Instructions for use: Nikomex solution for injection 50 mg/ml ampoule 2 ml No. 10
Composition
active ingredient: ethylmethylhydroxypyridine succinate;
1 ml of solution contains ethylmethylhydroxypyridine succinate 50 mg;
Excipients: sodium metabisulfite (E 223), water for injections.
Dosage form
Solution for injection.
Main physicochemical properties: clear colorless or slightly yellowish liquid.
Pharmacotherapeutic group
Drugs that affect the nervous system.
ATX code N07X X.
Pharmacological properties
Pharmacodynamics
Nikomex 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, improves microcirculation and rheological properties of blood, reduces platelet aggregation. Stabilizes membrane structures of blood cells (erythrocytes and platelets). Has a hypolipidemic effect, reduces the content of total cholesterol and low-density lipoproteins. Reduces enzymatic toxemia and endogenous intoxication in acute pancreatitis.
The mechanism of action is due to its antioxidant and membrane-protective effect. The drug inhibits lipid peroxidation, increases the activity of superoxide oxidase, increases the lipid-protein ratio, reduces membrane viscosity. Modulates the activity of membrane-bound enzymes (calcium-independent phosphodiesterase, adenylate cyclase, acetylcholinesterase), receptor complexes (benzodiazepine, GABA, acetylcholine), which enhances 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. Nikomex 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 ATP and creatine phosphate, activation of energy-synthesizing functions of mitochondria, stabilization of cell membranes.
Nikomex 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. Nikomex helps preserve retinal ganglion cells and optic nerve fibers in progressive neuropathy, the causes 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 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. Nikomex 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 cerebrovascular accident;
- traumatic brain injury, consequences of traumatic brain injuries;
- dyscirculatory encephalopathy;
- neurocirculatory dystonia;
- mild cognitive impairment 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
Acute hepatic or renal failure, increased individual sensitivity to the drug, children's age, pregnancy, breastfeeding.
Interaction with other medicinal products and other types of interactions
Nikomex enhances the effect of benzodiazepine anxiolytics, anticonvulsants (carbamazepine), antiparkinsonian drugs (levodopa). Reduces the toxic effect of ethyl alcohol.
Application features
In some cases, especially in patients with a limited allergic history, in patients with bronchial asthma, with increased sensitivity to sulfites, the development of severe hypersensitivity reactions is possible.
Use during pregnancy or breastfeeding
There is no information on the safety and effectiveness of the drug during pregnancy and breastfeeding, so Nycomex is not used during this period.
Ability to influence reaction speed when driving vehicles or other mechanisms
During treatment, it is necessary to avoid driving or working with complex mechanisms, given the possibility of side effects that may affect the speed of reactions and the ability to concentrate.
Method of administration and doses
Nikomex is administered intramuscularly or intravenously (by jet, drip). Doses are selected individually. When administered by infusion, the drug should be diluted in saline (200 ml). Adults begin treatment with a dose of 50-100 mg 1-3 times a day, gradually increasing the dose until a therapeutic effect is obtained. Nikomex is administered by jet slowly over 5-7 minutes, drip - at a rate of 40-60 drops per minute. The maximum daily dose should not exceed 800 mg.
In acute cerebral circulation disorders, Nikomex is prescribed as part of 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, Nycomex is 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, Nikomex 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 is 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 disorders, the drug is prescribed intramuscularly at a dose of 100-300 mg per day for 14-30 days.
In acute myocardial infarction, as part of complex therapy, Nikomex is administered intravenously or intramuscularly for 14 days, against the background of traditional myocardial infarction therapy, which includes nitrates, beta-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 Nikomex is desirable, in the next 9 days, intramuscular administration of Nikomex is possible. Intravenous administration of Nikomex is carried out by drip infusion, slowly (to avoid side effects), in 0.9% sodium chloride solution or 5% dextrose (glucose) solution in a volume of 100-150 ml for 30-90 minutes. If necessary, slow jet injection of Nycomex is possible for at least 5 minutes.
Nycomex is 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.
In open-angle glaucoma of various stages, as part of complex therapy, Nikomex is administered intramuscularly at 100-300 mg per day 1-3 times a day for 14 days.
For alcohol withdrawal syndrome, Nycomex 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, the drug is administered intravenously to adults 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. 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, Nikomex is prescribed to adults 100 mg 3 times a day intravenously drip (in isotonic sodium chloride solution) and intramuscularly. Mild necrotic pancreatitis: 100-200 mg 3 times a day intravenously drip (in isotonic sodium chloride solution) and intramuscularly. Moderate severity: adults - 200 mg 3 times a day intravenously drip (in isotonic sodium chloride solution). Severe course: in pulse dosing 800 mg on the first day with a double injection, then - 300 mg 2 times a day with a gradual decrease in the daily dose. 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 isotonic sodium chloride solution) with a gradual decrease in the daily dose.
Children
The safety and effectiveness of the drug in children have not been established, therefore, Nikomex is not used in this category of patients.
Overdose
Overdose may cause drowsiness. Treatment is detoxification therapy.
Adverse reactions
Possible nausea, dry mouth, allergic reactions, drowsiness, difficulty falling asleep, anxiety, emotional reactivity, distal hyperhidrosis, headache, impaired coordination, increased blood pressure, decreased blood pressure.
Expiration date
Shelf life after opening the ampoule. Unused contents of the ampoule should be destroyed and cannot be used for further use.
Shelf life after dilution: From a microbiological point of view, the product should be used immediately.
Storage conditions
Store at a temperature not exceeding 25 °C. Keep the ampoules in the outer package to protect from light. Keep out of the reach of children.
Incompatibility.
The drug should not be mixed with other medications. Use only solvents specified in the instructions.
Packaging
2 ml in glass ampoules No. 10 (5x2) in blisters in a cardboard pack. 5 ml in glass ampoules No. 5 (5x1) in blisters in a cardboard pack.
Vacation category
According to the recipe.
Producer
JSC "Lekhim-Kharkiv".
Location of the manufacturer and address of its place of business
Ukraine, 61115, Kharkiv, 36, 16th Party Congress St.
Applicant
LLC "PHARMACELL".
Applicant's location
Ukraine, 07850, Kyiv region, Borodyanskyi district, Klavdievo-Tarasovoe village, Karl Marx St., 44 b.
