Elfunate 50 mg / ml solution of 2 ml ampoule № 10

Amount in a package 10
Product form Ampoules Solution
Manufacturer Rompharm Company (Romania)
Registration certificate UA/14711/01/01
The main medicament Elfoonat
morion code 326735

ELFUNAT instruction manual

Composition

active ingredient: ethylmethylhydroxypyridine succinate, 1 ml ethylmethylhydroxypyridine succinate 50 mg
excipients: water for injection.

Dosage form

Injection.

Basic physical and chemical properties:

a clear, colorless or slightly brownish solution.

Pharmacological group

Means that affect the nervous system. Code АТХ N07X X.

Pharmacological properties

Pharmacodynamics.

Elfunat is an inhibitor of free-radical processes, membrane-protector, has antihypoxic, stress-protective, nootropic, anticonvulsant and anxiolytic effects. The drug increases the resistance of the body to the effects of various damaging factors, to the kisnevozalezhnyh pathological conditions (shock, hypoxia and ischemia, cerebral circulation disorders, intoxication with alcohol and antipsychotic drugs (neuroleptics)).

The drug improves cerebral metabolism i blood supply to the brain, microcirculation and rheological properties of blood, reduces platelet aggregation. Stabilizes the membrane structures of blood cells (erythrocytes i thrombocytes) during hemolysis. Has hypolipidemic effect, reduces the content of total cholesterol and low-density lipoprotein (LDL). Reduces enzymatic toxemia and endogenous intoxication in acute pancreatitis.

The mechanism of action of the drug is due to its antioxidant and membrane-protective action. The protein inhibits lipid peroxidation, increases the activity of superoxide dismutase, increases the lipid-protein ratio, reduces the viscosity of the membrane, and increases its fluidity. Modulates the activity of membrane-bound enzymes (calcium-non-phosphodiesterase, adenylate cyclase, acetylcholinesterase), receptor complexes (benzodiazepine, gamma-aminobutyric acid (GABA), acetylcholine acid), which enhances their ability to bind with ligands, facilitates the preservation of the structural and functional organization of biomembranes, transport of neurotransmitters i to the improvement of synaptic transfer. Elfunat increases the content in the brain of dopamine. It causes an increase in the compensatory activation of aerobic glycolysis and a decrease in the degree of inhibition of oxidative processes in the Krebs cycle under conditions of hypoxia with an increase in the content of adenosine triphosphate (ATP) i of creatine phosphate, activation of energy-synthesizing functions of mitochondria, stabilization of cell membranes.

Elfunat normalizes metabolic processes in the ischemic myocardium, reduces the necrosis zone, restores and improves electrical activity and contractility of the myocardium, and also increases coronary blood flow in the ischemia zone, reduces the effects of reperfusion syndrome in acute coronary insufficiency. Increases the antianginal activity of nitro drugs. Elfunat helps maintain retinal ganglion cells and optic nerve fibers with progressive neuropathy, the consequences of which are chronic ischemia and hypoxia. It improves the functional activity of the retina and optic nerve, increasing visual acuity.

Pharmacokinetics.

With the introduction of the drug is determined in the blood plasma for 4:00 after administration. The time to reach the maximum concentration is 0.45-0.5 hours. The maximum concentration at doses of 400-500 mg is 3.5-4.0 μg / ml.Elfunat quickly passes from the bloodstream into the organs of tissue and is rapidly excreted from the body. It is excreted from the body with urine, mainly in glucuronconjugation form and in small amounts - in unchanged form.

Indications

    • Acute disorders of cerebral circulation
    • craniocerebral trauma, consequences of craniocerebral injuries;
    • encephalopathy
    • cardiopsychoneurosis;
    • mild cognitive impairment of atherosclerotic origin;
    • anxiety disorders with neurotic i neurosis-like conditions;
    • acute myocardial infarction (from the first day), as part of complex therapy;
    • primary open-angle glaucoma of various stages, as part of complex therapy;
    • relief of abstinence syndrome with alcoholism with prevalence of neurosis-like and vegetative-vascular disorders;
    • acute intoxication with antipsychotic drugs;
    • acute purulent-inflammatory processes in the abdominal cavity (acute necrotic pancreatitis, peritonitis) as part of complex therapy.

Contraindications

Acute hepatic or renal failure, hypersensitivity to the drug, child age, pregnancy, lactation.

Interaction with other drugs and other interactions

Elfunat enhances the action of benzodiazepine anxiolytics, anticonvulsants (carbamazepine), anti-Parkinsonian drugs (levodopa). Reduces the toxic effect of ethyl alcohol.

Application features

In some cases, especially in predisposed patients, in patients with bronchial asthma with increased sensitivity to sulfites, it is possible to develop severe hypersensitivity reactions.

Use during pregnancy or lactation

Strictly controlled clinical trials of drug safety during pregnancy and lactation were not conducted, so Elfunat is not used during this period.

The ability to influence the reaction rate when driving vehicles or other mechanisms

During the treatment period, care must be taken when driving vehicles or operating machinery, taking into account the likelihood of side effects that may affect reaction speed and the ability to concentrate attention.

Dosing and Administration

Elfunat is prescribed intramuscularly or intravenously (struino, drip). Doses are selected individually. With the infusion method of administration, the drug should be diluted in a physiological solution of sodium chloride (200 ml). Begin the treatment of adults with a dose of 50-100 mg 1-3 times a day, gradually increasing the dose to obtain a therapeutic effect. Stream Elfunat injected slowly for 5-7 minutes, drip - at a speed of 40-60 drops in 1 minute. The maximum daily dose should not exceed 800 mg.

In acute disorders of cerebral circulation, Elfunat is prescribed in complex therapy in the first 2-4 days intravenously drip adult 200-300 mg once a day, then intramuscularly at 100 mg 3 times a day. The duration of treatment is 10-14 days.

With craniocerebral trauma and the consequences of craniocerebral trauma, Elfunat is used for 10-15 days by intravenous drip injection of 200-500 mg 2-4 times a day.

With discirculatory encephalopathy in the phase of decompensation, Elfunt should be administered intravenously in a stream or drip in a dose of 100 mg 2-3 times a day for 14 days. Then the drug is administered intramuscularly at 100 mg per day for 2 weeks.

For the course of prophylaxis of discirculatory encephalopathy, the drug is administered intramuscularly at 100 mg twice a day for 10-14 days.

For mild cognitive impairment in elderly patients and in anxious states, the drug is administered intramuscularly at a dose of 100-300 mg per day for 14-30 days.

In acute myocardial infarction as part of complex therapy, Elfunat is administered intravenously or intramuscularly for 14 days against the background of traditional therapy of myocardial infarction, including nitrates, beta-blockers, ACE inhibitors, thrombolytic agents, anticoagulant and antiplatelet agents, and symptomatic remedies . In the first 5 days to achieve maximum effect, it is desirable to administer Elfuntu, in the next 9 days, an intramuscular injection of the drug is possible. The drug is administered by slow drop infusion (to avoid side effects) on a 0.9% solution of sodium chloride or 5% glucose solution (glucose) in a volume of 100-150 ml for 30-90 minutes. If necessary, a slow jet injection of the drug for at least 5 minutes is possible.

Introduction Elfuntu (intravenous or intramuscular) is administered 3 times a day, every 8:00. The daily therapeutic dose is 6-9 mg per 1 kg of body weight per day, a single dose of 2-3 mg / kg of body weight. The maximum daily dose should not exceed 800 mg, single dose - 250 mg.

When glaucoma of different stages in the complex therapy, Elfunat is administered intramuscularly at 100-300 mg 1-3 times a day for 14 days.

With abstinent alcohol syndrome, Elfunat is administered in a dose of 100-200 mg intramuscularly 2-3 times a day or intravenously drip 1-2 times a day for 5-7 days.

In acute intoxication with antipsychotic drugs, the drug is administered intravenously at a dose of 50-300 mg per day for 7-14 days.

In acute purulent-inflammatory processes of the abdominal cavity (acute necrotic pancreatitis, peritonitis), the drug is prescribed on the first day in both the preoperative and i in the postoperative period. Doses depend on the form and severity of the disease, the prevalence of the process, the options for the clinical course. Cancellation of the drug should be carried out gradually, only after a stable positive clinical and laboratory effect. In acute edematous (interstitial) pancreatitis, Elfunat is prescribed 100 mg 3 times a day intravenously drip (in isotonic sodium chloride solution) and intramuscularly. Light degree of necrotic pancreatitis: 100-200 mg 3 times a day intravenously drip (in isotonic sodium chloride solution) and intramuscularly. Average degree: adults - 200 mg 3 times a day intravenously drip (in isotonic sodium chloride solution). Severe course: in the pulse dosage of 800 mg per day with a double administration, then - 300 mg twice a day with a gradual decrease in the daily dose. Very severe course: at an initial dose of 800 mg per day until the stable elimination of the manifestation of pancreatogenic shock, after stabilization of the state - 300-400 mg 2 times a day intravenously drip (in isotonic sodium chloride solution) with a gradual decrease in the daily dose.

Children

Do not appoint to children.

Overdose

Overdose may cause drowsiness. Treatment - detoxification therapy.

Adverse Reactions

Rarely - nausea, dryness of the oral mucosa, allergic reactions, drowsiness, disturbed sleep, anxiety, emotional reactivity, distal hyperhidrosis, headaches, impaired coordination, increased blood pressure, lower blood pressure.

Shelf life

3 years.

Storage conditions

Store at a temperature not higher than 25 ° C in a place inaccessible to children.

Packaging

For 2 ml in ampoules No. 10 (5 × 2) in contour mesh packages, in a cardboard box.

Category of leave

On prescription.

 

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