Marux
Maruksa: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. In case of impaired renal function
- 12. For violations of liver function
- 13. Drug interactions
- 14. Analogs
- 15. Terms and conditions of storage
- 16. Terms of dispensing from pharmacies
- 17. Reviews
- 18. Price in pharmacies
Latin name: Maruxa
ATX code: N06DX01
Active ingredient: memantine (memantin)
Manufacturer: Krka-Rus (Russia)
Description and photo update: 2018-21-11
Prices in pharmacies: from 358 rubles.
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Maruksa is a drug with a nootropic, neurometabolic effect.
Release form and composition
Dosage form Maruksa - film-coated tablets: white, oval biconvex; 10 mg tablets - on one side with a line; at the break - a white uneven rough surface (in a cardboard box 3 or 6 blister packs of 10 tablets).
Composition of 1 tablet:
- active substance: memantine hydrochloride - 10 or 20 mg;
- auxiliary components (10/20 mg): colloidal silicon dioxide - 2.5 / 5 mg; magnesium stearate - 1.25 / 2.5 mg; lactose monohydrate - 51.45 / 102.9 mg; talc - 9.8 / 19.6 mg; microcrystalline cellulose - 175/350 mg;
- shell (10/20 mg): simethicone - 0.01 / 0.02 mg; 30% aqueous dispersion of a copolymer of ethyl acrylate and methacrylic acid (1: 1) - 0.6 / 1.2 mg; triacetin - 0.12 / 0.24 mg; talc - 0.27 / 0.54 mg.
Pharmacological properties
Pharmacodynamics
Memantine is an adamantane derivative, a non-competitive antagonist of N-methyl-D-aspartate (NMDA) receptors. It has a modulating effect on the glutamatergic system.
The main properties of memantine:
- blocking calcium channels;
- regulation of ion transport;
- improving the transmission of nerve impulses;
- normalization of membrane potential;
- increased daily activity;
- improvement of cognitive processes.
Pharmacokinetics
Memantine is rapidly and completely absorbed after oral administration of Maruksa. Tmax (time to reach maximum concentration) in blood plasma ranges from 3 to 8 hours. In the absence of impaired renal function, accumulation of the substance is not observed.
With a daily intake of Maruksa in a daily dose of 20 mg Css (equilibrium concentration) of the substance in the blood plasma - 70-150 ng / ml. When the drug is taken in a daily dose of 5-30 mg, the calculated ratio of the average concentration in the cerebrospinal fluid to the plasma concentration is 0.52. Vd (volume of distribution) - approximately 10 l / kg. Plasma protein binding is approximately 45%.
Excretion occurs mainly unchanged (about 80%). The main metabolites are N-3,5-dimethyl-gludantane, 1-nitroso-3-5-dimethyl-adamantane, and an isomeric mixture of 4- and 6-hydroxy-memantine (they do not have their own pharmacological activity). Metabolism carried out by cytochrome P450 isoenzymes has not been identified. On average, 84% of the dose is excreted within 20 days mainly (more than 99%) by the kidneys.
It is excreted from the body monoexponentially. T 1/2 (half-life) of the terminal phase - 60-100 hours. The total clearance in the absence of impaired renal function is 170 ml / min / 1.73 m 2, part of the total renal clearance is achieved due to tubular secretion. The excretion of memantine by the kidneys also includes tubular reabsorption, which may be indirectly associated with cationic transport proteins. Under conditions of an alkaline urine reaction, the rate of renal elimination of memantine can decrease by 7-9 times. Alkalization of urine can be associated with abrupt changes in nutrition, for example, when switching from a diet that includes foods of animal origin to a vegetarian diet, or as a result of intensive use of alkaline gastric buffers.
The linearity of the pharmacokinetic parameters of memantine has been proven for a dose range of 10–40 mg per day.
The level of concentration in the cerebrospinal fluid with the use of memantine at a dose of 20 mg per day corresponds to the value of the inhibition constant (0.5 μmol in the frontal cortex).
Indications for use
According to the instructions, Maruks is prescribed for the treatment of moderate to severe Alzheimer's disease.
Contraindications
Absolute:
- lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome;
- severe hepatic impairment (Child-Pugh scale, class C);
- age up to 18 years;
- pregnancy and lactation;
- individual intolerance to the components of the drug.
Relative (Maruksa is prescribed under medical supervision):
- renal tubular acidosis;
- factors that increase urine pH (sudden changes in diet, for example, switching to a vegetarian diet, copious intake of alkaline gastric buffers);
- severe urinary tract infections caused by Proteus spp.;
- burdened history of myocardial infarction;
- heart failure (NYHA classification - III – IV functional class);
- epilepsy;
- predisposition to the development of seizures;
- thyrotoxicosis;
- combined use with other NMDA receptor antagonists (ketamine, amantadine, dextromethorphan);
- renal / hepatic impairment;
- uncontrolled arterial hypertension.
Instructions for the use of Maruksa: method and dosage
Maruksa is taken orally, regardless of the meal. The drug should always be taken at the same time, 1 time per day.
You can start therapy only if the person regularly caring for the patient monitors the intake of the medication. The drug should be administered under the supervision of a physician experienced in the diagnosis and treatment of dementia in Alzheimer's disease.
During the first three months of treatment, the tolerance and dose of Maruksa should be regularly assessed. In the future, the clinical efficacy of the drug and the tolerability of therapy should be assessed. With good tolerance and the presence of a therapeutic effect, Maruksa can be taken indefinitely.
A gradual increase in the daily dose helps to reduce the likelihood of side effects. The initial daily dose is 5 mg. Then, during the first three weeks, it is increased 1 time per week to 10, 15 and 20 (the recommended maintenance dose) mg.
Scheme of using Maruksa for impaired renal function (depending on creatinine clearance):
- 30–49 ml / min: 10 mg per day; in case of good tolerance for 7 days, the dose according to the standard scheme can be increased to 20 mg;
- 5-29 ml / min: 10 mg daily.
Side effects
The severity of adverse reactions while taking Maruksa is usually mild to moderate in severity. The development of dizziness, headache, constipation, arterial hypertension and drowsiness is most often noted.
Possible adverse reactions (> 10% - very often;> 1% and 0.1% and 0.01% and <0.1% - rarely; <0.01% - very rare; with an uncertain frequency - in cases where the frequency of the violation cannot be determined from the available information):
- lymphatic system and blood: with an uncertain frequency - thrombocytopenic purpura, leukopenia (including neutropenia), thrombocytopenia, pancytopenia, agranulocytosis;
- parasitic / infectious diseases: rarely - fungal infections;
- immune system: often - hypersensitivity reactions;
- nervous system: often - imbalance, dizziness; infrequently - gait disturbance; very rarely - convulsions;
- psyche: often - drowsiness; infrequently - hallucinations, confusion; with an indefinite frequency - psychotic reactions;
- respiratory system: often - shortness of breath;
- cardiovascular system: often - increased blood pressure; infrequently - venous thrombosis / thromboembolism, heart failure;
- digestive system: often - constipation; infrequently - vomiting, nausea; with an indefinite frequency - pancreatitis;
- subcutaneous tissue and skin: with an uncertain frequency - Stevens-Johnson syndrome;
- urinary tract and kidneys: with an uncertain frequency - acute renal failure;
- biliary tract and liver: often - increased activity of liver enzymes; with an undefined frequency - hepatitis;
- general disorders: often - headache; infrequently - fatigue.
Adverse reactions, the development of which was noted during the post-registration use of Maruksa: increased excitability and fatigue, drowsiness, dizziness, anxiety, headache, allergic reactions, increased intracranial and blood pressure, vomiting, nausea, muscle hypertonia, hallucinations, impaired consciousness, convulsions, depression, gait disturbance, psychotic reactions, increased libido, suicidal thoughts, constipation, nausea, candidiasis, pancreatitis, cystitis, venous thrombosis, thromboembolism.
Overdose
The main symptoms: increased severity of adverse reactions - fatigue, weakness, diarrhea, confusion, drowsiness, dizziness, agitation, hallucinations, gait disturbances, nausea. In the most severe known overdose case (2000 mg memantine), the patient survived, however, the development of disorders of the nervous system was noted (coma for 10 days, then agitation and diplopia). The patient received plasmapheresis and symptomatic therapy. Further complications were not observed. In another described case of severe overdose (400 mg), the patient also survived and recovered. Side effects from the central nervous system are described: convulsive readiness, psychosis, anxiety, visual hallucinations, drowsiness, loss of consciousness and stupor.
Therapy: symptomatic. There is no specific antidote. It is shown that standard therapeutic measures are carried out, which are aimed at removing the active substance from the stomach, in particular, the intake of activated carbon, gastric lavage, acidification of urine, forced diuresis can be prescribed.
special instructions
Since amantadine, ketamine or dextromethorphan (NMDA receptor antagonists) act on the same receptor system as Marux, side reactions (including disorders of the nervous system) when used together can occur more often and be more pronounced (combinations are recommended to be avoided).
In the presence of factors that influence the increase in urine pH, as well as renal tubular acidosis or severe urinary tract infections caused by Proteus spp., Careful monitoring of the patient's condition is required. In addition, special attention is required when using Maruksa in patients with a history of myocardial infarction, decompensated chronic heart failure (NYHA functional class III – IV) or uncontrolled arterial hypertension, which is associated with a lack of experience in use.
Influence on the ability to drive vehicles and complex mechanisms
With Alzheimer's disease in moderate to severe dementia, the ability to drive is usually impaired. Marux can also influence the change in the reaction rate, and therefore patients should refuse to drive vehicles.
Application during pregnancy and lactation
Maruksa is not prescribed during pregnancy / lactation.
Pediatric use
Therapy in patients under 18 years of age is contraindicated.
With impaired renal function
Renal failure: therapy should be carried out under medical supervision.
For violations of liver function
- severe hepatic impairment (on the Child-Pugh scale, class C): Maruks are contraindicated;
- liver failure: therapy should be carried out under the supervision of a physician.
Drug interactions
- antidepressants, selective serotonin reuptake inhibitors and monoamine oxidase inhibitors: during combined use, careful monitoring of the patient's condition is required;
- levodopa, dopamine receptor agonists and anticholinergic drugs: potentiation of effects;
- barbiturates, antipsychotics: their effectiveness decreases;
- amantadine, phenytoin, ketamine, dextromethorphan: the risk of developing psychosis increases; the combination is not recommended;
- dantrolene, baclofen, antispasmodics: their effect changes, which may require dose adjustment;
- cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine: the likelihood of an increase in the plasma concentration of memantine in the blood increases;
- oral indirect anticoagulants (warfarin): increased MHO (international normalized ratio), requires prothrombin time and MHO control;
- hydrochlorothiazide: its plasma concentration in the blood decreases (associated with an increase in its excretion from the body).
Analogs
The analogues of Maruksa are: Akatinol Memantine, Memantal, Memantine, Memorel, Noodzheron, Memantinol, Noodzheron-Teva, Tingrex, Memikar, Memaneirin.
Terms and conditions of storage
Store at temperatures up to 25 ° C. Keep out of the reach of children.
Shelf life is 2 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Maruks
Reviews about Maruks are few. Among analogues, the drug is advised as being cheaper.
Price for Maruksa in pharmacies
The approximate price for Maruksa (30 or 60 tablets of 10 mg) is 706-743 or 1208-1274 rubles.
Maruksa: prices in online pharmacies
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Drug name Price Pharmacy |
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Maruksa 10 mg film-coated tablets 30 pcs. 358 RUB Buy |
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Maruksa tablets p.o. 10mg 30 pcs. 757 r Buy |
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Maruksa 10 mg film-coated tablets 60 pcs. 1239 RUB Buy |
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Maruksa 20 mg film-coated tablets 30 pcs. 1265 RUB Buy |
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Maruksa tablets p.o. 20mg 30 pcs. 1274 RUB Buy |
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Maruksa tablets p.o. 10mg 60 pcs. 1277 RUB Buy |
Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
