Index of drugs

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

1 tabl powl. contains 10 mg of Memantine hydrochloride. The preparation contains lactose.

Memantine is a potential-dependent, medium-affinity non-competitive NMDA receptor antagonist. It modifies the effect of pathologically increased concentrations of glutamate, which may lead to neuronal dysfunction. The absolute bioavailability of memantine is approximately 100%. The maximum plasma concentration occurs between 3 and 8 hours after taking the drug. Memantine is approximately 45% bound to plasma proteins. Approx. 80% of the drug occurs in the circulation unchanged. The main metabolites are: N-3,5-dimethylglutantane, a mixture of 4- and 6-hydroxymemantyne isomers and 1-nitroso-3,5-dimethyladamantane. These metabolites have no NMDA antagonistic activity. In researchin vitro no cytochrome P-450 enzymatic system was observed in metabolic processes. The drug is excreted through the kidneys in more than 99%. 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 active substance or to any of the excipients.

Caution is advised in patients with epilepsy, history of seizures or patients with predisposing factors for epilepsy. The simultaneous use of NMDA antagonists such as amantadine, ketamine or dextromethorphan should be avoided. Careful monitoring of patients with factors that may lead to an increase in urine pH (eg: drastic changes in diet, eg meat diet to vegetarian or high doses of antacids, as well as tuberculosis and severe infections of the roads) urinary tract caused by bacteria of the genusProteus). Due to the limited amount of data, patients with recent myocardial infarction, uncompensated congestive heart failure (NYHA III-IV) or uncontrolled hypertension should be closely monitored. It is not recommended for use in patients with severe hepatic impairment. The preparation is not recommended for use in children and adolescents under 18 years due to the lack of data on safety and efficacy. The preparation contains lactose - should not be used in patients with rare hereditary galactose intolerance, lactase deficiency (Lapp type) or malabsorption of glucose-galactose.

Memantine should 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. The risk for people is unknown. It is not known whether memantine is excreted in human milk. However, this is possible due to the lipophilic properties of the drug. Women taking memantine should not breast-feed.

Common: hypersensitivity to the drug, drowsiness, dizziness, balance disorders, hypertension, dyspnea, constipation, increased liver enzymes, headaches. Uncommon: fungal infections, confusion, hallucinations (mainly in patients with severe Alzheimer's disease), abnormal gait, heart failure, venous thrombosis and embolism, vomiting, fatigue. Very rare: epileptic seizures. Frequency unknown: psychotic reactions, pancreatitis, hepatitis. Alzheimer's disease is associated with depression, suicidal ideation and suicide - post-marketing experience has 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 caregiver provides constant supervision over the patient's taking the medicine. Diagnosis should be made in accordance with the current guidelines.The tolerance and dosage of memantine should be regularly evaluated, especially within the first 3 months of starting treatment. Then, the therapeutic effect of memantine and treatment tolerance should be regularly assessed in accordance with current guidelines. Maintenance treatment can be continued as long as the beneficial therapeutic effect is maintained and the patient tolerates well the memantine treatment. Discontinuation of treatment should be considered when there is no indication of therapeutic effect or in case of poor tolerance of treatment. Adults. The maximum daily dose is 20 mg per day. In order to reduce the risk of adverse reactions within the first 3 weeks, the dose should be increased gradually, by 5 mg every week, until the maintenance dose is reached, according to the following scheme: 1. week (day 1 - 7): 1/2 tabl. 10 mg (5 mg) daily for 7 days; 2nd week (day 8-14): 1 plate 10 mg (10 mg) daily for 7 days; 3rd week (day 15.-21.): 1 and 1/2 tabl. 10 mg (15 mg) daily for 7 days; starting from the 4th week: 2 tabl. 10 mg (20 mg) per day. 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 the 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 use in patients with severe hepatic impairment. The product should be administered once a day, at the same time each day, with or without food.