Index of drugs

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

1 tabl powl. contains 10 mg of Memantine hydrochloride.

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%. 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 memantine 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. Care should be taken to monitor the condition of patients who are prone to increase urine pH (eg: radical diet changes, eg meat diets for vegetarian, high doses of stomach alkalising preparations, as well as tuberculosis and severe urinary tract infections) 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.

Memantine should not be used during pregnancy unless clearly necessary (animal studies indicate a risk of suppression of intrauterine growth of the fetus). It is unknown whether memantine is excreted in human milk, but it is possible due to its lipophilic properties - women taking the drug should not breastfeed.

Common: hypersensitivity to the drug, drowsiness, dizziness, balance disorders, hypertension, dyspnoea, constipation, increased liver enzymes, headache. Uncommon: fungal infections, confusion, hallucinations, abnormal gait, heart failure, venous thrombosis and / or embolism, vomiting, fatigue. Very rare: epileptic seizures. Frequency unknown: psychotic reactions, pancreatitis, hepatitis. Alzheimer's disease is associated with depression, suicidal thoughts and suicides; post-marketing experience has been reported in patients treated with memantine.

Orally. Treatment should be initiated 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 if there is no evidence of therapeutic effect or if treatment tolerance is poor.Adults. The maximum daily dose is 20 mg per day. To reduce the risk of adverse reactions, the dose should be gradually increased in the first 3 weeks of treatment with 5 mg every week until the maintenance dose is reached, according to the following schedule: 1. week (day 1-7): 5 mg per day 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 product should be administered once a day, at the same time each day, with or without food. Table. 10 mg can be divided into equal doses.