active substance:thioctic acid (?-lipoic)
1 ampoule of solution contains trometamol salt of ?-lipoic (thioctic) acid 952,29 mg (equivalent to 600 mg ?-lipoic (thioctic) acid)
other ingredients:trometamol, water for injection.The
Solution for injection.The
products that affect the digestive system and metabolic processes. Thioctic acid. PBX code A16A H01.
Treatment of symptoms of peripheral (sensomotor) diabetic polyneuropathy.
Hypersensitivity to thioctic acid and other components of the drug.
the basis of diabetic polyneuropathy treatment is optimal diabetic control.
the Dose and duration of treatment set individually.
in the presence of symptoms of peripheral (sensorimotor) diabetic polyneuropathy, the recommended daily dose for adults is 24 ml of injection solution (which corresponds to 600 mg of thioctic acid per day) intravenously.
Administration can be done without dilution with an injection syringe for at least 12 minutes.
during the initial treatment period, the injection solution should be administered intravenously for 2-4 weeks.
rules of infusion.
To prepare infusion solution should only be used 0.9% solution of sodium chloride!
the Drug is administered intravenously within 30 minutes before this vial of the drug Thioctacid 600 T diluted in 250 ml of 0.9% solution of sodium chloride.
Since the active substance of the product is sensitive to the action of light, a solution for short-term infusion should be prepared immediately before use. The infusion solution should be protected from light (for example, with aluminum foil). Protected from light, the infusion solution can be used during about 6:00. It is necessary to carefully ensure that the introduction of infusion lasted at least 12 minutes.
it is Recommended to continue treatment with ?-lipoic acid in the form of oral forms to the Thioctacid 600 HR in a dose of 600 mg per day.
from the Central nervous system:in isolated cases - change or violation of taste sensations.
it is very rare after the introduction of ?-lipoic acid observed heaviness in the head, headache, tides, increased sweating, difficulty breathing, increased intracranial pressure, dizziness, convulsions, visual impairment and double vision. In most cases, all these symptoms pass on their own.
on the part of the hemopoietic system:is very rare after the introduction of the developed purpura, was observed petechial hemorrhages in the mucous membranes, the skin, impaired platelet function, anticoagulation, thrombosis and thrombocytopathy.
from the digestive tract:in some cases - nausea and vomiting, which take place independently.
Allergic reactions:in isolated cases - skin rash, urticaria, itching, eczema, as well as systemic reactions even to anaphylactic shock.
Reactions at the injection site:have been observed very rarely a burning pain at the injection site.
on the part of the cardiovascular system:pain in the heart region, tachycardia.
Metabolic disorders:hypoglycemia (dizziness, sweating, headache, visual impairment) is possible due to improved glucose utilization.
General disorders:after a quick injection, there may be a feeling of pressure in the head and difficulty breathing, which pass on their own.
as a Result of improved glucose uptake,levels may decrease in some cases
sugar in the blood. In this regard, it was noted the appearance of symptoms of hypoglycemia, such as dizziness, sweating, headache and blurred vision.
Symptoms:headache, nausea, vomiting. In case of overdose or suspected adverse reactions, the injection should be stopped immediately and, without removing the injection needle, slowly inject 0.9% sodium chloride solution.
there is evidence that as a result of accidental or intentional use of thioctic acid at a dose of 10-40 g in alcoholic intoxication, isolated cases with severe signs of intoxication, including lethal outcome, were observed. Clinical manifestations of intoxication manifested in the form of psychomotor excitation or dizziness with subsequent generalized seizures and the development of lactate acidosis. As the effects of intoxication thioctic acid is hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow suppression and multiple organ failure.
Treatment:in acute poisoning with thioctic acid are shown immediate hospitalization with conducting General therapeutic measures of detoxification of the body (artificial respiration, vomiting, gastric lavage, activated charcoal). For the treatment of generalized seizures, lactate acidosis and other effects of intoxication should be guided by means of intensive care and symptomatic approach to accelerate the elimination of thioctic acid. There is no specific antidote.
thioctic acid Use during pregnancy is not recommended due to the lack of appropriate clinical data.
Data on the penetration of thioctic acid in breast milk is not, therefore, apply it in the period of breast-feeding is not recommended.The
does Not apply to children.
alcohol consumption can reduce the effectiveness of the drug. Therefore, it is recommended to refrain from taking alcohol during treatment with the drug. In patients with diabetes, especially at the beginning of treatment, blood glucose control is necessary, hypoglycemia is possible due to improved glucose utilization. During the treatment of polyneuropathy, thanks to regenerative processes, perhaps a short-term increase in sensitivity, accompanied by paresthesia with a feeling of"creeping goosebumps".
After applying the Thioctacid 600 T may experience an unusual smell of urine.
the Drug is light sensitive, therefore, the vials should be removed from the packaging only immediately before use.
Certain restrictions on the introduction of drugs thioctic acid is an elderly age (over 75 years).The
in applying the drug should refrain from driving vehicles and work with potentially dangerous machinery.The
Thioctic acid reacts with ionic metal complexes (e.g. cisplatin), therefore, while the use of Thioctacid 600 T and cisplatin reduced the effectiveness of the latter.
thioctic acid is a metal chelator, so It should not be used with metals (iron, magnesium).
With molecules of sugar (solution levulose) thioctic acid forms a sparingly soluble complex compounds.
While treatment Thioctacid 600 T may increase hypoglycemic effect of insulin and other antidiabetic agents. In this regard, especially at the beginning of treatment with ?-lipoic acid, regular monitoring of blood sugar levels is shown. To prevent the appearance of symptoms of hypoglycemia in some cases, it may be necessary to reduce the dose of insulin and/or oral antidiabetic agent.
the Regular use of alcohol is a significant risk factor for the development and progression of the clinical picture of neuropathy, and may thus adversely affect the process of treatment with Thioctacid 600 T Therefore, patients with diabetic polyneuropathy is usually recommended to refrain from alcohol consumption. The restriction also applies to interruptions between courses of treatment.The
Farmacodinamica.?-lipoic acid is a vitamin-like substance of endogenous origin, has the function of coenzyme in oxidant decarboxylation of ?-keto acids.
Hyperglycemia caused by diabetes mellitus leads to the accumulation of the so-called "end products of advanced glucosylation". This process leads to a decrease in endoneural blood flow and endoneural hypoxia and ischemia, accompanied by increased formation of free oxygen radicals, which, in turn, damage the peripheral nerve. Also in peripheral nerves there is a decrease in the level of antioxidants (such as glutathione).
?-lipoic acid intervened in these processes, leading to a decrease in the formation of end products of glucosuvannia, improvement of endoneural blood flow, increasing the physiological level of antioxidants such as glutathione, which is an antioxidant for free oxygen radicals in the diabetic nerve.
These effects, observed in the experiment, support the theory that the functionality of peripheral nerves can be improved with the help of ?-lipoic acid. This applies to sensory disorders in diabetic polyneuropathy, manifested dysesthesia, paresthesia, such as burning sensation, pain, numbness and "creeping goosebumps".
Pharmacokinetics.the Primary conversion of ?-lipoic acid occurs in the liver. There are no significant differences between patients regarding systemic availability of ?-lipoic acid. ?-lipoic acid is metabolized by oxidation of lateral chains and conjugation, and is excreted mainly by the kidneys.
the half-life of ?-lipoic acid from blood plasma in humans is about 25 minutes, total clearance of plasma is 10-15 ml/min per kg. At the end of infusion of 600 mg for 12 minutes concentration in plasma is about 47 µg/ml. In experiments on animals (rats, dogs) radioactive symbols helped to determine the predominantly renal clearance in the form of metabolites in the proportion of 80-90%. In humans, just a small part of the intact substance is in the urine. Metabolism mainly occurs in the form of oxidation of lateral chains (beta-oxidation) and/or S-methylation of the corresponding thiol groups.
transparent yellow solution practically free from visible particles.The
is Not checked.The
Keep out of reach of children and protected from light place at temperature not exceeding 25 ° C
the light-Protected solution for infusions on saline solution can be maintained for 6:00.The
24 ml ampoule, 5 ampoules in an open blister in a cardboard package.The
According to the recipe.The
Hamelin Pharmaceuticals Ltd,
hameln pharmaceuticals GmbH,
MEDA Pharma GmbH & Co.KG
MEDA Pharma GmbH & amp; co. KG.The
Langes Feld 13 31789 Hameln, Germany,
Langes Feld 13 31789 Наmeln, Germany.
Benzstra?e 1, 61352, Bad Homburg, Germany,
Benzstrasse 1, 61352, Bad Homburg, Germany.
Thioctacid refers to a category of drugs neuroprotective and hypoglycemic action. The tool allows you to regulate metabolism and metabolic processes in the body.
the component of the preparation is alpha-lipoic (thioctic) acid – coenzyme, which takes part in metabolism and oxidative reactions. When taking the drug, hypoxia, endoneural ischemia and the degree of damage to the nerve fibers decrease, the degree of oxygen compounds increases.
a Medicine recommended for use with:
the Preparation is intended for administration by intravenous injection or infusion. The daily dose is 24 ml of the drug used in one dose. When injecting the drug is used in its pure form without additional dilution, the duration of injection is not less than 12 minutes. For infusion (intravenous drip infusion) the drug is diluted with 250 ml of sodium chloride 0.9% solution and is used for 30 minutes.