Active substanceMemantineMemantine
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  • Dosage form: & nbspfilm-coated tablets
    Composition:

    1 tablet, film-coated, contains:

    active substance: memantine hydrochloride 10.0 mg;

    Excipients: core tablet - lactose monohydrate 149.75 mg, microcrystalline cellulose 27.10 mg, talc 11.15 mg, silicon dioxide colloid 1.25 mg, magnesium stearate 0.75 mg; shell - Opadrai "white (lactose monohydrate 2.16 mg, hypromellose 1.68 mg, titanium dioxide 1.56 mg, macrogol-4000 0.60 mg) 6.00 mg.

    Description:Round biconvex tablets of white color, film-coated with a wide risk on one side and labeled 'M9MN' and '10' on the other.
    Pharmacotherapeutic group:Dementia remedy
    ATX: & nbsp

    N.06.D.X.01   Memantine

    N.06.D.X   Other drugs for the treatment of dementia

    Pharmacodynamics:The adamantane derivative. It is a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) -receptors, has a modulating effect on the glutamatergic system. It regulates ion transport, blocks calcium channels, normalizes the membrane potential, improves the process of nerve impulse transmission. Improves cognitive processes, increases daily activity.
    Pharmacokinetics:

    After oral administration memantine quickly and completely absorbed from the gastrointestinal tract. The maximum concentration in the blood plasma is reached within 2-6 hours.

    With normal renal function, no cumulation of memantine was observed.

    The excretion takes place biphasic. The half-life period averages in the first phase 4-9 hours, in the second phase - 40-65 hours. About 80% of memantine is excreted unchanged. Metabolites do not have their own pharmacological activity. It is excreted in the urine. With an alkaline reaction, urinary excretion slows down.

    Indications:Dementia of the Alzheimer's type of moderate and severe degree.
    Contraindications:Individual hypersensitivity to the drug, severe renal dysfunction (creatinine clearance (CK) less than 5-29 ml / min),severe hepatic insufficiency, pregnancy, breastfeeding, children under 18 years of age (efficacy and safety not established), lactose intolerance, lactase deficiency Lappa or glucose-galactose malabsorption (the drug contains lactose monohydrate).
    Carefully:Be wary appoint patients with thyrotoxicosis, epilepsy; a predisposition to the development of seizures, the simultaneous use of NMDA receptor antagonists (amantadine, ketamine, dextromethorphan), the presence of factors that increase the pH of urine (a dramatic diet change, a copious intake of alkaline gastric buffers), renal tubular acidosis, severe urinary tract infections, a history of myocardial infarction, cardiac insufficiency III-IV functional class (according to NYHA classification), uncontrolled arterial hypertension, renal and hepatic insufficiency.
    Pregnancy and lactation:

    There is no data on the use of memantine in pregnant women. Memantine Should be used only if the expected benefit to the mother exceeds the potential risk to the fetus.

    There is no data on the penetration of memantine into breast milk.Taking into account the lipophilic structure of the active substance of the preparation, it can be assumed that memantine can penetrate into breast milk, in connection with which it is recommended to stop breastfeeding while taking the drug.

    Dosing and Administration:

    Therapy should be carried out under the supervision of a physician experienced in the diagnosis and treatment of dementia in Alzheimer's disease. Therapy should be started only if the person who provides regular patient care will monitor the patient taking the medication. The diagnosis should be made in accordance with the current recommendations.

    The tolerability and dosage of the drug should be evaluated on a regular basis, mainly within three months after initiation of therapy. Then, the clinical efficacy of the drug and the tolerability of therapy should be regularly assessed in accordance with current clinical guidelines. Supportive therapy can be continued indefinitely for a therapeutic effect and good tolerability of the drug. Discontinue use if the therapeutic effect is no longer observed or if the patient does not tolerate treatment.

    The drug is taken orally, once a day, always at the same time, regardless of food intake. The dosage regimen is set individually. Begin the treatment recommended with the appointment of the minimum effective dose.

    Assign the drug during the first week of therapy (days 1-7) at a dose of 5 mg / day, during the second week (days 8-14) - at a dose of 10 mg / day, during the 3rd week (days 15-21) - in a dose of 15 mg / day, during the 4th week (days 22-28) - in a dose of 20 mg / day. The maximum daily dose of 20 mg.

    In patients older than 65 years, as well as patients with KK 50-80 ml / min, dose adjustment is not required. For patients with moderate renal failure (CK 30-49 ml / min) daily dose is 10 mg. In the future, with good tolerability of the drug for 7 weeks, the dose can be increased to 20 mg according to the standard scheme.

    Instructions for the division of tablets

    Place the tablet round side on a hard surface with a risk upward. Press the index finger and thumb of one of the hands on opposite sides of the tablet, continue to press the fingers until the tablet breaks into two parts (see the illustration below).

    Side effects:

    The incidence of adverse reactions was classified as follows: very often (≥1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100),rarely (≥1 / 10000, <1/1000), very rarely (<1/10000), the frequency is not established (there is currently no data on the prevalence of adverse reactions).

    Infectious and parasitic diseases: infrequently - fungal infections.

    From the immune system: often - a hypersensitivity to memantine or other components that make up the drug.

    Disorders of the psyche: infrequently - confusion, hallucinations (mainly in patients with severe Alzheimer's disease); frequency is not established - psychotic reactions.

    From the nervous system: often - headache, drowsiness, dizziness, imbalance; infrequently - gait disturbance; very rarely - seizures, epileptic seizures;

    From the heart: infrequently - heart failure, heart defects.

    From the side of the vessels: often - increased blood pressure, venous thrombosis and / or thromboembolism.

    From the respiratory system of the chest and mediastinum: often - shortness of breath.

    From the gastrointestinal tract: often constipation; rarely - nausea, vomiting; frequency not established - pancreatitis.

    From the liver and bile ducts: often - a violation of functional liver tests.

    Other: infrequently fatigue, general weakness.

    In Alzheimer's disease, depression, suicidal thoughts and suicide cases were recorded in post-marketing studies.

    In the postmarketing period, the following adverse reactions were reported: agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia, thrombocytopenic purpura, hepatitis, acute renal failure, Stevens-Johnson syndrome.

    Overdose:

    Symptoms: dizziness, tremor, agitation, drowsiness, confusion, agitation, stupor, convulsions, psychosis, afdesivnost, hallucinations, vomiting, unsteadiness of gait, diarrhea.

    Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy. There is no specific antidote.

    Interaction:

    With the simultaneous use of levodopa, dopamine receptor antagonists, m-holinoblokatorami with the drugs, the effect of the latter can be enhanced.

    With simultaneous use with barbiturates and neuroleptics, the effect of the latter may decrease.

    When combined, the effect of dantrolene or baclofen can be altered (enhanced or decreased), so the doses of the drugs should be selected individually. Simultaneous administration with amantadine, ketamine, phenytoin and dextromethorphan should be avoided because of the increased risk of developing psychosis.

    There may be an increase in plasma concentrations of cimetidine, ranitidia, procainamide, quinidine, quinine and nicotine when taken together with memantine. It is possible to reduce the level of hydrochlorothiazide when combined with memantine. Memantine is able to increase the excretion of hydrochlorothiazide.

    Possible an increase in INR (an international normalized ratio) in patients taking oral anticoagulants (warfarin).

    Simultaneous use with antidepressants, selective serotonin reuptake inhibitors and monoamine oxidase inhibitors requires close monitoring of patients.

    In vitro memantine does not inhibit isoenzymes CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A, flavin-containing monooxidase, epoxide hydrolase or sulfation.

    Special instructions:Be wary appoint patients with thyrotoxicosis, epilepsy, convulsions (including in the anamnesis); simultaneous use of NMDA receptor antagonists (amantadine, ketamine, dextromethorphan), the presence of factors that increase the pH of urine (a sharp diet change, a copious intake of alkaline gastric buffers), severe urinary tract infections, a history of myocardial infarction, heart failure III-IV functional class (according to NYIIA classification), uncontrolled hypertension, renal and hepatic insufficiency.
    Effect on the ability to drive transp. cf. and fur:Memantine can cause a change in the reaction rate, so it is necessary to refrain from potentially dangerous activities that require increased concentration and speed of psychomotor reactions.
    Form release / dosage:Pills. covered with a film coating of 10 mg.
    Packaging:

    For 10 or 14 tablets in Al / PVC blister. For 3, 6, 9 and 10 blisters for 10 tablets or 2 and 8 blisters for 14 tablets together with instructions for use in a pack of cardboard.

    In the case of packaging and packaging of the drug, ZAO "FarmFirma Soteks", Russia

    For 10 tablets in a planar cell packaging made of polyvinylchloride film and aluminum foil.

    By 3, 6 or 9 blisters together with instructions for use in a pack of cardboard.

    Storage conditions:

    At a temperature of no higher than 25 ° C.

    Keep out of the reach of children!

    Shelf life:3 years. Do not use after the expiry date printed on the package.
    Terms of leave from pharmacies:On prescription
    Registration number:LP-000824
    Date of registration:07.10.2011 / 10.10.2016
    Expiration Date:Unlimited
    The owner of the registration certificate:FarmSirma Soteks, ZAO FarmSirma Soteks, ZAO Russia
    Manufacturer: & nbsp
    Representation: & nbspPharm Company Sotex CJSC Pharm Company Sotex CJSC Russia
    Information update date: & nbsp23.04.2018
    Illustrated instructions
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