Vinpotropile tablet 10mg + 800mg, 60pcs

Composition

1 film-coated tablet contains:

active ingredients:

vinpocetine 10 mg,

piracetam 800 mg;

excipients:

calcium hydrophosphate dihydrate 120 mg,

croscarmellose sodium (primellose) 33 mg,

magnesium stearate 7 mg,

povidone 21 mg,

talc 7 mg,

microcrystalline cellulose 102 mg;

composition of the film shell:

Opadray II brown 35 mg, including: hypromellose (hydroxypropylmethylcellulose) 9.8 mg, macrogol (polyethylene glycol) 3.5 mg, lactose monohydrate (milk sugar) 12.6 mg, iron oxide red dye 3.08 mg, iron oxide black dye 5.985 mg, titanium dioxide 0.035 mg

Pharmacological action

Pharmacodynamics

Vinpotropile is a combination drug. It has properties that are characteristic of a drug that improves cerebral blood flow (vinpocetine), and for a nootropic agent (piracetam).

As a means of improving cerebral blood flow

Improves brain metabolism by increasing the consumption of glucose and oxygen by brain tissue. Increases the resistance of neurons to hypoxia, increases the transport of glucose to the brain through the blood-brain barrier; transfers the process of glucose breakdown to an energy-efficient, aerobic pathway; selectively blocks Ca2+ – dependent phosphodiesterase; increases the levels of adenosine monophosphate (AMP), cyclic guanosine monophosphate (cGMP) and adenosine triphosphate (ATP) of the brain. Increases the exchange of norepinephrine and serotonin in the brain; has an antioxidant effect.

Reduces platelet aggregation and increased blood viscosity; increases the elasticity of red blood cells and blocks the utilization of adenosine by red blood cells; helps to increase the return of oxygen by red blood cells. Increases cerebral blood flow; reduces resistance of cerebral vessels without significant changes in the parameters of systemic circulation. It does not have the effect of” stealing ” and increases blood supply, primarily in ischemic areas of the brain. Penetrates the placental barrier.

As a nootropic agent

Improves the integrative activity of the brain, promotes memory consolidation, facilitates the learning process; changes the rate of propagation of excitation in the brain, improves microcirculation, without having a vasodilating effect, suppresses the aggregation of activated platelets; has a protective effect on brain damage caused by hypoxia, intoxication, electric shock; increases α – and β-activity, reduces δ-activity on the electroencephalogram, reduces the severity of vestibular nystagmus; improves connections between the cerebral hemispheres and the brain. synaptic conduction in neocortical structures, increases mental activity, increases cerebral blood flow; does not have a sedative, psychostimulating effect. The effect develops gradually.

It has a pronounced effect on the symptoms of the initial manifestations of cognitive disorders of cerebral and vascular genesis in elderly and senile patients. Recommended in psychogeriatric practice.

Pharmacokinetics

Vinpocetine is rapidly absorbed. The therapeutic plasma concentration is 10-20 ng / ml. The time to reach the maximum concentration in blood plasma is 1 hour. Absorption occurs mainly in the proximal parts of the gastrointestinal tract. When passing through the intestinal wall, it is not metabolized.

The maximum concentration in the tissues is observed 2-4 hours after ingestion. Protein binding – 66%, oral bioavailability-7%. The clearance of 66.7 l / h exceeds the plasma volume of the liver (50 l / h), which indicates extrahepatic metabolism. The main metabolite is apovincamic acid, which has some pharmacological activity. Other inactive metabolites are hydroxy-vinpocetine, hydroxy-apovincamic acid, and hydroxy-vinpocetine-glycinate. With repeated doses, the kinetics is linear. The half-life (T1 / 2) in humans is 4.83±1.29 hours. It is excreted by the kidneys and through the intestines in a ratio of 3: 2.

Piracetam after oral use is well absorbed and penetrates into various organs and tissues. Bioavailability is about 100%. After a single oral dose of 3.2 g, the maximum concentration is 84 mcg/ml, after repeated (3.2 g 3 times a day) – 115 mcg/ml. The time to reach the maximum concentration in plasma is 1 hour, and the time to reach the maximum concentration in cerebrospinal fluid is 5 hours.

The volume of distribution is about 0.6 l / kg. Penetrates through the blood-brain and placental barriers, selectively accumulates in the tissues of the cerebral cortex. Practically does not undergo biotransformation and is excreted unchanged by the kidneys by glomerular filtration. Total clearance 80-90 ml / min. T1 / 2 from blood plasma – 4-5 hours, from cerebrospinal fluid-8.5 hours.

Indications

• Cerebral circulatory insufficiency (recovery period of ischemic and hemorrhagic stroke);
• chronic cerebral circulatory insufficiency of hypertensive and post-traumatic genesis, Parkinsonism of vascular genesis, intoxication;
• psychoorganic syndrome with a predominance of signs of asthenia and adynamia;
• symptomatic treatment of dizziness;
• prevention of migraines and kinetoses.

Use during pregnancy and lactation

The drug is contraindicated during pregnancy and lactation.

Contraindications

• Hypersensitivity to the components of the drug,
• pregnancy,
• lactation,
• severe cardiac arrhythmias,
• ischemic heart disease (severe course),
• hemorrhagic stroke,
• severe CRF (creatinine clearance (CC) less than 20 ml / min),
• liver failure,
• patient’s age up to 18 years.

With caution: Impaired hemostasis, extensive surgery, severe bleeding, CRF (creatinine clearance 20-80 ml / min).

Side effects

From the cardiovascular system: ECG changes (ST-segment depression, prolongation of the Q-T interval), tachycardia, extrasystole, lability of blood pressure (BP) (more often a decrease).

From the central nervous system( CNS): motor disinhibition, irritability, depression, asthenia, dizziness, headache, sleep disorders (insomnia, increased drowsiness), mental agitation, balance disorders, exacerbation 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.

Sensory disorders: vertigo.

From the skin: dermatitis, pruritus, urticaria, hyperemia of the skin.

Allergic reactions: hypersensitivity, anaphylactic reactions, angioedema.

Local reactions: pain at the injection site, thrombophlebitis.

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

Interaction

Increases: the risk of hemorrhagic complications on the background of heparin therapy, the effects of thyroid hormones, antipsychotics (neuroleptics), psychostimulants, indirect anticoagulants, including acenocoumarol (a more pronounced decrease in platelet aggregation, fibrinogen content, von Willebrand factor, plasma and blood viscosity).

There may be some increase in the antihypertensive effect when used simultaneously with methyldopa (blood pressure monitoring is necessary).

Weakens: the effect of anticonvulsants (reduces the seizure threshold).

Despite the lack of data confirming the possibility of interaction, it is recommended to exercise caution when prescribing concomitantly with drugs of central, antiarrhythmic action.

How to take, course of use and dosage

The course of treatment and dosage is determined by the attending physician.

For patients 18 years and older: inside, regardless of food intake,1 tablet 2-3 times a day, washed down with a sufficient amount of water. The last appointment is 4 hours before bedtime. The duration of the course of treatment is from 2-3 weeks to 2-6 months.

Before discontinuation of the drug, the dose should be gradually reduced (it is possible to use Vinpotropile® in another dosage form: capsules containing 5 mg of vinpocetine and 400 mg of piracetam).

Overdose

Symptoms: abdominal pain, diarrhea mixed with blood.

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

Special instructions

The presence of prolonged QT syndrome and the use of drugs that cause prolongation of the QT interval requires periodic monitoring of the ECG.

Due to the effect of piracetam on platelet aggregation, caution is recommended when prescribing the drug to patients with impaired hemostasis, during major surgical operations, or patients with symptoms of severe bleeding.

Influence on the ability to drive motor vehicles and manage mechanisms

During the treatment period, care should be taken when driving vehicles and working with mechanisms.

Form of production

film-coated tablets

Storage conditions

Store in a dry place protected from light at a temperature not exceeding 25 °C.

Shelf

life is 2 years.

Active ingredient

Vinpocetine, Piracetam

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Concussion and other traumatic brain injuries, Circulatory disorders, Meniere’s disease, Migraines, Consequences of stroke, Asthenia