Product Overview
Composition
1 film-coated tablet contains:
active substance:
memantin hydrochloride 10.00 mg;
excipients:
nucleus tablets - lactose monohydrate 149.75 mg,
microcrystalline cellulose 27.10 mg,
talc 11.15 mg,
colloidal silicon dioxide 1.25 mg,
magnesium stearate 0.75 mg;
Pharmacological action
Pharmacotherapy group:
ATX Code: N06DX01
Pharmacological properties
Pharmacodynamics
It has a nootropic, cerebrozodilating, antihypoxic and psychostimulating effects. The derivative of adamantane is close to amantadine in chemical structure and pharmacological properties. Blocks glutamate N-methyl-D-aspartate receptors (NMDA receptors) (including in the black substance), thereby reducing the excessive stimulating effect of cortical glutamate neurons on neostratum, which develops against the background of insufficient dopamine secretion.
By reducing the intake of ionized calcium into neurons, it reduces the possibility of their destruction. It has a greater effect on stiffness (rigidity and bradykinesia). Improves weakened memory, concentration, reduces fatigue and symptoms of depression, reduces spasticity caused by diseases and brain damage.
Pharmacokinetics
After ingestion, memantin is quickly and completely absorbed from the gastrointestinal tract. The maximum plasma concentration is reached within 2-6 hours.
Memantin cumulation is not noted in normal kidney function.
Indications
Dementia of medium and severe severity in Alzheimer's disease.
Contraindications
Individual hypersensitivity to the drug, severe kidney dysfunction (creatinine clearance (CC) less than 5-29 ml/min), severe liver failure, pregnancy, breastfeeding, children under 18 years of age (efficiency and safety are not established); lactose intolerance, Lappa lactase deficiency or glucose-
With caution
Side effects
The frequency 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), frequency is not established (currently there are no data on the prevalence of adverse reactions).
From the central nervous system: often - headache, drowsiness, dizziness; rarely - confusion, hallucinations (mainly in patients with Alzheimer's disease at the stage of severe dementia), gait disorders; very rarely - seizures; frequency is not established - psychotic reactions.
From the digestive system: often - constipation; rarely - nausea, vomiting; frequency is not set - pancreatitis.
From the cardiovascular system: rarely - arterial hypertension, venous thrombosis/thromboembolism.
Others: rarely - fatigue, fungal infections.
Dizziness, drowsiness, increased excitability, increased fatigue, anxiety, increased intracranial pressure, nausea, hallucinations, headache, consciousness disorders, muscle hypertension, gait disorders, depression, seizures, psychotic reactions, suicidal thoughts, constipation, nausea, pancreatitis,
Interaction
When used simultaneously with levodopa preparations, dopamine receptor antagonists, m-choline blockers, the effect of the latter may increase. When used simultaneously with barbiturates and neuroleptics, the effect of the latter may decrease.
When used together, it can change (strengthen or decrease) the effect of dantrolene or baclofen, so doses of drugs should be selected individually.
Simultaneous administration with amantadine, ketamine, phenytoin and dextromethorphan should be avoided due to the increased risk of psychosis.
It is possible to increase the concentration of cimetidine, ranitadine, procainamide, quinidine, quinine and nicotine in blood plasma when taken together with memantin.
It is possible to reduce the level of hydrochlorothiazide when used in conjunction with memantin. Memantin is able to increase the excretion of hydrochlorothiazide. MHO (international normalized attitude) may increase in patients taking oral anticoagulants (warfarin).
How to take, course of administration and dosage
The drug is taken orally, once a day, always at the same time, regardless of meals. The dosing mode is set individually. It is recommended to start treatment by prescribing a minimum effective dose.
Prescribe the drug during the 1st week of therapy (days 1-7) at a dose of 5 mg/day, during the 2nd week (days 8-14) - at a dose of 10 mg/day, during the 3rd week (days 15-21) - at a dose of 15 mg/day, within the 4th week (days 22-28) - at a dose of 20 mg/day. The maximum daily dose is 20 mg. In patients over 65 years of age, as well as patients with QC of 50-80 ml/min, dose correction is not required. For patients with moderate renal failure (CC 30-49 ml/min), the daily dose is 10 mg. In the future, with good tolerance of the drug for 7 weeks, the dose can be increased to 20 mg according to the standard scheme.
Pill division instructions
Overdose
Symptoms: dizziness, tremors, agitation, drowsiness, confusion, excitement, stupor, seizures, psychosis, aggression, hallucinations, vomiting, shaky gait, diarrhea.
Description
Tablets: round, biconvex, coated with white film, with a wide risk on one side and markings "M9MN" and "10" on the other.
Special instructions
Patients with thyrotoxicosis, epilepsy, seizures (including history); simultaneous use of NMDA receptor antagonists (amantadine, ketamine, dextromethorphan), the presence of factors that increase the pH of urine (sharpick dietary change, abundant use of alkaline gastric buffers), severe urinary tract infections, history of myocardial infarction, heart failure (III-IV functional class according to the NYHA classification), uncontrolled arterial hypertension, renal and liver failure.
Impact on the ability to drive vehicles and drive mechanisms
Storage conditions
At a temperature not exceeding 25 °C. Keep out of reach of children!
Shelf life
3 years.