Universal reference book for medicines
Product name: OMARON ® (OMARON)

Active substance: cinnarizine, piracetam

Type: A drug that improves blood circulation and brain metabolism

Manufacturer: NIZHFARM (Russia) manufactured by MAKIZ-PHARMA (Russia)
Composition, form of production and packaging
Tablets of
white color, flat-cylindrical, with a risk;
Marble surface is allowed.
1 tab.

piracetam 400 mg

cinnarizine 25 mg

Auxiliary substances: lactose monohydrate - 23.5 mg, magnesium hydroxycarbonate pentahydrate - 46.8 mg, povidone (collidon 30) - 3.9 mg, silicon dioxide colloid (aerosil A-380) 5.2 mg, calcium stearate monohydrate 5.2 mg, crospovidone (collidine CL- M) - 10.4 mg.

10 pieces.
- packings cellular planimetric (3) - packs cardboard.
10 pieces.
- packings cellular planimetric (6) - packs cardboard.
10 pieces.
- packings cellular planimetric (9) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.

Description of the drug approved by the manufacturer for the printed edition of 2013.

PHARMACHOLOGIC EFFECT

Combination 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, 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 depot of the plasmolemma, reduces the tone of the smooth muscles of arterioles, reduces their response to biogenic vasoconstrictors (epinephrine, norepinephrine, dopamine, angiotensin, vasopressin).
It 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 ingestion, piracetam and cinnarizine are quickly and almost completely absorbed into the digestive tract.
The bioavailability of piracetam is about 100%. C maxpyracetam is achieved after 0.5-1 h after administration. C max cinnarizine in plasma is achieved after 1 to 3 hours. The bioavailability of cinnarizine increases in an acidic environment.
Distribution

Pyracetam does not bind to blood plasma proteins.
V d is about 0.6 l / kg. Penetrates through the BBB and placental barriers, to all organs and tissues, as well as through the filter membranes used in hemodialysis. In studies on animals, it was found that pyracetam selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, the cerebellum and basal ganglia.
The binding of cinnarizine to plasma proteins is 91%.
1-4 h after ingestion 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 process of metabolism begins 30 minutes after ingestion.
Excretion

More than 95% of the ingested dose of pyracetam is excreted by the kidneys unchanged by renal filtration for 30 hours.
The renal clearance of piracetam in healthy volunteers is 86 ml / min. T 1/2 - 4-5 h from plasma and 8.5 h from cerebrospinal fluid. In patients with renal insufficiency, T 1/2 is lengthened. 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 - by the kidneys, 2/3 - through the intestine), T 1/2 - about 4 hours.

INDICATIONS

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

As part of complex therapy:

- Insufficiency of cerebral circulation (atherosclerosis of cerebral vessels, recovery period after ischemic and hemorrhagic stroke);

- post-toxicity or post-traumatic encephalopathy;

- Depression;

- Psycho-organic syndrome with predominance of signs of asthenia and adynamia;

- Vestibular disorders;

- Meniere's syndrome;

- lagging behind the intellectual development of children;

- prevention of migraine;

- prevention of kinetosis in adults and children.

DOSING MODE

Inside, during or after a meal.

Adults - 1-2 tablespoons.
3 times / 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 tables.
1-2 times / day. Do not use for more than 3 months.
For the prevention of kinetosis : adults - 1 tab., Children over 5 years - 1/2 tab.
30 minutes before the start of travel, with repeated admission (if necessary) every 6-8 hours.
In chronic renal failure (creatinine clearance 20-80 ml / min) - 1 tab.
2 times / day.
SIDE EFFECT

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 cardiovascular system: a decrease or increase in blood pressure.

On the part of 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.
CONTRAINDICATIONS

severe hepatic impairment;

- 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's age till 5 years;

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

- Hypersensitivity to the main and / or auxiliary components of the drug.

With caution: 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 cerebral vessels; propensity to neurotic reactions.
PREGNANCY AND LACTATION

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

APPLICATION FOR FUNCTIONS OF THE LIVER

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 FOR VIOLATIONS OF THE FUNCTION OF KIDNEYS

Contraindicated in severe hepatic insufficiency.

APPLICATION FOR CHILDREN

Children over 5 years - 1-2 tables.
1-2 times / day. Do not use for more than 3 months.
For the prevention of kinetosis : children older than 5 years - 1/2 tab.
30 minutes before the start of travel, with repeated admission (if necessary) every 6-8 hours.
Contraindicated for children under 5 years.

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.
Impact on the ability to drive vehicles and manage mechanisms

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

OVERDOSE

Symptoms of overdose caused mainly by the 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, carry out symptomatic and maintenance therapy. The efficacy of hemodialysis for piracetam is 50-60%.
DRUG INTERACTION

With simultaneous use, it is possible to strengthen 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 the simultaneous use of piracetam enhances the central effects of thyroid hormones (possible tremor, anxiety, irritability, sleep disturbances).

May intensify the effect of oral anticoagulants.

TERMS OF RELEASE FROM PHARMACY

The drug is released by prescription.

TERMS AND CONDITIONS OF STORAGE

The drug should be stored out of reach of children, dry, protected from light at a temperature of no higher than 25 ° C.
Shelf life - 3 years.
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