Thiogamma infusion solution 12mg/ml vial, 50ml

Composition

1 bottle of 50 ml infusion solution contains:  

Active ingredient:

megluminic salt of thioctic acid – 1167.7 mg (equivalent to 600 mg of thioctic acid);

excipients:

meglumin,

macrogol 300,

water for injection.

Pharmacological action

Thiogamma has hepatoprotective, hypoglycemic, detoxifying, hypolipidemic, hypocholesterolemic effects.

Thioctic acid (alpha-lipoic acid ) is an endogenous antioxidant (binds free radicals), formed in the body during oxidative decarboxylation of alpha-ketoxylot. As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids.

It helps to reduce the concentration of glucose in the blood and increase glycogen in the liver, as well as to overcome insulin resistance. By the nature of its biochemical action, it is close to vitamins of group B. It participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function.

It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects. Improves neuron trophism. The use of meglumin salt of thioctic acid in solutions for intravenous use (which has a neutral reaction) reduces the severity of adverse reactions.

Pharmacokinetics

When taken orally, it is rapidly and completely absorbed from the gastrointestinal tract (ingestion with food reduces absorption). The time to reach the maximum concentration is 40-60 minutes. Bioavailability – 30%.

It has a “first pass” effect through the liver. The formation of metabolites occurs as a result of side chain 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 elimination half-life is 20-50 minutes. Total plasma clearance is 10-15 ml/min.

With intravenous use, the time to reach the maximum concentration is 10-11 minutes, the maximum concentration is 25-38 mcg / ml. The area under the concentration – time curve is about 5 µg h / ml.

Indications

Diabetic polyneuropathy, alcoholic polyneuropathy.

Use during pregnancy and lactation

The drug Tiogamma is contraindicated for use during pregnancy. If it is necessary to use the drug during lactation, stop breastfeeding.

No teratogenic effect of thioctic acid was detected in experimental studies on animals. Similar studies in humans have not been conducted.

There are no data on the excretion of thioctic acid in breast milk.

Contraindications

-hypersensitivity to the components of the drug – – pregnancy; – breast-feeding period. There are no clinical data on the use of Thiogamma in children, so the drug should not be prescribed to children.

Side effects

From the central nervous system:  rarely (after intravenous use of the drug) – convulsions, diplopia; with rapid use-increased intracranial pressure.

From the side of the blood coagulation system:  after intravenous use of the drug – hemorrhagic rash, thrombophlebitis, spot hemorrhages in the mucous membranes and skin.

Allergic reactions:  urticaria, systemic reactions (up to anaphylactic shock).

Other services:  hypoglycemia may develop (due to improved glucose uptake); after rapid intravenous use – difficulty breathing (passes on its own).

Interaction

When combined with Thiogamma in the form of a solution for injection reduces the effectiveness of cisplatin.

When used concomitantly, Thiogamma enhances the effect of insulin and oral hypoglycemic agents.

When taken concomitantly with ethanol, the therapeutic efficacy of thioctic acid may decrease.

Pharmaceutical interaction

In vitro thioctic acid reacts with complex metal ions (for example, cisplatin), and also forms moderately soluble complex compounds with sugar molecules. Consequently, the infusion solution is incompatible with glucose solution, Ringer’s solution, and with solutions that can react with SH groups or disulfide bridges.

How to take, course of use and dosage

The drug is also administered intravenously at a dose of 600 mg per day (1 ampoule of concentrate for preparing an infusion solution of 30 mg / ml or 1 bottle of infusion solution of 12 mg / ml).

At the beginning of the course, the drug is administered intravenously for 2-4 weeks. Then you can continue taking the drug inside at a dose of 300-600 mg per day.

The drug should be administered slowly, i. e. in no more than 50 mg of thioctic acid per 1 minute (which is equivalent to 1.7 ml of concentrate for preparing an infusion solution of 30 mg / ml).

Overdose

Symptoms:  nausea, vomiting, headache.

Treatment:  conduct symptomatic therapy. There is no specific antidote.

Special instructions

Patients taking Tiogamma should refrain from drinking alcohol.

During treatment with Tiogamma, especially at the beginning of therapy, it is necessary to monitor blood glucose levels.

In some cases, it may be necessary to adjust the dose of hypoglycemic drugs.

Form of production

Solution for infusions

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

5 years

Active ingredient

Thioctic acid

Conditions of release from pharmacies

By prescription

Dosage form

solution for infusions

Description

For adults as directed by your doctor

Indications

Type 1 Diabetes, Type 2 Diabetes, Polyneuropathy, Alcoholism