Thiogamma 12 mg/ml, 50 ml 10pcs

1 vial of 50 ml infusion solution contains: 

active substance:

 meglumine salt of thioctic acid - 1167.7 mg (which is equivalent to 600 mg of thioctic acid); 

Excipients:

 meglumine

macrogol 300,

water for injections.

Thiogamma has a hepatoprotective, hypoglycemic, detoxification, hypolipidemic, hypocholesterolemic effect.

Thioctic acid (alpha lipoic acid) - an endogenous antioxidant (binds free radicals), is formed in the body by oxidative decarboxylation of alpha ketoxylate. As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids.

It helps to reduce the concentration of glucose in the blood and increase glycogen in the liver, as well as to overcome insulin resistance. By the nature of the biochemical action, it is close to B vitamins. Participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function.

It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect. Improves trophic neurons. The use of the meglumine salt of thioctic acid in solutions for intravenous administration (having a neutral reaction) can reduce the severity of adverse reactions.

Pharmacokinetics

When taken orally, it is rapidly and completely absorbed from the gastrointestinal tract (ingestion reduces absorption). The time to reach maximum concentration is 40-60 minutes. Bioavailability is 30%.

It has the effect of "first passage" through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation.

The volume of distribution is about 450 ml / kg. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The elimination half-life is 20-50 minutes. The total plasma clearance is 10-15 ml / min.

With intravenous administration, the time to reach the maximum concentration is 10-11 minutes, the maximum concentration is 25-38 mcg / ml. The area under the concentration-time curve is about 5 μg h / ml.

Diabetic polyneuropathy, alcoholic polyneuropathy.

The drug Thiogamma is contraindicated in pregnancy. If necessary, use the drug during lactation should stop breastfeeding.

In experimental animal studies, no teratogenic effect of thioctic acid was detected. No similar human studies have been conducted.

There is no data on the excretion of thioctic acid with breast milk.

   - Hypersensitivity to the components of the drug;
   - pregnancy;
   - period of breastfeeding.
There are no clinical data on the use of Thiogamma in children, therefore, children should not be prescribed the drug.

From the side of the central nervous system: rarely (after iv administration of the drug) - convulsions, diplopia; with rapid administration, an increase in intracranial pressure.

On the part of the blood coagulation system: after iv administration of the drug - hemorrhagic rash, thrombophlebitis, pinpoint hemorrhages in the mucous membranes and skin.

Allergic reactions: urticaria, systemic reactions (up to anaphylactic shock).

Other: hypoglycemia may develop (due to improved glucose uptake); after rapid iv administration - difficulty breathing (passes independently).

With the combined use of Thiogamma in the form of a solution for injection, the effectiveness of cisplatin is reduced.

With the simultaneous use of Thiogamma enhances the action of insulin and oral hypoglycemic agents.

With simultaneous administration with ethanol, the therapeutic effectiveness of thioctic acid may decrease.

Pharmaceutical interaction

In vitro, thioctic acid reacts with complex metal ions (for example, cisplatin), and also forms moderately soluble complex compounds with sugar molecules. Therefore, the infusion solution is incompatible with glucose solution, Ringer's solution and with solutions that can react with SH-groups or disulfide bridges.

The drug is also administered intravenously at a dose of 600 mg per day (1 ampoule of concentrate for preparing a solution for infusion of 30 mg / ml or 1 bottle of solution for infusion of 12 mg / ml).

At the beginning of the course, the drug is administered intravenously for 2-4 weeks. Then you can continue taking the drug inside at a dose of 300-600 mg per day.

The drug should be administered slowly, there is not more than 50 mg of thioctic acid in 1 minute (which is equivalent to 1.7 ml of concentrate for the preparation of a solution for infusion of 30 mg / ml).

Symptoms: nausea, vomiting, headache.

Treatment: conduct symptomatic therapy. There is no specific antidote.

Patients taking Thiogamma should refrain from drinking alcohol.

During the treatment with Tiogamma, especially at the beginning of therapy, it is necessary to monitor the level of glucose in the blood.

In some cases, a dose adjustment of hypoglycemic drugs may be required.

Infusion solution