Thiogamma 600 mg, 60 pcs.

1 tablet contains:

Active substance:

thioctic acid 600 mg;

Excipients:

MCC;

lactose;

talc;

colloidal silicon dioxide;

lactose monohydrate;

sodium carboxymethyl cellulose;

simethicone;

methyl hydroxypropyl cellulose (hypromellose);

magnesium stearate;

macrogol 6000;

sodium lauryl sulfate.

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, hepatitis, neuralgia.

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.

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.

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

From the digestive system : when taking the drug inside - dyspepsia (including nausea, vomiting, heartburn).

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

Inside, 600 mg is prescribed once a day. Tablets are taken without chewing, washed down with a small amount of liquid.

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).

The rules for preparing the solution

The content of 1 ampoule (which is equivalent to the content of thioctic acid 600 mg) is mixed with 50-250 ml of 0.9% sodium chloride solution and administered as an infusion for 20-30 minutes. Infusions are made from bottles that are placed in the attached hanging light-protective cases made of black polyethylene. When using the solution for infusion in infusion bottles, Thiogamma is made directly from these bottles, which are placed in the attached hanging light-protective cases made of black polyethylene.

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.

Coated tablets.