Mebicar, tablets 300 mg 20 pcs

The drug belongs to the anxiolytic, stress-protective, nootropic drugs.

It improves myocardial tissue oxygen supply; normalizes the disturbed electrolyte balance of blood, the content of potassium ions in plasma, erythrocytes and myocardial cells; promotes increased protein synthesis and increased energy resources of the cell.

It regulates disturbed night sleep without a direct sleeping effect. It does not have a cholinolytic and muscle relaxant effect, does not affect the coordination of movements. It facilitates or relieves nicotine withdrawal.

Pharmacokinetics

Extracted completely in the urine within 24 hours.

Indications

Neuroses and neurosis-like states (irritability, emotional instability, anxiety, fear).
Cardialgia of various origins (not associated with coronary heart disease). Improving tolerability of antipsychotics and tranquilizers.
Nicotine withdrawal (as part of complex therapy to reduce the desire to smoke tobacco).

Pharmacological effect

Pharmacotherapeutic group: Psychoanaleptics; other psychostimulants and nootropic drugs.

ATX code: N06BX21

Pharmacological properties

Pharmacodynamics

Temgicoluril, the active substance of the drug Mebicar®, is an anxiolytic agent. Temgicoluril is close in chemical structure to the body’s natural metabolites – its molecule consists of two methylated urea fragments that are part of the bicyclic structure. Easily soluble in water and many organic solvents. Temgicoluril does not interact with acids, alkalis, oxidizing and reducing agents, various medications and food components.
In addition to the anxiolytic effect, temgicoluril also has nootropic properties. Temgicoluril acts on the activity of structures included in the limbic-reticular complex, partially on the emotiogenic zones of the hypothalamus, and also affects all 4 main neurotransmitter systems – GABA (gamma-aminobutyric acid), choline-, serotonin- and adrenergic, promoting their balance and integration, but does not have a peripheral adrenergic effect.

Pharmacodynamic action

Temgicoluril has moderate anxiolytic activity, eliminates or reduces anxiety, anxiety, fear, internal emotional tension and irritability. The anxiolytic effect of the drug is not accompanied by muscle relaxation and impaired coordination of movements. The drug does not reduce mental and motor activity, so temgicoluril can be used during the working day and school. Temgicoluril does not have a hypnotic effect, but it enhances the effect of hypnotics and improves sleep in case of sleep disturbances. Temgicoluril has anxiolytic and nootropic properties; reduces unwanted side reactions caused by antipsychotics and tranquilizers of the benzodiazepine group (emotional depression, excessive sedative effect, muscle weakness), has an anti-alcohol effect.
In patients with alcoholism, the level of endogenous ethyl alcohol in the blood plasma is reduced, this is one of the reasons for the increased craving for alcohol. Temgicoluril increases endogenous alcohol levels more than other tranquilizers, reducing the craving for alcohol. Temgicoluril alleviates or relieves nicotine withdrawal.

Temgicoluril does not create an elevated mood, a feeling of euphoria, addiction and dependence, or withdrawal syndrome are not observed.
Clinical efficacy and safety
Clinical studies have found that temgicoluril increases logic, associative thinking, improves attention and mental performance, without stimulating the symptoms of productive psychopathological disorders – delirium, pathological emotional activity.

Pharmacokinetics

Suction

After oral administration, the drug is well (77–80%) absorbed from the gastrointestinal tract, up to 40% of the dose taken is bound to red blood cells. The rest does not bind to blood plasma proteins and is found in the plasma in a free form, so the active substance is freely distributed throughout the body and freely passes through cell membranes.

Distribution

The volume of distribution is 0.9 l/kg. The maximum concentration of the active substance in the blood is reached 0.5 hours after taking the drug and the high level remains for 3–4 hours, then gradually decreases.

Biotransformation

Temgicoluril is not metabolized in the body. Elimination
55–70% of the dose taken is excreted from the body in the urine, the rest is excreted unchanged in feces during the day.
Temgicoluril does not accumulate in the body.

Special instructions

Isolated reports of acute hypersensitivity reactions have been received.

Impact on the ability to drive vehicles and machinery

The drug may cause low blood pressure and weakness, which may impair your ability to drive and operate machinery. Please be careful.

Active ingredient

(Temgicoluril) Tetramethyltetraazabicyclooctanedione

Composition

Active ingredient: temgicoluril (tetramethyltetraazabicyclooctanedione) – 300.0 mg.

Excipients: povidone K-90 (high molecular weight polyvinylpyrrolidone), calcium stearate.

Pregnancy

The active substance penetrates well into all tissues and fluids of the body. There are no adequately controlled clinical studies of the use of the drug during pregnancy and breastfeeding, therefore prescribing the drug is not recommended.

Contraindications

Hypersensitivity to the active substance or components of the drug. Children under 18 years of age (there are no adequately controlled clinical studies of the use of the drug in children).

Side Effects

Mebicar®, like other medicines, may cause side effects that may not affect all patients.
Frequency of side effects:

very often (>1/10); often (>1/100 and 1/1000 and 1/10000 and <1/1000); very rare (< 1/10000), frequency unknown (cannot be determined from available data).Nervous system disorders: rarely – dizziness.Vascular disorders: rarely – hypotension.Gastrointestinal disorders: rarely – indigestion.Skin and subcutaneous tissue disorders: rarely – after taking high doses, allergic reactions (itching of the skin) are possible. In case of an allergic reaction, you should stop taking the drug.General disorders and reactions at the injection site: rarely – hypothermia, weakness.If blood pressure and/or body temperature decrease (body temperature may drop by 1–1.5 °C), there is no need to stop taking the drugBlood pressure and body temperature normalize on their own.

Interaction

Interactions with other drugs Mebicar® can be combined with antipsychotics, tranquilizers (benzodiazepines), hypnotics, antidepressants and psychostimulants.

Overdose

The drug is low toxic. Two reports of overdose have been received. A single dose of 30 g of the drug had no effect on health.

Treatment: in case of overdose, generally accepted detoxification methods and symptomatic therapy are carried out.

No specific antidote is known.

Recommendations for use

Orally, regardless of meals, 300–600 mg 2–3 times a day.

The maximum single dose is 3 g, the highest daily dose is 10 g. The duration of treatment is from several days to 2–3 months.
In complex therapy as a means of reducing the desire to smoke tobacco – 300–900 mg per day for 5–6 weeks.

Pediatric population

There are no data on the safety and effectiveness of Mebicar® in children and adolescents under 18 years of age.
Elderly patients do not require dose reduction.
Patients with liver failure do not need to reduce the dose.
Dose adjustment has not been studied in patients with renal impairment. In these patients, the drug should be prescribed with caution.

Manufacturer

Tatchimpharmpreparaty, Russia