Thiogamma pills 600mg, 60pcs

Composition

1 film-coated tablet contains:

Active ingredient: thioctic acid 600 mg;

excipients: hypromellose 25,00 mg, silicon dioxide colloid of 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 silica colloidal anhydrous 94: 6), magnesium stearate 16,00 mg; shell: macrogol 6000 – 0,60 mg, hypromellose 2,80 mg, talc 2.00 mg, sodium lauryl 0,025 mg.

Pharmacological properties

Pharmacotherapeutic group: Metabolic means. ATX code: A 16 AH 01 Pharmacological action:

Pharmacodynamics :

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

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

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 reduce insulin resistance.

It participates in the regulation of lipid and carbohydrate metabolism, affects cholesterol metabolism, improves liver function, and has a detoxifying effect in cases of poisoning with heavy metal salts and other intoxications. It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects. Improves neuron trophism.

In diabetes mellitus, thioctic acid reduces the formation of end products of glycation, improves endoneural blood flow, increases the content of glutathione to a physiological value, which as a result leads to an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.

Pharmacokinetics:

When taken orally, it is rapidly and completely absorbed in the gastrointestinal tract, while simultaneous intake with food reduces absorption. Bioavailability – 30-60% due to the effect of “first pass” through the liver. The time to reach the maximum concentration (4 micrograms / ml) is about 30 minutes. It is metabolized in the liver by side chain oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in small amounts – in unchanged form. The elimination half-life is 25 minutes.

Indications

Diabetic polyneuropathy and alcoholic polyneuropathy.

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 lactation. (See the section “Use during pregnancy and lactation”).

·Be sure to consult your doctor before taking the drug.

Side effects

The frequency of adverse side effects is given in accordance with the WHO classification:

Very rare (:

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

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

Nervous system disorders: changes or disturbances in taste sensations.

Metabolic and nutritional disorders: due to improved glucose uptake, the blood glucose concentration may decrease. At the same time, symptoms of hypoglycemia may occur – dizziness, increased sweating, headache, and visual disturbances.

Frequency not known (cannot be determined from available data):

Skin and subcutaneous disorders: eczema.

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

Interaction

Thioctic acid enhances the anti-inflammatory effect of glucocorticosteroids. With simultaneous use of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin.

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

Ethanol and its metabolites weaken the effect of thioctic acid.

· If you are already taking other medications or are about to take them, be sure to consult your doctor before taking Tiogamma®.

How to take, course of use and dosage

Assign inside 600 mg (1 tablet) of the drug Tiogamma® 1 time a day. Tablets are taken on an empty stomach, without chewing, with a small amount of liquid.

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

Overdose

Symptoms: nausea, vomiting, headache.

In the case of taking doses from 10 to 40 g of thioctic acid in combination with alcohol, cases of intoxication were observed, up to a fatal outcome. Symptoms of acute overdose: psychomotor agitation or confusion, usually followed by the development of generalized seizures and the formation of lactic acidosis.

Cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression, and multi-organ failure are also described.

Treatment is symptomatic. There is no specific antidote.

Description

Oblong, biconvex tablets, film-coated, with a smooth and slightly shiny surface, with a single dividing risk on both sides, yellow in color with possible inclusions of white and dark yellow.

Special instructions

Patients with rare hereditary problems of fructose intolerance, glucose–galactose malabsorption syndrome, or glucose–isomaltose deficiency should not take Tiogamma.

In patients with diabetes mellitus, constant monitoring of blood glucose concentration is necessary, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or an oral hypoglycemic drug to avoid the development of hypoglycemia.

If hypoglycemia develops, Tiogamma should be discontinued immediately.

If symptoms of hypersensitivity occur, you should immediately stop taking Tiogamma®.

Patients taking Tiogamma® should refrain from drinking alcohol.

Alcohol consumption during Tiogamma therapy reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy.

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

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

Influence on the ability to drive vehicles and work with mechanisms:

Taking Tiogamma® it does not affect the ability to drive vehicles or work with other mechanisms.

Storage conditions

Store in a dry place, at a temperature not exceeding 25 ° C.

Keep out of reach of children.

Shelf

life is 3 years.

Do not use after the expiration date indicated on the package.

Active ingredient

Thioctic acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Purpose

For adults as directed by your doctor

Indications

Type 2 Diabetes, Polyneuropathy, Type 1 Diabetes, Alcoholism