Vinpocetine, concentrate 5 mg/ml 10 ml 5 pcs

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Indications

Neurology: transient ischemic attack, symptomatic therapy of the consequences of ischemic stroke, vascular vertebrobasilar insufficiency, vascular dementia, atherosclerosis of cerebral vessels, post-traumatic, hypertensive encephalopathy.

Ophthalmology: chronic vascular diseases of the retina and choroid.

Otology: perceptual hearing loss, Meniere’s disease, tinnitus, vascular or toxic (including drug-induced) hearing impairment.

Active ingredient

Composition

One ampoule contains:

the active ingredient:

vinpocetine – 5 mg;

excipients:

ascorbic acid – 0.5 mg,

benzyl alcohol – 10 mg,

sodium disulfite (sodium metabisulfite) – 1 mg,

How to take, the dosage

The drug is intended for intravenous drip infusion only, administer slowly (infusion rate should not exceed 80 drops/minute).

Intravenous administration of the undiluted drug is not allowed. The infusion solution should be administered within 3 hours after preparation!

To prepare the infusion, 0.9% sodium chloride solution or solutions containing dextrose may be used.

The initial daily dose is 20 mg in 500 ml of infusion solution. Depending on tolerance, within 2-3 days the dose may be increased to no more than 1 mg/kg/day. The average duration of treatment is 10-14 days.

The average daily dose at a body weight of 70 kg is 50 mg.

In case of liver or kidney disease no dose adjustment is required.

When the course of parenteral administration is completed, the drug is switched to oral administration (10 mg 3 times daily). The dose should be gradually reduced before withdrawing the drug.

Interaction

Methyldopa may increase the hypotensive effect of vinpocetine; therefore, systematic BP control is required when using them concomitantly.

Despite the lack of clinical data, concomitant use with agents affecting the central nervous system, anticoagulants and antiarrhythmic agents should be used with caution.

Vinpocetine solution is pharmaceutically incompatible with heparin and solutions containing amino acids.

Special Instructions

The drug should be used with caution in intracranial hypertension, when concomitant use with antiarrhythmic drugs, as well as in prolonged QT interval syndrome or concomitant use with drugs prolonging the QT interval. ECG monitoring should be performed in case of prolonged QT interval syndrome or concomitant use of QT interval prolonging drugs.

There have been no studies on the effect on driving ability. Caution should be exercised when driving vehicles and operating moving machinery if adverse reactions from the nervous system occur.

Synopsis

Contraindications

Acute phase of hemorrhagic stroke, severe coronary heart disease, severe heart rhythm disturbances.

Hypersensitivity to vinpocetine or other components of the drug.

Pregnancy, lactation period.

Children under 18 years of age (due to lack of clinical trial data).

Side effects

Undesired reactions are classified according to their frequency of occurrence: very frequently (≥1/10), frequently (≥1/100, < 1/10), infrequently (≥1/1000, < 1/100), rarely (≥1/10000, < 1/1000), very rarely (< 1/10000), frequency is unknown (due to insufficient data).

Blood and lymphatic system disorders: rare – thrombocytopenia, erythrocyte agglutination; very rare – anemia.

Immune system disorders: very rare – hypersensitivity.

Metabolism and nutrition disorders: rarely – hypercholesterolemia, diabetes, decreased appetite, very rarely – anorexia.

Mental disorders: infrequent – euphoria; rare – anxiety; very rare – depression, sleep disorders.

Nervous system disorders: rarely – headache, dizziness, hemiparesis, somnolence; very rarely – tremor, loss of consciousness, hypotension, preconsciousness.

Visual organ disorders: rare – bleeding in the anterior chamber of the eye, hyperopia, decreased visual acuity, myopia; very rare – conjunctival hyperemia, edema of the optic disk, diplopia.

Hearing and labyrinth disorders: rare – hearing loss, hyperacusis, hypoacusis, true vertigo; very rare – tinnitus.

Cardiac disorders: rare – ischemia/myocardial infarction, angina pectoris, bradycardia, tachycardia, extrasystole, palpitations; very rare – heart failure, atrial fibrillation, arrhythmia.

Vascular disorders: rare – hypotension, hypertension, hot flashes; very rare – fluctuations in blood pressure, thrombophlebitis.

Gastrointestinal disorders: rare – abdominal discomfort, epigastric pain, dry mouth, nausea; very rare – hypersecretion of saliva, vomiting, dysphagia, stomatitis.

Skin and subcutaneous tissue pathology: rarely – erythema, hyperhidrosis, urticaria; very rarely – dermatitis, itching.

General disorders and reactions at the injection site: rarely – asthenia, malaise, burning sensation and inflammation at the injection site, thrombosis, discomfort in the chest.

Laboratory disorders: infrequent – decreased blood pressure; rare – increased blood pressure; hypertriglyceridemia, ST-segment depression, eosinopenia, impaired liver function tests, QT segment prolongation; very rare – increased LDH, abnormal EEG, PR prolongation.

Pregnancy use

The use during pregnancy and lactation is contraindicated.

Pregnancy

Vinpocetine penetrates through the placenta, but the plasma concentration, in the placenta and in the fetus is lower than in the mother. Teratogenic and embryotoxic effects were not detected. In animal studies, placental bleeding and abortions have occurred at high doses (presumably due to increased placental blood flow).

Breastfeeding

Vinpocetine penetrates into breast milk. According to preclinical studies with radioactively labeled vinpocetine, its concentration in breast milk was 10 times higher than in the blood of the mother. In 1 hour, 0.25% of the administered dose penetrates into the milk.

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