Thiogamma® Turbo (Lipoic Acid/Thioctic Acid) 12 mg/ml solution for injection (10 bottles x 50 ml)

Structure

50 ml of solution contains the active substance - thioctic acid meglumine salt - 1167.70 mg (equivalent to 600 mg of thioctic acid),
auxiliary substances: meglumine 5.0 - 25.0 mg, macrogol 300 - 4000.0 mg, water for injection 45557.3 - 45577.3 mg.

Indications for use

- peripheral (sensory-motor) diabetic polyneuropathy

Method of administration and dosage

The daily dose is 1 bottle of Tiogamma® Turbo (600 mg / day) for 2-4 weeks daily, intravenously, drip, in the initial phase of treatment.

The drug should be administered slowly, over at least 30 minutes, not more than 50 mg per minute (equivalent to 1.7 ml of solution for infusion).

The maximum daily dose is 600 mg.

Thiogamma® Turbo infusions are made directly from vials using the included light-shielding pendant cases. The vial with the preparation is taken out of the box just before use and immediately covered with the supplied light-protective case, since thioctic acid is sensitive to light.

Further treatment should include 600 mg of thioctic acid daily as an oral tablet.

 

Side effects

allergic skin reactions in the form of urticaria, itching, eczema, skin rash

systemic allergic reactions, up to the development of anaphylactic shock

hives or eczema at the injection site

hemorrhagic rash (purpura), thrombophlebitis

hypoglycemic symptoms (dizziness, sweating, headache and visual disturbances) due to low blood sugar

increased intracranial pressure and dyspnea with rapid intravenous administration

nausea, vomiting, abdominal pain, diarrhea

Rarely

changes or disturbances in taste

 

Contraindications

- hypersensitivity to drug components
- stomach ulcer, hyperacid gastritis
- decompensated form of diabetes mellitus
- pregnancy, lactation period
- children and adolescents up to 18 years old

Drug interactions

A decrease in the effectiveness of cisplatin was noted when administered simultaneously with Tiogamma® Turbo. The drug should not be administered concurrently with iron, magnesium, potassium preparations, the time interval between taking these drugs should be at least 5 hours.

Since the hypoglycemic effect of insulin or oral antidiabetic agents may increase, regular monitoring of blood sugar is recommended, especially at the beginning of Thiogammma® Turbo therapy.

To avoid symptoms of hypoglycemia, blood glucose levels must be carefully monitored.

Thioctic (alpha-lipoic) acid forms poorly soluble complex compounds with sugar molecules (for example, a solution of levulose). Thiogamma® Turbo is incompatible with glucose solution, Ringer's solution and solutions that react with SH-groups or disulfide bridges.

When Tiogamma® Turbo is administered as an infusion, if necessary, only physiological saline solution should be used as the primary vehicle.

Special instructions

During treatment with the drug, the use of alcohol is contraindicated. Alcohol consumption during therapy with Thiogamma-Turbo reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy.

In isolated cases, patients with decompensated and adequately uncontrolled diabetes, as well as in the presence of a pronounced general poor state of health, may develop serious anaphylactic reactions associated with the use of Thiogamma® Turbo.

Patients with diabetes mellitus require constant monitoring of blood glucose concentration, 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. If symptoms of hypoglycemia occur (dizziness, increased sweating, headache, visual disturbances, nausea), therapy should be stopped immediately.

Pregnancy and lactation

Pregnant and lactating women can only undergo treatment with thioctic acid if the doctor determines that the need for treatment is strictly vital.

Features of the influence of the drug on the ability to drive a vehicle and potentially dangerous mechanisms

Care should be taken when driving vehicles and potentially dangerous machinery.

Overdose

Symptoms in case of probable intoxication with Tiogamma® Turbo (more than 6000 mg in an adult or more than 50 mg per kilogram of weight in a child): generalized convulsive seizures, blurred consciousness, severe acid-base balance disorders leading to lactic acidosis, severe blood clotting disorders.

Treatment: Treatment of generalized seizures, lactic acidosis and other life-threatening consequences should be carried out in accordance with the principles of modern intensive care, according to the symptoms. Benefits of using hemodialysis, hemoperfusion, or filtration as a method of forced eradication thioctic acid have not been conclusively proven.

Release form and packaging

50 ml each is poured into vials of type II brown hydrolytic glass, sealed with a pink bromobutyl rubber stopper, rolled up with an aluminum cap and a polypropylene ring.

1 bottle or 10 bottles with hanging light-protective cases according to the number of bottles made of black polyethylene, together with instructions for medical use in the state and Russian languages, are placed in cardboard boxes with cardboard partitions.

Storage conditions

Store at a temperature not exceeding 25 ° C.
Protect from light.
Keep out of the reach of children!

Shelf life 5 years
Do not use after the expiration date.