Tiogamma solution for infusion 1.2%, 50ml No. 10

• Diabetic polyneuropathy,

• alcoholic polyneuropathy.

At the beginning of therapy, the drug ThiogammaЃ, a solution for infusion, is administered intravenously at a dose of 600 mg (1 bottle) per day for 2-4 weeks. The vial with the preparation is taken out of the box and immediately covered with the enclosed light-protective case. thioctic acid is light sensitive. Infusion is made directly from the vial using a device (system) for intravenous infusion of infusion solutions. Enter slowly, about 1.7 ml / min, over 30 minutes Then they switch to maintenance therapy with thioctic acid for oral administration at a dose of 600 mg per day. The duration of the course of therapy and the need to repeat it is determined by the attending physician.

The solution for infusion is clear, light yellow or yellowish green in color.

1 fl.

thioctic acid meglumine salt 1167.7 mg,

which is equivalent to thioctic acid 600 mg

Excipients: macrogol 300 - 4000 mg, meglumine, water for injection - up to 50 ml.

• Hypersensitivity to thioctic acid or other components of the drug.

• Children under the age of 18.

• Pregnancy and the period of breastfeeding.

Before taking the drug, be sure to consult your doctor.

Pharmacodynamics

Thioctic (alpha lipoic) acid is an endogenous antioxidant of direct (binds free radicals) and indirect (restores the physiological concentration of glutathione, increases the activity of superoxide dismutase). As a coenzyme of mitochondrial multienzyme complexes, it participates in the reactions of oxidative phosphorylation of pyruvic acid (PVC) and alpha-keto acids. Biochemical mechanism of action is close to B vitamins. Thioctic acid has antioxidant, neurotrophic, hypoglycemic effect, improves lipid metabolism: - by binding with an excess amount of free oxygen radicals, protects cells from damage by decay products; in diabetes mellitus, it reduces the formation of end products of progressive glycation of proteins in nerve cells, reduces endoneural hypoxia and ischemia,increases the concentration of the antioxidant glutathione, thereby weakening the manifestations of polyneuropathy in the form of paresthesia, burning sensation, pain and numbness of the extremities; - participates in the regulation of carbohydrate metabolism (helps to reduce the concentration of glucose in the blood plasma and increase the concentration of glycogen in the liver, reduces tissue insulin resistance); - stimulates the metabolism of cholesterol, reducing its concentration in blood plasma; participating in the metabolism of fats, thioctic acid increases the biosynthesis of phospholipids, in particular phosphoinositides, thereby restoring the damaged structure of cell membranes; energy metabolism and nerve impulses are normalized.- participates in the regulation of carbohydrate metabolism (helps to reduce the concentration of glucose in the blood plasma and increase the concentration of glycogen in the liver, reduces tissue insulin resistance); - stimulates the metabolism of cholesterol, reducing its concentration in blood plasma; participating in the metabolism of fats, thioctic acid increases the biosynthesis of phospholipids, in particular phosphoinositides, thereby restoring the damaged structure of cell membranes; energy metabolism and nerve impulses are normalized.- participates in the regulation of carbohydrate metabolism (helps to reduce the concentration of glucose in the blood plasma and increase the concentration of glycogen in the liver, reduces tissue insulin resistance); - stimulates the metabolism of cholesterol, reducing its concentration in blood plasma; participating in the metabolism of fats, thioctic acid increases the biosynthesis of phospholipids, in particular phosphoinositides, thereby restoring the damaged structure of cell membranes; energy metabolism and nerve impulses are normalized.thioctic acid increases the biosynthesis of phospholipids, in particular phosphoinositides, thereby restoring the damaged structure of cell membranes; energy metabolism and nerve impulses are normalized.thioctic acid increases the biosynthesis of phospholipids, in particular phosphoinositides, thereby restoring the damaged structure of cell membranes; energy metabolism and nerve impulses are normalized.

Pharmacokinetics

When administered intravenously, the time to reach the maximum concentration is 10-11 minutes, the maximum concentration is about 20 ?g / ml. Has a 'first pass' effect through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation. The total plasma clearance is 10-15 ml / min. Thioctic acid and its metabolites are excreted by the kidneys (80 - 90%), in small amounts - unchanged. The half-life is 25 minutes.

Application during pregnancy and during breastfeeding:

Use during pregnancy and lactation is contraindicated.

Side effects:

Disturbances from the blood and lymphatic system: very rarely: punctate hemorrhages in the mucous membranes, skin, thrombocytopenia, hemorrhagic rash (purpura), thrombophlebitis; Immune system disorders: frequency unknown: systemic allergic reactions (up to the development of anaphylactic shock); frequency unknown: autoimmune insulin syndrome (AIS) in patients with diabetes mellitus, which is characterized by frequent hypoglycemia in the presence of autoantibodies to insulin. Nervous system disorders: very rare: change or violation of taste; very rare: convulsions; Violations of the organ of vision: very rare: diplopia; Skin and subcutaneous tissue disorders: frequency unknown: allergic reactions - urticaria, itching, eczema, rash. General disorders and disorders at the injection site:the frequency is unknown: due to the improvement in glucose uptake, 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; very rare: allergic reactions at the injection site - irritation, hyperemia or swelling; very rarely: in the case of rapid administration of the drug, an increase in intracranial pressure is possible (there is a feeling of heaviness in the head), difficulty in breathing.in the case of rapid administration of the drug, an increase in intracranial pressure is possible (there is a feeling of heaviness in the head), difficulty in breathing.in the case of rapid administration of the drug, an increase in intracranial pressure is possible (there is a feeling of heaviness in the head), difficulty in breathing.

These reactions go away on their own.

Х If any of the side effects indicated in the instructions are aggravated, or you notice any other side effects not listed in the instructions, inform your doctor.

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 and including death. Symptoms of acute overdose: psychomotor agitation or clouding of consciousness, usually followed by the development of generalized seizures and the development of lactic acidosis. Cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression, and multi-organ failure have also been described. Treatment is symptomatic. There is no specific antidote.

Interaction with other medicinal products:

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 difficult-to-dissolve complexes, for example, with a solution of levulose (fructose). Strengthens the anti-inflammatory effect of glucocorticosteroid drugs. Thioctic acid infusion solution is incompatible with dextrose solution, Ringer's solution and with solutions that react with disulfide and SH - groups. With the 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.

Х If you are already taking or intending to take other medications before taking Thiogamma? be sure to consult your doctor.

Special instructions:

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 symptoms of hypoglycemia occur (dizziness, increased sweating, headache, visual disturbances, nausea), therapy should be discontinued immediately. In isolated cases, when using the drug ThiogammaЃ in patients with lack of glycemic control and in a severe general condition, serious anaphylactic reactions may develop. Alcohol consumption during therapy with ThiogammaЃ reduces the effectiveness of the drug and is a risk factor contributing to the development and progression of neuropathy. For patients taking ThiogammaЃ,you should refrain from drinking alcohol. Cases of the development of autoimmune insulin syndrome (AIS) during treatment with thioctic acid have been described. The possibility of AIS occurrence is determined by the presence of HLA-DRB1 * 04: 06 and HLA-DRB1 * 04: 03 alleles in patients.

Influence on the ability to drive vehicles and work with mechanisms: Does not affect the ability to drive a motor vehicle and work with other mechanisms.