Instructions for use Alzmerat oral solution 600 mg/7 ml bottle 7 ml No. 10
Composition
active ingredient: choline alfoscerate;
7 ml of solution contains choline alfoscerate 600 mg;
Excipients: methyl parahydroxybenzoate (E 218), propyl parahydroxybenzoate (E 216), sodium saccharin, orange flavoring (contains propylene glycol), purified water.
Dosage form
Oral solution.
Main physicochemical properties: transparent colorless or almost colorless solution.
Pharmacotherapeutic group
Agents acting on the nervous system. Other agents acting on the nervous system. Parasympathomimetics. Other parasympathomimetics. Choline alfoscerate. ATX code N07A X02.
Pharmacological properties
Pharmacodynamics
Alzmerate is a drug belonging to the group of central cholinomimetics with a predominant effect on the central nervous system (CNS). Choline alfoscerate as a choline carrier and a precursor of phosphatidylcholine has the potential to prevent and correct biochemical damage, which is of particular importance among the pathogenic factors of psychoorganic involutional syndrome, i.e. it can affect the reduced cholinergic tone and the altered phospholipid composition of nerve cell membranes. The drug contains 40.5% metabolically protected choline. Metabolic protection ensures the release of choline in the brain. Alzmerate has a positive effect on memory functions and cognitive abilities, as well as on indicators of emotional state and behavior, the deterioration of which was caused by the development of involutional brain pathology.
The mechanism of action is based on the fact that when choline enters the body, alfoscerate is broken down by enzymes into choline and glycerophosphate: choline takes part in the biosynthesis of acetylcholine - one of the main mediators of the transmission of nerve impulses of excitation; glycerophosphate is a precursor of phospholipids (phosphatidylcholine) of the neuronal membrane. Thus, Alzmerate improves the transmission of nerve impulses in cholinergic neurons, has a positive effect on the plasticity of neuronal membranes and the function of receptors. Alzmerate improves cerebral blood flow, enhances metabolic processes in the brain, activates the structures of the reticular formation of the brain and restores consciousness in traumatic brain injury.
Pharmacokinetics
There is evidence that the pharmacokinetic properties determined when using the labeled compound are similar in studies on different animal species and are as follows: rapid and complete gastrointestinal absorption (on average, about 88% of the administered dose of choline alfoscerate is absorbed); rapid absorption and distribution in various organs and tissues. Penetrates the blood-brain barrier. The drug accumulates mainly in the brain (the concentration in the brain is 45% of that in plasma) in the lungs and liver; only renal excretion (approximately 10% of the administered radioactive dose in 96 hours); higher availability in the brain compared to tritium-labeled choline.
Indication
Degenerative-involutional brain psychoorganic syndromes or secondary consequences of cerebrovascular insufficiency, i.e. primary and secondary disorders of mental activity in the elderly, characterized by memory impairment, confusion, disorientation, decreased motivation and initiative, decreased ability to concentrate; changes in the emotional and behavioral sphere: emotional instability, irritability, indifference to the environment; pseudomelancholia in the elderly.
Contraindication
Known hypersensitivity to the drug or its components. Patients with psychosomatic syndrome, with severe psychomotor agitation. Pregnancy or breastfeeding.
Interaction with other medicinal products and other types of interactions
Clinically significant drug interactions with other drugs have not been established.
Application features
Nausea may occur (probably due to secondary dopaminergic activation). In this case, the dose of the drug should be reduced. The efficacy and safety of the drug in children under 18 years of age have not been established. The presence of methylparaben (E 218) and propylparaben (E 216) in the composition may cause allergic reactions (possibly delayed).
Ability to influence reaction speed when driving vehicles or other mechanisms
The drug does not affect driving and working with other mechanisms.
Use during pregnancy or breastfeeding
The drug is contraindicated for use during pregnancy and breastfeeding.
Method of administration and doses
Take one vial of oral solution 2 times a day.
The indicated dose may be increased by the doctor.
Children
There is no experience with the use of Alzmerat in children.
Overdose
In case of overdose of Alzmerat, which may manifest as nausea, anxiety, agitation, insomnia, the dose of the drug should be reduced. Treatment: symptomatic therapy, taking adsorbing drugs (for example, activated charcoal). The effectiveness of dialysis has not been established.
Adverse reactions
The drug is usually well tolerated even with long-term use.
During the first days or weeks of treatment, the following adverse reactions may occur: anxiety, agitation, insomnia. These symptoms are temporary and do not require discontinuation of treatment, but a temporary dose reduction is possible.
Nausea (mainly due to secondary dopaminergic activation), decreased blood pressure, headache, very rarely abdominal pain and short-term confusion may occur. In this case, the dose of the drug should be reduced.
Hypersensitivity reactions including rash, itching, urticaria, angioedema, skin redness are possible. May cause allergic reactions (possibly delayed).
Expiration date
2 years.
Storage conditions
Store in the original packaging at a temperature not exceeding 25 °C.
Keep out of reach of children.
Packaging
7 ml of solution per vial. 10 vials per box.
Vacation category
According to the recipe.
Producer
Technolog PJSC.
Location of the manufacturer and its business address
Ukraine, 20300, Cherkasy region, Uman city, Stara Prorizna Street, building 8.
