Memantine (Maruxa) 10 mg – [60 tablets]

Description

Maruksa Pharmacodynamics
Adamantan derivative. It is a non-competitive antagonist of N-methyl-D-aspartate (NMDA)-receptors, has modulating effect on glutamatergic system. It regulates ion transport, blocks calcium channels, normalizes membrane potential, improves nerve impulse transmission. Improves cognitive processes, increases daily activity.

Indications
Moderate to severe dementia in Alzheimer’s disease.

Contraindications
– Hypersensitivity to memantine and other components of the drug.
– Severe hepatic insufficiency (class C of the Child-Pugh scale).
– Pregnancy and breast-feeding.
– Age under 18 years (effectiveness and safety have not been established).
– Lactase deficiency, lactose intolerance, glucose-galactose malabsorption syndrome, because Maruksa® contains lactose.

Dosage and administration regimen

• Therapy should be controlled by physician experienced in questions of diagnosis and treatment of dementia in Alzheimer’s disease. Therapy should only be initiated if the regular caregiver will monitor the patient’s intake of the drug. The diagnosis should be made in accordance with current guidelines.
• The tolerability and dose of Maruksa® should be evaluated regularly, preferably within three months of starting therapy. Thereafter, the clinical efficacy of the drug and the tolerability of therapy should be regularly evaluated according to current clinical guidelines. Maintenance therapy can be continued indefinitely in case of therapeutic effect and good tolerability of Maruksa®. Maruksa® should be discontinued if the therapeutic effect is no longer observed or if the patient cannot tolerate the therapy.
• Orally, once a day and always at the same time, regardless of meals.
• The therapy with Maruksa® , film-coated tablets in a dose of 20 mg cannot be selected.
• For selection of therapy, memantine tablets in lower dose of 10 mg can be used.
• In order to reduce the risk of side effects, a gradual increase in dose is recommended: 5 mg per week during the first 3 weeks of therapy. The recommended maintenance dose is 20 mg per day.
• The following dosing regimen is recommended:
  Week 1 (day 1-7): daily dose is 5 mg.
  2-nd week (day 8-14): Daily dose is 10 mg.
  Week 3 (days 15-21): Daily dose – 15 mg.
  Starting from the 4th week: Daily dose – 20 mg.
• Elderly patients (over 65 years)
  No dose adjustment is required.
• Renal dysfunction
  No dose adjustment is required in patients with a creatinine clearance (CK) of 50-80 ml/min. In patients with moderate renal insufficiency (CKR 30-49 ml/min) 10 mg/day is recommended. In case of good tolerance of the drug within 7 days, the dose can be increased to 20 mg/day according to the standard scheme. In patients with severe renal insufficiency (CKR 5-29 ml/min) the daily dose should be 10 mg/day.
• Impaired liver function.
  No dose adjustment is required in patients with mild to moderate hepatic impairment (Child-Pugh grades A and B). In patients with severe hepatic impairment (Child-Pugh class C), Maruksa® is contraindicated.