Memantine Canon, 15 mg 30 pcs

Moderate to severe dementia of the Alzheimer type.

Active ingredient

Composition

1 film-coated tablet, 15 mg contains:

the active ingredient:

Memantine hydrochloride 15 mg;

excipients:

calcium hydrophosphate dihydrate 45.5 mg,

colloidal silicon dioxide 4.2 mg,

croscarmellose sodium 6 mg,

Lactose monohydrate 130.3 mg,

Magnesium stearate 1.5 mg,

Povidone K-30 7.5 mg;

film coating:

Opadray white 6 mg, including: hypromellose (hydroxypropyl methylcellulose) 2.025 mg, hyprolose (hydroxypropylcellulose)2.025 mg, talc 1.2 mg, titanium dioxide 0.75 mg.

How to take, the dosage

The therapy should be supervised by a physician experienced in the diagnosis and treatment of dementia in Alzheimer’s disease. Therapy should be initiated if the patient (or the patient’s full-time caregiver) is willing to monitor the medication regularly. The diagnosis should be made in accordance with current guidelines. Tolerability and dosage of Memantine Canon should be assessed regularly, preferably within three months of initiation of therapy. Thereafter, the clinical efficacy of the drug and the tolerability of therapy should be evaluated regularly according to current clinical guidelines. Maintenance therapy can be continued indefinitely in the presence of a positive effect and good tolerability of Memantine Canon. The drug should be discontinued if there is no longer a positive therapeutic effect or if the patient cannot tolerate the therapy.

The drug should be taken orally, once a day, at the same time, without chewing, with plenty of fluid, regardless of meals. The maximum daily dose is 20 mg.

The dosage regimen is determined individually. It is recommended to start treatment with the lowest effective dose. To decrease the risk of side effects, the fixed dose is taken in increasing titration of 5 mg weekly for the first three weeks according to the following regimen:

Week 1 (days 1-7): one 5 mg tablet each day for seven days.

Week 2 (days 8-14): one 10 mg tablet every day for seven days.

Week 3 (days 15-21): One 15 mg tablet every day for seven days.

From week 4: one 20 mg tablet every day.

Use in selected patient groups

Patients in the elderly

For patients over 65 years of age, the recommended dose is 20 mg daily.

Patients with impaired renal function

In patients with mild impaired renal function (creatinine clearance
50-80 ml/min) no dose adjustment is required.

In patients with moderate renal impairment (creatinine clearance of 30-49 ml/min) the dose of the drug should be 10 mg per day. If this dose is well tolerated for at least 7 days of treatment, it can be increased to 20 mg daily according to the standard dosing regimen.

In patients with severe renal impairment (creatinine clearance 5-29 ml/min) the dose of the drug should not exceed 10 mg daily.

Patients with hepatic impairment

Patients with mild to moderate hepatic impairment (Child-Pugh grades A and B) do not require dose adjustment.

In patients with severe hepatic impairment (Child-Pugh class C), use of Memantine Canon is contraindicated.

Interaction

Levodopa, dopamine receptor agonists and m-cholinoblockers. In concomitant use of memantine with levodopa preparations, dopamine receptor antagonists, m-cholinoblockers, the effect of the latter may increase, as well as in concomitant use with other NMDA-receptor antagonists.

Barbiturates and neuroleptics. When used concomitantly with barbiturates, neuroleptics the effect of the latter may be reduced. When used together it can change (increase or decrease) the effect of dantrolene or baclofen, therefore the doses of the drugs should be adjusted individually.

Amantadine, ketamine, dextromethorphan. Concomitant use with amantadine, ketamine, phenytoin and dextromethorphan should be avoided because of the increased risk of psychosis. These drugs are chemically related NMDA receptor antagonists.

Phenytoin. Co-administration of memantine with phenytoin should be avoided.

Cimetidine, ranitidine, procainamide, quinidine, quinine, nicotine. Plasma concentrations of cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine may increase with memantine due to the same renal cationic transport system.

Hydrochlorothiazide. There may be a decrease in concentrations of hydrochlorothiazide or any combination with hydrochlorothiazide when concomitantly taken with memantine.

Indirect anticoagulants. International normalized ratio (MHO) may increase in patients taking indirect anticoagulants (warfarin). Although there is no causal relationship, close monitoring of prothrombin time and INR is recommended in patients simultaneously taking warfarin and memantine.

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

Lack of interactions. No interactions of memantine with glibenclamide or metformin or donepezil or galantamine have been identified in single-dose pharmacokinetic studies. Memantine does not inhibit the CYP1A2, CYP2A6, CYP2C9, CYP2D6, CYP2E1, CYP3A, flavin monoxidase, epoxide hydrolase or sulfation isoenzymes in vitro.

Special Instructions

Perhaps with caution in patients with epilepsy, a history of seizures, or in patients with a predisposition to epilepsy.

Prescribing memantine with other NMDA receptor antagonists (amantadine, ketamine, dextromethorphan) should be avoided, since adverse reactions may be more frequent and more intense, mainly at the CNS level.

The presence in a patient of factors affecting elevated urinary pH (abrupt dietary changes, such as switching from a diet that includes animal products to a vegetarian diet, or heavy consumption of alkaline gastric buffers), and renal tubular acidosis or severe urinary tract infections caused by Proteus spp. require close monitoring of the patient.

Patients with a history of myocardial infarction, decompensated chronic heart failure (NYHA functional class III-IV), or uncontrolled arterial hypertension were excluded from most clinical trials. Therefore, data on the use of memantine in such patients are limited and the drug should be administered under close medical supervision.

Impact on the ability to drive vehicles and engage in other potentially dangerous activities

In patients with Alzheimer’s disease at the stage of moderate to severe dementia the ability to drive vehicles and operate complex mechanisms is usually impaired. In addition, Memantine Canon may cause changes in reaction speed, so patients should refrain from driving and operating complex machinery.

Contraindications

Prevalence.With caution

Side effects

WHO Classification of the incidence of adverse reactions:

very common – ≥1/10 appointments (>10%)

often – ≥1/100 to <1/10 appointments (>1% and <10%)

infrequent – ≥1/1000 to <1/100 appointments (>0.1% and <1%)

rare – ≥1/10000 to <1/1000 appointments (>0.01% and <0.1%)

very rare – <1/10000 appointments (<0.01%)

frequency is unknown – the incidence cannot be determined from the available data.

Infectious and parasitic diseases

Infrequent: fungal infections.

Immune system disorders

Often: hypersensitivity to the components of the drug.

Mental disorders

Infrequent: confusion, hallucinations (observed mainly in patients with severe Alzheimer’s disease).

Prevalence not known: psychotic reactions.

Nervous system disorders

Often: headache, dizziness, somnolence, impaired balance.

Infrequent: impaired gait.

Very rarely: seizures, epileptic seizures.

Cardiac disorders

Infrequent: heart failure, heart defects.

Vascular disorders

Often: increase in blood pressure.

Infrequent: venous thrombosis and/or thromboembolism.

Respiratory system, thorax and mediastinum disorders

Often: dyspnea.

Gastrointestinal tract disorders

Often: constipation.

Infrequent: nausea, vomiting.

Infrequent not known: pancreatitis.

Hepatic and biliary tract disorders

Often: impaired liver function tests.

Prevalence not known: hepatitis.

Hematopoietic disorders

Prevalence not known: agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia, thromocytopenic purpura.

Renal and urinary tract disorders

Prevalence not known: acute renal failure.

Skin and subcutaneous tissue disorders

Prevalence not known: Stevens-Johnson syndrome.

General disorders and disorders at the site of administration

Infrequent: fatigue, general weakness.

In Alzheimer’s disease, depression, suicidal ideation, and suicidal episodes have been reported in patients in post-registration studies.

Overdose

Symptoms:

In cases of overdose of less than 140 mg once or when an unknown dose was taken, patients have had adverse reactions from the central nervous system: confusion, hypersomnia, drowsiness, dizziness, agitation, aggression, hallucinations, gait disturbances; and from the cardiovascular system: vomiting, diarrhea.

In relatively large overdoses (200 mg once and 105 mg/day for 3 days) the following symptoms were observed: fatigue, weakness, and/or diarrhea or no symptoms.

In the most severe case of overdose, the patient survived the 2000 mg dose of memantine and had central nervous system adverse reactions (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 a severe overdose, the patient survived and recovered after receiving memantine at a dose of 400 mg once. The patient experienced central nervous system adverse reactions: anxiety, psychosis, visual hallucinations, decreased seizure threshold, drowsiness, stupor, and loss of consciousness.

Treatment: There is no specific antidote for memantine intoxication. Standard procedures should be carried out to remove the drug from the body by gastric lavage, taking activated charcoal, conducting forced diuresis, increasing the acidity of the urine.

Similarities