Instructions for use: Nikomex solution for injection 50 mg/ml ampoule 5 ml No. 5
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.
The drug 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 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 form and in small quantities in unchanged form.
Indication
Acute cerebrovascular accident;
traumatic brain injury, consequences of traumatic brain injuries;
dyscirculatory encephalopathy;
vegetative dystonia syndrome;
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 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.
Contraindication
Acute hepatic or renal failure, increased individual sensitivity to the drug, childhood, 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.
It should be used with caution 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, it is recommended to continue using the drug orally in the form of tablets to maintain the achieved effect.
Use during pregnancy or breastfeeding
Nycomex is contraindicated during pregnancy and breastfeeding.
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 0.9% sodium chloride solution (200 ml). Treatment of adults begins 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 1200 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 200-500 mg once a day, then intramuscularly 200-500 mg 2-3 times a day. The treatment period is 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 200-500 mg 1-2 times a day for 14 days. Then the drug is administered intramuscularly at 100-250 mg per day for the next 2 weeks.
For course prevention of dyscirculatory encephalopathy, the drug is administered intramuscularly to adults at 200-500 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 the drug 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% 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 200-500 mg intravenously or intramuscularly 2-3 times a day for 5-7 days.
In acute intoxication with antipsychotic drugs, the drug is administered intravenously to adults at a dose of 200-500 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, Nikomex is prescribed to adults at 200-500 mg 3 times a day intravenously drip (in 0.9% sodium chloride solution) and intramuscularly. Mild severity: 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). Severe course: in pulse dosing 800 mg on the first day with a double injection, then - 200-500 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 - 300-500 mg 2 times a day intravenously drip (in 0.9% sodium chloride solution) with a gradual decrease in the daily dose.
Strictly controlled clinical studies of the safety of the drug in children have not been conducted, therefore, Nycomex is contraindicated for use in this category of patients.
Overdose
Symptoms: drowsiness, insomnia.
Treatment: due to low toxicity, overdose is unlikely. Treatment is usually not required, symptoms resolve on their own within 1 day. In case of severe manifestations, supportive and symptomatic treatment is carried out.
Side effects
To avoid adverse reactions, it is recommended to adhere to the dosage regimen and rate of administration of the drug. The frequency of side effects was determined according to the classification of the World Health Organization (WHO): very common (≥ 10%); common (≥ 1% but ≤ 10%); uncommon (≥ 0.1% but ≤ 1%); rare (≥ 0.01% but ≤ 0.1%); very rare (≤ 0.01%); frequency unknown (frequency cannot be estimated from the available data).
On the part of the immune system: very rarely - anaphylactic shock, angioedema, urticaria; frequency unknown - allergic reactions, hyperemia, severe hypersensitivity reactions are possible.
Mental disorders: very rarely - drowsiness; frequency unknown - sleep disturbance, feeling of anxiety, emotional reactivity.
Cardiovascular system: frequency unknown - palpitations, tachycardia.
From the nervous system: very rarely - headache, dizziness (may be associated with an excessively high rate of administration and be short-term); frequency unknown - impaired coordination, tremor.
Vascular: very rarely - decreased blood pressure, increased blood pressure (may be associated with an excessively high rate of administration and be short-term).
On the part of the respiratory system, chest organs and mediastinum: very rarely - dry cough, sore throat, chest discomfort, difficulty breathing (may be associated with an excessively high rate of administration and be of a short-term nature); frequency unknown - bronchospasm.
Gastrointestinal: very rarely - dry mouth, nausea, bad breath, metallic taste in the mouth; frequency unknown - dyspeptic disorders, diarrhea.
Skin and subcutaneous tissue disorders: very rarely - itching, rash, facial flushing; frequency unknown - distal hyperhidrosis.
General disorders and administration site conditions: very rare – feeling of warmth; frequency unknown – changes at the injection site.
Against the background of long-term administration of the drug, the following side effects may occur: flatulence, weakness, peripheral edema.
Reporting of suspected adverse reactions
Reporting adverse reactions after the registration of a medicinal product is important. This allows monitoring of the benefit/risk ratio when using this medicinal product. Medical and pharmaceutical professionals, as well as patients or their legal representatives, should report all cases of suspected adverse reactions and lack of efficacy of the medicinal product via the Automated Information System for Pharmacovigilance at the link: https://aisf.dec.gov.ua.
Expiration date
The shelf life of the medicine in its original packaging is
3 years.
Shelf life after opening the ampoule
Unused contents of the ampoule should be destroyed and cannot be used for further application.
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 the solvents specified in the instructions.
Packaging
2 ml in an ampoule; 5 ampoules in a blister; 2 blisters in a cardboard pack;
5 ml in an ampoule; 5 ampoules in a blister; 1 blister in a cardboard pack.
Vacation category
According to the recipe.
Producer
LLC "PHARMACELL".
JSC "Farmak".
Location of the manufacturer and address of its place of business
Ukraine, 07408, Kyiv region, Brovarskyi district, Kvitneve village, Prorizna st., 3.
Ukraine, 04080, Kyiv, Kyrylivska St., 74.
Applicant
LLC "PHARMACELL".
Applicant's location
Ukraine, 07408, Kyiv region, Brovarskyi district, Kvitneve village, Prorizna st., 3.
