Maruksa 10mg, No. 30
Expiration Date: 05/2027
Russian Pharmacy name:
Марукса 10мг, №30
Treatment of patients with moderate to severe Alzheimer's disease.
Inside, once a day and always at the same time, regardless of the meal.
Therapy should be supervised by a physician experienced in the diagnosis and treatment of dementia in Alzheimer's disease. Therapy should only be started if the patient's caregiver monitors the patient's medication. The diagnosis should be made in accordance with current guidelines.
The tolerance and dose of MaruksaЃ should be regularly assessed, preferably within 3 months after starting therapy. Then, the clinical efficacy of the drug and the tolerability of therapy should be regularly assessed in accordance with current clinical guidelines. Supportive therapy can be continued indefinitely if there is a therapeutic effect and good tolerance for MaruxaЃ. The use of MaruksaЃ should be discontinued if the therapeutic effect is no longer observed or the patient does not tolerate therapy.
In order to reduce the risk of side effects, a gradual increase in dose is recommended: 5 mg / week during the first 3 weeks of therapy. The recommended maintenance dose is 20 mg / day.
The following dosing regimen is recommended:
1st week (1-7th day): daily dose - 5 mg (on? Tab. MaruksaЃ 10 mg every day for 7 days);
2nd week (8-14th day): daily dose - 10 mg (1 tab. MaruksaЃ 10 mg every day for 7 days);
3rd week (15-21 days): daily dose - 15 mg (1? Tab. MaruksaЃ 10 mg every day for 7 days);
starting from the 4th week: daily dose - 20 mg (2 tablets. MaruksaЃ 10 mg every day).
Special patient groups
Elderly patients (over 65 years old). No dose adjustment is required.
Impaired renal function. In patients with Cl creatinine 50Ц80 ml / min, dose adjustment is not required. For patients with moderate renal impairment (Cl creatinine 30Ц49 ml / min), a dose of 10 mg / day is recommended. If the drug is well tolerated for 7 days, the dose can be increased to 20 mg / day according to the standard regimen. In patients with severe renal impairment (Cl creatinine 5Ц29 ml / min), the dose should be 10 mg / day.
Liver dysfunction. In patients with mild to moderate hepatic impairment (class A and B on the Child-Pugh scale), dose adjustment is not required.
| Film-coated tablets | 1 tab. |
| core: | |
| active substance: | |
| memantine hydrochloride | 10 mg |
| excipients: lactose monohydrate - 51.45 mg; MCC - 175 mg; colloidal silicon dioxide - 2.5 mg; talc - 9.8 mg; magnesium stearate - 1.25 mg | |
| film shell: methacrylic acid and ethyl acrylate copolymer (1: 1), 30% aqueous dispersion * - 0.6 mg **; talc - 0.27 mg; triacetin - 0.12 mg; simethicone - 0.01 mg | |
| * 30% aqueous dispersion contains, in addition to methacrylic acid and ethyl acrylate copolymer, also sodium lauryl sulfate (0.7%; calculated on dry matter in suspension) and polysorbate 80 (2.3%; calculated on dry matter in suspension) as emulsifiers | |
| ** Expressed as the mass of dry matter included in a 30% aqueous dispersion |
hypersensitivity to memantine and other components of the drug;
severe hepatic impairment (class C on the Child-Pugh scale);
lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome, because the composition of the drug MaruksaЃ contains lactose;
pregnancy;
breastfeeding period;
age up to 18 years (efficacy and safety have not been established).
With care: epilepsy; thyrotoxicosis; predisposition to the development of seizures; concomitant use of other NMDA receptor antagonists (amantadine, ketamine, dextromethorphan); factors that increase the pH of urine (a sharp change in diet, for example, switching to vegetarianism, abundant intake of alkaline gastric buffers); renal tubular acidosis; severe urinary tract infections caused by Proteus spp .; myocardial infarction (history); heart failure III Ц IV functional class according to NYHA classification; uncontrolled arterial hypertension; renal failure; liver failure.