Thiogamma 600 instructions for use tablets reviews

Rating 4.3/5
Efficiency
Price quality
Side effects

Thiogamma (Thiogamma): 8 doctor reviews, 3 patient reviews, instructions for use, analogues, infographics, 3 release forms.

Prices for thiogamma in Moscow pharmacies

solution for infusion 12 mg/ml 50 ml 10 pieces. ≈ 1699 rub.
12 mg/ml 50 ml 1 PC. ≈ 222 rub.
pills 600 mg 30 pcs. ≈ 844.5 rub.
600 mg 60 pcs. ≈ 1595 rub.



tiogamma-600-instrukciya-po-RDOkX.webp

Reviews from doctors about thiogamma

Rating 4.2 / 5
Efficiency
Price quality
Side effects

"Tiogamma" is a drug for restoring damaged nerve fibers. For pain in patients with alcoholic and diabetic polyneuropathies, it is ideal after a course of intravenous drip infusions. The course of treatment with tablets is 3 months, 2 times a year.

Patients tolerate it well. And the price is cheaper than the original drug. There was a patient with a side effect in the form of nausea from the original drug, but she tolerated Tiogamma perfectly, both in tablets and in infusions.

Rating 5.0 / 5
Efficiency
Price quality
Side effects

Ideal price-quality ratio, convenient dosage regimen - 1 capsule 600 mg in the morning for 2 weeks.

Few doctors know the strengths of this drug, otherwise it would be used much more often.

Today, the best alpha-lipoic acid preparation for the treatment of neuropathies, neuritis and neuralgia of various origins.

Rating 4.6/5
Efficiency
Price quality
Side effects

The drug "Tiogamma" in the form of an oblong tablet with a score in the middle is ideal for patients undergoing chemotherapy, due to severe intoxication during chemotherapy and the impossibility of prescribing many other restorative drugs. As an antioxidant, the drug "Tiogamma" helps eliminate free radicals.

There is a weak research base on the effects of the drug on children, as a result of which the instructions indicate that it is contraindicated for children.

Rating 3.8/5
Efficiency
Price quality
Side effects

A high-quality preparation of thioctic acid. There is no need to prepare a solution for intravenous infusion. It is cheaper than imported drugs and is highly effective.

The cost of course treatment is still high.

An indispensable drug for the treatment of diabetic polyneuropathy, significantly slowing its progression. Significantly reduces the healing time of trophic ulcers in the complex treatment of diabetic foot syndrome.

Rating 2.9/5
Efficiency
Price quality
Side effects

An excellent generic with antioxidant properties. Almost a “native” drug for people suffering from diabetes and polyneuropathy. Convenient form of use. There are no adverse drug reactions in practice.

If the price were even lower, it would be great.

I use it in clinical practice.

Rating 4.6/5
Efficiency
Price/quality
Side effects

The effectiveness is close to the official drug. The only drug with the possibility of intravenous drip administration of 600 mg. in a ready-made bottle of 50 ml. Only 50 ml.! No need to dilute + comes with a dark bag to protect from light. Compliance 100%.

An excellent generic that has proven itself.

Rating 4.6/5
Efficiency
Price quality
Side effects

The drug thioctic acid has found wide use in the treatment of polyneuropathies, diabetes mellitus, and toxic polyneuropathies (alcoholic), post-traumatic, postherpetic, as well as hepatic encephalopathies! Course therapy: initially, 10 courses of intravenous infusion, then transfer to tablet form for up to 1-1.5 months, 2-3 times a year.

Rating 4.6/5
Efficiency
Price quality
Side effects

Excellent quality, different release forms. The presence of a bottle-shaped form is very convenient for patients with “bad” veins to reduce infusion time, or for hypertensive patients who do not want to inject a large volume of liquid.

Course treatment is quite expensive.

Well tolerated. Large niche for application. Various metabolic disorders can be compensated for. It is good both for damage to individual nerves (facial, ulnar, radial) and for multiple damage to nerve endings (for example, in patients with diabetes or alcoholism).

Patient reviews of thiogamma

I have been suffering from diabetes for thirty years. I vitally need this drug; every year I receive treatment with Tiogamma. Thanks to this drug, my wounds heal quickly, there are no ulcers on my feet, and the sensitivity of my limbs is normal. The price is, of course, high. After a bite of "Tiogamoy" you need to take "Thiolepta" in tablets; without tablets there is little benefit. After a month of treatment, your fingertips stop going numb, you begin to feel more energetic, you have more strength in your legs, and in general, your health improves.

I have been suffering from diabetes for a long time (21 years). Over time, unpleasant sensations began to appear in the lower extremities: muscles ached, a feeling of numbness in the feet sometimes, like goosebumps. I was prescribed a course of Thiogamma intravenously once a day for 10 days. Then I was prescribed pills for another two weeks (1 tablet 2 times a day). All symptoms disappeared and my legs stopped getting tired quickly. In general, I felt relief after 3 droppers. I take this course once a year.

My grandmother has had type 2 diabetes for many years. Atrophy of the lower extremities began. To restore muscle function, Thiogamma was prescribed. They gave me an intravenous course and then took the pills. My health has improved significantly. I began to walk a little. Pain sensitivity was restored.

Release forms

Dosage Packing Storage Sale Best before date
5; 10; 20 50 30, 60, 100

Instructions for use of thiogamma

Short description

The German drug thiogamma is a metabolic drug that controls the metabolism of lipids and carbohydrates and is used in the treatment of diabetic and alcoholic polyneuropathy (multiple lesions of areas of the peripheral nervous system). The pharmacologically active substance of the drug is thioctic acid. Diabetic polyneuropathy (polyneuropathy) is a typical complication of diabetes mellitus. It begins to manifest itself with numbness, burning and pain in the limbs at rest. Over time, this whole complex of unpleasant sensations gains intensity and begins to overwhelm the patient constantly. Polyneuropathy is characterized by movement disorders and reflex disorders. The first to become involved in the pathological process are thin sensory nerve fibers, the defeat of which entails a decrease or complete loss of temperature and pain sensitivity. Then comes the turn of thick nerve fibers, the “switching off” of which leads to disruption of proprioceptive (sensing the position of body parts relative to each other) and vibration sensitivity, inhibition of the spread of excitation. The “attack” of the disease on the motor nerves leads to atrophic changes in the small muscles of the foot and interosseous muscles, impaired muscle tone of the flexors and extensors of the fingers. The reason for such serious consequences of diabetes is prolonged and uncontrolled hyperglycemia. To prevent these complications, it is necessary to constantly maintain blood glucose levels within normal limits. But in addition to the pathogenetic therapy of diabetes, one cannot do without a symptomatic component, namely, the effect on damaged nerve fibers. In the treatment of diabetic polyneuropathy, the drug thiogamma based on thioctic acid, a coenzyme produced in the human body, has proven itself well. Thioctic acid provides transmembrane transport of glucose, participates in the process of formation of glucose from other compounds, thereby replenishing energy deficiency.

Regulates the metabolism of carbohydrates and lipids, stimulates cholesterol metabolism, improves liver function. It has a hepatoprotective effect and reduces the amount of “bad” cholesterol. Improves nervous trophism. Reduces the level of free radicals (antioxidant properties). A number of studies have demonstrated the hypoglycemic properties of thioctic acid. In type 2 diabetes mellitus, the amount of thioctic acid synthesized in the human body is significantly reduced. Its lack negatively affects energy metabolism. In such situations, it is almost impossible to do without replenishing the deficiency of this substance from external sources, which is the drug thiogamma. The results of recent clinical trials of this drug indicate normalization of glutathione concentrations in peripheral nerves, which has a beneficial effect on their conductivity. In addition, while taking the drug, the signs of oxidative stress that develops under the influence of free radicals and developed endoneural hypoxia are leveled. Thioctic acid is able to dissolve in both water and lipids, which allows it to be active in aqueous and fatty environments and is rightfully considered one of the most powerful antioxidants. This compound accumulates in large quantities in peripheral nervous tissue, normalizing the blood supply to nerve fibers and increasing the speed of excitation. Thiogamma is a well-studied drug with a favorable safety profile. Its initial daily dose should be 600 mg. The treatment tactics are as follows: first, thiogamma is administered intravenously for 2-4 weeks, then they switch to using the drug in tablet form at a dose of 600 mg once a day. For preventive purposes, thiogamma is prescribed in tablet form to take 600 mg of the drug once a day for a long time.

Pharmacology

Metabolic drug. Thioctic (α-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.

Pharmacokinetics

After oral administration, thioctic acid is quickly and almost completely absorbed from the gastrointestinal tract. When taken simultaneously with food, absorption is reduced. Time to reach Cmax (4 mcg/ml) - about 30 minutes. 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. T1/2 is 25 min.

Release form

Film-coated tablets, oblong, biconvex, with a smooth and slightly shiny surface, with one dividing line on both sides, yellow in color with possible inclusions of white or dark yellow.

1 tab.
thioctic acid 600 mg

Excipients: hypromellose - 25 mg, colloidal silicon dioxide - 25 mg, microcrystalline cellulose - 49 mg, lactose monohydrate - 49 mg, carmellose sodium - 16 mg, talc - 36.364 mg, simethicone (dimethicone and colloidal silicon dioxide in a ratio of 94:6 ) - 3.636 mg, magnesium stearate - 16 mg.

Shell composition: macrogol 6000 - 0.6 mg, hypromellose - 2.8 mg, talc - 2 mg, sodium lauryl sulfate - 0.025 mg.

10 pieces. - blisters (3) - cardboard packs.
10 pieces. - blisters (6) - cardboard packs.
10 pieces. - blisters (10) - cardboard packs.

Dosage

Prescribed orally 600 mg (1 tablet) 1 time/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.

Overdose

Symptoms: nausea, vomiting, headache. In the case of taking from 10 to 40 g of thioctic acid in combination with alcohol, cases of intoxication, including death, have been observed.

Symptoms of acute overdose: psychomotor agitation or confusion, usually followed by the development of generalized convulsions and the formation of lactic acidosis. Cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow suppression, and multiorgan failure have also been described.

Treatment: carry out symptomatic therapy. There is no specific antidote.

Interaction

Thioctic acid enhances the anti-inflammatory effect of GCS.

With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is observed.

Thioctic acid binds metals, so it should not be prescribed simultaneously with drugs containing metals (for example, iron, magnesium, calcium) - the interval between doses should be at least 2 hours.

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

Ethanol and its metabolites weaken the effect of thioctic acid.

Side effects

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

Often more than 1 in 10 treated
Often in less than 1 in 10 but more than 1 in 100 treated
Infrequently in less than 1 in 100 but more than 1 in 1000 treated
Rarely in 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

Very rare ( ® contraindicated during pregnancy and lactation (breastfeeding).

Use in children

special instructions

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

Patients with diabetes mellitus during treatment with Thiogamma ®, especially at the beginning of therapy, need to monitor blood glucose levels. In some cases, it may be necessary to adjust the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia.

Patients taking the drug Thiogamma ® should refrain from drinking alcohol. Alcohol consumption during therapy with Thiogamma ® reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy.

1 tablet of Thiogamma ® 600 mg contains less than 0.0041 XE.

Impact on the ability to drive vehicles and operate machinery

Taking the drug Thiogamma ® does not affect the ability to drive vehicles or operate other mechanisms.

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.



tiogamma-600-instrukciya-po-zOfpe.webp

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.



tiogamma-600-instrukciya-po-ueERxPp.webp

  1. The order is placed on Vseapteki.ru

Clinical and pharmacological group

Active substance

Release form, composition and packaging

Film-coated tablets, oblong, biconvex, with a smooth and slightly shiny surface, with one dividing line on both sides, yellow in color with possible inclusions of white or dark yellow.

1 tab.
thioctic acid 600 mg

Excipients: hypromellose - 25 mg, colloidal silicon dioxide - 25 mg, microcrystalline cellulose - 49 mg, lactose monohydrate - 49 mg, croscarmellose sodium - 16 mg, talc - 36.364 mg, simethicone - 3.636 mg (dimethicone and colloidal silicon dioxide 94: 6), magnesium stearate - 16 mg.

Shell composition: macrogol 6000 - 0.6 mg, hypromellose - 2.8 mg, talc - 2 mg, sodium lauryl sulfate - 0.025 mg.

10 pieces. - blisters (3) - cardboard packs.
10 pieces. - blisters (6) - cardboard packs.
10 pieces. - blisters (10) - cardboard packs.



tiogamma-600-instrukciya-po-bqyIyBF.webp

pharmachologic effect

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

In the body it is formed 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 in the liver, as well as reduce 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, hypoglycemic effects. Improves trophism of neurons.

In diabetes mellitus, thioctic acid reduces the formation of advanced glycation end products, improves endoneurial blood flow, increases glutathione content to physiological values, which ultimately leads to an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.

Pharmacokinetics

When taken orally, it is quickly and completely absorbed from the gastrointestinal tract; simultaneous intake with food reduces absorption. Bioavailability - 30-60% due to the “first pass” effect through the liver. The time to reach Cmax (6 μg/ml) is about 30 minutes.

Metabolism and excretion

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. T 1/2 - 25 min.

Indications

Contraindications

- hypersensitivity to thioctic acid or other components of the drug;

— age up to 18 years;

- hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption;

- period of breastfeeding.

Dosage

The drug is taken orally at 600 mg (1 tablet) 1 time/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.

Side effects

The frequency of adverse reactions is given in accordance with the WHO classification: very often (more than 1 in 10 people undergoing treatment), often (less than 1 in 10, but more than 1 in 100 people undergoing treatment), sometimes (less than 1 in 100, but more than 1 in 1000 treated), rare (less than 1 in 1000, but more than 1 in 10,000 treated), very rare (less than 1 in 10,000, including isolated cases) ), frequency unknown (cannot be determined from available data).

Very rarely (Gastrointestinal disorders: nausea, vomiting, abdominal pain, diarrhea.

From the immune system: allergic reactions (up to the development of anaphylactic shock), skin rash, urticaria, itching; autoimmune insulin syndrome (AIS), clinical manifestations of AIS can be: dizziness, sweating, muscle tremors, increased heart rate, nausea, headache, confusion, impaired visual perception, loss of consciousness, coma.

From the nervous system: change or disturbance of taste sensations.

From the side of metabolism and nutrition: due to improved absorption of glucose, a decrease in the concentration of glucose in the blood is possible. In this case, symptoms of hypoglycemia may occur - dizziness, increased sweating, headache, visual disturbances.

Frequency unknown (cannot be determined from available data):

From the skin and subcutaneous tissues: eczema.

If any of the side effects indicated in the instructions are aggravated or any other side effects not specified in the instructions are noted, the patient should inform the doctor.

Overdose

Symptoms: nausea, vomiting, headache.

When thioctic acid was taken in doses of 10 to 40 g in combination with alcohol, cases of intoxication, including death, were observed.

Symptoms of acute overdose: psychomotor agitation or confusion, usually followed by the development of generalized convulsions and the formation of lactic acidosis. Cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression and multiorgan failure have also been described.

Treatment: symptomatic. There is no specific antidote.

Drug interactions

Thioctic acid enhances the anti-inflammatory effect of GCS.

With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is observed.

Thioctic acid binds metals, so it should not be prescribed simultaneously with drugs containing metals (for example, iron, magnesium, calcium) - the interval between doses should be at least 2 hours.

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

Ethanol and its metabolites weaken the effect of thioctic acid.

If the patient is already taking other medications or is planning to take them, it is necessary to consult a doctor before taking Tiogamma.

special instructions

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

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 hypoglycemia develops, you must immediately stop taking Thiogamma.

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

Patients taking Thiogamma should avoid drinking alcohol. Alcohol consumption during therapy with Thiogamma 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 the development of autoimmune insulin syndrome (AIS) during treatment with thioctic acid have been described. The possibility of AIS is determined by the presence of the HLA-DRB1 *04:06 and HLA-DRB1 *04:03 alleles in patients.

Impact on the ability to drive vehicles and operate machinery

Taking the drug Thiogamma does not affect the ability to drive vehicles or operate other mechanisms.