Thiogamma infusion solution 12mg/ml vial 50ml, 10pcs

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 B vitamins.

Participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, 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

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 Tiogamma.
• Pregnancy the period of breastfeeding.
• Children’s age (efficacy and safety of use have not been established).

Side effects

After intravenous use, convulsions are very rarely possible; diplopia; spot hemorrhages in the mucous membranes, skin; thrombocytopenia, hemorrhagic rash (purpura), thrombophlebitis; with rapid use, an increase in intracranial pressure (the appearance of a feeling of heaviness in the head); difficulty breathing. The listed side effects go away on their own.

Possible allergic reactions: urticaria, systemic allergic reactions (up to the development of anaphylactic shock). Hypoglycemia may occur (due to improved glucose uptake).

Composition

In vitro interaction thioctic acid reacts with metal ionic complexes (for example, with cisplatin), so the simultaneous use of Thiogamma (infusion solution) may reduce the effect of cisplatin. Thioctic acid forms poorly soluble complex compounds with sugar molecules.

Consequently, the infusion solution of thioctic acid is incompatible with dextrose solution, Ringer’s solution and with solutions that can react with SH-group compounds or have disulfide bonds. When used concomitantly, Thiogamma enhances the effect of insulin and oral hypoglycemic agents. Alcohol (ethanol) reduces the therapeutic activity of thioctic acid.

How to take, course of use and dosage

The drug Tiogamma is 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).

When using the solution for infusions in vials, Thiogamma infusions are made directly from these vials, which are placed in the attached suspended light-proof cases made of black polyethylene.

Overdose

Symptoms: nausea, vomiting, headache.

Treatment is symptomatic. There is no specific antidote.

Special instructions

Patients taking Tiogamma should refrain from drinking alcohol. In patients with diabetes mellitus, constant monitoring of blood glucose concentration is necessary, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or an oral hypoglycemic drug to avoid the development of hypoglycemia.

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 2 Diabetes, Type 1 Diabetes, Alcoholism