Thiogamma, 600 mg 60 pcs

Pharmacotherapeutic group: Metabolic agent.

ATX code: A16AX01

Pharmacological action:

Pharmacodynamics:

Tioctic acid is an endogenous antioxidant (binds free radicals).

In the body is formed by oxidative decarboxylation of alpha-keto acids.

As a coenzyme of mitochondrial multienzyme complexes is involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. It promotes reduction of blood glucose concentration and increase of glycogen in the liver as well as reduction of insulin resistance.

Participates in the regulation of lipid and carbohydrate metabolism, affects cholesterol metabolism, improves liver function, has detoxifying effect during poisoning with salts of heavy metals and other intoxications. It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect. It improves the trophism of neurons.

In case of diabetes thioctic acid decreases formation of final glycation products, improves endoneural blood flow, increases glutathione content to physiological level that results in improvement of functional condition of peripheral nerve fibers in diabetic polyneuropathy.

Pharmacokinetics:

In oral administration it is quickly and completely absorbed in the gastrointestinal tract, simultaneous intake with food reduces absorption. Bioavailability is 30-60% due to the effect of “first passage” through the liver. Time to reach maximum concentration (4 µg/ml) is about 30 min. Metabolized in the liver by oxidation of the side chain and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in small amounts unchanged. The elimination half-life is 25 minutes.

Indications

Diabetic polyneuropathy and alcoholic polyneuropathy.

Active ingredient

Composition

1 film-coated tablet contains:

the active ingredient: thioctic acid-600 mg;

excipients: Hypromellose 25.00 mg, colloidal silica 25.00 mg, microcrystalline cellulose 49.00 mg, lactose monohydrate 49.00 mg, croscarmellose sodium 16.00 mg, talc 36.364 mg, simethicone 3.636 mg (dimethicone and colloidal silica 94:6), magnesium stearate 16.00 mg; shell: macrogol 6000 0.60 mg, hypromellose 2.80 mg, talc 2.00 mg, sodium lauryl sulfate 0.025 mg.

How to take, the dosage

Tyogamma® is given orally in 600 mg (1 tablet) once a day. The tablets are taken on an empty stomach, without chewing, with a small amount of liquid.

The course of treatment lasts 30-60 days depending on the severity of the disease. It is possible to repeat the course of treatment 2-3 times a year.

Interaction

Thioctic acid increases the anti-inflammatory effect of glucocorticosteroid drugs. When concomitant administration of thioctic acid and cisplatin there is a decrease in the effectiveness of cisplatin.

Thioctic acid binds metals, therefore it should not be administered simultaneously with preparations containing metals (for example, preparations of iron, magnesium, calcium) – the interval between doses should be at least 2 hours. In concomitant use of thioctic acid and insulin or oral hypoglycemic drugs their effect may increase.

Ethanol and its metabolites weaken the effect of thioctic acid.

If you are already taking other medicines or are planning to take them, always consult your physician before taking Thiogamma®.

Special Instructions

Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome or glucose-isomaltose deficiency should not take Thiogamma®.

In patients with diabetes mellitus, continuous monitoring of blood glucose concentrations is necessary, especially in the initial phase of therapy. In some cases it is necessary to decrease the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia.

If hypoglycemia develops, Tiogamma® should be stopped immediately.

If symptoms of hypoglycemia occur, Tiogamma® should be stopped immediately.

Patients taking Thiogamma® should refrain from drinking alcohol.

The consumption of alcohol during therapy with Thiogamma® decreases the therapeutic effect and is a risk factor for the development and progression of neuropathy.

1 film-coated tablet of Thiogamma® 600 mg contains less than 0.0041 bread units.

The development of autoimmune insulin syndrome (AIS) during treatment with thioctic acid has been described. The possibility of AIS is determined by the presence of HLA-DRB1*04:06 and HLA-DRB1*04:03 alleles in patients.

The effect on the ability to drive vehicles and operate machinery:

The administration of Thiogamma® does not affect the ability to drive vehicles or operate other mechanisms.

Synopsis

Contraindications

Hypersensitivity to thioctic acid or other components of the drug.

Children under 18 years of age.

Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.

Pregnancy and the period of breastfeeding. (See section “Use in pregnancy and during breastfeeding”).

Please talk to your doctor before taking this medicine.

Side effects

The frequency of adverse reactions is given according to the WHO classification:

Very common

In more than 1 in 10 treated

Frequently

In less than 1 in 10, but more than 1 in 100 treated

In case

less than 1 in 100 but more than 1 in 1,000 treated

Rarely

less than 1 in 1,000 but more than 1 in 10,000 treated

Very rarely

less than 1 in 10,000, including isolated cases

Not known

cannot be determined from available data

Very rarely (< 1/10000) the following side effects develop:

Gastrointestinal (GI) disorders: nausea, vomiting, abdominal pain, diarrhea.

Immune system disorders: allergic reactions (up to development of anaphylactic shock), skin rash, urticaria, itching; autoimmune insulin syndrome (AIS), clinical manifestations of AIS may be: dizziness, sweating, muscle tremors, palpitations, nausea, headache, confusion, visual disturbances, loss of consciousness, and coma.

Nervous system disorders: change or disturbance of taste sensation.

Metabolic and nutritional disorders: due to improved absorption of glucose a decrease in blood glucose concentration is possible. In this case, there may be symptoms of hypoglycemia – dizziness, increased sweating, headache, visual disturbances.

The frequency is not known (cannot be ascertained from the available data):

Skin and subcutaneous disorders: eczema.

If any of the side effects listed in the instructions worsen, or if you notice any other side effects not listed in the instructions, tell your doctor.

Overdose

Symptoms: nausea, vomiting, headache.

In case of taking doses from 10 to 40 g of thioctic acid in combination with alcohol there have been cases of intoxication, up to death. Symptoms of acute overdose: psychomotor agitation or mental confusion, as a rule, with the subsequent development of generalized convulsions and formation of lactoacidosis.

Hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular clotting, bone marrow depression, and multi-organ failure have also been described.

The treatment is symptomatic. There is no specific antidote.

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