Vero-Vinpocetine (Tablets) Instructions for Use

Marketing Authorization Holder

Veropharm, JSC (Russia)

ATC Code

N06BX18 (Vinpocetine)

Active Substance

Vinpocetine (Rec.INN)

Dosage Form

Vero-Vinpocetine

Tablets 5 mg: 50 pcs.

Dosage Form, Packaging, and Composition

10 pcs. – blister packs (5) – cardboard packs.
50 pcs. – dark glass jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves cerebral circulation and metabolism

Pharmacotherapeutic Group

Cerebrovasodilating agent

Pharmacological Action

A drug that improves cerebral circulation and brain metabolism. It inhibits phosphodiesterase activity, which promotes the accumulation of cAMP in tissues. It has a vasodilating effect primarily on the cerebral vessels, which is due to a direct myotropic antispasmodic action. Systemic blood pressure decreases insignificantly.

It improves blood supply and microcirculation in brain tissues, reduces platelet aggregation, and promotes the normalization of blood rheological properties. It improves the tolerance of brain cells to hypoxia by facilitating oxygen transport to tissues due to decreased erythrocyte affinity for it, enhancing glucose uptake and metabolism. It increases the content of catecholamines in brain tissues.

Pharmacokinetics

When taken orally, it is rapidly absorbed from the gastrointestinal tract. C_max in blood plasma is reached approximately after 1 hour. With parenteral administration, V_d is 5.3 l/kg. T_1/2 is about 5 hours.

Indications

Acute and chronic cerebral circulation insufficiency. Dyscirculatory encephalopathy accompanied by memory impairment, dizziness, headache. Post-traumatic encephalopathy. Vascular diseases of the retina and choroid. Hearing impairment of vascular or toxic origin, Meniere’s disease, labyrinthine vertigo. Vegetative-vascular dystonia in menopausal syndrome.

ICD codes

Dosage Regimen

Administer the tablets orally with a full glass of water after a meal to minimize potential gastrointestinal discomfort.

For chronic cerebrovascular disorders, the typical adult dose is 5 mg to 10 mg taken three times daily.

Initiate therapy at the lower end of the dosage range and titrate upward based on individual patient tolerance and therapeutic response.

The maximum daily dose should generally not exceed 30 mg.

For the management of acute conditions, parenteral administration is primarily indicated.

The standard single intravenous dose is 20 mg.

With good patient tolerance, the dose may be carefully increased over a period of three to four days to a target of 1 mg per kilogram of body weight.

The typical duration of injectable therapy is 10 to 14 days.

Following the acute phase, transition to oral tablet administration for maintenance therapy.

The duration of oral treatment is determined by the treating physician based on the underlying condition and clinical progress.

Do not administer to children or adolescents under the age of 18.

Adverse Reactions

From the hematopoietic system rarely – leukopenia, thrombocytopenia, decrease/increase in the number of eosinophils; very rarely – anemia, erythrocyte agglutination, erythrocytopenia.

From the immune system very rarely – hypersensitivity reactions.

From metabolism infrequently – hypercholesterolemia; rarely – decreased appetite, anorexia, diabetes mellitus, hypertriglyceridemia; very rarely – increased body weight.

Mental disorders rarely – insomnia, sleep disorder, anxiety; very rarely – euphoria, depression.

From the nervous system infrequently – headache; rarely – dizziness, dysgeusia, stupor, hemiparesis, drowsiness, amnesia; very rarely – tremor, spasms.

From the organ of vision rarely – optic disc edema; very rarely – conjunctival hyperemia.

From the hearing organ and labyrinthine disorders infrequently – vertigo; rarely – hyperacusis, hypoacusis, tinnitus.

From the cardiovascular system infrequently – decreased blood pressure; rarely – myocardial ischemia/infarction, angina pectoris, bradycardia, tachycardia, extrasystole, palpitation sensation, increased blood pressure, flushing, thrombophlebitis; rarely – ST segment depression on ECG; very rarely – arrhythmia, atrial fibrillation, blood pressure lability.

From the digestive system infrequently – abdominal discomfort, dry mouth, nausea; rarely – epigastric pain, constipation, diarrhea, dyspepsia, vomiting, increased liver enzyme activity; very rarely – dysphagia, stomatitis.

From the skin and subcutaneous tissues rarely – erythema, hyperhidrosis, pruritus, urticaria, rash; very rarely – dermatitis.

Other rarely – asthenia, malaise, feeling of heat; very rarely – chest discomfort sensation, hypothermia, decreased prothrombin time values.

Contraindications

Hypersensitivity to vinpocetine; pregnancy, breastfeeding period; children and adolescents under 18 years of age; for parenteral use – acute phase of hemorrhagic stroke, severe coronary artery disease, severe forms of arrhythmia.

With caution

For parenteral use: increased intracranial pressure, use of antiarrhythmic drugs, long QT syndrome.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy.

Use during breastfeeding is contraindicated.

Use in Hepatic Impairment

In liver diseases, use at the usual dose.

Use in Renal Impairment

In kidney diseases, use at the usual dose.

Pediatric Use

Use in children and adolescents under 18 years of age is contraindicated.

Geriatric Use

Used in elderly patients as indicated.

Special Precautions

Use orally with caution in arrhythmia, angina pectoris, with unstable blood pressure and reduced vascular tone. Parenterally, as a rule, is used in acute cases until the clinical picture improves, then switch to oral administration. In chronic diseases, Vinpocetine is taken orally. In hemorrhagic cerebral stroke, parenteral administration of vinpocetine is allowed only after the acute phenomena have subsided (usually 5-7 days).

Drug Interactions

When used concomitantly with warfarin, a slight decrease in the anticoagulant effect of warfarin has been reported.

Concomitant use of vinpocetine and alpha-methyldopa sometimes caused some enhancement of the hypotensive effect, so regular blood pressure monitoring is required during such treatment.

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

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

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.