Meks-zdorovya

INSTRUCTION FOR MEDICAL USE OF THE MEDICINAL PRODUCT MEX-ZDOROVYE (MEX-ZDOROVYE)

Composition:

Active substance: ethylmethylhydroxypyridine succinate;

1 ml of the preparation contains ethylmethylhydroxypyridine succinate 50 mg;

Excipients: sodium metabisulfite (E 223), water for injections.

Pharmaceutical form. Solution for injection.

Main physico-chemical properties: clear, colorless or slightly yellowish liquid.

Pharmacotherapeutic group. Agents affecting the nervous system.

ATC code N07X X.

Pharmacological properties.

Pharmacodynamics.

The drug exerts an anti-hypoxic, stress-protective, membrane-protective, nootropic, anticonvulsant, and anxiolytic effect; increases the body's resistance to various damaging factors, including oxygen-dependent pathological conditions (shock, hypoxia and ischemia, cerebral circulation disorders, alcohol intoxication, and antipsychotic agents (neuroleptics)); improves cerebral metabolism and blood supply to the brain, enhances microcirculation and rheological properties of blood, reduces platelet aggregation; stabilizes blood cell membrane structures (erythrocytes and platelets) during hemolysis. It exerts a hypolipidemic effect, reducing total cholesterol and low-density lipoprotein levels.

Reduces enzymatic toxemia and endogenous intoxication in acute pancreatitis.

The mechanism of action of the drug is due to its antioxidant and membrane-protective effects. It inhibits lipid peroxidation processes, increases superoxide dismutase activity, improves the lipid-protein ratio, reduces membrane viscosity, and enhances membrane fluidity. It modulates the activity of membrane-bound enzymes (calcium-independent phosphodiesterase, adenylate cyclase, acetylcholinesterase) and receptor complexes (benzodiazepine, GABA, acetylcholine), thereby enhancing their ability to bind ligands, promoting preservation of the structural and functional organization of biomembranes, neurotransmitter transport, and improvement of synaptic transmission. Increases dopamine levels in the brain. Enhances compensatory activation of aerobic glycolysis and reduces the degree of inhibition of oxidative processes in the Krebs cycle under hypoxic conditions, resulting in increased ATP and creatine phosphate levels, activation of mitochondrial energy-synthesizing functions, and stabilization of cellular membranes.

The drug normalizes metabolic processes in ischemic myocardium, reduces the area of necrosis, restores and improves electrical activity and myocardial contractility, increases coronary blood flow in the ischemic area, reduces consequences of reperfusion syndrome in acute coronary insufficiency. Enhances antianginal activity of nitro-compounds. Helps preserve retinal ganglion cells and optic nerve fibers in progressive neuropathy caused by chronic ischemia and hypoxia. Improves functional activity of the retina and optic nerve, increases visual acuity.

Pharmacokinetics.

After intramuscular administration, the drug is detectable in blood plasma for up to 4 hours post-injection. Time to reach maximum concentration (Cmax) is 0.45–0.5 hours. Cmax following a 400–500 mg dose is 3.5–4.0 μg/mL. The drug rapidly transfers from the bloodstream into organs and tissues and is quickly eliminated from the body. The drug retention time is 0.7–1.3 hours. The drug is mainly excreted from the body via urine, primarily in glucuronide-conjugated form, with a minor amount excreted unchanged.

Clinical characteristics.

Indications.

• Acute cerebrovascular disorders;
• Traumatic brain injury, consequences of traumatic brain injuries;
  • Dyscirculatory encephalopathy;
  • Vegetative dystonia syndrome;
  • Mild cognitive disorders of atherosclerotic origin;
  • Anxiety disorders in neurotic and neurosis-like conditions;
• Acute myocardial infarction (from the first day), as part of complex therapy;
• Primary open-angle glaucoma at various stages, as part of complex therapy;
  • Management of alcohol withdrawal syndrome with predominant neurosis-like and vegetative-vascular disorders;
  • Acute intoxication with antipsychotic agents;
  • Acute purulent-inflammatory processes in the abdominal cavity (acute necrotic pancreatitis, peritonitis), as part of complex therapy.

Contraindications.

Acute hepatic or renal failure, increased individual sensitivity to the drug, childhood, pregnancy, breastfeeding.

Interaction with other medicinal products and other types of interactions.

Enhances the effect of benzodiazepine anxiolytics, anticonvulsants (carbamazepine), and antiparkinsonian agents (levodopa). Reduces the toxic effects of ethanol.

Special precautions.

In individual cases, especially in patients with bronchial asthma who are sensitive to sulfites, severe hypersensitivity reactions may occur. Sodium metabisulfite rarely may cause hypersensitivity reactions and bronchospasm.

Use during pregnancy or breastfeeding.

The drug is contraindicated during pregnancy and breastfeeding, as adequately controlled clinical studies on safety during pregnancy and breastfeeding have not been conducted.

Ability to influence reaction rate when driving or operating machinery.

Caution should be exercised in activities requiring rapid psychomotor reactions (driving vehicles, operating machinery, etc.).

Administration and Dosage

The drug is administered intramuscularly or intravenously (by bolus or infusion). When administered by infusion, the drug should be diluted in 0.9% sodium chloride solution.

Bolus administration: the drug is administered slowly over 5–7 minutes; infusion – at a rate of 40–60 drops per minute.

The maximum daily dose should not exceed 1200 mg.

In acute cerebrovascular disorders: during the first 10–14 days, administer intravenously by infusion 200–500 mg 2–4 times daily, then intramuscularly 200–250 mg 2–3 times daily for 2 weeks.

In traumatic brain injury and its consequences: administer intravenously by infusion 200–500 mg 2–4 times daily for 10–15 days.

In decompensated phase of dyscirculatory encephalopathy: administer intravenously by bolus or infusion at a dose of 200–500 mg 1–2 times daily for 14 days, followed by intramuscular administration of 100–250 mg daily for the next 2 weeks.

For course prophylaxis of dyscirculatory encephalopathy: administer intramuscularly at a dose of 200–250 mg twice daily for 10–14 days.

In mild cognitive impairments in elderly patients and anxiety disorders: administer intramuscularly at a daily dose of 100–300 mg daily for 14–30 days.

In acute myocardial infarction as part of combination therapy: administer the drug intravenously or intramuscularly for 14 days alongside conventional myocardial infarction therapy, which includes nitrates, beta-blockers, angiotensin-converting enzyme inhibitors, thrombolytics, anticoagulant and antiplatelet agents, as well as symptomatic treatments as indicated.

For the first 5 days, to achieve maximum effect, the drug should preferably be administered intravenously; thereafter, for the following 9 days, it may be administered intramuscularly.

Intravenous administration is performed by drip infusion slowly (to prevent adverse effects) in 0.9% sodium chloride solution or 5% dextrose (glucose) solution in a volume of 100–150 ml over 30–90 minutes. If necessary, slow bolus administration of the drug may be performed over no less than 5 minutes.

Administration of the drug (intravenous or intramuscular) should be performed 3 times daily, every 8 hours. The daily therapeutic dose is 6–9 mg/kg body weight, single dose – 2–3 mg/kg body weight. The maximum daily dose should not exceed 800 mg; single dose – 250 mg.

In open-angle glaucoma at various stages, as part of combination therapy: administer intramuscularly 100–300 mg daily, 1–3 times daily for 14 days.

In alcohol withdrawal syndrome: administer the drug at a dose of 200–500 mg intravenously by infusion or intramuscularly 2–3 times daily for 5–7 days.

In acute intoxication with antipsychotic agents: administer the drug intravenously at a dose of 200–500 mg daily for 7–14 days.

In acute purulent-inflammatory processes in the abdominal cavity (acute necrotic pancreatitis, peritonitis): the drug is prescribed on the first day both pre- and post-operatively. The administered doses depend on the form and severity of the disease, extent of the process, and clinical course variants. Discontinuation of the drug should be gradual and only after a sustained positive clinical and laboratory response.

In acute edematous (interstitial) pancreatitis: administer 200–500 mg 3 times daily intravenously by infusion (in 0.9% sodium chloride solution) and intramuscularly.

• Mild severity of necrotic pancreatitis: administer 100–200 mg 3 times daily intravenously by infusion (in 0.9% sodium chloride solution) and intramuscularly.
• Moderate severity: administer 200 mg 3 times daily intravenously by infusion (in 0.9% sodium chloride solution).
• Severe course: pulse-dose regimen – 800 mg on the first day with twice-daily administration; thereafter – 200–500 mg twice daily with gradual reduction of the daily dose.
• Very severe course: initial dose of 800 mg daily until sustained control of pancreatogenic shock symptoms; after stabilization of condition – 300–500 mg twice daily intravenously by infusion (in 0.9% sodium chloride solution) with gradual reduction of the daily dose.

Children.

The drug is contraindicated in children, as well-controlled clinical safety studies in children have not been conducted.

Overdose.

Symptoms: drowsiness, insomnia.

Treatment: due to low toxicity, overdose is unlikely. Treatment is usually not required; symptoms resolve spontaneously within 24 hours. In cases of pronounced symptoms, supportive and symptomatic therapy is administered.

Adverse reactions.

To avoid the occurrence of adverse reactions, it is recommended to follow the recommended dosage regimen and rate of administration. The frequency of adverse reactions was determined according to the classification of the World Health Organization (WHO): very common (≥ 10%); common (≥ 1%, < 10%); uncommon (≥ 0.1%, < 1%); rare (≥ 0.01%, < 0.1%); very rare (< 0.01%); frequency not known (frequency cannot be determined from available data).

Immune system disorders: very rare – anaphylactic shock, angioneurotic edema, urticaria.

Psychiatric disorders: very rare – drowsiness.

Nervous system disorders: very rare – headache, dizziness (may be related to excessively high rate of administration and is transient in nature).

Vascular disorders: very rare – decreased blood pressure, increased blood pressure (may be related to excessively high rate of administration and is transient in nature).

Respiratory, thoracic and mediastinal disorders: very rare – dry cough, throat irritation, chest discomfort, breathing difficulty (may be related to excessively high rate of administration and is transient in nature).

Gastrointestinal disorders: very rare – dry mouth, nausea, unpleasant odor sensation, metallic taste in mouth.

Skin and subcutaneous tissue disorders: very rare – itching, rash, hyperemia.

General disorders and administration site conditions: very rare – sensation of warmth.

Reporting suspected adverse reactions.

Reporting of suspected adverse reactions after drug registration is important. It allows continuous monitoring of the benefit-risk balance of the medicinal product. Healthcare professionals and patients or their legal representatives are encouraged to report any suspected adverse reactions and lack of efficacy through the Automated Pharmacovigilance Information System at the following link: https://aisf.dec.gov.ua.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 °C.

Keep out of reach and sight of children.

Incompatibilities.

The medicinal product must not be mixed with other medicinal products. Use only the solvents specified in the instructions.

Packaging. 2 ml in ampoules, packs of 5, 5×2, 10 in blisters in a box; 5 ml in ampoules, packs of 5 in a blister in a box.

Prescription status. Prescription only.

Manufacturer. LIMITED LIABILITY COMPANY "CORPORATION "ZDOROVIYA".

Manufacturer's address and place of business.

22 Shevchenko Street, Kharkiv, Kharkiv Oblast, 61013, Ukraine.