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medicalmeds.eu Medicines Muscle relaxant of the central action. Noodzheron

Noodzheron

Препарат Нооджерон. Teva (Тева) Израиль


Producer: Teva (Tev) Israel

Code of automatic telephone exchange: N06DX01

Release form: Firm dosage forms. Tablets.

Indications to use: Dementia.


General characteristics. Structure:

Active ingredient: мемантин (10 mg in the form of a memantin of a hydrochloride);
excipients: microcrystallic cellulose, calcium hydrophosphate, croscarmellose sodium, silicon dioxide colloid, magnesium stearate;
film cover: Опадрай the II gray 45F27505 (gipromelloza-2910/15sr, polydextrosum, titanium dioxide, makrogol/makrogol-4000, dye ferrous oxide black).

Description: oval biconvex tablets of gray color, film coated, with an engraving "10" and risky between figures on one party and an engraving of "MM" and risky between letters on other party.




Pharmacological properties:

Pharmacodynamics. Derivative an adamantana, on chemical structure and pharmacological properties it is close to an amantadin. N-methyl-D-aspartate (NMDA) - receptors, (including in black substance) is a non-competitive antagonist glutamate thereof reduces the excessive stimulating influence of cortical glutamate neurons on a neostriatum developing against the background of insufficient release of dopamine. Reducing receipt of Sa2 + in neurons, reduces a possibility of their destruction. Possesses nootropic, tserebrovazodilatiruyushchy, antihypoxemic and psychogogic action. More influences constraint (rigidity and a bradykinesia). Improves the weakened memory, concentration of attention, reduces fatigue and symptoms of a depression.

Pharmacokinetics. It vsasypatsya quickly and completely after intake. The maximum concentration (Cmax) is reached 3-8 hours later after reception. Food does not influence absorption. The daily dose of 20 mg results from 70 to 150 ng/ml in equilibrium plasma concentration. The volume of distribution makes 10 l/kg. Linkng with proteins - 45%. 80% of the memantin circulating in blood are presented by not changed substance. Metabolism proceeds without P450 cytochrome participation. The main metabolites - N-3,5-dimetilgludantan (in the form of 2 isomers) and 1-nitrozo-3,5-dimethyl-адамантан - have no pharmacological activity.
It is removed by kidneys. Elimination happens odnofazno, the poluvynedeiiya makes the period — 60-100 hours; the clearance makes 170ml/min/1,73 sq.m, drug partially cosecretes renal tubules. At alkali reaction of urine removal of drug is slowed down.


Indications to use:

Dementia of average and heavy degree of manifestation at Alzheimer's disease.


Route of administration and doses:

Inside, irrespective of meal.
Within the first week the daily dose makes in 5 mg (morning). On the second week the daily dose makes 10 mg (on 5 mg 2 times a day). During the third week a daily dose - 15 mg a day (10 mg in the morning and 5 mg in the evening). From fourth week the daily dose makes 20 mg a day. The maximum daily dose of 20 mg a day.
Dose adjustment is not required from elderly patients (65 years are more senior).
At a moderate renal failure (clearance of creatinine of 50-80 ml/min.) dose adjustment usually is not required; at clearance of creatinine of 30-49 ml/min. the daily dose originally does not exceed 10 mg, then in 7 days on condition of good tolerance the dose can be raised up to 20 mg. At a heavy renal failure (clearance of creatinine of 5-29 ml/min.) the daily dose should not exceed 10 mg.
At a slight and moderate liver failure (a class A and B on classification of Chayld-Pyyu) dose adjustment is not required.


Features of use:

At alkali reaction of urine more careful observation of such patients because of delay of removal of a memantin is required.
It is known that Alzheimer's disease exerts impact on ability to driving of the car; besides, treatment memantiny can also change speed of response that should be considered when driving and dangerous mechanisms.


Side effects:

From a nervous system: dizziness, headache, drowsiness, gait disturbance, confusion of consciousness, hallucination, spasm, psychosis, hyperexcitability.
From digestive tract: lock; vomiting; pancreatitis, nausea. Infections and invasions: fungal infections.
From cardiovascular system: increase in arterial pressure venous thrombosis, thromboembolism.
From an organism and whole: general weakness, increased fatigue, allergic reactions.


Interaction with other medicines:

At one temporary appointment can weaken effect of barbiturates and neuroleptics. Action of Baclofenum and dantrolen can change a floor influence of a memantin therefore correction of their doses can be required.
Effects of a levodopa, agonists of dopamine receptors and anticholinergics amplify at simultaneous use of NMDA antagonists.
Because мемантин and амантадин antagonists of NMDA receptors represent, it is necessary to avoid simultaneous use in connection with risk of development of toxic action. Also combinations of a memantin with ketamine, dextromethorphan and Phenytoinum are potentially toxic.
For transport of an amantadin, Cimetidinum, ranitidine, quinidine, quinine and nicotine in an organism the same renal cationic system is used that can cause interaction of these drugs with memantiny, leading to increase in its concentration in a blood plasma.
At simultaneous use мемантин can cause decrease in concentration of a hydrochlorothiazide in blood serum.
At simultaneous use with warfarin and other indirect anticoagulants careful control of a prothrombin time and the international normalized relation is required.


Contraindications:

Hypersensitivity to any of drug components, a heavy liver failure, pregnancy, breastfeeding, age up to 18 years (efficiency and safety of drug are not studied).
With care: epilepsy, a renal failure, a thyrotoxicosis, spasms in the anamnesis, arterial hypertension, a myocardial infarction in the anamnesis, heart failure.

Use during pregnancy and in the period of a lactation
 Miemangting has ability to slow down fetation. For the period of treatment memantiny breastfeeding should be interrupted.


Overdose:

Symptoms: dizziness, tremor, agitation, drowsiness, stupefaction, excitement, stupor, spasms, aggression, hallucinations, instability of gait, vomiting, diarrhea.
Treatment: gastric lavage, purpose of absorbent carbon; symptomatic therapy. There is no specific antidote.


Storage conditions:

To store at a temperature not above 25 °C. To store in the place, unavailable to children. Period of validity 2 years. Not to apply after the expiry date specified on packaging.


Issue conditions:

According to the recipe


Packaging:

Tablets, film coated 10 mg.
On 10 tablets in the blister from PVC/PVDH / aluminum foil. On 3, 6 or 9 blisters together with the application instruction in a cardboard pack.



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