Cavintazole (Tablets) Instructions for Use

Marketing Authorization Holder

Uralbiopharm, JSC (Russia)

ATC Code

N06BX18 (Vinpocetine)

Active Substance

Vinpocetine (Rec.INN registered by WHO)

Dosage Form

Cavintazole

Tablets 5 mg: 10, 20, 30, 40, 50, 60, 80 or 100 pcs.

Dosage Form, Packaging, and Composition

Tablets white or white with a yellowish tint, flat-cylindrical in shape, with a bevel and a score.

Excipients: lactose monohydrate (milk sugar) – 207.4 mg, potato starch – 29.1 mg, povidone (polyvinylpyrrolidone) – 6 mg, magnesium stearate – 2.5 mg.

10 pcs. – contour cell packs (1) – cardboard packs.
10 pcs. – contour cell packs (2) – cardboard packs.
10 pcs. – contour cell packs (3) – cardboard packs.
10 pcs. – contour cell packs (4) – cardboard packs.
10 pcs. – contour cell packs (5) – cardboard packs.
10 pcs. – contour cell packs (10) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
60 pcs. – polymer jars (1) – cardboard packs.
80 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Clinical-Pharmacological Group

A drug that improves cerebral circulation and metabolism

Pharmacotherapeutic Group

Psychostimulant and nootropic agent

Pharmacological Action

A drug that improves cerebral circulation and brain metabolism. It inhibits the activity of phosphodiesterase, which promotes the accumulation of cAMP in tissues.

It has a vasodilating effect mainly on the cerebral vessels, which is due to a direct myotropic antispasmodic action. Systemic blood pressure decreases slightly.

It improves blood supply and microcirculation in brain tissues, reduces platelet aggregation, and helps normalize the rheological properties of blood.

It improves the tolerance of brain cells to hypoxia by promoting oxygen transport to tissues due to a decrease in the affinity of erythrocytes for it, and enhances the uptake and metabolism of glucose.

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, dizziness of labyrinthine origin.

Vegetative-vascular dystonia in menopausal syndrome.

ICD codes

Dosage Regimen

Administer orally with water after meals.

The standard adult dosage is 5 mg to 10 mg taken three times daily.

For chronic conditions, initiate therapy with the lower end of the dosage range.

The maximum daily dose should not exceed 30 mg.

For acute conditions, parenteral administration is primarily indicated.

The single intravenous dose is 20 mg.

With good tolerance, increase the dose gradually over 3 to 4 days to a target of 1 mg per kg of body weight.

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

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

In cases of hemorrhagic stroke, delay parenteral administration until 5-7 days after the acute event has subsided.

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

Do not adjust the dosage without medical supervision.

Adverse Reactions

From the hematopoietic system rarely – leukopenia, thrombocytopenia, decrease/increase in the number of eosinophils; very rarely – anemia, agglutination of erythrocytes, 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 – edema of the optic disc; very rarely – conjunctival hyperemia.

From the organ of hearing 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, “hot flashes”, 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 activity of liver enzymes; very rarely – dysphagia, stomatitis.

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

Other rarely – asthenia, malaise, feeling of heat; very rarely – feeling of discomfort in the chest, hypothermia, decrease in 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

For liver diseases, use at the usual dose.

Use in Renal Impairment

For 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 according to indications.

Special Precautions

Use orally with caution in arrhythmia, angina pectoris, with unstable blood pressure and reduced vascular tone.

Parenterally, as a rule, it is used in acute cases until the clinical picture improves, then they switch to oral administration.

For 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 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 acting on the central nervous system and with drugs with 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.