Akatinol memantine pills 20mg №98

Composition

In 1 tablet, film coated, contains:

•  Active substance
  • Memantine hydrochloride 20 mg.

• Excipients

Microcrystalline cellulose 263.5 mg, croscarmellose sodium 13.5 mg, colloidal silicon dioxide 1.5 mg, Magnesium stearate 1.5 mg.

• Composition film coated  

Opadray pink 12 mg: hypromellose 7.5 mg, titanium dioxide (E 171) 3.3984 mg, macrogol 400: 0.75 mg, red iron oxide (E 172) 0.2004 mg, yellow iron oxide (E 172) 0, 1512 mg.

In a blister pack of 14 tablets. In a cardboard bundle 7 blister packs.

Indications for use

• Dementia (Latin dementia - insanity, insanity, synonym - dementia) - acquired as a result of organic destruction of the large hemispheres of the brain, a decrease in intelligence (characterized by simultaneous breakdown of several cognitive functions), which violates social adaptation. Diagnosis and treatment of D. depend on the underlying disease. moderate and severe severity of Alzheimer's disease (A. Alzheimer, 1864-1915, German. Doctor) is a type of presenile dementia, manifested along with the progressive development of amnesic dementia, aphasic, apraxic and agnostic disorders..

Pharmacokinetics

• Suction and distribution

After ingestion is quickly and completely absorbed.

The maximum concentration in a blood plasma is reached within 2 - 6 hours. In normal renal function, no accumulation of the drug was observed.

• Metabolism

Metabolites do not possess their own pharmacological activity.

• Removal

Excreted by the urine. With alkaline urine, excretion slows down. About 80% of Memantine is excreted unchanged.

Withdrawal proceeds in two phases. The half-life in the first phase is 4 to 9 hours, in the second phase it is 40 to 65 hours.

Clinical Pharmacology

Derived adamantane.

Being a noncompetitive antagonist of N - methyl - D - aspartate (NMDA) receptors, reduces the excessive stimulating effect of cortical glutamate neurons on the neostriatum.

It regulates ion transport, blocks Calcium channels, normalizes membrane potential, improves the transmission of nerve impulses. It improves cognitive processes, memory and learning ability, increases daily activity.

Use during pregnancy and lactation

Contraindicated in pregnancy and during breastfeeding.

Contraindications

• Individual hypersensitivity to the drug.
• Pregnancy.
• Breast-feeding.
• Severe renal failure (creatinine clearance 5 - 29 ml / min).
• Severe liver failure.
• Children under 18 years (due to lack of data).

Caution should be assigned:

• Thyrotoxicosis.
• Epilepsy.
• Convulsions (including history).
• Simultaneous use of NMDA antagonists - receptors:
  • Amantadine.
  • Ketamine.
  • Dextromethorphan.
• Factors that increase urine pH:
  • Abrupt change of diet (the transition to vegetarianism).
  • Abundant intake of alkaline gastric buffers.
• Severe urinary tract infections.
• Myocardial infarction (in history).
• Chronic heart failure III - IV functional class (according to the NYHA classification).
• Uncontrolled arterial hypertension.
• Liver failure.

Adverse effects

Adverse reactions are classified by clinical manifestations (according to the lesion of certain organ systems) and by frequency of occurrence:

• Very often:> 1/10.
• Often:> 1/100 to <1/10.
• Not often:> 1/1000 to <1/100.
• Seldom:> 1/10000 to <1/1000.
• Very rare: <1/10000.

• There are separate reports of the occurrence of these adverse reactions when using the drug in clinical practice (data obtained after the appearance of the drug on the market)

Vertigo (vertigo; synonym - vertigo) is a term that is used to designate a distorted perception of the position of one’s body in space, a feeling of imaginary movement of one’s own body or the environment. For details, see the article dizziness, drowsiness, irritability, fatigue, anxiety, increased intracranial pressure, nausea,  hallucinations, headache, impaired consciousness, muscle hypertonia, gait disturbance, Depression (from Latin. depressio - suppression) - a mental disorder, which is referred to as affective disorders (mood disorders). D.characterized by depressed sad mood with negative, pessimistic self-esteem of his position and future, a sense of abandonment, which is combined with anxiety, decreased psychomotor activity, fatigue, somatoform manifestations (loss of appetite, weight loss, constipation, decreased libido), sleep disorders., convulsions, psychotic reactions, suicidal thoughts, constipation, vomiting, pancreatitis, candidiasis, increased blood pressure, cystitis, increased libido, venous thrombosis, thromboembolism, allergic reactions.

• On the part of the body as a whole

Often - a headache.

             Rarely - fatigue.

• Infections

Rarely - fungal infections.

• From the psyche

Often - drowsiness.

Rarely - confusion, hallucinations.

Hallucinations were observed mainly in patients with Alzheimer's disease (A. Alzheimer, 1864-1915, German. Doctor) - a type of presenile dementia, manifested, along with the progressive development of amnestic dementia, aphasic, apraxic and agnostic disorders. at the stage of severe Dementia (Latin dementia - insanity, insanity, synonym - dementia) - acquired as a result of organic destruction of the large hemispheres of the brain, a decrease in intelligence (characterized by simultaneous breakdown of several cognitive functions), which violates social adaptation. Diagnosis and treatment of D. depend on the underlying disease..

• From the side of the cardiovascular system

Rarely - increased blood pressure, venous thrombosis, thromboembolism.

• Gastrointestinal tract

Often - constipation.

Rarely - nausea and vomiting.

Pancreatitis - frequency not set.

• From the central and peripheral nervous system

Often - Vertigo (vertigo; synonym - vertigo) - a term which is used to designate a distorted perception of the position of one’s body in space, a feeling of imaginary movement of one’s own body or the surrounding environment. See the Vertigo article for more details.

Rarely - nausea and vomiting.

Very rarely - cramps.

Interaction

• Interactions that enhance the actions of other drugs

With simultaneous use with levodopa preparations, dopamine receptor antagonists, m-anticholinergic drugs, the action of the latter can be enhanced.

• Interactions,  reducing effects of other drugs

With simultaneous use with barbiturates, neuroleptics, the effect of the latter may be reduced.

• Drug interactions that alter the pharmacokinetics of other drugs

When used together, it can change (increase or decrease) the effect of dantrolene or Baclofen, so the doses of drugs should be selected individually.

• Antagonist Interaction NMDA - receptors

Concurrent administration with amantadine, ketamine, phenytoin and dextromethofan should be avoided due to the increased risk of developing psychosis.

• Interactions that increase the concentration of other drugs It is possible to increase the concentration of cimetidine, Ranitidine, procainamide, quinidine, quinine and nicotine in plasma while taking it with memantine.

• Interactions that reduce the concentration of other drugs It is possible to reduce the level of hydrochlorothiazide while taking memantine.

• Interaction with indirect anticoagulants

May increase INR in patients taking oral anticoagulants (warfarin).

• Anti-prescription drug interactions

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

Overdose

• Symptoms: Vertigo (vertigo; synonym - vertigo) is a term that is used to designate a distorted perception of the position of your body in space, a feeling of imaginary movement of your own body or the environment. See the vertigo article for details. Intentional tremor (syn. Intentional tremor), (Latin intentio - goal, intention) - tremor (trembling hyperkinesis) with targeted movements, for example, with paltsenosovoy and heel-knee test, in which the amplitude of jitter increases as it approaches the final goal of movement. It is a type of action tremor (movement tremor). Particularly observed in lesions of the cerebellum. See also Promotional tremor, Tremor, agitation, drowsiness, confusion, agitation, stupor, convulsions, psychosis, aggressiveness, hallucinations, unsteady gait, vomiting, diarrhea.
• Treatment: gastric lavage, taking activated charcoal, symptomatic therapy. There is no specific antidote.

Dosage and administration

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

• During the 1st week (days 1 - 7): 5 mg / day.
• During the 2nd week (days 8 - 14): 10 mg / day.
• During the 3rd week (days 15-21): 15 mg / day.
• During the 4th week (days 22 - 28): 20 mg / day.

The maximum daily dose of 20 mg.

In patients older than 65 years, as well as patients with creatinine clearance of 50 - 80 ml / min, dose adjustment is not required.

For patients with moderate renal insufficiency (creatinine clearance 30–49 ml / min), the daily dose is 10 mg.

In the future, with good tolerability of the drug for 7 weeks, the dose can be increased to 20 mg according to the standard scheme.

Precautionary measures

• Influence on ability to drive vehicles and work with equipment

In patients with Alzheimer's disease (A. Alzheimer, 1864-1915, German. Doctor) is a type of presenile dementia, manifested, along with the progressive development of amnesic dementia, aphasic, apraxic and agnostic disorders. at the stage of moderate and severe Dementia (Latin dementia - insanity, insanity, synonym - dementia) - acquired as a result of organic lesion of the big hemispheres of the brain, a decrease in intelligence (characterized by simultaneous breakdown of several cognitive functions), violating social adaptation. Diagnosis and treatment of D. depend on the underlying disease. usually impaired ability to drive vehicles and management of complex mechanisms.

In addition, memantine can cause a change in the reaction rate, so patients should refrain from driving or working with complex mechanisms.

Storage conditions

• Store at a temperature not higher than + 25 ° С.
• Shelf life: 4 years.
• Keep out of reach of children.
• Do not use after expiration date.