Memantine pills 10mg, 90pcs

Composition

One film-coated tablet contains:

The dosage is 10 mg.

Active ingredient:

memantine hydrochloride – 10.0 mg;

Auxiliary substances:

microcrystalline cellulose-152.5 mg;

calcium hydrophosphate dihydrag-50.0 mg;

croscarmellose sodium-12.5 mg;

lactose monohydrate-10.0 mg;

hyprolose (hydroxypropylcellulose) – 5.0 mg;

talc – 5.0 mg;

colloidal silicon dioxide-2.5 mg;

magnesium stearate-2.5 mg;

Film shell:

[hypromellose – 4,000 mg hyprolose (hydroxypropyl cellulose) – 1,552 mg, talc – 1,568 mg, titanium dioxide – 0,880 mg] or [dry mix for film coating containing hypromellose (50%), hyprolose (hydroxypropylcellulose) (19,4%), talc (19,6%), titanium dioxide (11%)] to 8.0 mg.

Pharmacological action

One film-coated tablet contains:

The dosage is 10 mg.

Active ingredient:

memantine hydrochloride – 10.0 mg;

Auxiliary substances:

microcrystalline cellulose-152.5 mg;

calcium hydrophosphate dihydrag-50.0 mg;

croscarmellose sodium-12.5 mg;

lactose monohydrate-10.0 mg;

hyprolose (hydroxypropylcellulose) – 5.0 mg;

talc – 5.0 mg;

colloidal silicon dioxide-2.5 mg;

magnesium stearate-2.5 mg;

Film shell:

[hypromellose – 4,000 mg hyprolose (hydroxypropyl cellulose) – 1,552 mg, talc – 1,568 mg, titanium dioxide – 0,880 mg] or [dry mix for film coating containing hypromellose (50%), hyprolose (hydroxypropylcellulose) (19,4%), talc (19,6%), titanium dioxide (11%)] to 8.0 mg.

Indications

Moderate to severe Alzheimer’s dementia.

Use during pregnancy and lactation

Pregnancyprevention during pregnancy is contraindicated, as there is no data on the effect of memantine on the course of pregnancy. Experimental studies conducted in animals indicate the possibility of slowing intrauterine growth at the level of exposure to identical or slightly higher concentrations of memantine compared to those in humans. The potential risk to humans is unknown. Breast-feeding period There is no information about the excretion of memantine in breast milk, so women taking memantine should stop breastfeeding.

Recommendations for use

Memantine therapy should be initiated and supervised by a physician with experience in the diagnosis and treatment of Alzheimer’s-type dementia. The diagnosis should be made in accordance with the current guidelines.

Treatment should only be initiated if the patient’s permanent caregiver regularly monitors the patient’s medication intake.

The tolerability and dosage of memantine should be reviewed regularly, preferably within the first three months after starting treatment. Thereafter, the clinical efficacy of memantine and patient tolerability of treatment should be reviewed in accordance with current clinical guidelines.

Maintenance treatment can be continued indefinitely if there is a positive therapeutic effect and the drug is well tolerated. Memantine should be discontinued if there is no positive therapeutic effect or if the patient is intolerant of the drug.

The drug should be taken orally once a day and always at the same time, regardless of food intake. It is recommended to start treatment with memantine with the use of the minimum effective doses.

Use during the 1st week of therapy (days 1-7) in a dose of 5 mg/day, for 2 weeks (days 8-14) at a dose of 10 mg/day, for 3 weeks (days 15-21) at a dose of 15 mg/day, starting from the 4 th week – at a dose of 20 mg/day.

The recommended maintenance dose is 20 mg / day.

The maximum daily dose is 20 mg.

Special patient groups

Elderly patients (over 65 years of age)

No dose adjustment is required.

Patients with impaired renal function

In patients with a creatinine clearance of 50-80 ml/min, no dose adjustment is required.

In patients with moderate renal insufficiency (creatinine clearance 30-49 ml / min), the recommended daily dose is 10 mg. If this dose is well tolerated for 7 days, the dose can be increased to 20 mg / day in accordance with the standard scheme.

In patients with severe renal insufficiency (creatinine clearance 5-29 ml / min), the daily dose should not exceed 10 mg.

Patients with impaired liver function

In patients with mild to moderate hepatic impairment (Child-Pugh class A and B), no dose adjustment is required.

In patients with severe hepatic insufficiency (Child-Pugh class C), the drug is contraindicated.

Contraindications

– Hypersensitivity to memantine or any of the components included in the composition of the drug;

– liver failure, severe (class C classification for child-Pugh);

– lactose intolerance, lactase deficiency, a syndrome of glucose-galactose malabsorption;

– pregnancy;

– the period of breastfeeding;

– age under 18 years (effectiveness and safety not established).

With caution:

– Thyrotoxicosis;

– epilepsy predisposition to epilepsy;

convulsions (including in the anamnesis);

– simultaneous use of antagonists of NMDA receptors (amantadine, ketamine, dextromethorphan);

– the presence of factors that increase the pH of urine (abrupt change in diet, for example, the transition to a vegetarian diet, excessive intake of alkaline gastric buffers);

renal tubular acidosis;

– severe infections of the urinary tract caused by bacteria of the genus Proteus;

– a history of myocardial infarction;

– heart failure (NYHA functional class III-IV);

– Uncontrolled arterial hypertension;

– Renal failure;

– hepatic insufficiency (Child-Pugh class A and B).

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO): very common >1/10; often from >> 1/100 to >>< 1/10; infrequently from > 1/1000 to < 1/10; infrequently from >< 1/100; rarely from > 1/10000 to < 1/100; rarely from >< 1/1000; very rare

From the central nervous system:

often – headache, dizziness, drowsiness, impaired balance;

rarely, gait disturbance, confusion, hallucinations (hallucinations was observed mainly in patients with dementia of Alzheimer’s type, severe);

very rarely – convulsions;

the frequency is unknown – psychotic reaction, disturbance of consciousness, irritability, depression, anxiety, suicidal thoughts, increased intracranial pressure, muscle hypertonicity.

From the cardiovascular system:

often-increased blood pressure;

infrequently-venous thrombosis/thromboembolism, heart failure.

From the digestive system:

often-constipation;

infrequently-nausea, vomiting;

frequency unknown-pancreatitis, hepatitis.

Respiratory system disorders:

often-shortness of breath.

From the genitourinary system:

frequency unknown-acute renal failure, cystitis, increased libido.

Allergic reactions:

often – hypersensitivity to the components of the drug;

frequency unknown-allergic reactions, Stevens-Johnson syndrome.

From the side of the skin:

frequency unknown-thrombocytopenic purpura.

Laboratory parameters:

often-increased activity of “liver” enzymes;

frequency unknown-agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia.

Other services:

infrequently-increased fatigue;

rarely-fungal infections; frequency unknown-candidiasis.

Interaction

With the simultaneous use of memantine with levodopa drugs, dopamine receptor agonists, and anticholinergic agents, their effect may be enhanced.

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

With the simultaneous use of memantine with dantrolene or baclofen, as well as with antispasmodics, their effect may change (increase or decrease), so the doses of drugs should be selected individually.

Concomitant use of memantine with amantadine should be avoided because of the risk of psychosis. Both compounds are antagonists of NMDA receptors.

The risk of psychosis is also increased when memantine is co-administered with phenytoin, ketamine, and dextromethorphan.

Concomitant administration of memantine with cimetidine, ranitidine, procainamide, quinidine, quinine, and nicotine increases the risk of increased plasma concentrations of memantine.

When memantine is co-administered with hydrochlorothiazide, it is possible to reduce the concentration of hydrochlorothiazide in blood plasma by increasing its excretion from the body.

It is possible to increase the international normalized ratio (INR) in patients taking concomitant oral indirect anticoagulants (warfarin). Regular monitoring of prothrombin time or INR is recommended in patients taking concomitant indirect anticoagulants.

The concomitant use of memantine with antidepressants, selective serotonin reuptake inhibitors and monoamine oxidase inhibitors requires careful monitoring of patients.

According to the pharmacokinetic studies conducted, no drug interaction effects were detected in young healthy volunteers with a single simultaneous use of memantine with glibenclamide/ metformin or donepezil.

Clinical studies also did not reveal the effect of memantine on the pharmacokinetics of galantamine in young healthy volunteers.

In vitro studies, memantine did not inhibit the isoenzymes CYP 1 A 2,2 A 6,2 C 9,2 D6,2 E 1,3 A, flavin-containing monooxygenase, epoxidohydrolase, or sulfation. With the simultaneous use of memantine with levodopa drugs, dopamine receptor agonists, and anticholinergic agents, their effect may be enhanced.

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

With the simultaneous use of memantine with dantrolene or baclofen, as well as with antispasmodics, their effect may change (increase or decrease), so the doses of drugs should be selected individually.

Concomitant use of memantine with amantadine should be avoided because of the risk of psychosis. Both compounds are antagonists of NMDA receptors.

The risk of psychosis is also increased when memantine is co-administered with phenytoin, ketamine, and dextromethorphan.

Concomitant use of memantine with cimetidine, ranitidine, procainamide, quinidine, quinine, and nicotine increases the risk of increased plasma concentrations of memantine.

When memantine is co-administered with hydrochlorothiazide, it is possible to reduce the concentration of hydrochlorothiazide in blood plasma by increasing its excretion from the body.

It is possible to increase the international normalized ratio (INR) in patients taking concomitant oral indirect anticoagulants (warfarin). Regular monitoring of prothrombin time or INR is recommended in patients taking concomitant indirect anticoagulants.

The concomitant use of memantine with antidepressants, selective serotonin reuptake inhibitors and monoamine oxidase inhibitors requires careful monitoring of patients.

According to the pharmacokinetic studies conducted, no drug interaction effects were detected in young healthy volunteers with a single simultaneous use of memantine with glibenclamide/ metformin or donepezil.

Clinical studies also did not reveal the effect of memantine on the pharmacokinetics of galantamine in young healthy volunteers.

In vitro studies, memantine did not inhibit the isoenzymes CYP 1 A 2,2 A 6,2 C 9,2 D6,2 E 1,3 A, flavin-containing monooxygenase, epoxidohydrolase, or sulfation.

Overdose

There are limited overdose data available from clinical trials and post-marketing surveillance.

Symptoms

Overdose when taking relatively large doses of memantine (200 mg once, or 105 mg per day for 3 days) is expressed by symptoms of fatigue, weakness and/or diarrhea, or the absence of symptoms. Overdose when taking up to 140 mg of memantine once or an unknown amount of memantine is expressed by symptoms associated with the central nervous system (confusion, drowsiness, dizziness, vertigo, restlessness, agitation, hallucinations, gait disorders) and/or gastrointestinal disorders (vomiting, diarrhea).

In the most serious cases of overdose, the patient survived after taking more than 2000 mg of memantine with adverse events from the nervous system (coma for 10 days, later diplopia, agitation). The patient received symptomatic therapy and plasmapheresis, and recovered without consequences.

Another reported case of serious overdose was 400 mg of memantine once. The patient recovered without any consequences. There were adverse events from the nervous system: anxiety, psychosis, visual hallucinations, stupor, seizures, drowsiness, unconsciousness.

Treatment

Symptomatic therapy, gastric lavage, use of adsorbents (activated carbon), acidification of urine, forced diuresis (if necessary). There is no specific antidote.

Special instructions

If the urine is alkaline in patients, more careful monitoring of such patients is required due to a slowdown in the elimination of memantine. Factors that cause an increase in the pH of urine include: sudden changes in the diet, for example, replacing a meat-rich diet with a vegetarian one or intensive use of alkaline gastric buffers. In addition, the pH of the urine may increase due to renal tubular acidosis or a severe urinary tract infection caused by bacteria of the genus Proteus.

Data on the use of memantine in patients with a history of myocardial infarction, chronic heart failure (NYHA functional class III-IV) or uncontrolled arterial hypertension are limited, so careful medical monitoring of such patients is necessary.

Use with caution in patients with thyrotoxicosis, epilepsy, seizures (including in the anamnesis) and predisposition to epilepsy.

Concomitant use of memantine and NMDA receptor antagonists such as amantadine, ketamine, and dextromethorphan should be avoided. These compounds act on the same receptor system as memantine, and therefore adverse reactions (mainly from the central nervous system) may occur more often and be more pronounced.

Medication Memantine contains lactose monohydrate. Patients with hereditary galactose intolerance, lactase deficiency, or glucose-galactose malabsorption should not take this medicine. Memantine.

Influence on the ability to drive vehicles and mechanisms:

Patients with moderate to severe Alzheimer’s dementia usually have impaired ability to drive vehicles and manage complex mechanisms. In addition, memantine can cause changes in the reaction rate, so patients should refrain from driving vehicles or working with complex mechanisms.

Form of production

Film-coated tablets.

Storage conditions

Store in a dark place, at a temperature not exceeding 25 °C.

Keep out of the reach of children.

Shelf

life Store in a dark place, at a temperature not exceeding 25 °C. Keep out of reach of children.

Active ingredient

Memantine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets