Thiogamma injections instructions for use

In this article you can read the instructions for use of the drug Thiogamma. Reviews of site visitors - consumers of this medicine, as well as the opinions of specialist doctors on the use of Thiogamma in their practice are presented. We kindly ask you to actively add your reviews about the drug: whether the medicine helped or did not help get rid of the disease, what complications and side effects were observed, perhaps not stated by the manufacturer in the annotation. Analogues of Thiogamma in the presence of existing structural analogues. Use for the treatment of diabetic and alcoholic polyneuropathy in adults, children, as well as during pregnancy and lactation. Composition of the drug.

Thiogamma - metabolic drug. Thioctic (alpha-lipoic) acid is an endogenous antioxidant (binds free radicals), synthesized in the body during the 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. Helps reduce blood glucose concentrations and increase glycogen content in the liver, as well as overcome insulin resistance.

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

In diabetes mellitus, thioctic acid improves endoneurial blood flow, increases glutathione content to a physiological value, which ultimately leads to an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.

Compound

Thioctic acid + excipients.

Pharmacokinetics

After oral administration, Thiogamma is quickly and almost completely absorbed from the gastrointestinal tract. When taken simultaneously with food, absorption is reduced. Bioavailability - 30-60% due to the “first pass” effect through the liver. Metabolized in the liver by side chain oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in small quantities - unchanged.

Indications

1. diabetic polyneuropathy;
2. alcoholic polyneuropathy.

Release forms

Film-coated tablets 600 mg.

Solution for infusion (in droppers).

Concentrate for the preparation of a solution for infusion (injections in injection ampoules).

Instructions for use and method of use

Prescribed orally 600 mg (1 tablet) 1 time per day.

The 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. The course of treatment can be repeated 2-3 times a year.

At the beginning of the course of treatment, the drug is administered intravenously at a dose of 600 mg per day (1 ampoule of concentrate for preparing a solution for infusion or 1 bottle of solution for infusion) for 2-4 weeks. Then you can continue taking the drug orally at a dose of 600 mg per day.

Rules for preparing and administering an infusion solution (how to inject Thiogamma)

To prepare an infusion solution, the contents of 1 ampoule of concentrate (containing 600 mg of thioctic acid) are mixed with 50-250 ml of 0.9% sodium chloride solution.

Immediately after preparation, the bottle of infusion solution is immediately covered with the supplied light-protective case, because Thioctic acid is light sensitive. The solution for infusion should be administered immediately after preparation. The maximum storage time of the prepared solution for infusion is no more than 6 hours.

When using the prepared solution for infusion, the bottle with the drug is removed from the box and immediately covered with the supplied light-protective case, because Thioctic acid is light sensitive. The infusion is made directly from the bottle.

Inject slowly, about 1.7 ml/min, over 30 minutes.

Side effect

1. pinpoint hemorrhages in the mucous membranes, skin;
2. thrombocytopenia;
3. hemorrhagic rash (purpura);
4. thrombophlebitis;
5. systemic reactions (itching, nausea, discomfort) up to the development of anaphylactic shock;
6. hives;
7. change or disturbance of taste sensations;
8. convulsions up to an epileptic seizure;
9. diplopia;
10. eczema;
11. rash;
12. irritation, redness or swelling (at the injection site);
13. In case of rapid administration of the drug, intracranial pressure may increase (there is a feeling of heaviness in the head), difficulty breathing.

Contraindications

1. pregnancy;
2. lactation period (breastfeeding);
3. children under 18 years of age;
4. hypersensitivity to thioctic acid or other components of the drug.

Use during pregnancy and breastfeeding

The drug Thiogamma is contraindicated for use during pregnancy and lactation (breastfeeding).

Use in children

The drug is contraindicated for use in children and adolescents under 18 years of age.

special instructions

In patients with diabetes mellitus, constant monitoring of blood glucose concentrations is necessary, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia. If symptoms of hypoglycemia occur (dizziness, increased sweating, headache, visual disturbances, nausea), therapy should be stopped immediately. In isolated cases, when using the drug Thiogamma in patients with a lack of glycemic control and in severe general condition, serious anaphylactic reactions may develop.

Alcohol consumption during treatment with Thiogamma reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy. During treatment with Thiogamma, you should refrain from drinking alcohol.

Impact on the ability to drive vehicles and operate machinery

The use of the drug Thiogamma does not affect the ability to drive a vehicle or operate other mechanisms.

Drug interactions

Thioctic acid reduces the effectiveness of cisplatin when taken simultaneously, and also reacts with metal-containing drugs, such as iron and magnesium preparations.

Thioctic acid reacts with sugar molecules, forming poorly soluble complexes, for example with a solution of levulose (fructose).

Thiogamma enhances the anti-inflammatory effect of glucocorticosteroids (GCS).

With simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced.

Ethanol (alcohol) and its metabolites weaken the effect of thioctic acid.

Thioctic acid infusion solution is incompatible with dextrose solution, Ringer's solution and with solutions that react with disulfide and SH groups.

Analogues of the drug Tiogamma

Structural analogues of the active substance:

1. Alpha lipoic acid;
2. Berlition 300;
3. Berlition 600;
4. Lipamide tablets;
5. Lipoic acid;
6. Lipothioxone;
7. Neurolipon;
8. Octolipen;
9. Thioctacid 600;
10. Thioctacid BV;
11. Thiolepta;
12. Thiolipon;
13. Espa Lipon.

Thiogamma: instructions for use and reviews

Latin name: Thiogamma

ATX code: A16AX01

Active ingredient: Thioctic acid

Manufacturer: Verwag Pharma GmbH and Co. KG (Worwag Pharma GmbH & Co. KG), Böblingen, Germany

Update of description and photo: 05/02/2018

Prices in pharmacies: from 186 rubles.

Thiogamma is a drug that regulates lipid and carbohydrate metabolism.

Release form and composition

1. solution for infusion: transparent, light yellow or yellowish-green (50 ml in a dark glass bottle, 1 or 10 bottles in a cardboard box);
2. concentrate for the preparation of a solution for infusion: a transparent yellowish-green solution (20 ml in a dark glass ampoule, 5 ampoules in a tray, 1, 2 or 4 trays in a cardboard box);
3. film-coated tablets: oblong, convex on both sides, light yellow in color with white and yellow inclusions of varying intensity, with marks on both sides; a cross-section shows a light yellow core (10 pieces in a blister, 3, 6 or 10 blisters in a cardboard box).

Active substance – thioctic acid:

1. 1 ml of solution – 12 mg (600 mg in 1 bottle);
2. 1 ml of concentrate – 30 mg (600 mg in 1 ampoule);
3. 1 tablet – 600 mg.

1. solution: macrogol 300, meglumine, water for injection;
2. concentrate: macrogol 300, meglumine, water for injection;
3. tablets: colloidal silicon dioxide, croscarmellose sodium, microcrystalline cellulose, simethicone (dimethicone and colloidal silicon dioxide in a ratio of 94:6), lactose monohydrate, talc, magnesium stearate, hypromellose; shell composition: hypromellose, sodium lauryl sulfate, talc, macrogol 6000.

Pharmacological properties

Pharmacodynamics

The active ingredient of the drug is thioctic (alpha-lipoic) acid. It is an endogenous antioxidant that binds free radicals. Thioctic acid is formed in the body during the oxidative decarboxylation of alpha-keto acids. It is a coenzyme of multienzyme complexes in mitochondria and is involved in the oxidative decarboxylation of alpha-keto acids and pyruvic acid.

Alpha lipoic acid helps reduce blood glucose levels, increase glycogen concentrations in the liver and overcome insulin resistance. According to the mechanism of action, it is close to B vitamins.

Thioctic acid regulates carbohydrate and lipid metabolism, improves liver function and stimulates cholesterol metabolism. It has hypolipidemic, hypoglycemic, hepatoprotective and hypocholesterolemic effects. Helps improve neuron nutrition.

When using the megluminic salt of alpha-lipoic acid (has a neutral reaction) in solutions for intravenous administration, the severity of side effects can be reduced.

Pharmacokinetics

When administered orally, thioctic acid is quickly and completely absorbed from the gastrointestinal tract. When taken simultaneously with food, absorption of the drug is reduced. Bioavailability is 30%. To achieve the maximum concentration of the active substance, it takes from 40 to 60 minutes.

Thioctic acid undergoes a first-pass effect through the liver. Metabolized in two ways: by conjugation and by oxidation of the side chain.

The volume of distribution is approximately 450 ml/kg. Up to 80–90% of the dose taken is excreted by the kidneys in the form of metabolites and unchanged. The half-life ranges from 20 to 50 minutes. The total plasma clearance of the drug is 10–15 ml/min.

The time to reach maximum plasma concentration with intravenous administration of Thiogamma is 10–11 minutes, and the maximum plasma concentration is 25–38 mcg/ml. AUC (area under the concentration-time curve) is approximately 5 mcg/h/ml.

Indications for use

Thiogamma is a drug intended for the treatment of polyneuropathy (diabetic and alcoholic).

Contraindications

1. hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption (for tablets);
2. age under 18 years;
3. pregnancy;
4. breastfeeding period;
5. hypersensitivity to the components of the drug.

Instructions for use of Thiogamma: method and dosage

Solution for infusion and concentrate for the preparation of solution for infusion

The solution, including those prepared from concentrate, is administered intravenously.

The daily dose of Thiogamma is 600 mg (1 bottle of solution or 1 ampoule of concentrate).

The drug is administered over 30 minutes (at a rate of about 1.7 ml per minute).

Preparation of a solution from the concentrate: mix the contents of 1 ampoule with 50–250 ml of 0.9% sodium chloride solution. Immediately after preparation, the solution should be immediately covered with the included light-protective case. Store for no more than 6 hours.

When using the prepared solution, remove the bottle from the cardboard packaging and immediately cover it with a light-protective case. The infusion should be carried out directly from the vial.

The duration of treatment is 2–4 weeks. If it is necessary to continue therapy, the patient is transferred to the tablet form of the drug.

Film-coated tablets

The tablets should be taken orally on an empty stomach: swallowed whole and washed down with sufficient liquid.

The recommended dose of Thiogamma is 600 mg (1 tablet) per day.

The duration of treatment, depending on the severity of the disease, is 30–60 days.

If necessary, repeated courses can be conducted 2-3 times a year.

Side effects

Solution and concentrate

Thiogamma is generally well tolerated. Rarely, including isolated cases, the following side effects occur:

1. from the endocrine system: decreased concentration of glucose in the blood (visual disturbances, increased sweating, dizziness, headache);
2. from the central nervous system: disturbance or change in taste sensations, convulsions, epileptic seizure;
3. from the hematopoietic system: hemorrhagic rash (purpura), thrombocytopenia, thrombophlebitis, pinpoint hemorrhages in the skin and mucous membranes;
4. from the skin and subcutaneous tissue: eczema, itching, rash;
5. from the organ of vision: diplopia;
6. allergic reactions: urticaria, systemic reactions (discomfort, nausea, itching) up to the development of anaphylactic shock;
7. local reactions: hyperemia, irritation, swelling;
8. other: in case of rapid administration of the drug - difficulty breathing, increased intracranial pressure (a feeling of heaviness in the head occurs).

Film-coated tablets

Thiogamma is generally well tolerated. Rarely, including isolated cases, the following side effects occur:

1. allergic reactions: urticaria, skin rash, itching, systemic reactions up to the development of anaphylactic shock;
2. from the digestive system: abdominal pain, nausea, diarrhea, vomiting;
3. from the endocrine system: decreased concentration of glucose in the blood (visual disturbances, increased sweating, dizziness, headache).

Overdose

An overdose of thioctic acid causes the following symptoms: headache, nausea and vomiting. When taking 10–40 g of Thiogamma in combination with alcohol, cases of severe intoxication, even death, have been reported.

In case of an acute overdose of the drug, confusion or psychomotor agitation occurs, usually accompanied by lactic acidosis and generalized convulsions. Cases of hemolysis, rhabdomyolysis, hypoglycemia, bone marrow suppression, disseminated intravascular coagulation, multiorgan failure and shock have been described.

Treatment is symptomatic. There is no specific antidote for thioctic acid.

special instructions

Patients with diabetes mellitus during treatment (and especially at the initial stage) need to monitor the concentration of glucose in the blood and, if necessary, adjust the dose of insulin or an oral hypoglycemic drug.

During treatment with Thiogamma, you should not drink alcoholic beverages, since ethanol reduces the therapeutic effect of thioctic acid and promotes the development and progression of neuropathy.

Each tablet contains 49 mg of lactose monohydrate, which corresponds to at least 0.0041 bread units.

Thioctic acid does not affect the ability to operate potentially dangerous machinery or drive a car.

Use during pregnancy and lactation

The drug is prohibited for use in pregnant and lactating women.

Use in childhood

According to the instructions, Tiogamma is contraindicated for children and adolescents under 18 years of age.

Drug interactions

1. ethanol and its metabolites: the effect of thioctic acid is weakened;
2. cisplatin: its effectiveness decreases;
3. glucocorticosteroids: their anti-inflammatory effect is enhanced;
4. insulin, oral hypoglycemic drugs: their effect is enhanced.

Thioctic acid binds metals (iron, magnesium), therefore, if simultaneous use of drugs containing them is necessary, at least 2-hour intervals between doses should be observed.

Thioctic acid reacts with sugar molecules [for example, with a solution of levulose (fructose)], resulting in the formation of sparingly soluble complexes.

In the form of an infusion solution, Thiogamma is incompatible with solutions that react with disulfide and SH groups, Ringer's solution and dextrose solution.

Analogs

Analogues of Thiogamma are the following drugs: Thioctacid BV, Lipoic acid, Thiolepta, Berlition 300, Thioctacid 600T.

Terms and conditions of storage

Store out of reach of children, protected from light, at temperatures up to 25 °C.

Shelf life – 5 years.

Conditions for dispensing from pharmacies

Dispensed by prescription.

Reviews about Tiogamma

The drug is quite often prescribed to patients with diabetes mellitus and a predisposition to polyneuropathy, since it is a good prophylactic agent for diseases of the peripheral nervous system.

Reviews of Thiogamma note that with a relatively short course of treatment, the severe consequences of endocrine diseases can be prevented. The advantage of using the drug is the very rare development of possible side effects.

Experts also speak positively about Thiogamma, noting its therapeutic properties, the rare development of side effects and the low likelihood of overdose.

Allergic skin reactions that may occur during treatment are most often observed in patients with a predisposition. To avoid such reactions, it is recommended to conduct an allergy test before using the drug.

Price for Tiogamma in pharmacies

Prices for Tiogamma in pharmacies:

1. film-coated tablets, 600 mg (30 pieces per package) – from 894 rubles;
2. film-coated tablets, 600 mg (60 pieces per package) – from 1835 rubles;
3. solution for infusion (50 ml bottle, 1 pc.) – from 211 rubles;
4. solution for infusion (50 ml bottle, 10 pcs.) – from 1,784 rubles.
5. concentrate for preparing a solution for infusion (20 ml ampoules, 10 pcs.) – from 1800 rubles.

Prices in online pharmacies:

Thiogamma is a drug with antioxidant and metabolic effects; regulates carbohydrate and lipid metabolism.

Release form and composition

Thiogamma is available in the following forms:

1. film-coated tablets: biconvex, oblong, light yellow with white or yellow inclusions of varying intensity, there are marks on both sides; the cut shows a light yellow kernel (10 pieces in blisters, 3, 6 or 10 blisters in a cardboard pack);
2. solution for infusion: transparent, yellowish-green or light yellow liquid (50 ml in dark glass bottles, 1 or 10 bottles in a cardboard box);
3. concentrate for preparing a solution for infusion: transparent yellowish-green liquid (20 ml in dark glass ampoules, 5 ampoules in cardboard trays, 1, 2 or 4 trays in a cardboard pack).

1 tablet contains:

1. active ingredient: thioctic (alpha-lipoic) acid – 600 mg;
2. auxiliary components: microcrystalline cellulose, croscarmellose sodium, simethicone, colloidal silicon dioxide, lactose monohydrate, talc, magnesium stearate, hypromellose;
3. shell: talc, macrogol 6000, sodium lauryl sulfate, hypromellose.

1 ml of solution for infusion contains:

1. active ingredient: thioctic (alpha-lipoic) acid – 12 mg (per 1 bottle – 600 mg);
2. auxiliary components: macrogol 300, meglumine (to correct the pH value), water for injection.

1 ml of concentrate for the preparation of solution for infusion contains:

1. active ingredient: thioctic acid – 30 mg (per 1 ampoule – 600 mg);
2. auxiliary components: macrogol 300, meglumine (to correct the pH value), water for injection.

Indications for use

The drug Thiogamma is used to treat alcoholic and diabetic polyneuropathy.

Contraindications

1. children and adolescents up to 18 years of age;
2. pregnancy period;
3. breastfeeding period;
4. glucose-galactose malabsorption, lactase deficiency, hereditary galactose intolerance (for tablets);
5. hypersensitivity to the main or auxiliary ingredients of the drug.

Directions for use and dosage

Film-coated tablets

The drug Thiogamma in tablet form is taken orally, on an empty stomach, with a small amount of liquid.

Recommended dose – 1 pc. (600 mg) once a day. The duration of therapy depends on the severity of the disease and ranges from 30 to 60 days.

During the year, the course of treatment can be repeated 2-3 times.

Solution for infusion, concentrate for the preparation of solution for infusion

The drug Thiogamma in the form of a solution is administered intravenously slowly, at a rate of about 1.7 ml/min for 30 minutes.

The recommended daily dose is 600 mg (1 bottle of solution for infusion or 1 ampoule of concentrate for preparing an infusion solution). The drug is administered once a day for 2–4 weeks. After which the patient can be transferred to the oral form of Thiogamma in the same doses (600 mg per day).

The drug in the form of a solution for infusion is ready for use. After releasing the bottle from the box, it is immediately covered with a special light-protective case to prevent light from reaching the thioctic acid, which is sensitive to its effects. Intravenous infusion is performed directly from the bottle.

When using Thiogamma in the form of a concentrate, you must first prepare an infusion solution. To do this, the contents of one ampoule of concentrate are mixed with 50–250 ml of isotonic sodium chloride solution. The prepared solution is immediately covered with a light-protective case. The infusion solution is administered immediately after preparation. Its storage duration is no more than 6 hours.

Side effects

Film-coated tablets

1. digestive system: vomiting, nausea, diarrhea, abdominal pain;
2. central nervous system: change or disturbance of taste;
3. endocrine system: a decrease in the concentration of glucose in the blood and the resulting symptoms of hypoglycemia (headache, dizziness, visual disturbances, increased sweating);
4. allergic reactions: urticaria, itching, skin rash, systemic reactions (up to anaphylactic shock).

Solution for infusion

1. central nervous system: change or disturbance of taste, convulsions (up to epileptic seizures);
2. organ of vision: bifurcation of visible objects;
3. hematopoietic system: thrombocytopenia, thrombophlebitis, hemorrhagic rash, pinpoint hemorrhages in the skin and mucous membranes;
4. skin and subcutaneous tissue: eczema, itching, rash;
5. endocrine system: a decrease in the concentration of glucose in the blood and the resulting symptoms of hypoglycemia (headache, dizziness, visual disturbances, increased sweating);
6. allergic reactions: urticaria, systemic reactions in the form of nausea, itching and discomfort (up to anaphylactic shock);
7. reactions at the injection site: hyperemia, irritation or swelling;
8. other reactions: difficulty breathing and increased intracranial pressure (with rapid administration of the drug).

special instructions

In patients with diabetes, especially at the beginning of drug therapy, blood glucose levels should be monitored. If necessary, doses of oral hypoglycemic agents and insulin are adjusted.

If symptoms of hypoglycemia appear, Thiogamma should be discontinued immediately.

During the treatment period, it is necessary to refrain from drinking alcohol-containing drinks, since alcohol reduces the effectiveness of the drug and is a risk factor for the development and progression of neuropathy.

One 600 mg tablet contains less than 0.0041 XE (bread units).

Direct use of Thiogamma does not affect the patient’s ability to drive vehicles or operate other potentially dangerous mechanisms. But it is necessary to take into account possible side effects from the endocrine system, due to a decrease in blood glucose levels, such as visual disturbances and dizziness.

Drug interactions

When thioctic acid is used together with glucocorticosteroids, their anti-inflammatory effect is enhanced; with cisplatin – the effectiveness of cisplatin decreases; with insulin or oral hypoglycemic agents - their effect may be enhanced; with ethanol and its metabolites - the effectiveness of thioctic acid decreases.

Thiogamma binds metals, so the drug should not be used together with medications containing metals (for example, magnesium, iron, calcium). There should be an interval of at least 2 hours between taking thioctic acid and these drugs.

The solution for infusion should not be mixed with Ringer's solution, dextrose solution and solutions that react with SH groups and disulfide groups.

Terms and conditions of storage

Store in a dry place at a temperature not exceeding 25 °C. Keep away from children.

The shelf life of the drug is 5 years.

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