Noodzheron tablets p / o 10mg, No. 30

Dementia of moderate to severe severity in Alzheimer's disease.

Inside, regardless of the meal.
During the first week, the daily dose is 5 mg (in the morning). In the second week, the daily dose is 10 mg (5 mg 2 times a day). During the third week, the daily dose is 15 mg per day (10 mg in the morning and 5 mg in the evening). From the fourth week, the daily dose is 20 mg per day. The maximum daily dose is 20 mg per day.
No dose adjustment is required in elderly patients (over 65 years of age).
With moderate renal failure (creatinine clearance 50-80 ml / min), dose adjustment is usually not required; with creatinine clearance of 30-49 ml / min, the daily dose initially does not exceed 10 mg, then after 7 days, subject to good tolerance, the dose can be increased up to 20 mg. In severe renal failure (creatinine clearance 5-29 ml / min), the daily dose should not exceed 10 mg.
With mild to moderate hepatic impairment (class A and B according to the Child-Pugh classification), dose adjustment is not required.

Active substance:

memantine hydrochloride - 10 mg

Excipients:

microcrystalline cellulose - 144 mg, colloidal silicon dioxide - 1 mg, croscarmellose sodium - 3.4 mg, magnesium stearate - 1.6 mg.

The composition of the film shell: Opadray 03A28315 white - 4.8 mg (hypromellose 6cP - 3.12 mg, titanium dioxide (E171) 1.440 mg, talc - 0.24 mg).

Hypersensitivity to any component of the drug, severe hepatic failure, pregnancy, breastfeeding, age up to 18 years (the effectiveness and safety of the drug have not been studied).
With care: epilepsy, renal failure, thyrotoxicosis, a history of convulsions, arterial hypertension, a history of myocardial infarction, heart failure.

Trade name of the drug: Noodzheron - Teva

International non-proprietary name:

memantine

Dosage form:

film-coated tablets

Description:

White or almost white film-coated tablets, oval, biconvex, on one side with a line and engraved 'M' on the right and left sides of the line, on the other side with a line and engraved '1' to the left of the line and '0' to the right of the risks.

Composition:

Active substance:

memantine hydrochloride - 10 mg

Excipients:

microcrystalline cellulose - 144 mg, colloidal silicon dioxide - 1 mg, croscarmellose sodium - 3.4 mg, magnesium stearate - 1.6 mg.

The composition of the film shell: Opadray 03A28315 white - 4.8 mg (hypromellose 6cP - 3.12 mg, titanium dioxide (E171) 1.440 mg, talc - 0.24 mg).

Pharmacological group: centrally acting muscle relaxant.

Pharmacological properties
Pharmacodynamics. The adamantane derivative is close to amantadine in chemical structure and pharmacological properties. It is a non-competitive antagonist of glutamate N-methyl-D-aspartate (NMDA) -receptors (including in the substantia nigra), as a result of which it reduces the excessive stimulating effect of cortical glutamate neurons on the neostriatum, which develops against the background of insufficient release of dopamine. By reducing the supply of Ca2 + to neurons, it reduces the possibility of their destruction. It has a nootropic, cerebrovasodilating, antihypoxic and psychostimulating effect. Mostly affects stiffness (rigidity and bradykinesia). Improves impaired memory, concentration, fatigue and depression symptoms.
Pharmacokinetics.It is rapidly and completely absorbed after oral administration. The maximum concentration (Cmax) is reached 3-8 hours after ingestion. Food does not affect absorption. A daily dose of 20 mg leads to an equilibrium plasma concentration of 70 to 150 ng / ml. The volume of distribution is 10 l / kg. Protein binding - 45%. 80% of memantine circulating in the blood is represented by an unchanged substance. Metabolism proceeds without the participation of cytochrome P450. The main metabolites - N-3,5-dimethylgludantane (in the form of 2 isomers) and 1-nitroso-3,5-dimethyl-adamantane - have no pharmacological activity.
It is excreted by the kidneys. Elimination occurs in one phase, the half-life is 60-100 hours; clearance is 170 ml / min / 1.73 m2, the drug is partially secreted by the renal tubules. With an alkaline reaction of urine, the elimination of the drug slows down.

Indications for use
Moderate and severe dementia in Alzheimer's disease.

Contraindications
Hypersensitivity to any of the components of the drug, severe hepatic impairment, pregnancy, breastfeeding, age up to 18 years (the effectiveness and safety of the drug have not been studied).
With care: epilepsy, renal failure, thyrotoxicosis, a history of convulsions, arterial hypertension, a history of myocardial infarction, heart failure.

Application during pregnancy and lactation
Memantine has the ability to slow down the development of the fetus. During treatment with memantine, breastfeeding should be interrupted.

Route of administration and dosage
Inside, regardless of food intake.
During the first week, the daily dose is 5 mg (in the morning). In the second week, the daily dose is 10 mg (5 mg 2 times a day). During the third week, the daily dose is 15 mg per day (10 mg in the morning and 5 mg in the evening). From the fourth week, the daily dose is 20 mg per day. The maximum daily dose is 20 mg per day.
No dose adjustment is required in elderly patients (over 65 years of age).
With moderate renal failure (creatinine clearance 50-80 ml / min), dose adjustment is usually not required; with creatinine clearance of 30-49 ml / min, the daily dose initially does not exceed 10 mg, then after 7 days, subject to good tolerance, the dose can be increased up to 20 mg. In severe renal failure (creatinine clearance 5-29 ml / min), the daily dose should not exceed 10 mg.
With mild to moderate hepatic impairment (class A and B according to the Child-Pugh classification), dose adjustment is not required.

Side effect
From the nervous system: dizziness, headache, drowsiness, gait disturbance, confusion, hallucinations, convulsions, psychosis, increased excitability.
From the gastrointestinal tract: constipation; vomiting; pancreatitis, nausea. Infections and invasions: fungal infections.
From the side of the cardiovascular system: increased blood pressure, venous thrombosis, thromboembolism.
On the part of the body as a whole: general weakness, increased fatigue, allergic reactions.

Overdose
Symptoms: dizziness, tremors, agitation, drowsiness, confusion, agitation, stupor, convulsions, aggressiveness, hallucinations, gait instability, vomiting, diarrhea.
Treatment: gastric lavage, the appointment of activated carbon; symptomatic therapy. There is no specific antidote.

Interaction with other medicinal products
When administered simultaneously, it can weaken the effect of barbiturates and antipsychotics. The effects of baclofen and dantrolene can be sex-altered by memantine, so dose adjustments may be required.
The effects of levodopa, dopamine receptor agonists and anticholinergics are enhanced by concomitant use of NMDA antagonists.
Due to the fact that memantine and amantadine are NMDA receptor antagonists, simultaneous use should be avoided due to the risk of toxic effects. Combinations of memantine with ketamine, dextromethorphan and phenytoin are also potentially toxic.
For the transport of amantadine, cimetidine, ranitidine, quinidine, quinine and nicotine in the body, the same renal cation system is used, which may cause the interaction of these drugs with memantine, leading to an increase in its concentration in blood plasma.
With the simultaneous use of memantine can cause a decrease in the concentration of hydrochlorothiazide in the blood serum.
When used simultaneously with warfarin and other indirect anticoagulants, careful monitoring of prothrombin time and international normalized ratio is required.

Special instructions
In case of an alkaline urine reaction, more careful monitoring of such patients is required due to the slowdown in the excretion of memantine.
Alzheimer's disease is known to affect the ability to drive a car; in addition, treatment with memantine can also change the reaction rate, which should be taken into account when driving and dangerous machinery.

Release form
Tablets, film-coated 10 mg.
10 tablets in a PVC / PVDC / aluminum foil blister. 3, 6 or 9 blisters with instructions for use in a cardboard box.

Storage
conditions Store at a temperature not exceeding 25 ? —.
Keep out of the reach of children.

Shelf life is
2 years.
Do not use after the expiration date printed on the package

Vacation conditions: by prescription.