Memantinol 10mg pills 10

Indications

— moderate to severe dementia in Alzheimer's disease.

Dosage and administration

Memantinol treatment^® should begin and be carried out under the supervision of a physician experienced in the diagnosis and treatment of dementia in Alzheimer's disease. The diagnosis must be made in accordance with the current guidelines. Treatment should be initiated only if the person providing ongoing care for the patient will regularly monitor the patient's drug intake. Portability and The dose of Memantine should be regularly reviewed, preferably within the first 3 months from the start of therapy. After this period, the clinical efficacy of memantine and patient tolerance of treatment should be regularly reviewed in accordance with the current clinical guidelines. Supportive treatment can be continued indefinitely in the presence of a positive effect of therapy and good tolerability of treatment. Reception of memantine should be stopped in the absence of a positive therapeutic effect or intolerance to treatment by the patient.

The drug should be taken orally 1 time / day and always at the same time, regardless of the meal.

Adults

Dose titration

The maximum daily dose of 20 mg / day.In order to reduce the risk of adverse reactions, the dose of the drug is titrated by successively increasing by 5 mg every week for the first 3 weeks: during the 1st week of therapy (days 1-7), the patient should take memantine at a dose of 5 mg / day (0.5 tab. 10 mg), during the 2nd week (days 8-14) - at a dose of 10 mg / day (1 tab. 10 mg), during the 3rd week (days 15-21) - at a dose of 15 mg / day (1.5 tab 10 mg). Starting from the 4th week, the patient is prescribed memantine intake in a dose of 20 mg / day (2 tab. 10 mg each).

The recommended maintenance dose of 20 mg / day.

Elderly patients (over 65) dose adjustment is not required.

Patients with impaired renal function

In patients with CC 50-80 ml / min dose adjustment is not required. For patients with moderate renal insufficiency (CK 30-49 ml / min), the recommended daily dose is 10 mg / day. With good tolerability of this dose for 7 days, the dose can be increased to 20 mg / day in accordance with the standard titration scheme. In patients with severe renal insufficiency (CC 5-29 ml / min), the daily dose should not exceed 10 mg / day.

Patients with impaired liver function

In patients with mild and moderate liver dysfunction (class A and class B on the Child-Pugh scale) dose adjustment is not required. Data on the use of memantine in patients with severe liver dysfunction is not, therefore, the appointment of memantine in such patients is not recommended.

Adverse effects

Adverse reactions are classified according to clinical manifestations (according to the lesion of certain organ systems) and according to the frequency of occurrence according to the WHO classification: very often (≥1 / 10), often (≥1 / 100 to <1/10),infrequently (≥1 / 1000 to <1/100), rarely (≥1 / 10 000 to <1/1000), very rarely (<1/10 000), the frequency is not set (cannot be estimated from data available in availability).

In clinical studies of moderate to severe dementia, which included 1784 patients who received memantine and 1595 patients who received placebo, the overall incidence of adverse reactions when taking memantine did not differ from that of taking placebo. As a rule, undesirable reactions of mild or moderate severity were observed. The most frequent adverse reactions in the memantine group compared with the placebo group were: dizziness (6.3% versus 5.6%, respectively), headache (5.2% versus 3.9%), constipation (4.6% versus 2.6%), drowsiness (3.4% versus 2.2 %) and arterial hypertension (4.1% vs. 2.8%, respectively). Adverse reactions are presented in the table:

¹ Hallucinations have been observed mainly in patients with Alzheimer's disease at the stage of severe dementia.

² Separate reports received during the period of post-registration experience in the use of memantine.

When post-registration use, the following adverse reactions were reported: dizziness, drowsiness, irritability, fatigue, anxiety, increased intracranial pressure, nausea, hallucinations, headache, impaired consciousness, muscle hypertonus, gait disturbance, depression, convulsions, psychotic reactions, suicidal thoughts, constipation, nausea, pancreatitis, candidiasis, increased blood pressure, vomiting, cystitis, increased libido, venous thrombosis, thromboembolism, allergic reactions.

Contraindications

- pregnancy;

- breastfeeding period;

- age up to 18 years (efficiency and safety have not been established);

- Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome (since lactose is part of the drug);

- Hypersensitivity to memantine or any of the components that make up the drug.

WITH caution should take the drug for thyrotoxicosis, epilepsy, susceptibility to the development of seizures (including a history), the simultaneous use of NMDA receptor antagonists (amantadine, ketamine,dextromethorphan), in the presence of factors that increase the pH of urine (abrupt diet change, for example, switching to vegetarianism, abundant intake of alkaline gastric buffers), renal tubular acidosis, severe urinary tract infections caused by bacteria of the genus Proteus, myocardial infarction (in history), cardiac functional class III-IV failure (according to the NYHA classification), uncontrolled arterial hypertension, renal failure, liver failure.

Use during pregnancy and lactation

Contraindicated in pregnancy, because There are no clinical data on the effect of memantine on the course of pregnancy.

Animal studies indicate the possibility of the drug to cause intrauterine growth retardation at the level of exposure to identical or slightly superior concentrations of memantine compared with those in humans. The potential risk to humans is not known.

It is not known whether memantine is excreted into breast milk, therefore, women taking memantine should refrain from breastfeeding.

Application for violations of the liver

In patients with mild and moderate liver dysfunction (class A and class B on the Child-Pugh scale) dose adjustment is not required. Data on the use of memantine in patients with severe liver dysfunction is not, therefore, the appointment of memantine in such patients is not recommended.

Application for violations of kidney function

In patients with CC 50-80 ml / min dose adjustment is not required. For patients with moderate renal insufficiency (CK 30-49 ml / min), the recommended daily dose is 10 mg / day. With good tolerability of this dose for 7 days, the dose can be increased to 20 mg / day in accordance with the standard titration scheme. In patients with severe renal insufficiency (CC 5-29 ml / min), the daily dose should not exceed 10 mg / day.

Use in children

Contraindicated in children under the age of 18, because the effectiveness and safety have not been established.

Use in elderly patients

Elderly patients (over 65) dose adjustment is not required.

special instructions

It is recommended to be used with caution in patients with thyrotoxicosis, epilepsy, convulsions (including history), as well as in patients with a predisposition to epilepsy. The simultaneous use of antagonists of NMDA receptors (amantadine, ketamine, dextromethorphan) and memantine should be avoided. These compounds act on the same receptor system as memantine, in connection with which side reactions (mainly from the CNS) can occur more often and be more pronounced.

Taking into account the slowing down of memantine in patients with alkaline urine conditions, patients with factors that influence the increase in urine pH (abrupt diet change, for example, when switching from predominantly meat products to vegetarianism, intensive consumption of alkaline gastric buffers), need more careful monitoring, and also in cases of renal tubular acidosis or severe urinary tract infection caused by bacteria of the genus Proteus.

There is limited data on the administration of memantine in patients with myocardial infarction (in history) with chronic heart failure of the III-IV functional class (according to the NYHA classification) and uncontrolled arterial hypertension, therefore careful medical observation is necessary for such patients.

Influence on ability to drive motor transport and control mechanisms

In patients with Alzheimer's disease at the stage of moderate and severe dementia, the ability to drive vehicles and manage complex mechanisms is usually impaired. In addition, memantine can cause a change in the reaction rate, so patients should refrain from driving or working with complex mechanisms.

Overdose

There are limited data on overdose obtained during clinical trials and post-registration experience in the use of memantine.

Symptoms When used in relatively large doses (200 mg once and 105 mg / day for 3 days), the following symptoms were noted: fatigue, weakness and / or diarrhea or symptoms were absent. When taken in a dose of less than 140 mg once or in the case of receiving an unknown dose, patients experienced adverse reactions from the CNS: confusion, hypersomnia, drowsiness, dizziness, agitation, aggression, hallucinations, gait disturbance) and / or from the digestive system: vomiting diarrhea

In the most severe case of overdose, the patient survived after taking memantine in a dose of 2000 mg, he had adverse reactions from the central nervous system (coma for 10 days, then diplopia and agitation).The patient received symptomatic treatment and plasmapheresis. The patient recovered without further complications.

In another case of severe overdose, the patient survived and recovered after taking memantine at a dose of 400 mg once. The patient had adverse reactions from the central nervous system: anxiety, psychosis, visual hallucinations, lowering the threshold of convulsive readiness, drowsiness, stupor and loss of consciousness.

Treatment symptomatic. There is no specific antidote. It is necessary to carry out standard therapeutic measures aimed at removing the substance from the stomach, such as washing the stomach, taking Activated carbon, creating an acidic urine reaction, it is possible to conduct forced diuresis.

Drug interaction

With simultaneous use with levodopa preparations, dopamine receptor agonists, anticholinergic drugs, the action of the latter can be enhanced.

With simultaneous use with barbiturates, neuroleptics, the effect of the latter may be reduced.

With simultaneous use with dantrolen or Baclofen, as well as with antispasmodics, their effect may change (increase or decrease), therefore the doses of drugs should be adjusted.

The simultaneous use of memantine with amantadine due to the risk of developing psychosis should be avoided. Memantine and amantadine belong to the group of NMDA receptor antagonists. The risk of developing psychosis is also increased when used simultaneously with ketamine, dextromethorphan and phenytoin.

When taken simultaneously with cimetidine, Ranitidine, procainamide, quinidine, quinine and nicotine, plasma memantine concentrations may increase.

It is possible to reduce the level of hydrochlorothiazide while taking it with memantine by increasing its elimination from the body.

Perhaps an increase in MHO in patients simultaneously receiving oral indirect anticoagulants (warfarin).

It is recommended to constantly monitor prothrombin time or MHO.

Simultaneous use with antidepressants, selective serotonin reuptake inhibitors and MAO inhibitors requires careful monitoring of patients.

According to the results of pharmacokinetic studies in young healthy volunteers with a single simultaneous intake of memantine with glyburide / Metformin or donepezil, no effects of drug interactions were identified.

Clinical studies also did not reveal the effect of memantine on the pharmacokinetics of galantamine in young healthy volunteers.

In in vitro studies, memantine did not inhibit CYP1A2, 2A6, 2C9, 2D6, 2E1, 3A isoenzymes, monooxygenase, containing flavin, epoxyhydrolase, or sulfation.

Terms and conditions of storage

The drug should be stored in a dry, protected from light, out of reach of children at a temperature not exceeding 25 ° C.