ACTOVEGIN AMPOULES 40MG/ML 2ML

pharmachologic effect

Antihypoxant, which has three types of effects: metabolic, neuroprotective and microcirculatory. Actovegin® increases the absorption and utilization of oxygen; The phospho-oligosaccharides included in the formulation of inositol have a positive effect on glucose transport and utilization, which leads to an improvement in the energy metabolism of cells and a decrease in the formation of lactate under ischemic conditions.

We consider several ways to implement the neuroprotective mechanism of drug action.

Actovegin® inhibits the development of apoptosis induced by beta-amyloid (Aβ25-35).

Actovegin® modulates the activity of the nuclear factor kappa B (NF-kB), which plays an important role in the regulation of apoptosis and inflammation in the central and peripheral nervous system.

Another mechanism of action is associated with the nuclear enzyme poly (ADP-ribose) -polymerase (PARP). PARP plays an important role in identifying and repairing single-stranded DNA damage, but over-activation of the enzyme can trigger cell death processes in such conditions as cerebrovascular diseases and diabetic polyneuropathy. Actovegin®inhibits PARP activity, leading to a functional and morphological improvement of the central and peripheral nervous system.

The positive effects of the drug Actovegin®affecting the processes of microcirculation and endothelium are an increase in the speed of capillary blood flow, a decrease in the pericapillary zone, a decrease in the myogenic tone of precapillary arterioles and capillary sphincters, a decrease in the degree of arteriolovascular shunt blood flow with a predominant circulation of blood in the capillary bed, and stimulation of the endothelium systhone syringe in the capillary systhesis and stimulate the endohelial systhis Syndrome in the systhyl systhyl systhis syndrome in the systhyl systhyl systhis syndrome and in the systhyl systhis syndrome in the systhyl syphilic syphrosis of the shunt blood flow in the capillary arterioles mainstream.

In the course of various studies, it was found that the effect of the drug Actovegin® comes no later than 30 minutes after its reception. The maximum effect is observed 3 hours after parenteral and 2-6 hours after oral administration.

Pharmacokinetics

With the help of pharmacokinetic methods, it is impossible to study the pharmacokinetic parameters of the drug Actovegin®because it consists only of the physiological components that are usually present in the body.

Indications

In the complex therapy:

- cognitive impairment, including post-stroke cognitive impairment and dementia;

- disorders of peripheral circulation and their consequences;

- diabetic polyneuropathy.

Dosing regimen

The drug is used in / a, in / in (including in the form of infusion) and in / m.

Depending on the severity of the clinical picture, you must first enter 10-20 ml of the drug in / in or in / a daily; then - 5 ml i / v or v / m slowly, daily or several times a week.

For infusion from 10 to 50 ml of the drug should be added to 200-300 ml of the basic solution (isotonic sodium chloride solution or 5% glucose solution). Infusion rate of about 2 ml / min.

For i / m injection use no more than 5 ml of the drug, which should be administered slowly, because the solution is hypertonic.

ATacute ischemic stroke (from 5-7 days) - at 2000 mg / day in / in the drip up to 20 infusions with the transition to the pill form, 2 tab. 3 times / day (1200 mg / day). The total duration of treatment is 6 months.

Atdementia - 2000 mg / day in / in the drip. The duration of treatment is up to 4 weeks.

Atperipheral circulatory disorders and their consequences - 800-2000 mg / day in / a or in / in drip. The duration of treatment is up to 4 weeks.

Atdiabetic polyneuropathy - 2000 mg / day in / in the drip 20 infusions with the transition to the pill form in 3 tab. 3 times / day (1800 mg / day). The duration of treatment is from 4 to 5 months.

Instructions for using ampoules with a break point

Position the tip of the ampoule point up.

Gently tapping the finger and shaking the ampoule, let the solution from the tip of the ampoule flow down.

Holding the vial in one hand with the tip upwards, with the other hand break off the tip of the vial at the break point.

Side effect

The frequency of side effects was determined in accordance with the classification of the Council of International Medical Scientific Organizations (CIOMS): very often (≥1 / 10); often (≥1 / 100 to <1/10); infrequently (≥1 / 1000 to <1/100); rarely (≥1 / 10,000 to <1/1000); very rarely (<1/10 000); frequency unknown (cannot be estimated from available data).

Immune system: rarely - allergic reactions (drug fever, symptoms of shock).

From the skin and subcutaneous tissue: rarely - urticaria, sudden redness.

Musculoskeletal system: frequency unknown - myalgia.

Contraindications

- hypersensitivity to the drug Actovegin®similar to drugs or excipients;

- decompensated heart failure;

- pulmonary edema;

- oliguria, anuria;

- fluid retention in the body;

- children's and teenage age up to 18 years.

Use during pregnancy and lactation

During pregnancy and lactation Actovegin® it should be used only in cases where therapeutic benefit outweighs the potential risk to the fetus or child.

Application for violations of kidney function

Contraindicated in oliguria, anuria.

Use in children

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

special instructions

Parenteral administration of the drug should be carried out under sterile conditions.

Because of the possibility of an anaphylactic reaction, it is recommended to conduct a test injection (test for hypersensitivity).

In the case of electrolyte disorders (such as hyperchloremia and hypernatremia), these conditions should be adjusted accordingly.

Solution for injection has a slightly yellowish tint. The color intensity may vary from one batch to another, depending on the characteristics of the raw materials used, but this does not adversely affect the activity of the drug or its tolerance.

Do not use an opaque solution or a solution containing particles.

After opening the ampoule the solution cannot be stored.

Clinical data

In a multicenter, randomized, double-blind, placebo-controlled study ARTEMIDA (NCT01582854), the purpose of which was to study the therapeutic effect of Actovegin® for cognitive impairment in 503 patients with ischemic stroke, the overall incidence of serious adverse events and death was the same in both study groups. Although the frequency of recurrent ischemic strokes was within the expected in this patient population, a greater number of cases were recorded in the group that took the drug Actovegin®compared with the placebo group, however, this difference was not statistically significant. The relationship between cases of re-stroke and the study drug has not been established.

Use in pediatrics

Currently, data on the use of the drug Actovegin® pediatric patients are absent, so the use of the drug in this group of individuals is not recommended.

Influence on ability to drive motor transport and control mechanisms

Not established

Overdose

According to preclinical studies Actovegin® does not show toxic effects even at excess of a dose by 30-40 times in comparison with the doses recommended for use for the person. There were no cases of drug overdose Actovegin®.

Drug interaction

Drug interaction drug Actovegin® currently unknown.

Terms and conditions of storage

The drug should be stored out of the reach of children, protected from light at a temperature not higher than 25 ° C. Do not use after expiration date.

Pharmacy sales terms

The drug is available on prescription.