Active substance: thioctate trometamol – 952.2876, in terms of thioctic (alpha-lipoic) acid - 600 mg;

Excipients: trometamol, water for injection.

The solution for intravenous administration is 25 mg/ml.

24 ml of the solution in ampoules of dark glass, hydrolytic type 1. A marking is applied directly to the ampoule indicating the place of application of force to open the ampoule: two red rings and a white dot.

5 ampoules in a white plastic tray, 1 pallet each, together with instructions for use, in a cardboard pack.


Description of the dosage form

A clear yellowish solution.


Pharmacotherapeutic group

A metabolic remedy.


Pharmacokinetics

The main metabolic pathways are oxidation and conjugation. The volume of distribution is about 450 ml/kg. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The half–life is 20-50 minutes. The total plasma clearance is 10-15 ml/min.


Pharmacodynamics

Thioctic (alpha-lipoic) acid is found in the human body, where it performs the function of a coenzyme in the reactions of oxidative phosphorylation of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant, and its biochemical mechanism of action is close to B vitamins.

Thioctic acid helps protect cells from the toxic effects of free radicals that occur in metabolic processes; it also neutralizes exogenous toxic compounds that have entered the body. Thioctic acid increases the concentration of the endogenous antioxidant glutathione, which leads to a decrease in the severity of symptoms of polyneuropathy. The drug has a hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect; improves the trophism of neurons. The result of the synergistic action of thioctic acid and insulin is an increase in glucose utilization.


Indications for use

Diabetic and alcoholic polyneuropathy.


Contraindications to use

Hypersensitivity to thioctic acid or other components of the drug.

Pregnancy, breastfeeding (lack of sufficient experience with the drug).

There are no clinical data on the use of Thioctacid ® 600 T in children and adolescents, and therefore the drug cannot be prescribed to children and adolescents.


Side effects

The frequency of side effects is determined as follows: Very often: >1/10; Often:1/100; Infrequently:1/1000; Rarely:1/10000; Very rare:

Allergic reactions: Very rarely – skin rash, urticaria, itching, eczema, redness of the skin, systemic allergic reactions up to anaphylactic shock.

From the nervous system and sensory organs: Very rarely – seizures, diplopia.

From the blood and cardiovascular system: Very rarely – purpura, spot hemorrhages and a tendency to bleed (due to impaired platelet function), thrombocytopathy, thrombophlebitis.

General: Often – with rapid intravenous administration, there may be an increase in intracranial pressure and difficulty breathing, which pass on their own; Infrequently - a violation of taste sensations (metallic taste); Rarely allergic reactions may occur at the site of infusion; Rarely – nausea and vomiting; Very rarely – due to improved glucose utilization, glucose levels may decrease symptoms of hypoglycemia may appear in the blood (confusion, increased sweating, headache, visual disturbances).


Interaction with medicines

With simultaneous administration of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin. With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may increase, therefore, regular monitoring of blood glucose levels is recommended, especially at the beginning of therapy with thioctic acid. In some cases, it is permissible to reduce the dose of hypoglycemic drugs in order to avoid the development of symptoms of hypoglycemia.


Ethanol and its metabolites weaken the effect of thioctic acid.


Method of administration and dosage

The drug is administered intravenously. The recommended dose for severe polyneuropathy is 1 ampoule (600 mg) once a day for 2-4 weeks.

In the future, the patient is transferred to treatment with Thioctacid ® BV at a dose of 600 mg (1 tablet) per day.

Intravenous administration of the drug should be carried out slowly (no faster than 2 ml / min).

It is also possible to inject an undiluted solution intravenously using a syringe for injection and a perfuser. In this case, the injection time should be at least 12 minutes.

Due to the sensitivity of the active substance to light, ampoules should be removed from the cardboard packaging immediately before use.

The drug Thioctacid ® 600 T can be used as infusions in 0.9% sodium chloride solution (infusion volume - 100-250 ml) for 30 minutes.

The infusion solution should be protected from light (for example, by wrapping the vessel with aluminum foil).

The solution for intravenous administration, protected from light, is suitable for 6 hours.


Overdose

There were no cases of overdose with thioctic acid in the form of an intravenous solution.

In case of overdose, symptomatic treatment, if necessary, anticonvulsant therapy, measures to maintain the functions of vital organs.


Precautions and special instructions

Thioctic acid infusion solution is incompatible with dextrose solution, Ringer's solution and solutions reacting with disulfide and SH groups, ethanol. Alcohol consumption is a risk factor for the development of polyneuropathy and may reduce the effectiveness of the drug Thioctacid ® 600T, therefore, patients should refrain from taking alcoholic beverages both during treatment with the drug and during periods outside of treatment.


Treatment of diabetic polyneuropathy should be carried out against the background of maintaining an optimal concentration of glucose in the blood.


Storage conditions

Store at a temperature not exceeding 25 ° C

Thioctacid 600 T 25mg/ml 24ml 5 ampoules

  • Product Code: Thioctacid 600 T 25mg/ml 24ml 5 ampoules
  • Availability: In Stock
  • $55.00

  • Ex Tax: $55.00