Nikomex 5 ml No.5

NIKOMEX 5 ml No.5

Solution for injection 50 mg/ml 5 ml in ampoules No.5

1 ml of the solution contains 50 mg of ethylmethylhydroxypyridine succinate

Free-radical process inhibitor which increases resistance of the organism to disturbing factors and oxygen-related pathological conditions.

Marketing Authorization No. UA/15072/01/01

Composition

Active ingredient: ethylmethyl hydroxypyridine succinate;

1 ml of the solution contains 50 mg of ethylmethyl hydroxypyridine succinate;

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

Pharmaceutical form

Solution for injection.

Pharmacotherapeutical group

Medicines that have effect on nervous system. АТС Code N07X X.

Indications

  • severe cerebral circulation disorder;

  • discirculatory encephalopathy;

  • neurocirculatory asthenia;

  • sligh cognitive disturbances of atherosclerotic genesis;

  • anxiety disorder at neurotic and neurosis-like conditions;

  • relief of abstinence syndrome at alcoholism with prevailing neurosis-like and neural circulatory disorders;

  • acute intoxication with antipsychotic drugs;

  • acute suppurative inflammation processes in abdomen (acute necrotic pancreatitis, peritoneal inflammation) as the complex therapy.

Contraindications

Hypersensitivity to the product, acute liver and renal failure.

Posology and method of administration

Nikomex is prescribed for intramuscular or intravenous (streamlike, dropwise) administration. Dose is determined on individual basis. When administered as infusion, the product is dissolved in physiological sodium chloride solution (200 ml). The starting dose for adults is 50-100 mg 1-3 times per day, then it increased until therapeutic effect is obtained.  If Nikomex is taken streamlike, it is injected within 5-7 minutes and if it is taken dropwise, it is injected as 40-60 drops per 1 minute. The maximum daily dose should not be more than 800 mg.

In cases of severe cerebral circulation disorder, Nikomex is prescribed as the part complex therapy, 200-300 mg per day streamlike or dropwise among adults for the first 2-4 days, then the product is injected intramuscularly as 100 mg thrice a day. Treatment course should last within 10-14 days.

To prevent discirculary encephalopathy, the product is injected intramuscularly among adults as 100 mg 2 time per day within 10-14 days.

In case of discirculary encephalopathy at decompensation stage, Nikomex should be used intravenously streamlike or dropwise as 100 mg 2-3 times per day within 14 days. Then product is administered intramuscularly as 100 mg per day within the next 2 weeks.

In case of slight cognitive disturbances among elderly patients and at anxiety disorders, the product is administered intramuscularly as 100-300 mg per day within 14-30 days.

In case of abstinence alcoholic syndrome, Nikomex is injected intramuscularly as 100-200 mg 2-3 times per day or intrevanously dropwise 1-2 times per day within 5-7 days.

In case of acute intoxication with antipsychotic drugs among adults, the product is injected intravenously as 50-300 mg per day within 7-14 days.

In case of acute suppurative inflammation processes in abdomen (acute necrotic pancreatitis, peritoneal inflammations), the product is prescribed in the first day of pre-operation and post-operative periods. Doses are determined based on disease’s type and severity,  prevalence rate and clinical course. Drug cessation should be done gradually only upon stable positive clinical and laboratory effect. In case of acute edema (interstitial) pancreatitis, Nikomex is administered intravenously and intramuscularly dropwise as 100 mg thrice per day (in isotonic solution of sodium chloride). Mild necrotic pancreatitis among adults: 100-200 mg thrice a day intravenously dropwise (in isotonic sodium chloride) or intramuscularly. Medium severity: adults – 200 mg thrice a day intravenously dropwise (in isotonic solution of sodium chloride). Severe stage: 800 mg pulse-dose within the first day two-time injection, then administer 300 mg twice a day by gradually reducing the daily dose. Extremely severe stage: initial dose of 800 mg per day until stable relief of pancreatogenic shock,300-400 mg twice a day intravenously dropwise (in isotonic sodium chloride solution) by gradually reducing the dose.

Instruction for use of  ampule:

1. Separate one ampoule from the block and shake the contents gently, holding the ampoule by its neck.

2. Squeeze the ampoule in your hand (the product leakage shall not occur) and remove the cap by rotating it.

3. Immediately put a syringe in the ampoule through the obtained hole.


4. Turn the ampoule over and slowly suck the liquid in the syringe.

5. Put a needle on the syringe.

Adverse reactions

Possible nausea, dry mouth, allergic reactions, drowsiness, sleeping disorders, anxiety, emotional responsiveness, distal hyperhidrosis, headache, coordination impairment, hypertension, hypotension.

Overdose

When overdosed, drowsiness may appear. Treat with detoxification therapy.

Pregnancy and lactation

There is no data on safety and efficiency of use during pregnancy and lactation. Therefore, Nikomex is not used during the above period.

Children

There is no data on safety and efficiency of use among children. Therefore, Nikomex is not used among the above category of patients.

Precautions for use

In some cases, especially among the patients having limited allergic medical history, bronchial asthma, hypersensitivity to sulfites, severe hypersensitivity reactions are possible.

Effects on ability to drive and use machines

During the period of treatment, vehicle driving or working with complex machines should be avoided, taking into account possible adverse reactions that may affect response speed and concentration.

Interaction with other products and other forms of interaction

Nikomex increases activity of benzodiazepine anxiolytics, anti-convulsion medicines (carbamazepine), antiparkinsonian agents (levodopa). The product decreases the toxic effect of ethyl alcohol.

Pharmacological properties

Pharmacodynamics. Nikomex acts as the inhibitor of free radical processes and as membrane protector, it also induces antihypoxic, stress-protective, nootropic, anti-convulsion and antixyolityc effects. The product increases resistance to various damaging factors, to oxygen-dependent pathological conditions (shock, hypoxia and ischemia, cerebral circulation disorder, intoxication with alcohol or with antipsychotic drugs (neuroleptics)).

The product improves cerebral metabolism and cerebral blood supply, it also improves microcirculation and rheological blood properties and reduces aggregation of thrombocytes. It also stabilizes membrane structure of blood cells (erythrocytes and thrombocytes). The product induces lipid-lowering effect, decreases total cholesterol and low density lipoproteids. Nikomex reduces enzyme toxemia at acute pancreatitis.

Mechanism of action is associated with antioxidant and membrane protecting effect of the product. The product inhibits cross-oxidation of lipids, increases activity of superoxide- oxidase, increases lipids-protein ratio and decreases membrane viscosity. It modulates activity of membrane-bound enzymes (calcium-dependent phosphodiesterase, adenyl cyclase, acetylcholinesterase), receptor complex (benzodiazepine, GABA, acetylcholine) which increases their ability to bind with ligands, contributes to maintaining structural and functional  arrangement of bio membranes, transporting neuromediators and improvement of synapse transmission.  Nikomex increases dofamine content in the patient’s brain. It increases reinforcement of compensational activation of aerobic glycolisys and influences upon reduction of inhibition processes in Krebs cycle at hypoxia with increased ATP and creatine phosphate and activation of energy-synthesizing functions of mitochondria and stabilization of cell membranes.

Pharmacokinetics. When injected intramuscularly, the product is detected in blood plasma within 4 hours upon injection. Time for maximum concentration is 0.45-0.5 hours. The maximum concentration at 400-500 mg is 3.5 – 4.0 mkg/ml. Nikomex quickly penetrates from blood circulation into organs and tissues and quickly eliminates out of the organism. The product is excreted with urine, mainly in glucuronide conjugate form, its small quantities may be excreted unchanged.

Main physical and chemical properties

clear colorless or slightly yellowish liquid.

Incompatibility

The product should not be mixed with other products. Use only that solvents mentioned herein.

Shelf life

In original package – 2 years.

When opened: unused content of ampoule must be destroyed. It must not be stored for further use.

When diluted : from microbiological point of view, the product is used immediately.

Storage conditions

Store in secondary package to protect from light at the temperature not above 25 ºС. Keep away from children.

Package

2 ml in ampoules No.10 and 5 ml in ampoules No.5

Prescription category

Following the doctor’s prescription.

Feedback

Materials on the medicine

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Calculation of dose

Режим дозирования гемаксама индивидуальный, зависит от клинической картины. Вводить внутривенно – капельно, струйно.

Выберите показатель массы тела пациента и получите необходимое количество ампул.

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