Thioctic acid (Tablets, Concentrate) Instructions for Use

Instructions
Dosage forms

ATC Code

A16AX01 (Thioctic acid)

Active Substance

Thioctic acid (BAN)

Clinical-Pharmacological Group

Drug with antioxidant action, regulating carbohydrate and lipid metabolism. Hepatoprotector

Pharmacotherapeutic Group

Other agents for the treatment of gastrointestinal diseases and metabolic disorders

Pharmacological Action

It is an endogenous antioxidant that binds free radicals. Thioctic (alpha-lipoic) acid is involved in the mitochondrial metabolism of the cell, where it functions as a coenzyme in the complex transformation of substances with 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

When taken orally, it is rapidly and completely absorbed from the gastrointestinal tract. C_max is reached 30 minutes after administration and is 4 µg/ml.

After intravenous administration of thioctic acid at a dose of 600 mg, C_max in blood plasma after 30 minutes is about 20 µg/ml.

Thioctic acid has a first-pass effect through the liver. Metabolite formation occurs as a result of side chain oxidation and conjugation. V_d is about 450 ml/kg.

Thioctic acid and its metabolites are excreted by the kidneys, predominantly as metabolites (80-90%), with a small amount excreted unchanged. T_1/2 is 25 minutes. Total plasma clearance is 10-15 ml/min/kg.

Indications

Diabetic polyneuropathy. Alcoholic polyneuropathy.

ICD codes

Open the list of ICD codes

ICD-10 code	Indication
G62.1	Alcoholic polyneuropathy
G63.2	Diabetic polyneuropathy

ICD-11 code	Indication
8C03.0	Diabetic polyneuropathy
8D44.0	Alcoholic polyneuropathy

Dosage Regimen

The method of application and dosage regimen for a specific drug depend on its form of release and other factors. The optimal dosage regimen is determined by the doctor. It is necessary to strictly adhere to the compliance of the dosage form of a specific drug with the indications for use and dosage regimen.

Administer a recommended dose of 600 mg once daily.

For diabetic polyneuropathy, initiate therapy with intravenous administration for 2-4 weeks in severe cases.

Follow intravenous administration with a transition to oral tablets for long-term management.

Administer intravenous doses by slow bolus injection or as an intravenous infusion.

Avoid rapid intravenous injection to minimize the risk of local reactions and systemic adverse effects.

Adjust the treatment duration and regimen individually based on disease severity and patient response.

Take tablets on an empty stomach, at least 30 minutes before a meal, for optimal absorption.

Do not take tablets concurrently with dairy products or mineral supplements containing calcium, magnesium, or iron.

Monitor blood glucose levels closely in diabetic patients, especially during the initial phase of therapy.

Reduce the dose of concomitant insulin or oral hypoglycemic agents if necessary to prevent hypoglycemia.

Discontinue use immediately if symptoms of hypoglycemia occur.

Exercise caution with intravenous administration in geriatric patients over 75 years of age.

Abstain from alcohol consumption during the entire treatment course due to reduced therapeutic efficacy.

Adverse Reactions

Immune system disorders: very rarely – allergic reactions (skin rash, eczema, urticaria, skin itching); frequency unknown – anaphylactic shock, autoimmune insulin syndrome in patients with diabetes mellitus, which is characterized by frequent hypoglycemia in the presence of autoantibodies to insulin.

Metabolism and nutrition disorders: very rarely – hypoglycemia (due to improved glucose uptake), the symptoms of which include dizziness, increased sweating, headache, and visual impairment.

Nervous system disorders: often – dizziness; very rarely – change or impairment of taste sensations, “flushes”, convulsions.

Gastrointestinal disorders: often – nausea, vomiting; very rarely – abdominal pain, diarrhea.

Blood and lymphatic system disorders: after intravenous administration very rarely – petechial hemorrhages in the mucous membranes, skin; hemorrhagic rash (purpura), thrombocytopathy, hypocoagulation.

Hepatobiliary disorders: after intravenous administration very rarely – increased activity of liver enzymes.

Cardiac disorders: with rapid intravenous administration very rarely – thrombophlebitis, pain in the heart area, tachycardia.

Eye disorders: after intravenous administration very rarely – diplopia, blurred vision.

Local reactions: after intravenous administration very rarely – burning sensation at the injection site, frequency unknown – allergic reactions at the injection site (irritation, hyperemia, or swelling).

General disorders and administration site conditions: with rapid intravenous administration very rarely – self-limiting increased intracranial pressure (feeling of heaviness in the head) and difficulty breathing, weakness.

Contraindications

Hypersensitivity to thioctic acid; pregnancy, lactation (breastfeeding); children and adolescents under 18 years of age.

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation (breastfeeding). If use during lactation is necessary, the issue of discontinuing breastfeeding should be decided.

Pediatric Use

Contraindicated for use in children and adolescents under 18 years of age.

Geriatric Use

Intravenous administration of thioctic acid should be carried out with caution in elderly patients (over 75 years of age).

Special Precautions

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

During the use of thioctic acid in patients with diabetes mellitus, constant monitoring of plasma glucose concentration 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, visual impairment, nausea), the use of thioctic acid should be stopped immediately.

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

Several cases of autoimmune insulin syndrome have been described in patients with diabetes mellitus during treatment with thioctic acid, which was characterized by frequent hypoglycemia in the presence of autoantibodies to insulin. The possibility of developing autoimmune insulin syndrome is determined by the presence of HLA-DRB1*0406 and HLA-DRB1*0403 haplotypes in patients.

Effect on ability to drive vehicles and operate machinery

During the use of thioctic acid, patients should exercise caution when driving vehicles and operating machinery, as well as when engaging in other potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Drug Interactions

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

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

With 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.

Thioctic acid enhances the anti-inflammatory effect of corticosteroids.

Ethanol and its metabolites weaken the action of thioctic acid.

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

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.

Medical Disclaimer

Brand (or Active Substance), Marketing Authorisation Holder, Dosage Form

Thioctic acid [AlTro, LLC (Russia)]
Concentrate for solution for infusion 30 mg/ml: 10 ml or 20 ml 10 pcs.

Marketing Authorization Holder

AlTro, LLC (Russia)

Manufactured By

Ecofarmplus, JSC (Russia)

Dosage Form

Thioctic acid

Concentrate for solution for infusion 30 mg/ml: 10 ml or 20 ml 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion in the form of a clear greenish-yellow liquid, with a characteristic odor.

	1 ml
Thioctic acid	30 mg

Excipients: ethylenediamine – 8.74 mg, edetate disodium – 0.1 mg, water for injections – up to 1 ml.

10 ml – ampoules (5) – blister packs (2) – cardboard boxes.
20 ml – ampoules (5) – blister packs (2) – cardboard boxes.

Thioctic acid [Atoll LLC (Russia)]
Film-coated tablets 300 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 200, or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Thioctic acid

Film-coated tablets 300 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 200, or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from yellow to yellow-green, round, biconvex; the core is from light yellow to yellow on the break.

	1 tab.
Thioctic acid	300 mg

Excipients: microcrystalline cellulose 165 mg, lactose monohydrate 60 mg, croscarmellose sodium 24 mg, povidone K-25 21 mg, colloidal silicon dioxide 18 mg, magnesium stearate 12 mg.

Film coating composition: hypromellose 5 mg, hyprolose 3.55 mg, macrogol-4000 2.1 mg, titanium dioxide 4.25 mg, quinoline yellow dye 0.1 mg.

10 pcs. – blister packs (aluminum/PVC) (1) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (3) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.
10 pcs. – blister packs (aluminum/PVC) (10) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (1) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (3) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.
20 pcs. – blister packs (aluminum/PVC) (10) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (1) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (2) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (3) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (4) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (5) – cardboard packs.
30 pcs. – blister packs (aluminum/PVC) (10) – cardboard packs.
10 pcs. – polymer jars (1) – cardboard packs.
20 pcs. – polymer jars (1) – cardboard packs.
30 pcs. – polymer jars (1) – cardboard packs.
40 pcs. – polymer jars (1) – cardboard packs.
50 pcs. – polymer jars (1) – cardboard packs.
100 pcs. – polymer jars (1) – cardboard packs.

Thioctic acid [Atoll LLC (Russia)]
Film-coated tablets 600 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 200, or 300 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Thioctic acid

Film-coated tablets 600 mg: 10, 20, 30, 40, 50, 60, 80, 90, 100, 120, 150, 200, or 300 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from yellow to yellow-green, oval, biconvex; the core is from light yellow to yellow on the break.

	1 tab.
Thioctic acid	600 mg

Excipients: microcrystalline cellulose 330 mg, lactose monohydrate 120 mg, croscarmellose sodium 48 mg, povidone K-25 42 mg, colloidal silicon dioxide 36 mg, magnesium stearate 24 mg.

Film coating composition: hypromellose 10 mg, hyprolose 7.1 mg, macrogol-4000 4.2 mg, titanium dioxide 8.5 mg, quinoline yellow dye 0.2 mg.

Thioctic acid [Atoll LLC (Russia)]
Concentrate for solution for infusion 30 mg/ml: 10 ml amp. 5 or 10 pcs.

Marketing Authorization Holder

Atoll LLC (Russia)

Manufactured By

Ozon, LLC (Russia)

Dosage Form

Thioctic acid

Concentrate for solution for infusion 30 mg/ml: 10 ml amp. 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion greenish-yellow, clear, with a characteristic odor.

	1 ml
Thioctic acid	30 mg

Excipients: ethylenediamine – 8.8 mg, propylene glycol – 93.2 mg, water for injections – up to 1 ml.

10 ml – neutral glass ampoules (5) – blister packs (1) – cardboard boxes.
10 ml – neutral glass ampoules (5) – blister packs (2) – cardboard boxes.

Thioctic acid [Binergia JSC (Russia)]
Concentrate for solution for infusion 25 mg/1 ml: amp. 24 ml 5 or 10 pcs.

Marketing Authorization Holder

Binergia JSC (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Thioctic acid

Concentrate for solution for infusion 25 mg/1 ml: amp. 24 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion clear, greenish-yellow.

	1 ml
Thioctic acid	25 mg

Excipients: ethylenediamine, water for injections.

24 ml – light-protective glass ampoules (5) – plastic blister packs (trays) (1) – cardboard boxes.
24 ml – light-protective glass ampoules (5) – plastic blister packs (trays) (2) – cardboard boxes.

Thioctic acid [Promomed Rus LLC (Russia)]
Film-coated tablets 600 mg: 30, 60, 90, or 100 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Form

Thioctic acid

Film-coated tablets 600 mg: 30, 60, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets yellow, oval, biconvex; the core on the fracture is light yellow, the presence of white and yellow inclusions is allowed.

	1 tab.
Thioctic acid	600 mg

Excipients: lactose monohydrate – 212 mg, low-substituted hydroxypropyl cellulose – 110 mg, microcrystalline cellulose type 101 – 90 mg, colloidal silicon dioxide – 33 mg, magnesium stearate – 33 mg, hydroxypropyl cellulose – 22 mg.

Film coating composition ready film coating Opadry^® II 85F220151 yellow — 40 mg [partially hydrolyzed polyvinyl alcohol — 40%, macrogol 4000 (polyethylene glycol 4000) — 20.2%, titanium dioxide — 16%, talc — 14.8%, aluminum lake based on quinoline yellow dye (E104) — 8%, iron oxide yellow dye (E172) — 0.8%, aluminum lake based on sunset yellow FCF dye (E110) — 0.2%].

10 pcs. – contour cell blisters (3) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (9) – cardboard packs.
10 pcs. – contour cell blisters (10) – cardboard packs.
15 pcs. – contour cell blisters (2) – cardboard packs.
15 pcs. – contour cell blisters (4) – cardboard packs.
15 pcs. – contour cell blisters (6) – cardboard packs.
20 pcs. – contour cell blisters (3) – cardboard packs.
20 pcs. – contour cell blisters (5) – cardboard packs.
20 pcs. – jars – cardboard packs.
60 pcs. – jars – cardboard packs.

Thioctic acid [Promomed Rus LLC (Russia)]
Concentrate for solution for infusion 25 mg/1 ml: amp. 12 ml 5, 10 or 20 pcs., vial 12 ml or 24 ml 5 or 10 pcs.
Concentrate for solution for infusion 30 mg/1 ml: amp. 12 ml 5, 10 or 20 pcs., vial 12 ml or 24 ml 5 or 10 pcs.

Marketing Authorization Holder

Promomed Rus LLC (Russia)

Manufactured By

Biokhimik, JSC (Russia)

Dosage Forms

	Thioctic acid	Concentrate for solution for infusion 25 mg/1 ml: amp. 12 ml 5, 10 or 20 pcs., vial 12 ml or 24 ml 5 or 10 pcs.
		Concentrate for solution for infusion 30 mg/1 ml: amp. 12 ml 5, 10 or 20 pcs., vial 12 ml or 24 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion as a clear or slightly opalescent yellow or greenish-yellow solution.

	1 ml
Thioctic acid (as trometamol salt)	39.7 mg,
Equivalent to thioctic acid content	25 mg

Excipients: trometamol, water for injections.

12 ml – dark glass ampoules (5) – contour cell blisters (1) – cardboard packs.
12 ml – dark glass ampoules (5) – contour cell blisters (2) – cardboard packs.
12 ml – dark glass ampoules (5) – contour cell blisters (4) – cardboard packs.
12 ml – dark glass vials (5) – cardboard packs.
12 ml – dark glass vials (10) – cardboard packs.
24 ml – dark glass vials (5) – cardboard packs.
24 ml – dark glass vials (10) – cardboard packs.

Concentrate for solution for infusion as a clear or slightly opalescent yellow or greenish-yellow solution.

	1 ml
Thioctic acid (as trometamol salt)	47.6 mg,
Equivalent to thioctic acid content	30 mg

Excipients: trometamol, water for injections.

Thioctic acid [Ellara, LLC (Russia)]
Concentrate for solution for infusion 30 mg/1 ml: amp. 10 ml 3, 5, 6, 10, 12, 15, 20 or 25 pcs.

Marketing Authorization Holder

Ellara, LLC (Russia)

Dosage Form

Thioctic acid

Concentrate for solution for infusion 30 mg/1 ml: amp. 10 ml 3, 5, 6, 10, 12, 15, 20 or 25 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion as a clear, greenish-yellow solution.

	1 ml
Thioctic acid	30 mg*

* Each 10 ml ampoule contains 300 mg of thioctic acid.

Excipients: trometamol, water for injections.

10 ml – light-protective glass ampoules (3) – contour cell blisters (1) – cardboard packs.
10 ml – light-protective glass ampoules (3) – contour cell blisters (2) – cardboard packs.
10 ml – light-protective glass ampoules (3) – contour cell blisters (4) – cardboard packs.
10 ml – light-protective glass ampoules (3) – contour cell blisters (5) – cardboard packs.
10 ml – light-protective glass ampoules (5) – contour cell blisters (1) – cardboard packs.
10 ml – light-protective glass ampoules (5) – contour cell blisters (2) – cardboard packs.
10 ml – light-protective glass ampoules (5) – contour cell blisters (4) – cardboard packs.
10 ml – light-protective glass ampoules (5) – contour cell blisters (5) – cardboard packs.
10 ml – light-protective glass ampoules (3) – cardboard packs with corrugated insert.
10 ml – light-protective glass ampoules (5) – cardboard packs with corrugated insert.
10 ml – light-protective glass ampoules (6) – cardboard packs with corrugated insert.
10 ml – light-protective glass ampoules (10) – cardboard packs with corrugated insert.

Thioctic acid Velpharm [Velpharm-M, LLC (Russia)]
Film-coated tablets 300 mg
Film-coated tablets, 600 mg

Marketing Authorization Holder

Velpharm-M, LLC (Russia)

Manufactured By

Velpharm, LLC (Russia)

Velpharm-M, LLC (Russia)

Dosage Forms

	Thioctic acid Velpharm	Film-coated tablets 300 mg
		Film-coated tablets, 600 mg

Dosage Form, Packaging, and Composition

Film-coated tablets

	1 tab.
Thioctic (α-lipoic) acid	300 mg

10 pcs. – jars – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell blisters – cardboard packs (10 pcs.) – Prescription only
10 pcs. – contour cell blisters (10 pcs.) – cardboard packs (100 pcs.) – Prescription only
10 pcs. – contour cell blisters (11 pcs.) – cardboard packs (110 pcs.) – Prescription only
10 pcs. – contour cell blisters (12 pcs.) – cardboard packs (120 pcs.) – Prescription only
10 pcs. – contour cell blisters (2 pcs.) – cardboard packs (20 pcs.) – Prescription only
10 pcs. – contour cell blisters (3 pcs.) – cardboard packs (30 pcs.) – Prescription only
10 pcs. – contour cell blisters (5 pcs.) – cardboard packs (50 pcs.) – Prescription only
10 pcs. – contour cell blisters (6 pcs.) – cardboard packs (60 pcs.) – Prescription only
10 pcs. – contour cell blisters (7 pcs.) – cardboard packs (70 pcs.) – Prescription only
10 pcs. – contour cell blisters (8 pcs.) – cardboard packs (80 pcs.) – Prescription only
10 pcs. – contour cell blisters (9 pcs.) – cardboard packs (90 pcs.) – Prescription only
100 pcs. – jars – cardboard packs (100 pcs.) – Prescription only
110 pcs. – jars – cardboard packs (110 pcs.) – Prescription only
120 pcs. – jars – cardboard packs (120 pcs.) – Prescription only
20 pcs. – jars – cardboard packs (20 pcs.) – Prescription only
28 pcs. – jars – cardboard packs (28 pcs.) – Prescription only
30 pcs. – jars – cardboard packs (30 pcs.) – Prescription only
40 pcs. – jars – cardboard packs (40 pcs.) – Prescription only
50 pcs. – jars – cardboard packs (50 pcs.) – Prescription only
60 pcs. – jars – cardboard packs (60 pcs.) – Prescription only
70 pcs. – jars – cardboard packs (70 pcs.) – Prescription only
80 pcs. – jars – cardboard packs (80 pcs.) – Prescription only
90 pcs. – jars – cardboard packs (90 pcs.) – Prescription only

Film-coated tablets

	1 tab.
Thioctic (α-lipoic) acid	600 mg

Thioctic acid-Binergy [Binergia JSC (Russia)]
Concentrate for solution for infusion 30 mg/1 ml: amp. 10 ml or 20 ml 5 or 10 pcs.

Marketing Authorization Holder

Binergia JSC (Russia)

Manufactured By

Armavir Biopharmaceutical Plant, FSE (Russia)

Dosage Form

Thioctic acid-Binergy

Concentrate for solution for infusion 30 mg/1 ml: amp. 10 ml or 20 ml 5 or 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion as a clear greenish-yellow solution.

	1 ml
Meglumine thioctate* (in terms of thioctic acid)	58.4 mg (30 mg)

* meglumine thioctate* is formed as a result of the interaction of 30 mg of thioctic acid (α-lipoic acid) and 28.4 mg of meglumine.

Excipients: macrogol 400 – 200 mg, meglumine – from 1.1 to 2.9 mg (to pH 8.2-8.5), water for injections – up to 1 ml.

10 ml – dark glass ampoules (5) – contour plastic packs (1) – cardboard packs.
10 ml – dark glass ampoules (5) – contour plastic packs (2) – cardboard packs.
20 ml – dark glass ampoules (5) – contour plastic packs (1) – cardboard packs.
20 ml – dark glass ampoules (5) – contour plastic packs (2) – cardboard packs.

Thioctic acid-SZ [Severnaya Zvezda NAO (Russia)]
Concentrate for solution for infusion 30 mg/1 ml: amp. 10 ml 10 pcs.

Marketing Authorization Holder

Severnaya Zvezda NAO (Russia)

Dosage Form

Thioctic acid-SZ

Concentrate for solution for infusion 30 mg/1 ml: amp. 10 ml 10 pcs.

Dosage Form, Packaging, and Composition

Concentrate for solution for infusion as a clear or slightly opalescent yellow or greenish-yellow liquid.

	1 ml	1 amp.
Thioctic acid (as trometamol thioctate)	30 mg	300 mg

Excipients: trometamol, water for injections.

10 ml – dark glass ampoules (5) – contour cell blisters (2) – cardboard packs.

Thioctic acid-Vertex [Vertex, JSC (Russia)]
Film-coated tablets 600 mg: 14, 28, 30, 60, or 100 pcs.

Marketing Authorization Holder

Vertex, JSC (Russia)

Dosage Form

Thioctic acid-Vertex

Film-coated tablets 600 mg: 14, 28, 30, 60, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets from light yellow with a brownish tint to yellow, oblong, biconvex; the core on the cross-section is light yellow with white and yellow inclusions.

	1 tab.
Thioctic (α-lipoic) acid	600 mg

Excipients: lactose monohydrate – 212 mg, low-substituted hydroxypropyl cellulose – 110 mg, microcrystalline cellulose 102 – 90 mg, colloidal silicon dioxide – 33 mg, magnesium stearate – 33 mg, hydroxypropyl cellulose – 22 mg.

Film coating composition[hypromellose – 20 mg, hydroxypropyl cellulose – 7.76 mg, talc – 7.704 mg, titanium dioxide – 4.348 mg, iron oxide yellow dye (iron oxide) – 0.188 mg] or [dry mix for film coating, containing hypromellose (50%), hydroxypropyl cellulose (19.4%), talc (19.26%) titanium dioxide (10.87%), iron oxide yellow dye (iron oxide (0.47%)] – 40 mg.

7 pcs. – contour cell blisters (2) – cardboard packs.
7 pcs. – contour cell blisters (4) – cardboard packs.
10 pcs. – contour cell blisters (6) – cardboard packs.
10 pcs. – contour cell blisters (3) – cardboard packs.
30 pcs. – high-density polyethylene jars (1) – cardboard packs.
100 pcs. – high-density polyethylene jars (1) – cardboard packs.

Thioctic acid-Vial [Vial, LLC (Russia)]
Film-coated tablets 300 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
Film-coated tablets, 600 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Marketing Authorization Holder

Vial, LLC (Russia)

Manufactured By

YUGPHARM, LLC (Russia)

Dosage Forms

	Thioctic acid-Vial	Film-coated tablets 300 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.
		Film-coated tablets, 600 mg: 10, 20, 30, 40, 50, 60, 70, 80, 90, or 100 pcs.

Dosage Form, Packaging, and Composition

Film-coated tablets pale yellow, round, biconvex, with a score on one side, slight surface roughness is allowed; the fracture shows a core from light yellow to light yellow with a brownish tint, the presence of white and almost white inclusions along with darker inclusions is allowed.

	1 tab.
Thioctic acid	300 mg

Excipients: microcrystalline cellulose – 165 mg, lactose monohydrate – 60 mg, croscarmellose sodium – 24 mg, povidone K-25 – 21 mg, colloidal silicon dioxide – 18 mg, magnesium stearate – 12 mg.

Coating composition Opadry OY-S-22898 yellow (hypromellose – 6.597 mg, titanium dioxide – 3.9134 mg, sodium lauryl sulfate – 0.7096 mg, liquid paraffin – 0.676 mg, quinoline yellow dye – 0.075 mg, sunset yellow FCF dye – 0.029 mg) – 12 mg, liquid paraffin – 3 mg.

10 pcs. – blisters (1) – cardboard packs.
10 pcs. – blisters (2) – cardboard packs.
10 pcs. – blisters (3) – cardboard packs.
10 pcs. – blisters (4) – cardboard packs.
10 pcs. – blisters (5) – cardboard packs.
10 pcs. – blisters (6) – cardboard packs.
10 pcs. – blisters (7) – cardboard packs.
10 pcs. – blisters (8) – cardboard packs.
10 pcs. – blisters (9) – cardboard packs.
10 pcs. – blisters (10) – cardboard packs.
30 pcs. – jars (1) – cardboard packs.

Film-coated tablets pale yellow, oval, biconvex, with a score on one side, slight surface roughness is allowed; the fracture shows a core from light yellow to light yellow with a brownish tint, the presence of white and almost white inclusions along with darker inclusions is allowed.

	1 tab.
Thioctic acid	600 mg

Excipients: microcrystalline cellulose – 330 mg, lactose monohydrate – 120 mg, croscarmellose sodium – 48 mg, povidone K-25 – 42 mg, colloidal silicon dioxide – 36 mg, magnesium stearate – 24 mg.

Shell composition Opadry OY-S-22898 yellow (hypromellose – 13.194 mg, titanium dioxide – 7.8268 mg, sodium lauryl sulfate – 1.4192 mg, liquid paraffin – 1.352 mg, quinoline yellow dye – 0.15 mg, sunset yellow FCF dye – 0.058 mg) – 24 mg, liquid paraffin – 6 mg.

10 pcs. – blisters (1) – carton packs.
10 pcs. – blisters (2) – carton packs.
10 pcs. – blisters (3) – carton packs.
10 pcs. – blisters (4) – carton packs.
10 pcs. – blisters (5) – carton packs.
10 pcs. – blisters (6) – carton packs.
10 pcs. – blisters (7) – carton packs.
10 pcs. – blisters (8) – carton packs.
10 pcs. – blisters (9) – carton packs.
10 pcs. – blisters (10) – carton packs.
30 pcs. – jars (1) – carton packs.

Medixlife (Author)

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