataxia, worsening of epilepsy, extrapyramidal disorders, tremor, unsteadiness, decreased ability to concentrate, insomnia, agitation, anxiety, hallucinations, increased sexuality have been reported.

Cardiovascular system: decreased or increased blood pressure.

Digestive system disorders: dyspeptic phenomena, feeling of dry mouth; in single cases – nausea, vomiting, diarrhea, abdominal pain, cholestatic jaundice.

Skin disorders: dermatitis, itching, skin rash in single cases.

Metabolism: weight gain.

Allergic reactions: angioedema.

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

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Overdose

Symptoms of overdose mainly due to the m-cholin-blocking 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 overdose gastric lavage and administration of activated charcoal, symptomatic and supportive therapy are necessary.

The effectiveness of hemodialysis for piracetam is 50-60%.

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Pregnancy use

The drug is contraindicated in pregnancy and lactation.

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Similarities

Fezam, Combitropil