Vinpocetine-Akrikhin (Tablets) Instructions for Use

Marketing Authorization Holder

Akrikhin Chemical and Pharmaceutical Plant, JSC (Russia)

Contact Information

Akrikhin AO (Russia)

ATC Code

N06BX18 (Vinpocetine)

Active Substance

Vinpocetine (Rec.INN registered by WHO)

Dosage Form

Vinpocetine-Akrikhin

Tablets 5 mg: 50 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, flat-cylindrical, with a bevel, marbling is allowed.

Excipients: lactose, colloidal silicon dioxide (aerosil), potato starch, magnesium stearate.

10 pcs. – contour cell packs (5) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves cerebral circulation and metabolism

Pharmacotherapeutic Group

Psychostimulant and nootropic agent

Pharmacological Action

Vasodilator agent. Improves brain metabolism by increasing the consumption of glucose and oxygen by brain tissue.

Increases the resistance of neurons to hypoxia; facilitates the transport of glucose to the brain through the blood-brain barrier; shifts the process of glucose breakdown to a more energy-efficient aerobic pathway; selectively blocks calcium-dependent phosphodiesterase; increases the content of adenosine monophosphate (AMP), cyclic guanosine monophosphate (cGMP) and adenosine triphosphate (ATP) in the brain.

Promotes an increase in the content of norepinephrine and serotonin in brain tissues; has an antioxidant effect. Reduces platelet aggregation and increased blood viscosity; increases the deformability of erythrocytes and blocks the utilization of adenosine by erythrocytes; promotes increased release of oxygen by erythrocytes. Increases cerebral blood flow. Does not cause a “steal” effect and enhances blood supply primarily in ischemic areas of the brain.

Pharmacokinetics

When taken orally, it is rapidly absorbed. The time to reach C_max in blood plasma is 1 hour. Absorption occurs mainly in the proximal parts of the gastrointestinal tract. It is not metabolized when passing through the intestinal wall. C_max in tissues is noted 2-4 hours after oral administration. Protein binding is 66%, oral bioavailability is 7%. Clearance is 66.7 l/h, which exceeds the plasma volume of the liver (50 l/h), indicating extrahepatic metabolism. With repeated doses, the kinetics are linear. T_1/2 in humans is 4.83±1.29 hours. It is excreted by the kidneys and through the intestines in a ratio of 3:2. Penetrates the placental barrier.

Indications

• Reduction of the severity of neurological and mental symptoms in various forms of cerebral circulation insufficiency (including the recovery stage of ischemic or hemorrhagic stroke, consequences of a stroke; transient ischemic attack; vascular dementia; vertebrobasilar insufficiency; cerebral vascular atherosclerosis; post-traumatic and hypertensive encephalopathy);
• Chronic vascular diseases of the choroid and retina of the eye;
• Perceptive hearing loss, Ménière’s disease, idiopathic tinnitus.

ICD codes

Dosage Regimen

Administer orally, after meals, to minimize potential gastrointestinal discomfort.

The initial dosage is one 5 mg tablet three times daily, providing a total daily dose of 15 mg.

If well-tolerated and based on clinical assessment, the dose may be increased. The maximum daily dose is 30 mg, equivalent to two tablets three times daily.

For long-term management of chronic conditions, continue treatment for up to three months. Reevaluate the patient’s condition upon completion of the course.

In patients with renal impairment or hepatic impairment, no initial dosage adjustment is required; administer the standard dose.

Do not discontinue therapy abruptly. Prior to cessation, implement a gradual dose reduction over several days to prevent potential rebound effects.

Monitor patients with known prolonged QT interval or those taking other QT-prolonging drugs; perform periodic electrocardiogram (ECG) assessments.

Adverse Reactions

From the cardiovascular system: ECG changes (ST segment depression, QT interval prolongation), tachycardia, extrasystole, lability of blood pressure, sensation of hot flashes.

From the central nervous system: sleep disorders (insomnia or increased drowsiness), dizziness, headache.

From the digestive system: dry mouth, nausea, heartburn.

Other: allergic reactions, general weakness, increased sweating.

Contraindications

• Acute phase of hemorrhagic stroke, severe coronary artery disease, severe arrhythmias, hypersensitivity to any of the components of the drug;
• Pregnancy (possible placental bleeding and spontaneous abortions, probably as a result of increased placental blood supply);
• Lactation period (breastfeeding should be discontinued while using the drug);
• Children under 18 years of age (due to insufficient data).

Use in Pregnancy and Lactation

The drug is contraindicated during pregnancy (possible placental bleeding and spontaneous abortions, probably as a result of increased placental blood supply), as well as during lactation.

Use in Hepatic Impairment

For liver diseases, the drug is prescribed at the usual dose.

Use in Renal Impairment

For kidney diseases, the drug is prescribed at the usual dose.

Pediatric Use

The drug is contraindicated in children under 18 years of age (due to insufficient data).

Special Precautions

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

There are no data on the effect of vinpocetine on the ability to drive a car and perform work requiring quick psychomotor reactions.

Overdose

Symptoms: increased severity of side effects.

Treatment: gastric lavage, intake of activated charcoal, symptomatic therapy.

Drug Interactions

No interaction is observed with simultaneous use with β-blockers (chloranolol, pindolol), clopamide, glibenclamide, digoxin, acenocoumarol, hydrochlorothiazide, imipramine.

Simultaneous use of vinpocetine and methyldopa sometimes caused some enhancement of the hypotensive effect, therefore, with such treatment, regular blood pressure monitoring is required.

Despite the lack of data confirming the possibility of interaction, caution is recommended when co-administering with drugs of central, antiarrhythmic and anticoagulant action.

Increases the risk of hemorrhagic complications against the background of heparin therapy.

Storage Conditions

List B. The drug should be stored in a dry, light-protected place, at a temperature not exceeding 25°C (77°F). Keep out of reach of children.

Shelf Life

The shelf life is 4 years. Do not use after the expiration date.

Dispensing Status

The drug is dispensed by prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.