home Audience 1 Why is Actovegin 400 prescribed? Actovegin - instructions for use, reviews, analogs and forms of release (tablets, injections in injection ampoules, ointment, gel and cream) medications for the treatment of metabolic disorders of the brain in adults, children (newborns

Why is Actovegin 400 prescribed? Actovegin - instructions for use, reviews, analogs and forms of release (tablets, injections in injection ampoules, ointment, gel and cream) medications for the treatment of metabolic disorders of the brain in adults, children (newborns

Disorders of metabolic processes in the human body often lead to tissue damage. Such violations are fraught with consequences and can provoke a number of diseases. The drug Actovegin is one of the most common drugs used in various fields of medicine. The drug has the ability to restore damaged cells and improve metabolic processes. The instructions for using the medicine will allow you to familiarize yourself with the drug, but still it can only be taken as prescribed by a doctor.

Dosage form

Actovegin is available in several pharmaceutical forms: injection ampoules, ointment, gel or tablets. In this article we will look at the drug in the form of a solution for intramuscular or intravenous injection. Before purchasing the drug, it is important to pay attention to the dosage.

0.4 mg each, package contains 5 ampoules of 10 ml;
solution of 200 mg, No. 5 ampoules of 5 ml;
80 mg each, No. 25 ampoules of 2 ml.

Description and composition

Actovegin is a drug with a broad spectrum antihypoxic and antioxidant effect. The basic principle of action of the drug is based on tissue regeneration. The drug improves blood circulation, provides brain tissue with the necessary amount of oxygen and other useful components. Actovegin can be used in the complex treatment of many diseases. The drug provides the body with vital components and is often used for the complex treatment of a large number of diseases in adults and children, as well as pregnant women.

The active component of the drug is deproteinized hemoderivative of calf blood 50 mg, as well as auxiliary components, including sodium chloride, water for injection.

Pharmacological group

Actovegin in ampoules activates metabolic processes, increases the transport and accumulation of glucose to the brain. The drug restores the concentration of amino acids, ADP, and stimulates the utilization of glucose. The use of the drug stabilizes plasma membranes and improves the energy balance in tissues.

The antihypoxic effect of the drug appears within 30 minutes after parenteral administration and persists for 3 to 6 hours. Actovegin has the ability to heal tissue at the intracellular level and improve blood supply to brain structures. The principle of action of the drug increases the resistance of tissues and internal organs to oxygen starvation. The broad mechanism of action of the drug allows it to be used in various fields of medicine, but most often this drug is prescribed in neurology and cardiology in the complex treatment of a large number of diseases.

Actovegin is a multicomponent drug that contains various compounds that have a positive effect on the human body. The drug has been on the market for more than 10 years and is often used to treat diseases accompanied by metabolic disorders.

Indications for use

The instructions for the drug contain a fairly large list of diseases and conditions for which the drug can be used. Actovegin injections are often used in the complex treatment of diseases in children and adults.

for adults

The following diseases and conditions may be indications for Actovegin injections:

hemorrhagic stroke;
encephalopathy of various etiologies;
disturbances in the functioning of venous, peripheral or arterial blood;
ischemic stroke;
cerebral metabolic disorders;
traumatic brain injuries;
angiopathy;
damage to the cornea of the eye of various etiologies;
burns up to 3rd degree;
trophic skin damage;
wounds that are difficult to treat;
skin ulcers;
bedsores.

for children

In pediatrics, Actovegin is most often used in newborns for brain problems. The drug can be used from the first days of a child’s life during the acute period. The main indication for use of the drug is:

prenatal;
TBI during childbirth;
burns.

Indications for use include postpartum trauma in a child, cerebrovascular accident and other serious conditions.

for pregnant women and during lactation

Actovegin can be used during pregnancy, but with caution and under the strict supervision of a doctor. The drug is considered very safe for the fetus and the woman herself. It is often used for the following conditions:

disruption of placental blood supply;
underdevelopment of the placenta;
diabetes, type I or II;
arterial hypertonicity;
Rh factor conflict between the blood of the fetus and mother;
oxygen deficiency of the placenta and embryo.

Actovegin injections can be prescribed to pregnant women and as a prophylaxis in the presence of a risk of miscarriage or premature birth. Many doctors do not recommend using the drug when breastfeeding.

Contraindications

Actovegin is a physiological drug, so the only contraindication for use was an increased reaction of the body.

Applications and dosages

Actovegin solution is intended for intra-arterial, intramuscular, intravenous administration. If necessary, the drug is administered into the vascular bed in the form of infusions. Despite the good tolerability of the drug, a sensitivity test must be performed before using it.

For adults

According to the instructions for the drug, Actovegin solution is prescribed individually for each patient, depending on the diagnosis, the patient’s age, and the method of administration.

When administered intravenously, the drug is diluted in a 5% glucose solution or in 0.9% sodium chloride. The daily dose should not exceed 2000 mg per ¼ liter of solution.
When administered intramuscularly, the dosage is no more than 5 ml per day.
Intra-arterial administration of the drug varies from 5 to 20 ml per day.

Treatment with Actovegin ranges from 10 days to several weeks or months.

For children

The daily dose of the drug is calculated as 0.4-0.5 ml per 1 kg of body weight intramuscularly. Treatment with Actovegin significantly increases and improves the prognosis for recovery.

For pregnant women and during lactation

For pregnant women, the dose of the medicine is determined by the doctor individually for each patient.

After using the injections, the effect does not appear so quickly. The positive effect from taking it may appear no earlier than after 1 week and will persist for several months.

Side effects

The drug is well tolerated, but in rare cases, after administration of the drug, adverse reactions of the body may appear:

The medicine has no toxic effect on the body and is not addictive. If the patient has hypersensitivity to Actovegin, the doctor may prescribe analogues of the drug. The closest analogue of the medicine is.

Interaction with other drugs

The drug is often combined with other medications. There is no data on drug incompatibility.

Name:

Actovegin

Pharmachologic effect:

Actovegin activates cellular metabolism (metabolism) by increasing the transport and accumulation of glucose and oxygen, enhancing their intracellular utilization. These processes lead to an acceleration of ATP (adenosine triphosphoric acid) metabolism and an increase in the energy resources of the cell. Under conditions that limit the normal functions of energy metabolism (hypoxia / insufficient supply of tissue with oxygen or impaired absorption /, lack of substrate) and with increased energy consumption (healing, regeneration / tissue restoration /), Actovegin stimulates the energy processes of functional metabolism (metabolic process in body) and anabolism (the process of absorption of substances by the body). The secondary effect is increased blood supply.

Indications for use:

Cerebrovascular insufficiency, ischemic stroke (insufficient oxygen supply to brain tissue due to acute cerebrovascular accident), traumatic brain injury, peripheral circulatory disorders (arterial, venous), angiopathy (impaired vascular tone), trophic disorders (skin nutritional disorders) with varicose veins dilatation of the veins of the lower extremities (changes in the veins, characterized by an uneven increase in their lumen with the formation of a protrusion of the wall due to dysfunction of their valve apparatus), ulcers of various origins, bedsores (tissue necrosis caused by prolonged pressure on them due to lying down), burns, prevention and treatment of radiation injuries .

Damage to the cornea (the transparent membrane of the eye) and sclera (the opaque membrane of the eye): burns of the cornea (acids, alkalis, lime), corneal ulcers of various origins, keratitis (inflammation of the cornea), including after corneal transplantation, abrasions of the cornea in patients with contact lenses, prevention of lesions when selecting contact lenses in patients with degenerative processes in the cornea (for the use of eye jelly), as well as to accelerate the healing of trophic ulcers (slowly healing skin defects), bedsores (tissue necrosis caused by prolonged pressure on them due to lying ), burns, radiation damage to the skin, etc.

Method of application:

Doses and route of administration depend on the type and severity of the disease. The drug is prescribed orally, parenterally (bypassing the digestive tract) and locally.

1-2 tablets are prescribed orally 3 times a day before meals. Do not chew the pills, wash them down with a small amount of water.

For intravenous or intraarterial administration, depending on the severity of the disease, the initial dose is 10-20 ml. Then 5 ml is prescribed intravenously slowly or intramuscularly, 1 time per day every day or several times a week. 250 ml of solution for infusion is injected intravenously at a rate of 2-3 ml per minute once a day every day or several times a week. You can also use 10, 20 or 50 ml of solution for injection, diluted in 200-300 ml of glucose or saline. A total of 10-20 infusions per course of treatment. It is not recommended to add other drugs to the infusion solution.

Parenteral administration of Actovegin should be carried out with caution due to the possibility of developing an anaphylactic (allergic) reaction. Trial administrations are recommended, and conditions for emergency therapy must be provided. No more than 5 ml can be administered intravenously, since the solution has hypertonic properties (the osmotic pressure of the solution is higher than the osmotic pressure of the blood). When using the drug intravenously, it is recommended to monitor indicators of water and electrolyte metabolism.

Local application. The gel is prescribed for cleansing and treating open wounds and ulcers. For burns and radiation injuries, the gel is applied to the skin in a thin layer. When treating ulcers, the gel is applied to the skin in a thicker layer and covered with a compress with Actovegin ointment to prevent sticking to the wound. The dressing is changed once a week, for very wet ulcers - several times a day.

The cream is used to improve wound healing, as well as weeping wounds. Used after the formation of bedsores and prevention of radiation injuries.

Eye gel. Squeeze 1 drop of gel directly from the tube into the affected eye. Apply 2-3 times a day. After opening the package, the eye gel can be used for no more than 4 weeks.

Adverse events:

Allergic reactions: urticaria, feeling of a rush of blood, sweating, increased body temperature. Itching, burning in the area of application of the gel, ointment or cream, when using the eye gel - lacrimation, injection of the sclera (redness of the sclera).

Contraindications:

Hypersensitivity to the drug. Prescribe the drug with caution during pregnancy. During breastfeeding, the use of Actovegin is undesirable.

Release form of the drug:

Dragee forte in a package of 100 pieces. Solution for injection in ampoules of 2.5 and 10 ml (1 ml - 40 mg). Solution for infusion 10% and 20% with saline in 250 ml bottles. Gel 20% in tubes of 20 g. Cream 5% in tubes of 20 g. Ointment 5% in tubes of 20 g. Eye gel 20% in tubes of 5 g.

Storage conditions:

In a dry place at a temperature not exceeding +8 * C.

Compound:

Protein-free (deproteinized) extract (hemoderivate) from the blood of calves. Contains 40 mg of dry matter in 1 ml.

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Actovegin activates cellular metabolism (metabolism) by increasing the transport and accumulation of glucose and oxygen, enhancing their intracellular utilization. These processes lead to an acceleration of ATP (adenosine triphosphoric acid) metabolism and an increase in the energy resources of the cell. Under conditions that limit the normal functions of energy metabolism (hypoxia /insufficient supply of oxygen to tissue or impaired absorption/, lack of substrate) and with increased energy consumption (healing, regeneration /tissue restoration/), actovegin stimulates the energy processes of functional metabolism (the process of metabolism in the body) and anabolism (the process of absorption of substances by the body). The secondary effect is increased blood supply.

Indications for use

Cerebrovascular insufficiency, ischemic stroke (insufficient supply of brain tissue with oxygen due to acute cerebrovascular accident); traumatic brain injuries; disorders of peripheral circulation (arterial, venous); angiopathy (impaired vascular tone); trophic disorders (skin nutritional disorders) with varicose veins of the lower extremities (changes in the veins, characterized by an uneven increase in their lumen with the formation of a protrusion of the wall due to dysfunction of their valve apparatus); ulcers of various origins; bedsores (tissue death caused by prolonged pressure on them due to lying down); burns; prevention and treatment of radiation injuries.

Damage to the cornea (the transparent membrane of the eye) and sclera (the opaque membrane of the eye): burn of the cornea (acids, alkali, lime); corneal ulcers of various origins; keratitis (inflammation of the cornea), including after corneal transplantation; corneal abrasions in patients wearing contact lenses; prevention of lesions when selecting contact lenses in patients with degenerative processes in the cornea (for the use of eye jelly), as well as to accelerate the healing of trophic ulcers (slow-healing skin defects), bedsores (tissue necrosis caused by prolonged pressure on them due to lying), burns, radiation damage to the skin, etc.

Mode of application

Doses and route of administration depend on the type and severity of the disease. The drug is prescribed orally, parenterally (bypassing the digestive tract) and locally.
1-2 tablets are prescribed orally 3 times a day before meals. Do not chew the pills, wash them down with a small amount of water.
For intravenous or intraarterial administration, depending on the severity of the disease, the initial dose is 10-20 ml. Then 5 ml is prescribed intravenously slowly or intramuscularly, 1 time per day every day or several times a week. 250 ml of solution for infusion is injected intravenously at a rate of 2-3 ml per minute once a day every day or several times a week. You can also use 10, 20 or 50 ml of solution for injection, diluted in 200-300 ml of glucose or saline. A total of 10-20 infusions per course of treatment. It is not recommended to add other drugs to the infusion solution.

Metabolic and vascular disorders of the brain: from 5 to 25 ml (200 - 1000 mg per day) intravenously daily for two weeks, followed by switching to tablet form. Ischemic stroke: 20-50 ml (800 - 2000 mg) in 200-300 ml of 0.9% sodium chloride solution or 5% dextrose solution, intravenous drip daily for 1 week, then 10 - 20 ml (400 - 800 mg ) intravenous drip - 2 weeks, followed by switching to tablet form. Peripheral (arterial and venous) vascular disorders and their consequences: 20-30 ml (800 - 1000 mg) of the drug in 200 ml of 0.9% sodium chloride solution or 5% dextrose solution, intra-arterial or intravenous daily; Duration of treatment is 4 weeks. Diabetic polyneuropathy: 50 ml (2000 mg) per day intravenously for 3 weeks, followed by switching to tablet form - 2-3 tablets 3 times a day for at least 4-5 months. Wound healing: 10 ml (400 mg) intravenously or 5 ml intramuscularly daily or 3 to 4 times a week, depending on the healing process (in addition to local treatment with ACTOVEGIN® in dosage forms for external use). Prevention and treatment of radiation damage to the skin and mucous membranes during radiation therapy: the average dose is 5 ml (200 mg) intravenously daily during breaks from radiation exposure. Radiation cystitis: daily 10 ml (400 mg) transurethral in combination with antibiotic therapy. Rate of administration: about 2 ml/min. The duration of treatment is determined individually according to the symptoms and severity of the disease.)

The ointment is applied in a thin layer to the skin. Used for long-term treatment of wounds and ulcers in order to accelerate their epithelialization (healing) after therapy with gel or cream. To prevent bedsores, the ointment must be applied to the appropriate areas of the skin. To prevent radiation damage to the skin, the ointment should be applied after irradiation or in between sessions.
Eye gel. Squeeze 1 drop of gel directly from the tube into the affected eye. Apply 2-3 times a day. After opening the package, the eye gel can be used for no more than 4 weeks.

Side effects

Allergic reactions: urticaria, feeling of a rush of blood, sweating, increased body temperature. Itching, burning in the area of application of the gel, ointment or cream; when using eye gel - lacrimation, scleral injection (redness of the sclera).

Contraindications

Hypersensitivity to the drug. Prescribe the drug with caution during pregnancy. During breastfeeding, the use of Actovegin is undesirable.
Application of Actovegin tablets Allowed during pregnancy and lactation.
Application of Actovegin solution during pregnancy and lactation: use of the drug in pregnant women did not cause negative effects on the mother or fetus. However, when used in pregnant women, the potential risk to the fetus must be taken into account.

Release form

Storage conditions

In a dry place at a temperature not exceeding +8 * C.
(Actovegin tablets and Actovegin solution should be stored in a place protected from light at a temperature not exceeding 25 °C.)
Keep out of the reach of children!

Compound

Protein-free (deproteinized) extract (hemoderivate) from the blood of calves. Contains 40 mg of dry matter in 1 ml.
1 film-coated tablet of Akitovegin contains:
Core: active substance: blood components: deproteinized hemoderivative of calf blood – 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, diethyl phthalate – 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.
*Actovegin 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.

Main settings

Name:	Actovegin
ATX code:	D03AX50 -

Actovegin (lat. Actovegin) is a deproteinized (purified of protein) hemodialysate (extract) obtained from the blood of dairy calves. It is a generic version of the Swiss drug Solcoseryl.

According to its pharmacological properties, it belongs to the group of tissue regeneration stimulators. Improves the supply of oxygen and glucose to cells, accelerates metabolism and healing processes, and increases the body's energy resources.

It is used in neurology, ophthalmology, transplantology, dermatology and therapy. In the sports world it is known as one of the doping drugs.

An extract from the blood of calves was first proposed for medical use by specialists from the Swiss pharmaceutical company Solco.

The reason for the creation of the drug was the stories of Alpine shepherds, who claimed that wounds and scratches in dairy calves heal much faster than in adult cows.

Having studied the blood of young animals, scientists suggested that it contains a certain factor that accelerates the healing process.

An injectable form of purified calf blood extract was registered in Switzerland in 1957 under the brand name Solcoseryl. In the 60s, the development company introduced ointment and gel for external use to the market, and in the 70s - eye gel, adhesive paste and tablets.

In 1976, Solcoseryl was registered in the USSR. By 1990, the drug was introduced in 50 countries, including the USA and Canada.

In 1996, due to an epidemic of bovine spongiform encephalopathy*, the production of medicines made from bovine tissue was banned in Switzerland. For this reason, Solco moved the production of its products to Germany.

In the same year, the Austrian branch of the Swiss corporation Nikomed released a generic version of Solcoseryl under the brand name Actovegin. The main markets for the new drug are the CIS and Asian countries.

In 2000, one of the Tour de France participants, Lance Armstrong, was accused of using Actovegin to improve athletic performance.

Against the backdrop of the scandal, the International Olympic Committee added the drug to the list of prohibited drugs. However, already at the beginning of 2001, the drug was removed from the list due to the unproven doping effect.

* Spongiform encephalopathy (“mad cow disease”, prion disease, Creutzfeldt-Jakob disease) is a neurodegenerative disease that leads to irreversible changes in the cerebral cortex. Found among humans, cattle and sheep. The causative agent is a special type of high molecular weight protein - a prion. The disease manifests itself as dementia, mental disorders, and visual impairment. Previously, it was believed that prions arise spontaneously in the human body or that their formation is due to hereditary factors. In 1995, a new form of human pathology was described in Great Britain, the development of which was associated with the consumption of meat products from cows infected with encephalopathy.

Properties

Active component: deproteinized standardized hemodialysate (otherwise hemoderivat) from the blood of dairy calves (English: highly filtered extract obtained from calf blood).

International nonproprietary name: no.

The drug is a combination of various biologically active compounds:

amino acids (ornithine, leucine, alanine, glutamate, proline, glycine, taurine, etc.),
oligopeptides,
lipids,
oligosaccharides,
nucleosides (adenosine, uridine),
antioxidant enzymes
electrolytes (sodium, chlorine, potassium, magnesium, calcium, phosphorus, iron),
trace elements (copper, silicon, selenium, zinc).

Organic substances make up up to 30% of the dry mass of the extract.

The blood of calves under 3 months is used as the starting material for the preparation of the drug. The extract is produced by ultrafiltration, which, according to the manufacturer, ensures that it is free from pathogens of prion diseases.

Application in different countries

As of 2015, Actovegin is used in 17 countries:

About 70% of drug sales come from the countries of the former USSR.

For a long time, Actovegin was also used in the USA and Canada. In 2011, a ban was introduced in these countries on the import, sale and use of the drug.

It turned out that in countries where the drug is used, mental disorders were recorded 1.3 times more often than in countries where it was never used. Doctors suggested that this situation may be due to the presence of prion infection pathogens in the drug.

The sale of drugs made from bovine tissue has also been restricted in a number of other countries, including Russia, Ukraine and the Republic of Belarus. However, none of the countries of the former USSR included Actovegin among the prohibited drugs.

Calf blood extract has never been used as a medicine in Western Europe (except Switzerland), Japan and Australia.

Clinical researches

The use of Actovegin does not fully comply with the principles of evidence-based medicine. The drug has no known active principle, and its safety and effectiveness have not been confirmed according to international standards.

Most of the trials were carried out on a limited number of patients, so their results cannot be considered sufficiently convincing.

There are separate works that describe the effectiveness of Actovegin in patients with cognitive disorders. In 2002, European physicians V. Jansen and G. V. Bruckner published the results of the use of Actovegin in patients with cerebrovascular pathology.

120 volunteers took part in the experiment and were divided into 3 groups. The first one took the drug, 2 tablets. 3 times a day, the second - 2 tablets. 2 times a day. Patients of group 3 received placebo. After 3 months therapy, the authors noted that both dosing regimens of Actovegin significantly improved attention and memory in elderly patients.

In several experiments, the effectiveness of using the drug in the acute period of stroke was noted (Fedin A.I., Rumyantseva S.A. 2001-2004), in acute traumatic brain injuries (Mihalovich N., Hack J., 2004) and diseases of the peripheral nervous system (Shmyrev V.I., Bobrova T.A., 2002).

The first multicenter double placebo-controlled study of Actovegin was conducted under the auspices of Nycomed in 2008. The drug was used in 569 patients with diabetic polyneuropathy.

The effectiveness of therapy was assessed using the TSS scale (Total Symptom Score). In conclusion, the volunteers noted a decrease in the severity of pain, burning sensations and an improvement in overall well-being.

In April 2012, another 2-year multicenter study of the drug was launched, organized by the American FDA. Its results have not yet been published in international publications.

Composition, release forms, packaging

Actovegin is produced in the form:

4% solution for injection,
10% solution for infusion (in 0.9% sodium chloride solution or dextrose solution),
20% solution for infusion (in sodium chloride solution 0.9%),
film-coated tablets containing 200 mg of active substance,
5% cream for external use,
5% ointment for external use,
20% gel for external use,
20% eye gel.

The injection solution is packaged in ampoules of 2, 5 and 10 ml and then in boxes of 5 or 25 ampoules. The infusion solution is bottled in 250 ml clear glass bottles.

External gel, cream and ointment are available in aluminum tubes of 20, 30, 50 and 100 g. Eye gel - in a tube of 20 g.

Tablets are packaged in dark glass bottles of 10, 30 or 50 pieces.

Mechanism of action

Actovegin stimulates the flow of oxygen and glucose into cells, which leads to increased synthesis of energy molecules ATP. Thus, the drug acts as a kind of energy stimulant, activating the work of all body systems.

Increasing oxygen transport into brain cells has a positive effect on memory and learning processes. While taking the drug, patients experienced restoration of impaired cognitive functions and increased resistance of brain tissue to hypoxia.

In its ability to stimulate the uptake of glucose by cells, Actovegin is only 2 times inferior to insulin. At the same time, its effect is also manifested in patients with diabetes mellitus, helping to reduce the symptoms of polyneuropathy in them.

By improving energy metabolism in the walls of blood vessels, the drug enhances the release of endogenous vasodilators - nitric oxide and prostocycline. This effect leads to vasodilation, a decrease in total peripheral resistance and improved blood supply to organs.

Activation of energy metabolism entails increased synthesis of carbohydrates and proteins. The result of this is accelerated tissue healing. In animal experiments it was shown that the regenerative effects of Actovegin are most pronounced in relation to the liver, heart muscle and skin.

Metabolism and excretion

Actovegin is a multicomponent drug, which includes compounds originally contained in the human body, so it is not possible to study its pharmacokinetics.

In laboratory experiments, it was found that when used intravenously, the drug begins to act 5 minutes after administration, and the peak of its activity is observed after 120 minutes.

In patients with renal or hepatic insufficiency, no reduction in the pharmacological effects of Actovegin was observed.

Indications for use

The reasons for prescribing parenteral forms are:

acute and chronic disorders of peripheral and cerebral circulation,
dementia (dementia),
traumatic brain injuries,
ulcers of various origins,
long-term non-healing wounds,
burns,
radiation damage to the skin or mucous membranes,
radiation neuropathy.

angiopathy,
dementia,
traumatic brain injuries,
trophic ulcers, etc.

External soft forms (gel, cream, ointment) are used as wound healing agents for various skin lesions:

abrasions, cuts, wounds,
burns,
varicose ulcers,
bedsores (including for the purpose of prevention),
radiation damage.

Additional indications for Actovegin gel are pre-treatment of the skin before transplantation and treatment of burn disease.

Eye gel is indicated for the following conditions:

burns (chemical, radiation, thermal) and corneal injuries,
corneal ulcers,
keratitis of various origins,
corneal dystrophy,
dry keratoconjunctivitis,
selection of contact lenses (to prevent lesions).

Contraindications

A general contraindication for all forms of Actovegin is hypersensitivity to the drug.

For infusion solutions, the following are additionally indicated:

pulmonary edema,
fluid retention in the body,
urinary disorders (oligo- or anuria),
decompensated heart failure.

Pregnancy and lactation

Actovegin is allowed to be used during pregnancy and breastfeeding.

Directions for use and doses

The drug is used parenterally, orally and locally.

Take 1-2 tablets orally. 3 times a day for 4-6 weeks.

Injections are given intravenously (IV), intramuscularly (IM) or intra-arterially (IA). Dosages depend on the severity of the clinical picture. For the first time, 10-30 ml of the drug is administered IV or IM, then 5-10 ml IV or IM once a day. The course of treatment is 2-4 weeks.

Infusions are carried out intravenously or intravenously as a stream. Inject 250-500 ml of solution per day. Infusion rate - 2 ml/min. The course of treatment includes 10-20 procedures.

Apply a thin layer of ointment/cream/external gel to cleansed damaged areas of the skin 2 times a day. The course of therapy is at least 12 days. Treatment of ulcers begins with the use of a gel, gradually moving to a cream and then to an ointment.

In order to prevent radiation injuries, cream or ointment is rubbed in at intervals between radiation therapy sessions.

The eye gel is injected into the conjunctival sac 1 drop 2-3 times a day until the symptoms of the pathology disappear.

Side effects

Actovegin is well tolerated by most patients. A small number of patients may experience allergic reactions (skin rash, hyperthermia, redness of the skin). In such situations, standard symptomatic therapy is carried out.

When treating with a 20% external gel, slight swelling of the skin and pain may occur, which disappear as therapy continues.

When the eye gel is administered, a short-term mild burning sensation and lacrimation are felt.

special instructions

During long-term therapy with an infusion solution, it is necessary to monitor the water and electrolyte balance of the blood.

Do not use an infusion solution that is cloudy or contains suspended particles.

To reduce the risk of developing anaphylactic shock, the injection solution must be administered slowly. When using for the first time, it is recommended to do a test injection (inject 2 ml of solution intramuscularly).

Tablets and injection solution should be used with caution:

during pregnancy or lactation,
in patients with diabetes mellitus, hyperglycemia,
in patients with heart failure of 2-3 degrees,
with pulmonary edema,
with fluid retention in the body and urinary disorders.

Overdose

There have been no cases of overdose with Actovegin.

Interaction with other drugs

Not currently installed.

Vacation conditions

Cream, ointment, gel for external use are available without a prescription. Tablets, solution for infusion, solution for injection and eye gel - by prescription.

Storage

The drug is stored in a dry place, protected from light. Ointment, cream, gel for external use, tablets and solution for injection - at a temperature of 18-25ºС, solution for infusion and eye gel - at a temperature not exceeding 25ºС.

In pharmacies and medical institutions, tablets and injection solution are stored according to the conditions of List B.

Best before date

For cream, ointment, solution for injection, solution for infusion (in 0.9% sodium chloride solution) - 5 years.

For gel for external use, eye gel, tablets, solution for infusion (in dextrose solution) - 3 years.

After opening, the eye gel can be stored for no more than 4 weeks.

Manufacturer

From 1996 to 2011, Actovegin was produced by Nycomed Austria GmbH, which was a subsidiary of the Swiss corporation Nycomed.

Some batches of drugs released then (2010-2011) may still be available in retail sales.

In September 2011, Nycomed was purchased by the Japanese pharmaceutical giant Takeda Pharmaceutical Company Limited for 9.6 billion euros.

Currently, Actovegin continues to be produced at the same Austrian plant, but under the Takeda brand. The substrate for its production is purchased in Australia and France. Production is organized in accordance with the rules of the international GMP standard.

Analogues

The only complete replacement for Actovegin can be considered the original calf blood extract Solcoseryl, which is today produced by the German company Valeant.

The instructions for both drugs indicate similar therapeutic properties, indications for use and side effects. However, comparative clinical studies of analogues have not been conducted, so their biological equivalence has not been officially confirmed.

There are differences in brand product portfolios and concentrations of identical dosage forms. Thus, Solcoseryl’s assortment does not include a cream for external use and a 10% solution for infusion, but does include an adhesive dental paste.

Solcoseryl injection solution is available in a concentration of 4.25%, and skin gel in a concentration of 10%.

Analogues of local forms of Actovegin also include the Belarusian gel Diavitol, produced by the Dialek Unitary Enterprise. It contains deproteinized hemodialysate from the blood of cow embryos and the blood of young calves.

When comparing the pharmacological descriptions of the 3 drugs, discrepancies are found in age restrictions, drug interactions and the possibility of use during pregnancy and lactation.

Comparative characteristics of Actovegin and its analogues:

Tradename	Actovegin	Solcoseryl	Diavitol
Active ingredient		Deproteinized hemodialysate from the blood of dairy calves	Deproteinized hemodialysate from the blood of cow embryos and the blood of dairy calves
Implementation countries	CIS, South Korea, China	CIS, China, South Korea	Republic of Belarus
Dosage forms	Tablets 200 mg Ointment for external use 5% Cream for external use 5% Gel for external use 20% Ophthalmic gel 20% Solution for injection 4% Solutions for infusions 10 and 20%	Tablets 200 mg Gel for external use 10% Ointment for external use 5% Ophthalmic gel 20% Solution for injection 4, 25% Solution for infusion 20% Dental adhesive paste	Gel for external use 10%
Age restrictions	Not specified	Tablets and parenteral solutions are not recommended for use under 18 years of age	Should not be used under 12 years of age
Use during pregnancy and lactation	Can be applied	The drug should be used orally and parenterally with caution during pregnancy. During therapy during lactation, it is recommended to interrupt breastfeeding.	At the doctor's discretion
Drug interactions	Not installed	Parenteral forms are prohibited from being mixed with phytoextracts, becyclane fumarate, and naftidrofuryl.	Not installed

Publication date: 2015-07-3
Last modified: 2020-01-31

Dear visitors of the Farmamir website. This article does not constitute medical advice and should not serve as a substitute for consultation with a physician.

In this article you can read the instructions for use of the drug Actovegin. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Actovegin in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Actovegin in the presence of existing structural analogues. Use for the treatment of metabolic and vascular disorders of the brain, tissue trophism, burns and bedsores, diabetic polyneuropathy in adults, children (including newborns), as well as during pregnancy and lactation.

Actovegin- antihypoxant, is a hemoderivative, which is obtained through dialysis and ultrafiltration (compounds with a molecular weight of less than 5000 daltons penetrate).

It has a positive effect on the transport and utilization of glucose, stimulates oxygen consumption (which leads to the stabilization of plasma membranes of cells during ischemia and a decrease in the formation of lactates), thus providing an antihypoxic effect.

Actovegin increases the concentrations of ATP, ADP, phosphocreatine, as well as amino acids (glutamate, aspartate) and GABA.

The effect of the drug Actovegin on the absorption and utilization of oxygen, as well as insulin-like activity with stimulation of glucose transport and oxidation are significant in the treatment of diabetic polyneuropathy.

In patients with diabetes mellitus and diabetic polyneuropathy, Actovegin significantly reduces the symptoms of polyneuropathy (stabbing pain, burning sensation, paresthesia, numbness of the lower extremities). Sensitivity disorders are objectively reduced and the mental well-being of patients is improved.

The effect of Actovegin begins to appear no later than 30 minutes (10-30 minutes) after parenteral administration and reaches a maximum, on average, after 3 hours (2-6 hours).

Compound

Deproteinized hemoderivative from calf blood (Actovegin concentrate or granulate) + excipients.

Pharmacokinetics

Using pharmacokinetic methods, it is impossible to study the pharmacokinetic characteristics (absorption, distribution, excretion) of the active components of the drug Actovegin, since it consists only of physiological components that are usually present in the body.

To date, no decrease in the pharmacological effectiveness of hemoderivatives has been found in patients with altered pharmacokinetics (including liver or renal failure, metabolic changes associated with old age, due to metabolic characteristics in newborns).

Indications

metabolic and vascular disorders of the brain (including ischemic stroke, traumatic brain injury);
peripheral (arterial and venous) vascular disorders and their consequences (arterial angiopathy, trophic ulcers);
diabetic polyneuropathy;
wound healing (ulcers of various etiologies, trophic disorders /bedsores/, burns, impaired wound healing processes);
prevention and treatment of radiation injuries of the skin and mucous membranes during radiation therapy.

Release forms

Film-coated tablets 200 mg.

Solution for injections (injections) 40 mg/ml in ampoules of 5 ml and 10 ml.

Ointment for external use 5% (not supplied to Russia).

Cream for external use 5% (not supplied to Russia).

Gel for external use 20% (not supplied to Russia).

Instructions for use and dosage

Pills

Prescribe 1-2 tablets orally 3 times a day before meals. Do not chew the tablet, wash it down with a small amount of water. The duration of treatment is 4-6 weeks.

Ampoules

The injection solution is administered intraarterially, intravenously (including in the form of infusion or dropper) and intramuscularly. The infusion rate is about 2 ml/min. Due to the potential for anaphylactic reactions, it is recommended to test for hypersensitivity to the drug before starting the infusion.

The duration of treatment is determined individually, depending on the symptoms and severity of the disease.

Metabolic and vascular disorders of the brain: from 5 to 25 ml (200 - 1000 mg per day) intravenously daily for two weeks, followed by switching to tablet form.

Ischemic stroke: 20-50 ml (800 - 2000 mg) in 200-300 ml of 0.9% sodium chloride solution or 5% dextrose solution, intravenous drip daily for 1 week, then 10 - 20 ml (400 - 800 mg ) intravenous drip - 2 weeks, followed by switching to tablet form.

Peripheral (arterial and venous) vascular disorders and their consequences: 20-30 ml (800 - 1000 mg) of the drug in 200 ml of 0.9% sodium chloride solution or 5% dextrose solution, intra-arterial or intravenous daily; Duration of treatment is 4 weeks.

Diabetic polyneuropathy: 50 ml (2000 mg) per day intravenously for 3 weeks, followed by switching to tablet form - 2-3 tablets 3 times a day for at least 4-5 months.

Wound healing: 10 ml (400 mg) intravenously or 5 ml intramuscularly daily or 3 to 4 times a week depending on the healing process (in addition to local treatment with Actovegin in dosage forms for external use).

Prevention and treatment of radiation damage to the skin and mucous membranes during radiation therapy: the average dose is 5 ml (200 mg) intravenously daily during breaks from radiation exposure.

Radiation cystitis: daily 10 ml (400 mg) transurethral in combination with antibiotic therapy.

Side effect

Contraindications

decompensated heart failure;
pulmonary edema;
oliguria, anuria;
fluid retention in the body;
hypersensitivity to the components of the drug;
hypersensitivity to similar drugs.

Use during pregnancy and breastfeeding

The use of the drug during pregnancy did not have a negative effect on the mother or fetus, however, if it is necessary to use the drug during pregnancy, the potential risk to the fetus should be taken into account. So the use of Actovegin in these cases requires caution.

special instructions

Due to the potential for anaphylactic reactions, it is recommended to conduct a test (test injection of 2 ml IM) before starting the infusion.

In the case of intramuscular administration, the drug should be administered slowly in an amount of no more than 5 ml.

Actovegin solutions have a slightly yellowish tint. The color intensity may vary from one batch to another depending on the characteristics of the starting materials used, but this does not affect the effectiveness and tolerability of the drug.

Do not use a solution that is opaque or contains particles.

With repeated administrations, the water-electrolyte balance of the blood plasma should be monitored.

After opening the ampoule or bottle, the solution cannot be stored.

Drug interactions

Drug interactions with Actovegin have not been established.

However, in order to avoid possible pharmaceutical incompatibility, it is not recommended to add other drugs to the Actovegin infusion solution.

Analogues of the drug Actovegin

The drug Actovegin has no structural analogues for the active substance.

Analogs by pharmacological group (antihypoxants and antioxidants):

If there are no analogues of the drug for the active substance, you can follow the links below to the diseases for which the corresponding drug helps, and look at the available analogues for the therapeutic effect.