Vinpotropil - instructions for use, doses, side effects, contraindications

Active substanceVinpocetine + PyracetamVinpocetine + Pyracetam

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Vinpotropil®

concentrate in / in

CANONFARMA PRODUCTION, CJSC Russia

Vinpotropil®

capsules inwards

CANONFARMA PRODUCTION, CJSC Russia

Vinpotropil®

pills inwards

CANONFARMA PRODUCTION, CJSC Russia

Dosage form: & nbspconcentrate for solution for infusion

Composition:

1 ml of concentrate solution contains:

active substances: vinpocetine 1.0 mg, piracetam 80.0 mg;

Excipients: ascorbic acid 5.00 mg, succinic acid 13.40 mg, sodium disulfite (sodium metabisulphite) 3.00 mg, water for injection up to 1 ml.

Description:Transparent colorless or slightly colored liquid.

Pharmacotherapeutic group:cerebral blood flow improver + nootropic agent.

ATX: & nbsp

N.06.B.X.18 Vinpocetine

N.06.B.X.03 Pyracetam

Pharmacodynamics:

VINPOTROPIL® is a combined preparation. Has properties characteristic of cerebrozodilating (vinpocetine) and for nootropic (piracetam) of means.

Vinpocetine improves cerebral circulation, causes cerebral vasodilation, increased blood flow and improved supply of brain oxygen and glucose. Increases the resistance of brain cells to hypoxia, facilitating the transport of oxygen and substrates of energy supply to tissues (due to reduced affinity for erythrocytes, increased absorption and metabolism of glucose,switching it into an energetically more advantageous aerobic direction). It promotes the accumulation in the tissues of cyclic adenosine monophosphate and adenosine triphosphate (inhibition of phosphodiesterase and stimulation of adenylate cyclase), an increase in the content of catecholamines in the brain tissues. The vasodilating effect is associated with a direct relaxing effect on the smooth musculature of vessels predominantly of the brain, does not cause the phenomenon of "stealing," and enhances the blood supply of the ischemic region of the brain without changing the blood supply of intact regions. Improves microcirculation in the brain by reducing aggregation of platelets, reducing blood viscosity, increasing the elasticity of erythrocytes.

Pyracetam - a cyclic derivative of gamma-aminobutyric acid, acts directly on the brain, improving cognitive (cognitive) processes, such as learning ability, memory, attention, and mental performance. Has an effect on the central nervous system of various

ways: changes the speed of propagation of excitation in the brain, improves metabolic processes in nerve cells, improves microcirculation,affects the rheological characteristics of the blood, while not providing a vasodilating effect.

Improves the connection between the cerebral hemispheres and synaptic conductivity in neocortical structures, improves cerebral blood flow.

Inhibits the aggregation of platelets and restores the configuration properties of the outer membrane of rigid red blood cells, as well as the ability of the latter to pass through the vessels of the microcirculatory bed. At a dose of 9.6 g reduces the concentration of fibrinogen and von Willebrand factor by 30-40% and prolongs bleeding time.

It has a protective and restoring effect when the brain function is impaired due to hypoxia and intoxication.

Reduces the severity and duration of the vestibular nystagmus.

Pharmacokinetics:

For vinpocetine. The therapeutic concentration in plasma is 10-20 ng / ml. For parenteral administration, the volume of distribution is 5.3 l / kg. The connection with proteins - 66%, clearance - 66.7 l / h, exceeds the plasma volume of the liver (50 l / h), which indicates extrahepatic metabolism. Penetrates into breast milk (0.25% within 1 hour), through the placental barrier Easily penetrates through the histohematic barriers (incl.blood-brain barrier (BBB)). . The half-life T1 / 2 - h 3,54-6,12 excreted by the kidneys and intestines in a ratio of 3: 2. From the spinal cord fluid is excreted much more slowly than from other tissues.

For piracetam. The half-life T1 / 2 from plasma - 4.5 hours, from the brain of 7.7 hours, from cerebrospinal fluid -. 8.5 hours virtually no biotransformation and 2/3 of excreted by the kidneys in unchanged form within 30 hours .

The total clearance is 80-90 ml / min. The half-life T1 / 2 longer with chronic, "renal failure (CRF) (for ESRD - up to 59 h). Hepatic insufficiency does not affect the pharmacokinetics of piracetam. The specific volume of the Vd distribution is about 0.6 l / kg. Penetrates through the BBB and the placental barrier; is removed during hemodialysis. In animal experiments, it selectively accumulates in the tissues of the cerebral cortex, mainly in the frontal, parietal and occipital lobes, in the cerebellum and basal nuclei. Does not bind to plasma proteins.

Indications:Cerebral circulatory insufficiency (recovery period of ischemic and hemorrhagic stroke), encephalopathies of various origins, including,with alcoholism; Parkinsonism of vascular genesis, intoxication, brain trauma and other diseases of the central nervous system, accompanied by a decline in intellectual-mnestic functions; psychoorganic syndrome with predominance of asthenia and adynamia, asthenic syndrome; labyrinthopathy, Meniere's syndrome.

Contraindications:Hypersensitivity to the components of the drug, pregnancy, lactation, severe heart rhythm disturbances, coronary heart disease (severe course), hemorrhagic stroke, severe CRF (creatinine clearance less than 20 ml / min), liver failure, patient age 18 years .

Carefully:

Violation of hemostasis, extensive surgical interventions, heavy bleeding, CRF (KK 20-80 ml / min).

Pregnancy and lactation:The drug is not recommended for use during pregnancy and lactation.

Dosing and Administration:

Intravenously drip.

2-3 ampoules of the drug, previously diluted in 500 ml of infusion solution (0.9% solution of sodium chloride or solutions containing dextrose) 1 time per day (the infusion rate should not exceed 80 cap / min). The course of treatment -10 - 14 days.If necessary, it can be repeated after 6-8 weeks.

After achieving the improvement, they switch to oral administration in an oral dosage).

Side effects:

From the cardiovascular system: ECG changes (depression segment ST, elongation Q-T interval), tachycardia, arrythmia, labile blood pressure (BP) (usually decrease).

From the central nervous system (CNS): motor disinhibition, irritability, depression, fatigue, dizziness, headache, sleep disturbances (insomnia, hypersomnia), mental stimulation, impaired balance, aggravation of epilepsy, anxiety, hallucinations, confusion, extrapyramidal disorders, decreased ability to concentrate.

From the digestive system: nausea, vomiting, heartburn, diarrhea, abdominal pain, decreased appetite, gastralgia, constipation.

From the side of metabolism: increased body weight, increased sweating.

From the sense organs: Vertigo.

From the skin: dermatitis, itching, urticaria, skin hyperemia.

Allergic reactions:hypersensitivity, anaphylactic reactions, angioedema.

Local reactions: pain in the injection site, thrombophlebitis.

Other: fever, general weakness (may be a manifestation of the underlying disease), increased sexual activity.

Overdose:

Symptoms: abdominal pain, diarrhea with an admixture of blood.

Treatment: symptomatic therapy, hemodialysis (efficacy 50-60%).

There is no specific antidote.

Interaction:

The solution of vinpocetine is pharmaceutically incompatible with heparin, solutions,

containing amino acids. It is possible to intensify the hypotensive effect with simultaneous application with methyldopa (the control of a BP is necessary). The solution of piracetam is pharmaceutically compatible with dextrose solutions (5%, 10%, 20%), fructose (5%, 10%, 20%), 0.9% sodium chloride solution, Ringer's solution, 20% mannitol solution, hydroxyethyl starch (6% , 10%).

Increases the risk of hemorrhagic complications against heparin therapy, the effectiveness of thyroid hormones, antipsychotic drugs (neuroleptics), indirect anticoagulants (against the background of high doses of pyracetam) .. When used simultaneously with drugs,stimulating CNS, excessive stimulation of the CNS is possible.

Weaken the effect of anticonvulsants (reduces the convulsive threshold). When administered with neuroleptics reduces the risk of extrapyramidal disorders

Special instructions:

It is recommended to monitor the kidney function indefinitely (especially in patients with CRF) - with nitrogen content and creatinine concentration, while in patients with liver diseases - the functional state of the liver.

With prolonged therapy in elderly patients, regular monitoring of renal function is recommended, if necessary, correlate the dose depending on the concentration of creatinine.

It penetrates the hemodialysis apparatus through the filter membranes.

In the case of the original elongation Q-T interval, as well as with simultaneous use with drugs that extend Q-T interval, during the period of treatment, periodic ECG monitoring is necessary.

During the treatment period, care must be taken when driving vehicles and engaging in other potentially hazardous activities requiring an increased concentration of attention and speed of psychomotor reactions.

Form release / dosage:

Concentrate for the preparation of a solution for infusions 1 mg + 80 mg / ml.

Packaging:

5 ml per ampoule of glass of the 1st hydrolytic class of brown color, having a break point.

By 5 or 10 ampoules are placed in a "contoured cell pack, from a polyvinyl chloride film.

By 1 or. 2 contour mesh packs together with instructions for use are placed in a pack of cardboard.

It is allowed to put a scarifier in the pack.

Storage conditions:

In a dry, protected from light place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-000083

Date of registration:15.12.2010

The owner of the registration certificate:CANONFARMA PRODUCTION, CJSC CANONFARMA PRODUCTION, CJSC Russia

Manufacturer: & nbsp

Company DEKO, LLC Russia

Representation: & nbspCANONFARMA PRODUCTION CJSC CANONFARMA PRODUCTION CJSC Russia

Information update date: & nbsp27.08.2015

Illustrated instructions

Instructions

Vinpotropil® (Vinpotropile)