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Actovegin 200 mg, (50 tablets)

$52.00

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Description

Actovegin 200 mg, (50 tablets)

Registration Number: P N014635/03

Generic Name:

Deproteinized hemoderivative of calf blood

Dosage Form:

coated tablets.

Formulation:

1 coated tablet contains:
Core: active ingredient: Blood components: deproteinized hemoderivative of calf blood – 200.0 mg in the form of Actovegin® powder* – 345.0 mg, excipients: magnesium stearate – 2.0 mg, talc – 3.0 mg;
Shell: gum acacia – 6.8 mg, glycolic mineral wax – 0.1 mg, hypromellose phthalate – 29.45 mg, diethyl phthalate – 11.8 mg, aluminum quinoline yellow lacquer dye – 2.0 mg, macrogol-6000 – 2.95 mg, povidon-K 30 – 1.54 mg, sucrose – 52.3 mg, talc – 42.2 mg, titanium dioxide – 0.86 mg.
*Actovegin® powder contains: Active ingredient: blood components: deproteinized hemoderivative of calf blood – 200.0 mg, excipients: povidone-K 90 – 10.0 mg, microcrystalline cellulose – 135.0 mg.

Description:

round bright coated biconvex tablets, with greenish-yellow tint.

Therapeutic Category:

Tissue regeneration stimulator.

ATX Code: [B06AB]

Pharmacological Action:

Pharmacodynamic Properties
Actovegin® is antihypoxant having three types of effects: metabolic, neuroprotective, and microcirculatory. Actovegin® increases the uptake and utilization of oxygen; inositol phospho-oligosaccharides contained in the drug 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 in the presence of ischemia.

There are several ways under consideration to implement the neuroprotective mechanism of the drug.

Actovegin® prevents the development of apoptosis induced by beta-amyloid peptide (AP25-35).

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 a nuclear enzyme Poly-(ADP-ribose)-polymerase (PARP). PARP plays an important role in identifying damages and repairing single-stranded DNA, but over-activation of the enzyme can trigger cell death processes in such conditions as cerebrovascular diseases and diabetic polyneuropathy. Actovegin® inhibits PARP activity, resulting in a functional and morphological improvement of the central and peripheral nervous system.

Positive effects of Actovegin®, affecting microcirculation and endothelium, are an increase in capillary blood flow rate, a decrease in the pericapillary space, a decrease in myogenic tone of precapillary arterioles and capillary sphincters, reduction of the degree of arteri-venous shunt blood flow with preferential blood circulation in the capillary bed and stimulation of the function of endothelial synthase nitric oxide, affecting the microvasculature.

Various studies have found that the effect of Actovegin® occurs no later than 30 minutes after its administration. The maximum effect is noted 3 hours after parenteral and 2-6 hours after oral administration.

Pharmacokinetic Properties:

Using pharmacokinetic methods, it is not possible to study the pharmacokinetic parameters of Actovegin®, since it consists only of physiologically active components that are usually present in the body.

Indications:

As part of comprehensive treatment:

  • Symptomatic treatment of cognitive impairment, including post-stroke cognitive impairment and dementia.
  • Symptomatic treatment of peripheral circulatory 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 sucrase-isomaltase deficiency.
  • Age under 18 years.

Use with Caution:

Pregnancy and breastfeeding period.

Use during Pregnancy and Breastfeeding:

Actovegin® should be used only in cases where potential benefit to the mother outweighs any potential risk to the fetus or the child.

Dosage and Administration:

Ingestion, swallowing whole, before food, washing down with a small amount of liquid.

Post-stroke cognitive impairment
In acute period of ischemic stroke, starting from days 5-7, 2000 mg per day intravenously by drop infusion up to 20 infusions with switching to a tablet form – 2 tablets 3 times a day (1200 mg daily). The total duration of treatment is 6 months.

Dementia
2 tablets 3 times a day (1200 mg daily). The total duration of treatment is 20 weeks.

Peripheral circulatory disorders and their consequences
1-2 tablets 3 times a day (600 - 1200 mg daily). Duration of treatment is 4 to 6 weeks.

Diabetic polyneuropathy
2000 mg per day intravenously by drop infusion (20 infusions) switching to a tablet form – 3 tablets 3 times a day (1800 mg daily), duration is 4 to 5 months.

Adverse Reactions:

The frequency of side effects has been determined in accordance with the classification of the Council for International Organizations of Medical Sciences (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); unknown (cannot be estimated according to the available data).

Immune disorders
Rarely: allergic reactions (drug fever, shock symptoms).

Skin and subcutaneous tissue disorders
Rarely: urticaria, flush.

Overdose:

According to preclinical studies, Actovegin® does not exhibit toxic effects even when the dose is exceeded by 30–40 times compared to the doses recommended for use in humans. There have been no cases of overdose with Actovegin®.

Drug-to-Drug Interactions:

Currently unknown.

Special Warnings:

Clinical data
In a multicenter, randomized, double-blind, placebo-controlled study ARTEMIDA (NCT01582854) 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 recurrent ischemic strokes was as expected in this patient population, a greater number of cases have been recorded in the group that took Actovegin® compared with the placebo group, but this difference was not statistically significant.

Use in pediatric patients
Currently, no data on the use of the drug Actovegin® in children is available, therefore its use in this group is not recommended.

Effects on ability to drive and use machines
None found.

Dosage Form:

200 mg coated tablets.

50 tablets in a tamper-evident bottle of dark glass with a screw neck, corked by aluminum caps.

1 bottle with the patient information leaflet is placed in a cardboard pack. Transparent protective tamper-evident round stickers with holographic inscriptions are glued onto the pack.

Manufactured and/or packaged at Takeda Pharmaceuticals (Japan):
50 tablets in a tamper-evident bottle of dark glass with a screw neck, corked by aluminum caps.
1 bottle with the patient information leaflet is placed in a cardboard pack. Transparent protective tamper-evident round stickers with holographic inscriptions are glued onto the pack.

Shelf Life:

3 years. Do not use after expiration date.

Storage:

Store in the dark place at a temperature not exceeding 25 °C.

Keep out of the reach of children!

4 thoughts on “Actovegin 200 mg, (50 tablets)

  1. Anna Nevskaya

    I’ve been suffering from dysautonomia for 2 years now, with a disorder of cerebral circulation. Periodically there are severe headaches, and I react strongly to changes in the weather. My neurologist has used to prescribe me different drugs, after which I didn’t feel particularly better. A week ago, an aggravation occurred, my head became like a vacuum. I decided to take Mexidol, which was once prescribed – no effect, I felt that it became even worse. My partner has told about Actovegin and I decided to try. The price is, of course, crazy. BUT!!! After taking the first pill, I noticed a change for the better. And, after receiving the second – it became much easier. I will see what happens next, but for now, I am pleased that I finally found a drug that helps me.

    Reply
  2. Sammy

    I feel better, but I take the pills in combination with Mexidol, no more ringing in my ears, no more dizziness, my eyes are dimmer much rarely.

    Reply
  3. Ivan

    I used the drug for one month, and the result was not long in coming. Already on the next ultrasound, no hypoxia was detected, and the blood flow was restored to normal.

    Reply
  4. Ilona C.

    I’ve had a 25-day regimen. The effect was quickly noticed, first of all I felt much better, there was no such weakness as before the treatment. Skin color has changed, and I got cold much rarely. Before that, the hands were very cold and pale. Once, there was even a straight blush on the face, although for my pale skin it was a rarity. The ear stuffiness was gone. I was very afraid that the symptoms would recur, and this is a very unpleasant sensation, when the ears are constantly clogged and there are abnormal noises. After that, several times the ears still clogged, but not for such a long time. Last time my ears were clogged immediately after the treatment. But after two days it was gone and it no longer bothered me ever after. It has been almost 2 months since I finished taking Actovegin.

    Reply

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