Vinpocetine concentrate for solution for inf. 5mg / ml 2ml amp 10 pcs

Description

Composition
Active substance:
1 ml of solution contains: vinpocetine – 5.0 mg ;.
Product form:
Concentrate for solution for infusion, 5 mg / ml.
In 2 ml ampoules lighting glass.
10 ampoules were placed in a box made of cardboard.
5 or 10 vials were placed in blisters of PVC film and aluminum foil printed lacquered or without foil. 1 contour cell package with 10 ampoules or 1, 2 blisters with 5 ampoules were placed in a pile of cardboard.
In each pack, the box put the instructions for use, scarifier ampoule.
When using ampoules with a ring or a break-point and notched scarifier ampoule not invest.
Dosage
5 mg / ml
Indications
The acute phase of hemorrhagic stroke, a severe form of coronary heart disease, severe heart rhythm disorders, hypersensitivity to vinpocetine or other ingredients;
pregnancy (perhaps placental bleeding and spontaneous abortion, probably due to increased placental circulation);
breastfeeding;
Children up to age 18 years (due to lack of clinical trial data).
Before using the product, be sure to consult with your doctor.
Interaction with other drugs
The simultaneous use of vinpocetine and methyldopa sometimes caused some increased hypotensive effect, however in such treatment requires regular blood pressure control.
Despite the lack of data to support interoperable, caution is recommended, while the use central drugs of antiarrhythmic and anticoagulation action.
Vinpocetine and heparin are chemically incompatible, so forbidden administering them in one fluid mixture, however, possible to simultaneously conduct anticoagulant treatment and vinpocetine.
Vinpocetine is incompatible with solutions containing amino acids, so they can not be used for its breeding.
Overdose
Symptoms: increased severity of dose-dependent side effects.
Treatment: symptomatic therapy.
pharmachologic effect
Pharmacodynamics:
Improves brain metabolism by increasing the glucose consumption of oxygen and the brain tissue. Increases the resistance of neurons to hypoxia; enhances the transport of glucose to the brain through the blood-brain barrier; glucose decay process needs to energetically more economical, aerobic path; selectively blocks calcium-dependent phosphodiesterase; increases the concentration of adenosine monophosphate (AMP), cyclic guanosine monophosphate (cGMP) and adenosine triphosphate (ATP) in the brain. Enhances the exchange of norepinephrine and serotonin in the brain, has an antioxidant effect. Reduces platelet aggregation and increased blood viscosity; increases the deforming ability of red blood cells and red blood cells block the recycling of adenosine; enhances the impact of oxygen by red blood cells. Improves cerebral blood flow; reduces cerebral vascular resistance without significantly changing indicators of the systemic circulation. No effect “steal” and increases blood flow, especially in ischemic areas of the brain. It crosses the placental barrier.
Pharmacokinetics:
Therapeutic concentrations in parenteral administration in the plasma 1020 ng / ml, the volume of distribution of 5.3 l / kg. When administered to rats radiolabelled vinpocetine highest radioactivity detected in the liver and gastrointestinal tract. The maximum concentration observed in tissues 24 hours after administration. The concentration in the brain does not exceed the values ​​found in the blood. In humans, the connection to plasma proteins is 66%. About 7% bioavailability. The volume of distribution of 246,7 ± 88,5 liters, which indicates a high binding to the tissues. The total clearance (66.7 l / h) exceeds the hepatic blood flow rate (50 l / h), which indicates extrahepatic metabolism. Gistogematicalkie easily penetrates the barriers (including the blood brain barrier) in breast milk (about 0.25% for 1 hour).
Metabolism
The major metabolite is apovinkaminovaya acid (AVC), component 2 530% of the parent compound. The area under the curve “concentration-time” after ingestion AVC twice higher than that by intravenous administration of vinpocetine. Thus, vinpocetine exposed to marked effect of “first pass” through the liver. By way IU metabolite include gidroksivinpotsetin, gidroksiAVK, AVKdioksiglitsinat and their conjugates (sulfates and (or) glucuronides). Excretion of unchanged vinpocetine low (a few percent). In human liver or kidney correction dose is not required because no koumouliruet vinpocetine.
breeding
The half-life in humans is 4.83 ± 1.29 h studies with radiolabeled vinpocetine found that the excretion by the kidneys and intestines occurs at a ratio of 60:. 40%. In rats and dogs, the high concentration is found in the bile, however there has been a significant enterohepatic recycling. Pharmacokinetics in special patient groups
As vinpocetine is primarily intended for the treatment of elderly patients, it is necessary to take into account the distribution and slowing metabolism, and excretion in this age group, especially for prolonged use. According to the results of clinical studies found that the kinetics of vinpocetine in the elderly is not significantly different from the young, accumulation does not occur. In human liver and kidney accumulation is not observed, which allows for long-term therapy.
Pregnancy and breast-feeding
Use in pregnancy is contraindicated.
During the period of lactation should stop breastfeeding.
Conditions of supply of pharmacies
On prescription.
side effects
In clinical studies the most common adverse reactions occurred in the following sistemnoorgannyh classes (according to the classification of the Medical Dictionary for Regulatory Activities) and with the following frequency: uncommon (> 1/1000,
special instructions
In the case of the initial elongation interval QT, and while the use of drugs, prolong the interval QT, during treatment vinpocetine requires periodic monitoring of an electrocardiogram.
The preparation comprises sorbitol, therefore the presence of diabetes necessary to periodically monitor the concentration of glucose in the blood.
Use caution when operating machinery and performing tasks that require speed of psychomotor reactions.
Storage conditions
In the dark place at a temperature of from 15 to 25 ° C. Keep out of the reach of children.
Dosing and Administration
The preparation is intended only for intravenous drip infusion, administered slowly (infusion rate may not exceed 80 drops / min). To prepare the infusion can use 0.9% sodium chloride solution or solutions containing dextrose.
The initial daily dose of 20 mg per 500 ml of sodium chloride 0.9% solution or solutions containing dextrose. With good tolerability for 2-3 days, the dose was increased to a maximum – 1 mg / kg / day.
Average duration of treatment 10-14 days.
When liver or kidney dose adjustment is required.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist