TIONA [Thioctic acid] Solution for I.V. administration

instructions for the medical use of the medicinal product

TIONA

Tradename

Tiona, Тиона

International non-proprietary name or generic name

Thioctic acid, Тиоктовая кислота

Dosage form

Solution for I/V administration.

Composition per 12 ml ampoule:

active substance: thioctic acid 300 mg.

excipients: ethanediamine, water for injection.

Pharmacotherapeutic group

Metabolic agent.

ATX code: A16AX01

Pharmacological properties

Pharmacodynamics

It is an endogenous antioxidant that binds free radicals. Thioctic acid is involved in the mitochondrial metabolism of the cell; it functions as a coenzyme in the complex of transformation of substances that have a pronounced antitoxic effect. They protect the cell from reactive radicals arising during intermediate metabolism or during the breakdown of exogenous foreign substances, and from heavy metals. Thioctic acid exhibits synergism with insulin, which is associated with increased glucose utilization. In patients with diabetes mellitus, thioctic acid leads to a change in the concentration of pyruvic acid in the blood.

Pharmacokinetics

With intravenous administration of thioctic acid at a dose of 600 mg, Cmax in blood plasma after 30 minutes is about 20 mcg/ml.

Thioctic acid has a “first pass” effect through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation. Vd - about 450 ml/kg.

Thioctic acid and its metabolites are excreted by the kidneys mainly in the form of metabolites (80-90%), in small quantities - unchanged. T1/2 is 25 min. Total plasma clearance is 10-15 ml/min/kg.

Indications for use

• Diabetic polyneuropathy.

• Alcoholic polyneuropathy.

Contraindications

• Hypersensitivity to thioctic acid or to any other component of the drug.

• Pregnancy.

• Breastfeeding period.

• Children and adolescents under 18 years of age.

Method of administration and dosage

The drug is administered intravenously. Intravenous administration should be slow, with a maximum rate of 50 mg of thioctic acid per minute (about 1.7 ml/min).

Before use, the contents of 1-2 ampoules are diluted in 100 - 250 ml of 0.9% sodium chloride solution and administered intravenously slowly over at least 30 minutes.

Since the active substance is sensitive to light, the solution for infusion is prepared immediately before use. The prepared solution must be protected from light by wrapping the bottle with aluminum foil. Protected from light, the solution can be stored for about 6 hours.

At the beginning of therapy, Tiona is administered intravenously at a dose of 300-600 mg (1-2 ampoules) per day for 2-4 weeks. Then they switch to maintenance therapy with the oral form of Tiona at a dose of 600 mg per day. The duration of the course of treatment and the need to repeat it is determined by the doctor.

Glucose levels should be carefully monitored during treatment for diabetic peripheral neuropathy.Side effect

From the nervous system: convulsions, diplopia; With rapid intravenous administration, there may be a feeling of heaviness in the head (increased intracranial pressure) and difficulty breathing, which go away on their own.

From the blood coagulation system: petechiae on the skin and mucous membranes, thrombocytopathy, hemorrhagic rash (purpura), thrombophlebitis.

Metabolism: hypoglycemia (due to improved glucose absorption).

Allergic reactions: urticaria, systemic allergic reactions up to anaphylactic shock.

Local reactions: possible burning at the injection site.

If any of the side effects indicated in the instructions get worse, or you notice any other side effects not listed in the instructions, tell your doctor.

Interaction with other medicinal products

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

Thioctic acid is capable of forming chelate complexes with metals; co-administration with iron, magnesium, and calcium preparations should be avoided. Keep in mind that dairy products contain calcium. Therefore, it is also necessary to avoid using thioctic acid simultaneously with dairy products (due to their calcium content).

With simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced, 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 to avoid the development of symptoms of hypoglycemia.

Thioctic acid enhances the anti-inflammatory effect of GCS.

Ethanol and its metabolites weaken the effect of thioctic acid.

Thioctic acid forms poorly soluble complex compounds with sugar molecules. Thioctic acid is incompatible with solutions of dextrose (glucose), fructose, Ringer, as well as with solutions that react with disulfide or SH groups.

Special instructions and precautions

Before using the drug, consult your doctor.

For severe diabetic polyneuropathy, it is recommended to begin treatment with parenteral administration of thioctic acid for 2-4 weeks, followed by oral forms of thioctic acid.

During the period of use of thioctic acid in patients with diabetes mellitus, constant monitoring of the concentration of glucose in the blood plasma is necessary, especially at the initial stage of therapy. In some cases, it may be necessary to reduce the dose of insulin or oral hypoglycemic drugs to avoid the development of hypoglycemia. If symptoms of hypoglycemia occur (dizziness, increased sweating, headache, blurred vision, nausea), you should immediately stop using thioctic acid.

Alcohol intake reduces the effectiveness of treatment. During therapy, patients should refrain from drinking alcohol during the entire course of treatment, and, if possible, in between courses. Alcohol consumption during treatment with thioctic acid is also a risk factor for the development and progression of neuropathy.

Influence on the ability to drive vehicles and mechanisms

During the period of use of the drug, caution should be exercised when driving vehicles and machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Overdose

Symptoms: headache, nausea, vomiting.

When using very high doses of thioctic acid from 10 to 40 g, serious signs of intoxication may be observed (generalized convulsive seizures, severe acid-base imbalance leading to lactic acidosis, hypoglycemic coma, severe blood coagulation disorders, sometimes leading to death).

Treatment: symptomatic. If necessary, anticonvulsant therapy, measures to maintain the functions of vital organs. There is no specific antidote.

Release form

5 ampoules of 12 ml in a plastic tray. 2 plastic trays along with instructions for use in a cardboard box.

Storage conditions

Store in a place protected from light, at a temperature not exceeding 25°C.

Keep out of the reach of children!

Shelf life

2 years. Do not use after the expiry date stated on the packaging.

Vacation conditions

Dispensed by prescription.