Index of drugs

Treatment of patients with moderate to severe Alzheimer's disease.

1 tabl powl. contains 10 mg of Memantine hydrochloride; tablets contain lactose. 1 ml of solution contains 10 mg of memantine hydrochloride; the solution contains sorbitol.

Memantine is a potential-dependent, medium-affinity non-competitive NMDA receptor antagonist. It modifies the effects of pathologically increased concentrations of glutamate, which can lead to neuronal dysfunction. The absolute bioavailability of memantine is approximately 100%. It binds to plasma proteins in about 45%. Approx. 80% of memantine occurs in the unchanged form. In more than 99% it is excreted by the kidneys. Final T_0,5 60-100 h. In the case of alkalinisation of urine, the rate of excretion of memantine by the kidneys may be reduced by 7-9 times.

Hypersensitivity to the components of the preparation.

Use with caution in patients with epilepsy, history of seizures or in patients with predisposing factors for epilepsy. The concomitant use of N-methyl-D-aspartic acid antagonists such as amantadine, ketamine or dextromethorphan should be avoided. Careful monitoring of patients with factors that may increase the urine pH, i.e. patients with radical diet changes (from meat to vegetarian), taking high doses of stomach alkalising drugs, with renal tubular acidosis and severe urinary tract infections caused by bacteria of the genusProteus. The majority of clinical trials excluded patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV) or uncontrolled hypertension, therefore the number of available data on the use of memantine for these patients is limited. Patients with these diseases should undergo careful observation during treatment. Due to the lack of data on use and efficacy, administration of children <18 years is not recommended. The tablets contain lactose - they should not be used in patients with rare hereditary problems of galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose. The solution contains sorbitol - should not be used in patients with fructose intolerance.

Memantine must not be used during pregnancy unless clearly necessary. The results of animal studies indicate a risk of suppression of intrauterine fetal growth, with exposure levels identical or slightly higher than the human exposure levels. It is not known whether memantine is excreted in human milk. However, this is possible due to the lipophilic properties of the preparation. Women taking memantine should not breast-feed.

Common: hypersensitivity to the drug, drowsiness, dizziness, balance disorders, hypertension, dyspnoea, constipation, increased liver enzymes, headache. Uncommon: fungal infections, confusion, hallucinations (mainly in patients with severe Alzheimer's disease), abnormal gait, heart failure, venous thrombosis / embolism, vomiting, fatigue. Very rare: epileptic seizures. Frequency unknown: psychotic reactions, pancreatitis, hepatitis. Alzheimer's disease is associated with depression, suicidal thoughts and suicides. After the introduction of the product on the market, such cases have been reported in patients treated with memantine.

Orally. Treatment should be started and supervised by a doctor who has experience in the diagnosis and therapy of Alzheimer's disease. Treatment can only be started if the carer provides constant supervision over the patient's use of the medicine. Diagnosis should be made in accordance with the current guidelines. The tolerance and dosage of memantine should be regularly evaluated, especially during the first 3 months of treatment. Then, the therapeutic effect of memantine should be regularly evaluated and the patient should be tolerated according to the current guidelines.Maintenance treatment can be carried out as long as a beneficial therapeutic effect is maintained and the patient tolerates the treatment well. Discontinuation of treatment should be considered when there is no evidence of therapeutic effect or the patient can not tolerate treatment. Adults. The maximum daily dose is 20 mg per day. In order to reduce the risk of adverse reactions, the dose should be increased gradually, by 5 mg every week, until the maintenance dose is reached, according to the following schedule: 1. week (day 1-7): 5 mg, during the first 3 weeks of treatment. daily for 7 days; 2nd week (day 8-14): 10 mg daily for 7 days; 3rd week (day 15-21): 15 mg daily for 7 days; starting from 4 weeks: 20 mg daily. The recommended maintenance dose is 20 mg per day. In patients over 65 years, the recommended daily dose is 20 mg per day according to the diagram described above. In patients with slightly impaired renal function (creatinine clearance 50-80 ml / min) dose modification is not required. In patients with moderate renal impairment (creatinine clearance 30-49 ml / min) the daily dose should be 10 mg. If treatment is well tolerated for at least 7 days, the dose can be increased to 20 mg per day according to the standard schedule. In patients with severe renal impairment (creatinine clearance 5-29 ml / min), the daily dose should be 10 mg. In patients with mild or moderate hepatic impairment (Child-Pugh A and B), no dose adjustment is required. It is not recommended for patients with severe hepatic impairment. The preparation should be administered once a day, at the same time each day, regardless of meals. The tablets can be divided into two equal doses.