Thiogamma
Thiogamma: instructions for use and reviews
- 1. Release form and composition
- 2. Pharmacological properties
- 3. Indications for use
- 4. Contraindications
- 5. Method of application and dosage
- 6. Side effects
- 7. Overdose
- 8. Special instructions
- 9. Application during pregnancy and lactation
- 10. Use in childhood
- 11. Drug interactions
- 12. Analogs
- 13. Terms and conditions of storage
- 14. Terms of dispensing from pharmacies
- 15. Reviews
- 16. Price in pharmacies
Latin name: Thiogamma
ATX code: A16AX01
Active ingredient: Thioctic acid (Thioctic acid)
Manufacturer: Verwag Pharma GmbH & Co. KG (Worwag Pharma GmbH & Co. KG), Boeblingen, Germany
Description and photo update: 2019-12-08
Prices in pharmacies: from 191 rubles.
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Thiogamma is a drug that regulates lipid and carbohydrate metabolism.
Release form and composition
- solution for infusion: clear, light yellow or yellowish green in color (50 ml in a dark glass bottle, 1 or 10 bottles in a cardboard box);
- concentrate for the preparation of a solution for infusion: a clear yellowish-green solution (20 ml in a dark glass ampoule, 5 ampoules in a pallet, 1, 2 or 4 pallets in a cardboard box);
- coated tablets: oblong, convex on both sides, light yellow in color with white and yellow blotches of varying intensity, with risks on both sides; the cross section shows a light yellow core (10 pcs. in a blister, 3, 6 or 10 blisters in a cardboard box).
The active substance is thioctic acid:
- 1 ml of solution - 12 mg (600 mg in 1 bottle);
- 1 ml of concentrate - 30 mg (600 mg in 1 ampoule);
- 1 tablet - 600 mg.
Excipients:
- solution: macrogol 300, meglumin, water for injection;
- concentrate: macrogol 300, meglumine, water for injection;
- tablets: colloidal silicon dioxide, sodium croscarmellose, 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 to reduce blood glucose levels, increase the concentration of glycogen in the liver and overcome insulin resistance. By the mechanism of action, it is close to the B vitamins.
Thioctic acid regulates carbohydrate and lipid metabolism, improves liver function and stimulates cholesterol metabolism. It has hypolipidemic, hypoglycemic, hepatoprotective and hypocholesterolemic effects. Improves neuronal nutrition.
When using meglumine 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 rapidly and completely absorbed from the gastrointestinal tract. When taken simultaneously with food, the absorption of the drug is reduced. Bioavailability is 30%. It takes 40 to 60 minutes to reach the maximum concentration of the active ingredient.
Thioctic acid undergoes a "first pass" effect through the liver. It is metabolized in two ways: by conjugation and by side chain oxidation.
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 is 20 to 50 minutes. The total plasma clearance of the drug is 10-15 ml / min.
The time to reach the maximum plasma concentration with intravenous administration of Thiogamma is 10–11 minutes, and the maximum plasma concentration is 25–38 μg / ml. AUC (area under the concentration-time curve) is approximately 5 μg / h / ml.
Indications for use
Thiogamma is a drug intended for the treatment of polyneuropathy (diabetic and alcoholic).
Contraindications
- hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption (for tablets);
- age up to 18 years;
- pregnancy;
- period of breastfeeding;
- hypersensitivity to drug components.
Instructions for the use of Tiogamma: method and dosage
Solution for infusion and concentrate for preparation of solution for infusion
The solution, including one prepared from a concentrate, is administered intravenously.
The daily dose of Tiogamma 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 a 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 supplied light-protective case. Store no more than 6 hours.
When using the ready-made solution, it is necessary to remove the bottle from the cardboard packaging and immediately cover it with a light-protective case. Infusion should be carried out directly from the bottle.
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: swallow whole and drink plenty of liquid.
The recommended dose of Tiogamma is 600 mg (1 tablet) per day.
The duration of treatment, depending on the severity of the course of the disease, is 30-60 days.
If necessary, repeated courses can be carried out 2-3 times a year.
Side effects
Solution and concentrate
Thiogamma is generally well tolerated. Rarely, including isolated cases, the following side effects occur:
- on the part of the endocrine system: a decrease in the concentration of glucose in the blood (visual disturbances, increased sweating, dizziness, headache);
- from the central nervous system: disturbance or change in taste, convulsions, epileptic seizure;
- on the part of the hematopoietic system: hemorrhagic rash (purpura), thrombocytopenia, thrombophlebitis, punctate hemorrhages in the skin and mucous membranes;
- from the skin and subcutaneous tissue: eczema, itching, rash;
- on the part of the organ of vision: diplopia;
- allergic reactions: urticaria, systemic reactions (discomfort, nausea, itching) up to the development of anaphylactic shock;
- local reactions: hyperemia, irritation, swelling;
- others: in the case of rapid administration of the drug - difficulty breathing, increased intracranial pressure (there is a feeling of heaviness in the head).
Film-coated tablets
Thiogamma is generally well tolerated. Rarely, including isolated cases, the following side effects occur:
- allergic reactions: urticaria, skin rash, itching, systemic reactions up to the development of anaphylactic shock;
- from the digestive system: abdominal pain, nausea, diarrhea, vomiting;
- from the endocrine system: a decrease in the concentration of glucose in the blood (visual disturbances, increased sweating, dizziness, headache).
Overdose
With an overdose of thioctic acid, the following symptoms occur: headache, nausea and vomiting. When taking 10–40 g of Thiogamma in combination with alcohol, there have been cases of severe intoxication, up to and including death.
In case of an acute overdose of the drug, clouding of consciousness or psychomotor agitation occurs, accompanied, as a rule, by lactic acidosis and generalized convulsions. Cases of hemolysis, rhabdomyolysis, hypoglycemia, bone marrow suppression, disseminated intravascular coagulation, multi-organ failure and shock are 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 control the concentration of glucose in the blood and, if necessary, adjust the dose of insulin or an oral hypoglycemic drug.
During the period of therapy with Tiogamma, one should not drink alcoholic beverages, since ethanol reduces the therapeutic effect of thioctic acid, contributes to 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 work with potentially dangerous machinery and drive a car.
Application during pregnancy and lactation
The drug is prohibited for use in pregnant and lactating women.
Pediatric use
According to the instructions, Tiogamma is contraindicated in children and adolescents under 18 years of age.
Drug interactions
- ethanol and its metabolites: the effect of thioctic acid is weakened;
- cisplatin: its effectiveness decreases;
- glucocorticosteroids: their anti-inflammatory effect is enhanced;
- insulin, oral hypoglycemic drugs: their effect is enhanced.
Thioctic acid binds metals (iron, magnesium), therefore, if necessary, the simultaneous use of drugs containing them, you should observe at least 2-hour intervals between doses.
Thioctic acid reacts with sugar molecules [for example, with a solution of levulose (fructose)], as a result of which poorly soluble complexes are formed.
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
Analogs of Tiogamma are the following drugs: Thioctacid BV, Lipoic acid, Thiolepta, Berlition 300, Thioctacid 600T.
Terms and conditions of storage
Keep out of the reach of children, protected from light, at temperatures up to 25 ° C.
The shelf life is 5 years.
Terms of dispensing from pharmacies
Dispensed by prescription.
Reviews about Tiogamma
The drug is 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.
In reviews of Tiogamma it is noted 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 probability of overdose.
Allergic skin reactions that can occur during treatment are most often observed in patients with a predisposition. To avoid such reactions, it is recommended to conduct an allergic test before using the drug.
The price of Tiogamma in pharmacies
Prices for Tiogamma in pharmacies:
- film-coated tablets, 600 mg (30 pcs. in a package) - from 894 rubles;
- film-coated tablets, 600 mg (60 pcs. in a package) - from 1835 rubles;
- solution for infusion (bottle of 50 ml, 1 pc.) - from 211 rubles;
- solution for infusion (bottle 50 ml, 10 pcs.) - from 1784 rubles.
- concentrate for preparation of solution for infusion (ampoules of 20 ml, 10 pcs.) - from 1800 rubles.
Tiogamma: prices in online pharmacies
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Drug name Price Pharmacy |
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Thiogamma 12 mg / ml solution for infusion 50 ml 1 pc. 191 r Buy |
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Thiogamma solution for inf. 1.2% 50ml 220 RUB Buy |
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Tiogamma 600 mg film-coated tablets 30 pcs. 828 RUB Buy |
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Thiogamma tablets p.p. 600mg 30 pcs. 905 RUB Buy |
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Tiogamma 600 mg film-coated tablets 60 pcs. 1584 RUB Buy |
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Thiogamma 12 mg / ml solution for infusion 50 ml 10 pcs. 1629 RUB Buy |
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Thiogamma tablets p.p. 600mg 60 pcs. 1777 RUB Buy |
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Thiogamma solution for inf. 1.2% 50ml 10 pcs. 1875 RUB Buy |
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Anna Kozlova Medical journalist About the author
Education: Rostov State Medical University, specialty "General Medicine".
Information about the drug is generalized, provided for informational purposes only and does not replace the official instructions. Self-medication is hazardous to health!
