Memaneurin (Drops) Instructions for Use

Marketing Authorization Holder

Biological Research And Systems, CJSC (Russia)

ATC Code

N06DX01 (Memantine)

Active Substance

Memantine (Rec.INN registered by WHO)

Dosage Form

Memaneurin

Oral drops 10 mg/1 ml: bottle 50 ml 1 pc.

Dosage Form, Packaging, and Composition

Oral drops in the form of a transparent, colorless or slightly yellowish solution.

Excipients: potassium sorbate – 2 mg, sorbitol – 70 mg, purified water – up to 1 ml.

50 ml – dark glass bottles (1) with a dropper cap – cardboard packs.
100 ml – dark glass bottles (1) with a dropper cap – cardboard packs.

Clinical-Pharmacological Group

Glutamate NMDA-receptor blocker. Drug for the treatment of dementia

Pharmacotherapeutic Group

Dementia treatment agent

Pharmacological Action

Memantine is a drug that improves cerebral metabolism, used for the treatment of dementia; it has a muscle relaxant effect. It has nootropic, cerebrovasodilating, antihypoxic, neuroprotective and psychostimulating actions.

Being a non-competitive 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 the membrane potential, improves the process of nerve impulse transmission, improves cognitive processes, memory and learning ability, and increases daily activity.

Pharmacokinetics

Absorption and Distribution.

After oral administration, Memantine is rapidly and completely absorbed from the gastrointestinal tract. C_max is reached within 2-6 hours. No accumulation of memantine has been noted with normal renal function.

Elimination

Elimination occurs in two phases. T_1/2 averages 4-9 hours in the first phase and 40-65 hours in the second phase. It is excreted mainly by the kidneys (75-90%).

Indications

• Dementia of the Alzheimer’s type;
• Vascular dementia;
• Mixed dementia of all degrees of severity.

ICD codes

Dosage Regimen

Set individually. It is recommended to start treatment with the prescription of minimally effective doses.

The daily dose is evenly divided into several doses throughout the day. The drug should be taken with meals, the last dose is recommended to be taken before dinner.

Adults are prescribed the drug during the 1st week of therapy at a dose of up to 5 mg/day (12 drops), during the 2nd week – at a dose of up to 10 mg/day (24 drops), during the 3rd week – 15-20 mg/day (36-48 drops).

If necessary, a further weekly dose increase of 10 mg is possible until a daily dose of 30 mg (72 drops) is reached.

The approximate maintenance dose is 10-20 mg/day (24-48 drops).

Adverse Reactions

Adverse reactions are classified by clinical manifestations (according to the damage to certain organ systems) and by frequency of occurrence: very common (≥ 1/10), common (≥1/100 to < 1/10), uncommon (≥ 1/1,000 to ≤ 1/100), rare (≥1/10,000 to ≤ 1/1,000), very rare (≤ 1/10,000).

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

Contraindications

• Severe impairment of renal and liver function;
• Pregnancy;
• Breastfeeding;
• Children under 18 years of age (due to insufficient data);
• Hypersensitivity to the drug.

With caution, the drug should be prescribed for thyrotoxicosis, epilepsy, seizures (including in the anamnesis), myocardial infarction, heart failure.

Use in Pregnancy and Lactation

Memaneurin is contraindicated for use during pregnancy. If it is necessary to use Memaneurin during lactation, the issue of stopping breastfeeding should be decided. In experimental studies conducted on animals, it was shown that Memaneurin does not have embryotoxic or teratogenic effects.

Use in Hepatic Impairment

Contraindicated in severe liver dysfunction.

Use in Renal Impairment

Contraindicated in severe renal impairment.

For patients with impaired renal function, the dosage regimen is set individually, depending on clinical efficacy, under the control of renal function during treatment.

Pediatric Use

Contraindicated in children under 18 years of age.

Geriatric Use

Elderly patients are preferably prescribed the drug in the form of drops.

Special Precautions

Elderly patients are preferably prescribed the drug in the form of drops.

The optimal dose is achieved gradually, with the dose increasing each week.

For patients with impaired renal function, the dosage regimen is set individually, depending on clinical efficacy, under the control of renal function during treatment.

Use with caution while driving vehicles and for people whose profession is associated with increased concentration.

Overdose

Symptoms: possible intensification of the manifestations of the described side effects.

Treatment: gastric lavage, intake of activated charcoal; if necessary, symptomatic therapy is carried out.

Drug Interactions

When used concomitantly with levodopa preparations, dopamine agonists, and anticholinergic agents, the effects of the latter may be enhanced. When used concomitantly with barbiturates and antipsychotics, the effects of the latter may be reduced. When used concomitantly, it may change (enhance or reduce) the effect of dantrolene or baclofen, so the doses of the drugs should be selected individually. Concomitant administration with amantadine, ketamine and dextromethorphan should be avoided. Plasma levels of cimetidine, procainamide, quinidine, quinine and nicotine may increase when taken concomitantly with memantine. The level of hydrochlorothiazide may decrease when taken concomitantly with memantine.

Storage Conditions

In a place protected from light at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.