Memantal pills 10mg, 90pcs

Composition

of memantine hydrochloride 10.00 mg; excipients: tablet core-lactose monohydrate 149.75 mg, microcrystalline cellulose 27.10 mg, talc 11.15 mg, colloidal silicon dioxide 1.25 mg, magnesium stearate 0.75 mg; shell-Opadray white (lactose monohydrate 2.16 mg, hypromellose 1.68 mg, titanium dioxide 1.56 mg, macrogol-4000 0.60 mg) – 6.00 mg

Pharmacological action

A derivative of adamantane. It is a non-competitive antagonist of N-methyl-D-aspartate receptors (NMDA), and has a modulating effect on the glutamatergic system. Regulates ion transport, blocks calcium channels, normalizes the membrane potential, and improves the process of nerve impulse transmission. Improves cognitive processes, increases daily activity.

Indications

-moderate to severe Alzheimer’s dementia.

Use during pregnancy and lactation

There are no data on the use of memantine in pregnant women. Memantine should only be used when the expected benefit to the mother outweighs the potential risk to the fetus. There are no data on the penetration of memantine into breast milk. Taking into account the lipophilic structure of the Active ingredient of the drug, it can be assumed that memantine can penetrate into breast milk, and therefore it is recommended to stop breastfeeding while taking the drug

Recommendations for use

Therapy should be conducted under the supervision of a doctor who has experience in the diagnosis and treatment of dementia in Alzheimer’s disease. Therapy should only be initiated if the person providing regular care for the patient monitors the patient’s medication intake. The diagnosis should be made in accordance with the current guidelines. The tolerability and dose of the drug should be evaluated regularly, mainly within three months after the start of therapy. Then, the clinical efficacy of the drug and the tolerability of therapy should be regularly evaluated in accordance with current clinical guidelines. Maintenance therapy can be continued indefinitely if there is a therapeutic effect and the drug is well tolerated. Discontinue the use of the drug if the therapeutic effect is no longer observed or if the patient does not tolerate treatment. The drug is taken orally,1 time/day, always at the same time, regardless of food intake. The dosage regimen is set individually. It is recommended to start treatment with the minimum effective dose. Prescribe the drug during the 1st week of therapy (days 1-7) at a dose of 5 mg/day, during the 2nd week (days 8-14)-at a dose of 10 mg/day, during the 3rd week (days 15-21) — at a dose of 15 mg/day, during the 4th week (days 22-28)-at a dose of 20 mg/day. The maximum daily dose is 20 mg. In patients over 65 years of age, as well as in patients with creatinine clearance of 50-80 ml/min, no dose adjustment is required. For patients with moderate renal insufficiency (creatinine clearance 30-49 ml / min), the daily dose is 10 mg. In the future, if the drug is well tolerated for 7 weeks, the dose can be increased to 20 mg according to the standard scheme. Instructions for dividing the tablet Place the rounded side of the tablet on a hard surface with the risk up. Press the index finger and thumb of one of the hands on opposite sides of the tablet, continue to apply pressure with your fingers until the tablet breaks into two parts.

Contraindications

-individual hypersensitivity to the drug;- severe renal impairment (creatinine clearance less than 5-29 ml / min);- severe liver failure;— pregnancy;- breast-feeding; – children under 18 years of age (efficacy and safety have not been established);— lactose intolerance, lapp lactase deficiency or glucose-galactose malabsorption (the drug contains lactose monohydrate). Caution should be used in patients with thyrotoxicosis, epilepsy, predisposition to seizures, concomitant use of NMDA receptor antagonists (amantadine, ketamine, dextromethorphan), the presence of factors that increase the pH of urine (sudden change of diet, heavy intake of alkaline gastric buffers), renal tubular acidosis, severe urinary tract infections, a history of myocardial infarction, heart failure. -NYHA functional class IV, uncontrolled arterial hypertension, renal and hepatic insufficiency.

Side effects

The frequency of adverse reactions was classified as follows: very common (≥1/10), common (≥1/100, infrequent (≥1/1000, <1/100), rare (≥1/10 000, <1/1000), very rare (Infectious and parasitic diseases: infrequently-fungal infections. From the immune system: often – hypersensitivity to memantine or other components that make up the drug. Mental disorders: infrequently – confusion, hallucinations (mainly in patients with severe Alzheimer’s disease); frequency not established-psychotic reactions. From the nervous system: often-headache, drowsiness, dizziness, balance disorders; infrequently-gait disorders: very rarely – convulsions, epileptic seizures. From the heart: infrequently-heart failure, heart defects. From the vascular side: often-increased blood pressure, venous thrombosis and / or thromboembolism. Respiratory, thoracic and mediastinal disorders: often-shortness of breath. From the gastrointestinal tract: often-constipation; rarely-nausea, vomiting; frequency is not established-pancreatitis. From the liver and biliary tract: often-violation of liver function tests. Other: infrequently-fatigue, general weakness. In Alzheimer’s disease patients, depression, suicidal thoughts, and cases of suicide have been reported in post-marketing studies. In the post-marketing period, the following adverse reactions were reported: agranulocytosis, leukopenia (including neutropenia), pancytopenia, thrombocytopenia, thrombocytopenic purpura, hepatitis, acute renal failure, Stevens-Johnson syndrome.

Interaction

When used concomitantly with levodopa preparations, dopamine receptor antagonists, and m-holinoblockers, the effect of the latter may be enhanced. When used concomitantly with barbiturates and neuroleptics, the effect of the latter may decrease. When used together, it can change (increase or decrease) the effect of dantrolene or baclofen, so the dosage of drugs should be selected individually. Concomitant use with amantadine, ketamine, phenytoin, and dextromethorphan should be avoided because of the increased risk of psychosis. Plasma concentrations of cimetidine, ranitidine, procainamide, quinidine, quinine and nicotine may increase when co-administered with memantine. It is possible to reduce the level of hydrochlorothiazide when combined with memantine. Memantine can increase the excretion of hydrochlorothiazide. MHO may be increased in patients taking oral anticoagulants (warfarin). Concomitant use with antidepressants, selective serotonin reuptake inhibitors, and MAO inhibitors requires careful monitoring of patients. In vitro, memantine does not inhibit the isoenzymes CYP1A2,2A6,2C9,2D6,2E1A,3A, flavin-containing monooxydase, epoxidhydrolase, or sulfation.

Overdose

Symptoms: dizziness, tremor, agitation, drowsiness, confusion, agitation, stupor, convulsions, psychosis, aggressiveness, hallucinations, vomiting, unsteady gait, diarrhea. Treatment: gastric lavage, taking activated charcoal, symptomatic therapy. There is no specific antidote.

Special instructions

Use with caution in patients with thyrotoxicosis, epilepsy, seizures (including in the anamnesis); concomitant use of NMDA receptor antagonists (amantadine, ketamine, dextromethorphan). the presence of factors that increase the pH of urine (sudden change of diet, heavy intake of alkaline gastric buffers), severe urinary tract infections, a history of myocardial infarction, heart failure of functional class III-IV (according to NYHA classification), uncontrolled arterial hypertension, renal and hepatic insufficiency. Influence on the ability to drive vehicles and other mechanisms Imemantine can cause changes in the reaction rate, so it is necessary to refrain from potentially dangerous activities that require increased concentration of attention and the speed of psychomotor reactions.

Storage conditions

The drug should be stored out of the reach of children at a temperature not exceeding 25°C.

Shelf life

3 years

Active ingredient

Memantine

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Consequences of stroke, Alzheimer’s disease, Concussion and other traumatic brain injuries, Alcoholism, Acquired dementia