Thioctacid^® 600 T (Solution) Instructions for Use

Marketing Authorization Holder

Meda Pharma, GmbH & Co. KG (Germany)

Manufactured By

Siegfried Hameln, GmbH (Germany)

ATC Code

A16AX01 (Thioctic acid)

Active Substance

Thioctic acid (BAN)

Dosage Form

Thioctacid® 600 T

Solution for intravenous injection 25 mg/1 ml: amp. 24 ml 5 pcs.

Dosage Form, Packaging, and Composition

Solution for intravenous injection clear, yellowish.

Excipients: trometamol, water for injections.

24 ml – ampoules of dark glass, hydrolytic type 1 (5) – plastic trays (1) – cardboard packs.

Clinical-Pharmacological Group

Drug with antioxidant action, regulating carbohydrate and lipid metabolism

Pharmacotherapeutic Group

Metabolic agent

Pharmacological Action

Thioctic (alpha-lipoic) acid is present in the human body, where it functions as a coenzyme in the reactions of oxidative phosphorylation of pyruvic acid and alpha-keto acids.

Thioctic acid is an endogenous antioxidant, and in its biochemical mechanism of action, it is similar to B vitamins.

Thioctic acid helps protect the cell from the toxic effects of free radicals that arise 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 reduction in the severity of polyneuropathy symptoms.

The drug has hepatoprotective, hypolipidemic, hypocholesterolemic, and hypoglycemic effects; it improves neuronal trophism. The synergistic action of thioctic acid and insulin results in increased glucose utilization.

Pharmacokinetics

The main pathways of metabolism 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%). T_1/2 is 20-50 minutes. Total plasma clearance is 10-15 ml/min.

Indications

• Diabetic polyneuropathy;
• Alcoholic polyneuropathy.

ICD codes

Dosage Regimen

Administered intravenously. The recommended dose for severe polyneuropathy is 600 mg once daily for 2-4 weeks.

Subsequently, the patient is switched to oral administration of thioctic acid at a dose of 600 mg/day.

Intravenous administration of the drug should be performed slowly (no faster than 2 ml/min). Intravenous administration of the undiluted solution using an injection syringe and a perfusor is also possible. In this case, the administration time should be at least 12 minutes.

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

Adverse Reactions

The frequency of adverse effects is defined as follows: very common (>1/10); common (>1/100, <1/10); uncommon (>1/1000, <1/100); rare (>1/10,000, <1/1000); very rare (<1/10000).

Allergic reactions: very rare – skin rash, urticaria, itching, eczema, skin redness, systemic allergic reactions up to anaphylactic shock.

From the nervous system and sensory organs: very rare – convulsions, diplopia.

From the blood and cardiovascular system: very rare – purpura, petechial hemorrhages and tendency to bleed (due to impaired platelet function), thrombocytopathy, thrombophlebitis.

From the digestive system uncommon – taste disturbance (metallic taste); rare – nausea and vomiting.

From the body as a whole common – with rapid intravenous administration, increased intracranial pressure and difficulty breathing may occur, which resolve on their own; uncommon – taste disturbance (metallic taste).

Rare – allergic reactions at the infusion site, nausea, vomiting; very rare – due to improved glucose utilization, blood glucose levels may decrease and symptoms of hypoglycemia may appear (confusion, increased sweating, headache, visual disturbances).

Contraindications

• Hypersensitivity to thioctic (alpha-lipoic) acid and other components;
• Pregnancy (insufficient experience of use);
• Period of breastfeeding (insufficient experience of use);
• Childhood and adolescence (no clinical data on use in children and adolescents).

Use in Pregnancy and Lactation

Contraindicated during pregnancy and lactation, due to insufficient experience of use during these periods.

Pediatric Use

Contraindicated in childhood and adolescence (no clinical data on use in children and adolescents).

Special Precautions

Alcohol consumption is a risk factor for the development of polyneuropathy and may reduce effectiveness, so patients should refrain from consuming alcoholic beverages both during treatment and during periods without treatment.

Treatment of diabetic polyneuropathy should be carried out while maintaining optimal blood glucose concentration.

Drug Interactions

With the simultaneous administration of thioctic acid and cisplatin, a decrease in the effectiveness of cisplatin is noted.

With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their action may be enhanced, so regular monitoring of blood glucose levels is recommended, especially at the beginning of therapy with thioctic acid. In some cases, a reduction in the dose of hypoglycemic drugs may be acceptable to avoid the development of hypoglycemia symptoms.

Ethanol and its metabolites weaken the action of thioctic acid.

Pharmaceutical interactions

The infusion solution of thioctic acid is incompatible with dextrose solution, Ringer’s solution, and with solutions that react with disulfide and SH-groups, ethanol.

Storage Conditions

Store at 2°C (36°F) to 25°C (77°F). Keep in original packaging, protected from light. Keep out of reach of children.

Dispensing Status

Rx Only

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.