Description

Specifications
Active substances: Deproteinized hemoderivative of calf blood
Country of origin: Russia
ProducerTakeda Pharmasyyutikals, OOO
Release form: 200mg coated tablets – 50 pcs.
Store in a dark place.
Keep out of the reach of children.
Dosage form
Round biconvex tablets, coated with a shell of greenish-yellow color, shiny.
Composition
1 coated tablet contains:
Core: active substance: blood components: calf deproteinized hemoderivative – 200.0 mg in the form of Actovegin granulate * – 345.0 mg; excipients: magnesium stearate – 2.0 mg, talc – 3.0 mg;
Shell: acacia gum – 6.8 mg, mountain glycol wax – 0.1 mg, hypromellose phthalate – 29.45 mg, diethylphalate – 11.8 mg, dye quinoline yellow aluminum varnish – 2.0 mg, macrogol-6000 – 2 , 95 mg, povidone-K 30 – 1.54 mg, sucrose -52.3 mg, talc – 42.2 mg, titanium dioxide – 0.86 mg.
* Actovegin1 * granulate contains: active substance: blood components:
deproteinized hemoderivative of calf blood – 200.0 mg, excipients: povidone-K 90 – 10.0 mg, microcrystalline cellulose – 135.0 mg.
general description
Tissue regeneration stimulant.
Special conditions
Clinical data
In the ARTEMIDA multicenter, randomized, double-blind, placebo-controlled study (NCT01582854), which aimed to study the therapeutic effect of Actovegin® on cognitive impairment in 503 patients with ischemic stroke, the overall incidence of serious adverse events and death was the same in both treatment groups. Although the frequency of repeated ischemic strokes was within the expected range in this patient population, a greater number of cases were recorded in the Actovegin® group compared with the placebo group, but this difference was not statistically significant. The relationship between cases of recurrent stroke and the study drug was not found.
Use in pediatric patients
Currently, there are no data on the use of the drug Actovegin in children, so its use in this group of people is not recommended.
Influence on the ability to drive a car and other mechanisms
Not installed.
Drug interaction
Currently unknown.
Pharmacodynamics
Actovegin® is an antihypoxant that has three types of effects: metabolic, neuroprotective and microcirculatory. Actovegin increases the absorption and utilization of oxygen; phospho-oligosaccharides, which are part of the inositol preparation, have a positive effect on the transport and utilization of glucose, which leads to an improvement in the energy metabolism of cells and a decrease in the formation of lactate under conditions
ischemia.
Several ways of implementing the neuroprotective mechanism of action of the drug are considered.
Actovegin inhibits the development of apoptosis induced by the beta-amyloid peptide (A (325-35).
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 the detection and repair of damage to single-stranded DNA, however, excessive activation of the enzyme can trigger cell death processes in conditions such as cerebrovascular disease and diabetic polyneuropathy. Actovegin inhibits PARP activity, which leads to a functional and morphological improvement in the state of the central and peripheral nervous system.
The positive effects of Actovegin, affecting the 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 arteriovenular shunt blood flow with predominant blood circulation in the capillary endothelial function and nitrogen affecting the microvasculature.
In the course of various studies, it was found that the effect of the drug Actovegin occurs no later than 30 minutes after its administration. The maximum effect is observed 3 hours after parenteral and 2-6 hours after oral administration.
Pharmacokinetics
Using pharmacokinetic methods, it is impossible to study the pharmacokinetic parameters of Actovegin, since it consists only of physiological components that are usually present in the body.
Indications
As part of complex therapy:
• Symptomatic treatment of cognitive impairment, including post-stroke cognitive impairment and dementia.
• Symptomatic treatment of peripheral circulation disorders and their consequences.
• Symptomatic treatment of diabetic polyneuropathy (DPN).
Contraindications
• Hypersensitivity to Actovegin® and similar drugs or excipients.
• Fructose intolerance, glucose-galactose malabsorption, or sucrose-isomaltase deficiency.
• Children’s age up to 18 years.
Carefully
Pregnancy and the period of breastfeeding.
Use during pregnancy and during breastfeeding
Actovegin should be used only in cases where the therapeutic benefit exceeds the potential risk to the fetus or child.
Overdose
According to preclinical studies, Actovegin does not show toxic effects even when the dose is 30-40 times higher than the doses recommended for human use. There were no cases of overdose with Actovegin.
Side effects
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 (> 1/10000 to <1/1000); very rarely (<1/10000); not known (cannot be estimated from the available data). Immune System Disorders Rarely: allergic reactions (drug fever, shock symptoms). Disorders of the skin and subcutaneous tissue Rarely: urticaria, sudden redness.