Thiogamma solution for infusion bottle 1.2% 50ml N1
Condition: New product
988 Items
Rating:
Be the first to write a review!
More info
Active ingredients
Thioctic acid
Release form
Solution
Composition
1 ml of 1 fl. thioctic acid meglumine salt 23.354 mg 1167.7 mg, which corresponds. the content of thioctic acid 12 mg 600 mg. Excipients: meglumine (to maintain the pH level), macrogol 300 - 4 g, water d / and - up to 50 ml.
Pharmacological effect
Metabolic drug. Thioctic (α-lipoic) acid is an endogenous antioxidant (binds free radicals), is synthesized in the body during the oxidative decarboxylation of alpha keto acids. As a coenzyme, mitochondrial multienzyme complexes are involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. It helps to reduce the concentration of glucose in the blood and increase the glycogen content in the liver, as well as to overcome insulin resistance. It participates in the regulation of lipid and carbohydrate metabolism, affects cholesterol metabolism, improves liver function, and has a detoxification effect in case of poisoning with heavy metal salts and other intoxications. It has a hepatoprotective, hypolipidemic, hypocholesterolemic and hypoglycemic effect. Improves trophism of neurons. In diabetes mellitus, thioctic acid improves endoneural blood flow, increases glutathione content to a physiological value, which results in an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.
Pharmacokinetics
Absorption: With on / in the introduction of Tmax is 10-11 minutes, Cmax is about 20 μg / ml. Metabolism: Has the effect of "first pass" through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation. Withdrawal: The total plasma clearance is 10-15 ml / min. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in small quantities - unchanged. T1 / 2 is 25 minutes.
Indications
- diabetic polyneuropathy - alcoholic polyneuropathy.
Contraindications
- pregnancy - lactation period (breastfeeding) - children under the age of 18 years - hypersensitivity to thioctic acid or other components of the drug.
Use during pregnancy and lactation
The drug Tiogamma is contraindicated for use during pregnancy and lactation (breastfeeding).
Dosage and administration
At the beginning of the course of treatment, the drug is administered intravenously at a dose of 600 mg / day (1 amp. Concentrate to prepare 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 / day. Rules for the preparation and administration of an infusion solution 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 with the solution for infusion is immediately covered with the enclosed light-protective case, since thioctic acid is sensitive to light. The solution for infusion should be administered immediately after preparation. The maximum storage time of the prepared solution for infusion is not more than 6 hours. When using the prepared solution for infusion, the bottle with the preparation is removed from the box and immediately covered with the enclosed light-protective case, since thioctic acid is sensitive to light. Infusion is performed directly from the vial. Enter slowly, about 1.7 ml / min, over 30 min.
Side effects
The incidence of adverse reactions is given in accordance with the WHO classification: Very often, more than 1 in 10 undergoing treatment. Often less than 1 in 10, but more than 1 in 100 undergoing treatment. Not often less than 1 in 100, but more than. 1 out of 1000 undergoing treatment Rarely less than 1 out of 1000, but more than 1 out of 10,000 undergoing treatment. Very rarely less than 1 out of 10,000, including individual cases. From the hematopoietic system: very rarely - point hemorrhages in the mucous membranes. , skin, thrombocytopenia, hemorrhagic rash (pur hurray), thrombophlebitis. Allergic reactions: in some cases - systemic reactions (itching, nausea, discomfort) up to the development of anaphylactic shock, urticaria. From the side of the central nervous system: very rarely - a change or a violation of taste, convulsions up to an epileptic seizure. On the part of the organ of vision: very rarely - diplopia. On the part of the skin and subcutaneous tissue: in some cases - itching, eczema, rash. On the part of the endocrine system: in some cases, due to improved glucose uptake, a decrease in blood glucose concentration is possible. This may cause symptoms of hypoglycemia - dizziness, increased sweating, headache, visual disturbances. Local reactions: in some cases - irritation, hyperemia or swelling.Other: very rarely - in the case of rapid administration of the drug, an increase in intracranial pressure (a feeling of heaviness in the head), difficulty in breathing. These reactions take place independently.
Overdose
Symptoms: nausea, vomiting, headache. In the case of receiving from 10 to 40 g of thioctic acid in combination with alcohol, there were cases of intoxication, even death. Symptoms of acute overdose: psychomotor agitation or stupefaction, as a rule, with the subsequent development of generalized seizures and the formation of lactic acidosis. It also describes cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation of blood, bone marrow suppression and multiorgan failure. Treatment: conduct symptomatic therapy. There is no specific antidote.
Interaction with other drugs
Thioctic acid reduces the effectiveness of cisplatin while taking it, and also reacts with metal-containing preparations, such as preparations of iron, magnesium. Thioctic acid reacts with sugar molecules to form sparingly soluble complexes, for example, with a solution of levulose (fructose). Thioctic acid enhances the anti-inflammatory effect of SCS. With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their action may be enhanced. Ethanol and its metabolites weaken the action of thioctic acid. Pharmaceutical Interaction Thioctic acid infusion solution is incompatible with dextrose solution, Ringer's solution and with solutions that react with disulfide and SH-groups.
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 discontinued. In rare cases, when using the drug Thiogamma in patients with no glycemic control and in severe general condition, serious anaphylactic reactions can develop.Alcohol consumption during the treatment of the drug Thiogamma reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy. During treatment with the drug Tiogamma should refrain from alcohol. Influence on the ability to drive vehicles and control mechanisms The use of the drug Tiogamma does not affect the ability to drive a vehicle and work with other mechanisms.