Memantine-Vertex, 10 mg 30 pcs

Dementia treatment.

Pharmacodynamics:

.

Indications

Active ingredient

Composition

One film-coated tablet contains:

Dosage 10 mg

active ingredient:

memantine hydrochloride – 10.0 mg;

excipients:

Microcrystalline cellulose – 152.5 mg;

calcium hydrophosphate dihydrate – 50.0 mg;

croscarmellose sodium – 12.5 mg;

lactose monohydrate -10.0 mg;

Hyprolose (hydroxypropyl cellulose) – 5.0 mg;

Taalc, 5.0 mg;

Colloidal silicon dioxide – 2.5 mg;

Magnesium stearate – 2.5 mg;

coating:

[hypromellose – 4.000 mg, hyprolose (hydroxypropyl cellulose) – 1.552 mg, talc – 1.568 mg, titanium dioxide – 0.880 mg] or [dry film coating mixture containing hypromellose (50%), hyprolose (hydroxypropyl cellulose) (19.4%), talc (19.6%), titanium dioxide (11%)] – 8.0 mg.

Interaction

Directions for use

Memantine therapy should be initiated and administered under the supervision of a physician experienced in the diagnosis and treatment of Alzheimer-type dementia. The diagnosis should be made according to current guidelines.

The treatment should only be started if the patient’s full-time caregiver will monitor the patient’s medication intake regularly.

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

The maintenance treatment can be continued indefinitely if there is a positive therapeutic effect and good tolerability of the drug.

Memantine should be discontinued if there is no positive therapeutic effect or if the patient is intolerant to the drug.

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

It is recommended that treatment with memantine start with the lowest effective dose.

It is used during the 1st week of therapy (days 1-7) in a dose of 5 mg/day, during the 2nd week (days 8-14) in a dose of 10 mg/day, during the 3rd week (days 15-21) in a dose of 15 mg/day, starting from the 4th week in a dose of 20 mg/day.

The recommended maintenance dose is 20 mg/day.

The maximum daily dose is 20 mg.

Special patient groups

Patients in the elderly (over 65 years)

Dose adjustment is not required.

Patients with impaired renal function

Dose adjustment is not required in patients with a creatinine clearance of 50-80 ml/min.

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 according to the standard regimen.

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

Patients with hepatic impairment

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

Patients with severe hepatic impairment (Child-Pugh class C) are contraindicated.

Special Instructions

Contraindications

Side effects

Classification of the frequency of side effects according to the recommendations of the World Health Organization (WHO): Very common >1/10; common >1/100 to <1/10; infrequent >1/1000 to <1/100; rare >1/10000 to <1/1000; very rare <1/10000, including individual reports; frequency unknown – the incidence cannot be determined from available data.

Central nervous system disorders:

often – headache, dizziness, somnolence, impaired balance;

infrequent – gait disturbance, confusion, hallucinations (hallucinations have been observed mainly in patients with severe Alzheimer-type dementia);

very rarely – seizures;

frequency unknown – psychotic reactions, impaired consciousness, increased agitation, depression, anxiety, suicidal thoughts, increased intracranial pressure, muscle hypertonicity.

The cardiovascular system:

often – increased blood pressure;

infrequent – venous thrombosis/thromboembolism, heart failure.

Digestive system disorders:

often – constipation;

infrequent – nausea, vomiting;

frequency unknown – pancreatitis, hepatitis.

Respiratory system disorders:

often – shortness of breath.

Anxiety of the genitourinary system:

incidence unknown – acute renal failure, cystitis, increased libido.

Allergic reactions:

often – hypersensitivity to the components of the drug;

frequency unknown – allergic reactions, Stevens-Johnson syndrome.

Skin disorders:

incidence unknown – thrombocytopenic purpura.

Laboratory findings:

often – increased activity of “liver” enzymes;

often unknown – agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia.

Other:

infrequent – increased fatigue;

rarely – fungal infections; frequency unknown – candidiasis.

Overdose

There are limited data on overdose from clinical studies and post-registration surveillance.

Symptoms

Overdose with relatively large doses of memantine (200 mg once, or 105 mg daily for 3 days) is expressed by symptoms of fatigue, weakness and/or diarrhea or no symptoms. Overdose with up to 140 mg of memantine once or an unknown amount of memantine is expressed by symptoms related to the central nervous system (confusion, drowsiness, dizziness, vertigo, anxiety, agitation, hallucinations, gait disturbances) and/or gastrointestinal disturbances (vomiting, diarrhea).

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

The other described case of a serious overdose was 400 mg of memantine once. The patient recovered without sequelae. There were adverse effects on the nervous system: anxiety, psychosis, visual hallucinations, stupor, seizures, somnolence, unconsciousness.

Treatment

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

Pregnancy use

Similarities