Encephabolum

General characteristics. Structure:

5 ml of suspension (1 teaspoon) contain:
active component: Pyritinolum - 80,5 mg;
excipients: saccharinate sodium a dihydrate, пропилпарагидроксибензоат, methylparahydroxybenzoate, citric acid monohydrate, potassium sorbate, cocktail from natural essence, essence natural special, povidone, silicon dioxide colloid, hydroxyethylcellulose, glycerin of 85%, sorbitol solution of 70%, the water purified.

Description: milky-white color viscous suspension with a fragrant smell.

Pharmacological properties:

Pyritinolum increases patholologically reduced metabolism in a brain by means of increase in capture and utilization of glucose, increases metabolism of nucleic acids and release of acetylcholine in synapses of nervous cells, improves cholinergic transfer between cells of nervous tissue. Promotes stabilization of structure of a cellular membrane of nervous cells and their function by means of inhibition of enzymes of lysosomes, preventing these education of free radicals.
Pyritinolum improves rheological properties of blood, increases plasticity of erythrocytes by means of increase in content of ATP in their membrane that leads to decrease in viscosity of blood and improvement of a blood-groove. Pyritinolum, improving blood circulation in ischemic sites of a brain, increases their supply with oxygen; increases glucose exchange. As a result indicators of memory improve and the broken exchange processes in nervous tissue are recovered that promotes full functioning of its cells.

Pharmacokinetics. 
Pyritinolum is quickly soaked up at oral administration. Bioavailability averages 85% (76-93%). The maximum concentration in plasma is reached in 30-60 minutes after intake of 100 mg of Pyritinolum. Elimination half-life about 2,5 hours.
Pyritinolum quickly metabolizes. 20-40% of substance reversibly contact proteins of plasma. As the main metabolites are identified the following substances: 2-метил-3-гидрокси-4-гидроксиметил-5-метилмеркаптометилпиридин and 2-metil-3-gidroksi-4-гидроксиметил-5-метилсульфинилметилпиридин. The conjugated metabolites are removed preferential through kidneys. Total excretion with urine within 24 hours makes 72,4-74,2%. The greatest part of the received dose is excreted within the first 4 hours after reception. With excrements only 5% of a dose are removed.
At repeated peroral purpose of cumulation it is not observed. Toxic concentration do not develop even at an impaired renal function.
Gets through a blood-brain barrier, metabolites collect preferential in gray matter of a brain.
Pyritinolum gets through a placental barrier. The conducted researches did not reveal teratogenic or embriotoksichesky activity.

Indications to use:

Distsirkulyatorny and posttraumatic encephalopathy; dementia of various etiology; encephalitis effects.
In complex therapy of decrease in intellectual working capacity.
In pediatrics: delay of mental development, tserebroastenichesky syndrome, encephalopathy, oligophrenia; encephalitis effects, exogenous intoxications.

Route of administration and doses:

Adults: on 2 teaspoons of suspension 3 times a day (600 mg a day).
Newborns: about 3 days after the birth on 1 ml of suspension a day within a month, the dose is accepted in the morning. Since 2nd month after the birth, this dose is increased by 1 ml every week until the daily dose does not reach 5 ml (1 teaspoon).
Children of 1 year: on? To-1 teaspoon of suspension 1-3 times a day (from 50 to 300 mg a day depending on indications). Children of 7 years: on?-2 teaspoons of suspension 1-3 times a day (from 50 to 600 mg a day depending on indications). It is necessary to accept drug in time or after food. At sleep disorders the last day dose should not be accepted in the evening or for the night.
Duration of treatment depends on a clinical picture of a disease. At acute conditions and purpose of high doses the noticeable therapeutic effect is reached in several hours or days. At chronic diseases, such as effects of a craniocereberal injury or at dementia syndromes, noticeable therapeutic success is achieved after 2-4 weeks of treatment. The expressed effect occurs usually in 6-12 weeks. Treatment duration at chronic diseases has to make not less than 8 weeks. At newborns with high risk of development of perinatal pathology the average duration of treatment averages 6 months.
In three months it is necessary to check existence of indications for further treatment.

Features of use:

At patients with the known hypersensitivity to D-Penicillaminum similar side effects owing to chemical similarity to Pyritinolum (thiol groups) can be observed.
Drug is appointed with care to patients with a pseudorheumatism. Side effect of drug at this group of patients can be observed more often in connection with the main antiinflammatory therapy.
For newborns and children under 7 years drug is used in other dosage form (suspension).

Use at pregnancy and in the period of a lactation
The decision on use of drug during pregnancy and feeding by a breast has to be accepted after careful weighing of a ratio risk advantage.

Side effects:

Side effect
At reception of Entsefabola® according to indications and in the recommended doses by-effects arise extremely seldom.
Purpose of Pyritinolum can be followed by the following side reactions:
• Reactions of hypersensitivity of varying severity, it is preferential in the form of an enanthesis or mucous, an itch, nausea, vomiting, diarrhea, temperature increase;
• Sleep disorder;
Are seldom observed: 
• Hyperexcitability, loss of appetite, headache, dizziness, fatigue;
• Flavoring frustration, disturbance of functions of a liver (including increase in level of transaminases, cholestasia).
• Proteinuria.
In isolated cases: 
• Muscle and joints pain; a leukopenia (in isolated cases the agranulocytosis was noted), an eosinophilia, thrombocytopenia; increase in level of antinuclear antibodies; flat deprive; violent pemfigioidny reaction of skin, allopecia; онихолизис; диспноэ; myasthenia, polymiositis.

Contraindications:

Absolute: 
- hypersensitivity to Pyritinolum.
Relative: 
- abnormal liver function and kidneys;
- the expressed changes of a picture of blood;
- autoimmune diseases.
- children up to 7 years (for this dosage form).

Overdose:

In case of overdose expressiveness of by-effects increases. It is necessary to see a doctor. First aid consists in a gastric lavage, reception of absorbent carbon.

Storage conditions:

To store at a temperature of 20-25 °C, in the place, unavailable to children. Period of validity of 5 years. Not to use after a period of validity.

Issue conditions:

According to the recipe

Packaging:

On 200 ml in a bottle of dark glass. The bottle together with the application instruction is placed in a cardboard pack.