Acathinol Memantine - instructions for use, dose, side effects, contraindications

Excipients: lactose - 174.75 mg; cellulose microcrystalline - 52.1 mg; silicon dioxide colloidal - 1,25 mg; talc - 11.15 mg; magnesium stearate - 0.75 mg;

Sheath: methacrylic acid copolymer, type C - 1.449 mg, sodium lauryl sulfate - 0.01 mg; ylisorbate 80 - 0.034 mg; triacstium - 0.15 mg; simegicone emulsion - 0.007 mg; talc - 0.35 mg.

Description:

The tablets covered with a film cover - tablets of white color, oblong form, biconcave, having risk from each party.

Pharmacotherapeutic group:dementia treatment

ATX: & nbsp

N.06.D.X.01 Memantine

N.06.D.X Other drugs for the treatment of dementia

Pharmacodynamics:

Being a noncompetitive antagonist of N-methyl-D-aspartate (NMDA) -receptors, it has a modulating effect on the glutamatergic system. It regulates ion transport, blocks calcium channels, normalizes membrane potential, improves the process of nerve impulse transmission. Improves cognitive processes, increases daily activity.

Pharmacokinetics:

After oral administration, it is quickly and completely absorbed. The maximum concentration in the blood plasma is reached within 2-6 hours. With normal renal function, no cumulation of the drug was noted. The excretion takes place biphasic. The half-life period is 4-9 hours in the first phase, 40-65 hours in the second phase. It is excreted in the urine.

Indications:Alzheimer's dementia, vascular dementia, mixed dementia of all degrees of severity.

Contraindications:

Individual hypersensitivity to the drug, severe renal dysfunction, pregnancy, breastfeeding, children under 18 years (due to insufficient data).

Carefully:Carefully prescribe patients with thyrotoxicosis, epilepsy, seizures (including in the anamnesis), with myocardial infarction, heart failure.

Pregnancy and lactation:

Contraindicated.

Dosing and Administration:

Inside, with food.

The dosage regimen is set individually. It is recommended to begin treatment with the appointment of minimally effective doses.

Adults with dementia prescribe during the first week of therapy at a dose of 5 mg / day, during the 2nd week - at a dose of 10 mg / day. During the 3rd week - in a dose of 15-20 mg / day. If necessary, further weekly increase in the dose of 10 mg to achieve a daily dose of 30 mg.

The optimal dose is achieved gradually, with increasing doses every week.

Side effects:

Adverse reactions are classified according to clinical manifestations (according to the damage of certain organ systems) and frequency: very often (≥1 / 10), often (≥1 / 100 to <1/10), not often (≥1 / 1000 to <1/100), rarely (≥1 / 10000 to <1/1000), very rarely (<1/10000), the frequency is not established (there is currently no data on the prevalence of adverse reactions).

From the side body as a whole - general adverse reactions	Often	Headache
From the side body as a whole - general adverse reactions	Rarely	Fatigability
Infections	Rarely	Fungal infection
Mental disorders	Often	Drowsiness
	Rarely	Confusion consciousnesses
	Rarely	Hallucinations¹
	Frequency not set	Psychotic reactions²
Violations cardiovascular systems	Rarely	Hypertension
	Rarely	Venous thrombosis / thromboembolism
	Infrequently	Cardiac failure
Respiratory disorders systems	Often	Dyspnea
Gastrointestinal disorders	Often	Constipation
	Rarely	Nausea, vomiting
	Frequency not set	Pancreatitis²
Infringements from central and peripheral nervous system	Often	Dizziness
	Rarely	Violation of gait
	Rarely	Convulsions

¹Hallucinations were observed, mainly, in patients with Alzheimer's disease at the stage of severe dementia.

²There are separate reports of the occurrence of these adverse reactions when the drug is used in clinical practice (data obtained after the appearance of the drug on sale).

Overdose:

Symptoms: increased severity of side effects.

Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy.

Interaction:

With simultaneous use with drugs L-dopes, dopamine agonists, anticholinergic agents, the effect of the latter can be enhanced.

With simultaneous use with barbiturates, neuroleptics, the effect of the latter may decrease.

When combined, the effect of dantrolene or baclofen can be altered (enhanced or decreased), so the doses of the drugs should be selected individually.

Simultaneous administration with amantadine, ketamine and dexamethophan should be avoided.

There may be an increase in plasma levels of cimetidine, procainamide, kinidine, kinin and nicotine with simultaneous administration with memantine.

It is possible to reduce the level of hydrochlorothiazide when taken concomitantly with memantine.

Effect on the ability to drive transp. cf. and fur:

In patients with Alzheimer's disease, the ability to drive vehicles and manage complex mechanisms is usually impaired in the stage of moderate and severe dementia. Besides, memantine can cause a change in the reaction rate, so patients receiving treatment on an outpatient basis should be especially careful when driving vehicles or controlling mechanisms.

Form release / dosage:

Tablets, film-coated, 10 mg.

Packaging:

For 10 tablets in a blister of polyvinylchloride film and aluminum foil.

3 or 9 blisters together with instructions for use are placed in a cardboard box.

Storage conditions:

At temperatures not higher than 25 ° C, in places inaccessible to children.

Shelf life:

4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:П N014961 / 01

Date of registration:28.03.2008 / 30.06.2015

Expiration Date:Unlimited

The owner of the registration certificate:Merz Pharma GmbH & Co. KG. KGaAMerz Pharma GmbH & Co. KG. KGaA Germany

Manufacturer: & nbsp

MERZ PHARMA GmbH & Co., KGaA Germany

ZIO-HEALTH, JSC Russia

Representation: & nbspMERZ PHARMA LLCMERZ PHARMA LLCRussia

Information update date: & nbsp02.10.2016

Illustrated instructions

Instructions

Acathinol Memantine (Akatinol Memantine)