Instructions Armadin solution for injection 50 mg/ml ampoule 2 ml cassette No. 10
Composition
active ingredient: mexidol;
1 ampoule contains 2-ethyl-6-methyl-3-hydroxypyridine succinate 100 mg;
excipient: water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: colorless or slightly colored transparent liquid.
Pharmacotherapeutic group
Drugs affecting the nervous system. ATC code N07X X.
Pharmacological properties
Pharmacodynamics
ARMADIN is an inhibitor of free radical processes, a membrane protector, has antihypoxic, stress-protective, nootropic, anticonvulsant and anxiolytic effects. The drug increases the body's resistance to the action of various damaging factors, to oxygen-dependent pathological conditions (shock, hypoxia and ischemia, cerebral circulation disorders, intoxication with alcohol and antipsychotics (neuroleptics)).
The drug improves cerebral metabolism and blood supply to the brain, microcirculation and rheological properties of blood, reduces platelet aggregation. Stabilizes membrane structures of blood cells (erythrocytes and platelets) during hemolysis. Has a hypolipidemic effect, reduces the content of total cholesterol and low-density lipoproteins (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 effect. It inhibits lipid peroxidation, increases the activity of superoxide dismutase, increases the lipid-protein ratio, reduces membrane viscosity, increases its fluidity. Modulates the activity of membrane-binding enzymes (calcium-independent phosphodiesterase, adenylate cyclase, acetylcholinesterase), receptor complexes (benzodiazepine, γ-aminobutyric acid (GABA), acetylcholine), which increases their ability to bind to ligands, contributes to the preservation of the structural and functional organization of biomembranes, the transport of neurotransmitters and the improvement of synaptic transmission. ARMADIN increases the content of dopamine in the brain. Causes increased 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) and creatine phosphate, activation of energy-synthesizing functions of mitochondria, stabilization of cell membranes.
ARMADIN normalizes metabolic processes in ischemic myocardium, reduces the area of necrosis, restores and improves electrical activity and myocardial contractility, and also increases coronary blood flow in the ischemic area, reduces the effects of reperfusion syndrome in acute coronary insufficiency. Increases the antianginal activity of nitro drugs. ARMADIN contributes to the preservation of retinal ganglion cells and optic nerve fibers in progressive neuropathy, the consequences of which are chronic ischemia and hypoxia. Improves the functional activity of the retina and optic nerve, increasing visual acuity.
Pharmacokinetics
When administered intramuscularly, the drug is detected in the blood plasma within 4 hours after administration. The time to reach maximum concentration is 0.45–0.5 hours. The maximum concentration at doses of 400–500 mg is 3.5–4.0 μg/ml. ARMADIN quickly passes from the bloodstream into organs and tissues and is quickly eliminated from the body. The drug is excreted from the body with urine, mainly in the glucuronide conjugated form and in small quantities in unchanged form.
Indication
Acute cerebral circulatory disorders; traumatic brain injury, consequences of traumatic brain injuries; dyscirculatory encephalopathy; neurocirculatory dystonia; mild cognitive disorders of atherosclerotic genesis; anxiety disorders in neurotic and 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 withdrawal syndrome in alcoholism with a predominance of neurosis-like and neurocirculatory disorders; acute intoxication with antipsychotic drugs; acute purulent-inflammatory processes in the abdominal cavity (acute necrotic pancreatitis, peritonitis), as part of complex therapy.
Contraindication
Increased individual sensitivity to the drug, acute hepatic or renal failure. Pregnancy or breastfeeding. Children's age.
Interaction with other medicinal products and other types of interactions
ARMADIN enhances the effect of benzodiazepine anxiolytics, anticonvulsants (carbamazepine), antiparkinsonian drugs (levodopa). Reduces the toxic effect of ethyl alcohol.
Increases the antianginal activity of nitro drugs and the antihypertensive activity of ACE and β-blockers. Concomitant use with nibentan, propranolol and verapamil reduces the risk of developing arrhythmogenic effects of the latter, concomitant use with neuroleptics reduces the risk of developing and severity of side effects of the latter.
Application features
In some cases, especially in predisposed patients, in patients with bronchial asthma, with increased sensitivity to sulfites, the development of severe hypersensitivity reactions is possible. It should be used with restrictions in patients with diabetic retinopathy (the course should not exceed 7–10 days) due to the property of potentiating proliferative processes.
After completion of parenteral administration, to maintain the achieved effect, it is recommended to continue using the drug orally in the form of tablets.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment, caution should be exercised when driving or operating complex machinery, given the likelihood of side effects that may affect reaction speed and ability to concentrate.
Use during pregnancy or breastfeeding
Strictly controlled clinical studies of the safety of the drug during pregnancy or breastfeeding have not been conducted, therefore ARMADIN should not be used during these periods.
Method of administration and doses
ARMADIN is administered intramuscularly or intravenously (by jet or drip). Doses should be selected individually. When administered by infusion, the drug should be diluted in 0.9% sodium chloride solution (200 ml). Start treatment for adults with a dose of 50–100 mg 1–3 times a day, gradually increasing the dose until a therapeutic effect is obtained. ARMADIN should be administered by jet slowly over 5–7 minutes, by drip - at a rate of 40–60 drops per minute. The maximum daily dose should not exceed 800 mg.
In acute cerebrovascular accidents, ARMADIN is prescribed as a complex therapy in the first 2–4 days intravenously or drip to adults 200–300 mg once a day, then intramuscularly 100 mg 3 times a day. The treatment period is 10–14 days.
In case of traumatic brain injury and consequences of traumatic brain injury, ARMADIN should be used for 10–15 days by intravenous drip injection of 200–500 mg 2–4 times a day.
In case of dyscirculatory encephalopathy in the decompensation phase, ARMADIN should be administered intravenously by jet or drip at a dose of 100 mg 2–3 times a day for 14 days. Then the drug should be administered intramuscularly at 100 mg per day for the next 2 weeks.
For course prevention of dyscirculatory encephalopathy, the drug is administered intramuscularly to adults at a dose of 100 mg 2 times a day for 10–14 days.
For mild cognitive impairment in elderly patients and anxiety, 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, ARMADIN should be administered intravenously or intramuscularly for 14 days, against the background of traditional myocardial infarction therapy, which includes nitrates, β-blockers, angiotensin-converting enzyme (ACE) inhibitors, thrombolytics, anticoagulants and antiplatelet agents, as well as symptomatic agents according to indications. In the first 5 days, to achieve maximum effect, intravenous administration of ARMADIN is desirable, in the next 9 days intramuscular administration is possible. Intravenous administration of ARMADIN is carried out by drip infusion, slowly (to avoid side effects), in 0.9% sodium chloride solution or 5% glucose solution in a volume of 100–150 ml for 30–90 minutes. If necessary, a slow jet injection of the drug is possible for at least 5 minutes.
ARMADIN should be administered (intravenously or intramuscularly) 3 times a day, every 8 hours. The daily therapeutic dose is 6–9 mg per kilogram of body weight per day, a single dose is 2–3 mg/kg of body weight. The maximum daily dose should not exceed 800 mg, a single dose is 250 mg.
For open-angle glaucoma of various stages, as part of complex therapy, ARMADIN should be administered intramuscularly at 100–300 mg per day, 1–3 times a day, for 14 days.
For alcohol withdrawal syndrome, ARMADIN is administered at 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 in adults, the drug should be 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 both in the preoperative and postoperative periods. The doses depend on the form and severity of the disease, the prevalence of the process, and the clinical course. The drug should be discontinued gradually, only after a stable positive clinical and laboratory effect.
In acute edematous (interstitial) pancreatitis, ARMADIN is prescribed to adults at 100 mg 3 times a day intravenously drip (in 0.9% sodium chloride solution) and intramuscularly. Mild necrotic pancreatitis: 100–200 mg 3 times a day intravenously drip (in 0.9% sodium chloride solution) and intramuscularly. Moderate severity: adults - 200 mg 3 times a day intravenously drip (in 0.9% sodium chloride solution).
Very severe course: in the initial dose of 800 mg per day until stable relief of the manifestation of pancreatogenic shock, after stabilization of the condition - 300–400 mg 2 times a day intravenously drip (in 0.9% sodium chloride solution) with a gradual decrease in the daily dose.
Children
Strictly controlled clinical studies of the safety of the drug in children have not been conducted, therefore ARMADIN should not be used in this category of patients.
Overdose
Overdose may cause drowsiness and insomnia, and intravenous administration may cause a short-term and slight increase in blood pressure in some cases.
The development of overdose symptoms, as a rule, does not require the use of antipyretics. These symptoms of sleep disturbance disappear on their own within a day. In especially severe cases, the use of one of the tableted hypnotics and anxiolytics (nitrazepam 10 mg, oxazepam 10 mg or diazepam 5 mg) is recommended. In case of excessive increase in blood pressure, antihypertensive drugs should be used under blood pressure control and/or therapy should be supplemented with nitro-containing drugs. Treatment is detoxification therapy.
Adverse reactions
From the cardiovascular system: increase or decrease in blood pressure.
From the nervous system: dizziness, drowsiness, sleep disturbance, feeling of anxiety, emotional reactivity, headache, coordination disorder.
On the part of the digestive system: nausea, dry mouth.
On the part of the immune system: with individual hypersensitivity to the drug, allergic reactions may occur, including skin rashes, urticaria, itching, angioedema, severe hypersensitivity reactions, bronchospasm are possible.
Skin and subcutaneous tissue disorders: distal hyperhidrosis, changes at the injection site.
With intravenous administration, especially jet, a metallic taste in the mouth, a feeling of heat throughout the body, an unpleasant odor, a scratchy throat and discomfort in the chest, shortness of breath, a feeling of palpitations, tachycardia, tremor, facial flushing may occur. As a rule, these phenomena are associated with excessive speed of drug administration and are short-term in nature.
Against the background of long-term administration of the drug, the following side effects may occur: flatulence, weakness, peripheral edema.
Expiration date
5 years.
Storage conditions
Store at a temperature not exceeding 30 °C in the original packaging.
Keep out of reach of children.
Packaging
2 ml in ampoules, 10 ampoules (5×2) in a cardboard pack.
Vacation category
According to the recipe.
Producer
CJSC "Lekhim-Kharkiv".
Location of the manufacturer and its business address
Ukraine, 93000, Luhansk region, Rubizhne, Lenina st., building 33.
