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

Active substanceMemantineMemantine

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Dosage form: & nbspMr.tablets collection

Composition:

1 tablet, film-coated, contains:

Active substance: memantine hydrochloride 5 mg

Excipients:

Cellulose microcrystalline: 65.875 mg

Croscarmellose sodium: 3.375 mg

Silica colloidal dioxide: 0.375 mg

Magnesium stearate: 0.375 mg

Sheath:

Deficient white: 3 mg consisting of:

- Hypromellose: 1,875 mg

- Titanium dioxide E171: 0.9375 mg

- Macrogol 400: 0.1875 mg

1 tablet, film-coated, contains:

Active substance: memantine hydrochloride 10 mg

Excipients:

Cellulose microcrystalline: 131.75 mg

Croscarmellose sodium: 6.75 mg

Silica colloidal dioxide: 0.75 mg

Magnesium stearate: 0.75 mg

Sheath:

Fill yellow: 6 mg consisting of:

- Hypromellose: 3.75 mg

- Titanium dioxide E171: 1.8 mg

- Macrogol 400: 0.375 mg

- Iron oxide yellow E172: 0.075 mg

1 tablet, film-coated, contains

Active substance: memantine hydrochloride 15 mg

Excipients:

Microcrystalline cellulose: 197.625 mg

Croscarmellose sodium: 10,125 mg

Silicon dioxide colloid: 1,125 mg

Magnesium stearate: 1.125 mg

Sheath:

Ophade orange: 9 mg consisting of:

- Hypromellose: 5,625 mg

- Titanium dioxide E171: 2.22275 mg

- Macrogol 400: 0.5625 mg

- Iron oxide yellow E172: 0.549 mg

- Iron oxide red E172: 0.036 mg

1 tablet, film-coated, contains:

Active substance: memantine hydrochloride 20 mg

Excipients:

Microcrystalline cellulose: 263.5 mg

Croscarmellose sodium: 13.5 mg

Silica colloidal dioxide: 1.5 mg

Magnesium stearate: 1.5 mg

Sheath:

Foam pink: 12 mg consisting of:

- Hypromellose: 7.5 mg

- Titanium dioxide E171: 3.3984 mg

- Macrogol 400: 0.75 mg

- Iron oxide red E172: 0.2004 mg

- Iron oxide yellow E172: 0.1512 mg

Description:

Tablets, 5 mg - from white to almost white, oval in shape, covered with a film shell, engraved with "5" on one side and "MEM" on the other side.

Tablets, 10 mg - from light yellow to brownish-yellow in color, oval in shape, covered with a film sheath,with the risk on each side and with the engraving "M" on the left and right of the risks on one side, and on the other hand with the engraving "1" to the left of the risks and "0" to the right of the risks.

Tablets, 15 mg - from orange to brownish-orange in color, oval in shape, covered with a film sheath, engraved with "15" on one side and "MEM" on the other side.

Tablets, 20 mg - from pink to brownish pink in color, oval in shape, covered with a film sheath, engraved with "20" on one side and "MEM" on the other side.

Pharmacotherapeutic group:Dementia remedy

ATX: & nbsp

N.06.D.X.01 Memantine

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

Pharmacodynamics:

The adamantane derivative. 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 3-8 hours. With normal renal function, no cumulation of memantine was observed.

Distribution: daily doses of 20 mg per day lead to a stable concentration of memantine in plasma 70-150 ng / ml.

Metabolism: About 80% of memantine is excreted unchanged. In the experiments in vitro metabolism, carried out by cytochrome P₄₅₀, it was not revealed. Metabolites do not have their own pharmacological activity.

It is excreted from the body monoexponentially, with a half-life of the terminal phase of 60-100 hours. It is excreted in the urine. With an alkaline reaction, urinary excretion slows down.

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

Contraindications:

Hypersensitivity to the drug, severe renal failure (creatinine clearance 5-29 ml / min), severe hepatic impairment, pregnancy, breastfeeding, children under 18 years of age (due to insufficient data).

Carefully:

With caution appoint a patient with thyrotoxicosis, epilepsy; predisposition to the development of seizures, simultaneous use of antagonists NMDA-receptors (amantadine, ketamine, dextromethorphan), the presence of factors that increase the pH of urine (a sudden change in diet, for example, the transition to vegetarianism, a copious intake of alkaline buffer solutions), severe urinary tract infections (caused by Proteus bacteria), myocardial infarction (in the anamnesis), heart failure III-IV functional class NYHA), uncontrolled arterial hypertension, renal failure, hepatic insufficiency.

Dosing and Administration:

The drug should be taken orally once a day and always at the same time.

Can be taken regardless of food intake.

Assign:

1st week (days 1-7): one tablet with a dosage of 5 mg every day for seven days.

The 2nd week (days 8-14): one tablet with a dosage of 10 mg every day for seven days.

3rd week (days 15-21): one tablet with a dosage of 15 mg every day for seven days.

Starting with the 4th week: one tablet with a dosage of 20 mg every day.

Side effects:

Adverse reactions are classified according to clinical manifestations (in accordance with the damage of certain organ systems) and frequency of occurrence: very often (≥ 1/10), often (≥ 1/100 to <1/10), infrequently (≥ 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).

On the part of the body as a whole - general adverse reactions	Often	Headache
	Infrequently	Fatigability
Immune system disorders	Often	Hypersensitivity to the drug components
Infections	Infrequently	Fungal infections
Mental disorders	Often	Drowsiness
	Infrequently	Confusion of consciousness
	Infrequently	Hallucinations¹
	Frequency not set	Psychotic reactions
Disorders from the cardiovascular system	Often	Increased blood pressure
	Infrequently	Venous thrombosis / thromboembolism
	Infrequently	Heart failure
Disturbances from the respiratory system	Often	Dyspnea
Disorders from the gastrointestinal tract	Often	Constipation
	Infrequently	Nausea, vomiting
	Frequency not set	Pancreatitis
Infringements from central and peripheral nervous system	Often	Dizziness
	Infrequently	Violation of gait
	Rarely	Convulsions
Disturbances from the liver and bile ducts	Often Frequency not set	Increase in biochemical parameters of liver function Hepatitis

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

There are separate reports on the occurrence of these adverse reactions when the drug is used in clinical practice (data obtained after the appearance of the drug on sale): agranulocytosis,leukopenia (including neutropenia), pancytopenia, thrombocytopenia, thrombocytopenic purpura, acute renal insufficiency, Stevens-Johnson syndrome, dizziness, drowsiness, anxiety, fatigue, anxiety, increased intracranial pressure, nausea, hallucinations, headache, impairment of consciousness, muscle hypertonicity , gait disorders, depression, seizures, psychotic reactions, suicidal thoughts, constipation, nausea, pancreatitis, candidiasis, increased blood pressure, vomiting, cystitis, increasing libido, venous thrombosis, thromboembolism, allergic reactions.

Overdose:

Symptoms: increased severity of side effects, such as: fatigue, weakness, diarrhea, confusion, drowsiness, dizziness, agitation, hallucinations, gait disturbance, nausea.

In the worst case of overdose (2000 mg memantine), the patient survived, with adverse reactions from the nervous system (coma 10 days, then diplopia and agitation). The patient received symptomatic treatment and plasmapheresis. The patient recovered without further complications.

Treatment: gastric lavage, reception of activated charcoal, symptomatic therapy, urine acidification, forced diuresis.

Interaction:

With the simultaneous use of levodopa, dopamine receptor antagonists, m-holinoblokatorami with the drugs, 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 application with amantadine, ketamine, phenytoin and dextromethorphan should be avoided because of the increased risk of developing psychosis.

Possible increase in plasma concentrations of cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine while taking with memantine.

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

Perhaps an increase in INR (the international normalized ratio) in patients taking indirect anticoagulants (warfarin).

Memantine can increase the excretion of hydrochlorothiazide.

Simultaneous use with antidepressants, selective serotonin reuptake inhibitors and monoamine oxidase inhibitors requires close monitoring of patients.

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 need to refrain from managing motor vehicles or working with complex mechanisms.

Form release / dosage:

Film-coated tablets: a set of tablets 5 mg, 10 mg, 15 mg and 20 mg.

Packaging:

4 blisters made of polyvinylchloride film and aluminum foil containing 7 tablets with a 5 mg dose, 7 tablets with 10 mg dosage, 7 tablets with a dosage of 15 mg and 7 tablets with a dosage of 20 mg in one cardboard folding package.

1 cardboard folding packaging, together with the instruction for use, is placed in a cardboard box.

Storage conditions:

At a temperature not higher than 25 ° C, out of the reach of children.

Shelf life:

4 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-001433

Date of registration:13.01.2012 / 05.04.2017

Expiration Date:13.01.2017

The owner of the registration certificate:MERCZ PHARMA, LLC MERCZ PHARMA, LLC Russia

Manufacturer: & nbsp

MERZ PHARMA GmbH & Co., KGaA Germany

Representation: & nbspMERZ PHARMA LLCMERZ PHARMA LLCRussia

Information update date: & nbsp23.06.2017

Illustrated instructions

Instructions

Acathinol Memantine (Akatinol Memantine)