Thiogamma - instructions for use, dose, side effects, contraindications

Excipients: 25.00 mg Hypromellose, colloidal silicon dioxide 25.00 mg Microcrystalline cellulose 49.00 mg Lactose monohydrate 49.00 mg, 16.00 mg carmellose sodium, Talc 36.364 mg, 3.636 mg Simethicone (dimethicone and silicon dioxide colloidal 94: 6), magnesium stearate 16.00 mg; shell: macrogol 6000 - 0.60 mg, hypromellose 2.80 mg, talc 2.00 mg, sodium lauryl sulfate 0.025 mg.

Description:

Oblong, biconcave tablets, film-coated shell, with a smooth and slightly shiny surface, with one separation risk on both sides, yellow with possible blotches of white and dark yellow color.

Pharmacotherapeutic group:metabolic

ATX: & nbsp

A.16.A.X.01 Thioctic acid

Pharmacodynamics:

Thioctic acid is an endogenous antioxidant (binds free radicals).

In the body formed with oxidative decarboxylation of alpha-ketoxylot.

As a coenzyme mitochondrial multienzyme complexes is involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Helps reduce blood glucose and glycogen in the liver, as well as reduce insulin resistance.

Participates in the regulation of lipid and carbohydrate metabolism, affects the exchange of cholesterol, improves liver function, has a detoxification effect in poisoning with salts of heavy metals and other intoxications. Has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic action. Improves trophic neurons.

With diabetes mellitus thioctic acid reduces the formation of final glycation products, improves endoneural blood flow,increases the content of glutathione to a physiological value, which as a result leads to an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.

Pharmacokinetics:

When ingested quickly and completely absorbed in the gastrointestinal tract, simultaneous intake with food reduces absorption. Bioavailability - 30-60% due to the effect of "first passage" through the liver. The time to reach the maximum concentration (4 μg / ml) is about 30 minutes. Metabolized in the liver by side chain oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in a small amount - in unchanged form. Elimination half-life 25 min.

Indications:

Diabetic polyneuropathy and alcoholic polyneuropathy.

Contraindications:

Hypersensitivity to thiectic acid or other components of the drug. Children under 18 years.

Hereditary intolerance to galactose, deficiency of lactase or glucose-galactose malabsorption.

Pregnancy and the period of breastfeeding. (See section "Application during pregnancy and in the triode of breastfeeding".

- Before taking the drug, always consult a doctor.

Pregnancy and lactation:

The use of the preparation Thiogamma during pregnancy and during lactation is contraindicated. (See section "Contraindications").

Dosing and Administration:

Assign inside 600 mg (1 tablet) of Thiogamma ® once a day. Tablets are taken on an empty stomach, without chewing, with a small amount of liquid. Duration of treatment is 30 - 60 days, depending on the severity of the disease. It is possible to repeat the course of treatment 2-3 times a year.

Side effects:

The incidence of adverse adverse reactions is given in accordance with the WHO classification:

Often - more than 1 in 10 treated

Often - less than 1 in 10, but more than 1 in 100 treated

On occasion - less than 1 in 100, but more than 1 in 1,000 treated

Rarely less than 1 in 1000, but more than 1 in 10,000 undergoing treatment

Rarely - less than 1 in 10,000, including individual cases

Very rarely (<1/10000) the following side effects develop:

From the gastrointestinal tract (GIT): nausea, vomiting, abdominal pain, diarrhea;

Hypersensitivity reactions:

allergic reactions (up to the development of anaphylactic shock), skin rash, hives, itching;

From the central nervous system SNS): a change or violation of taste sensations;

Other side effects:

in connection with the improvement of glucose assimilation, it is possible to reduce the concentration of glucose in the blood. This may cause symptoms of hypoglycemia - dizziness, increased sweating, headache, vision disorders.

- If any of the side effects listed in the manual are aggravated, or if you notice any other side effects not indicated in the instructions, tell your doctor.

Overdose:

Symptoms: nausea, vomiting, headache.

In the case of taking doses of 10 to 40 grams of thioctic acid in combination with alcohol, there were cases of intoxication, up to a lethal outcome.

Symptoms of acute overdose: psychomotor agitation or confusion of the mind, usually with the subsequent development of generalized seizures and the formation of lactic acidosis. Also described are cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation,depression of bone marrow and multi-organ failure.

Treatment is symptomatic. There is no specific antidote.

Interaction:

Thioctic acid enhances the anti-inflammatory effect of glucocorticosteroid agents. With the simultaneous administration of thioctic acid and cisplatin, cisplatin is less effective.

Thioctic acid binds metals, so it should not be prescribed simultaneously with preparations containing metals (for example, preparations of iron, magnesium, calcium) - the interval between doses should be at least 2 hours.

With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced.

Ethanol and its metabolites weaken the action of thioctic acid.

- In case you are already taking other drugs or are going to take them

Before taking Tiogamma ®, always consult a doctor.

Special instructions:

Patients with rare hereditary intolerance to fructose, glucose-galactose malabsorption syndrome, or glucose-isomalt-deficiency should not take Thiogamma.

Patients with diabetes 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 in order to avoid the development of hypoglycemia.

Patients taking the drug Tiogamma® should refrain from drinking alcohol. Alcohol consumption during therapy with Thiogamma® reduces

therapeutic effect and is a risk factor that contributes to the development and progression of neuropathy.

1 tablet coated with Tiogamma® 600 mg contains less than 0.0041 units of bread.

Influence on the ability to drive vehicles and work with mechanisms:

Reception of Thiogamma® does not affect the ability to drive vehicles and work with other mechanisms.

Form release / dosage:

Tablets coated with 600 mg.

Packaging:For 10 tablets, coated in a blister of PVC / PVDC / aluminum foil.

For 3.6 or 10 blisters together with instructions for use in a cardboard bundle.

Storage conditions:

Store in a dry place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

5 years.

Do not use after the expiration date indicated on the package.

Terms of leave from pharmacies:On prescription

Registration number:П N011140 / 01

Date of registration:24.05.2010

The owner of the registration certificate:Wörwag Pharma GmbH & Co. KG. KGWörwag Pharma GmbH & Co. KG. KG Germany

Manufacturer: & nbsp

ARTESAN PHARMA, GmbH & Co. KG. KG Germany

Representation: & nbspVEVWAG PHARMA GmbH & Co. KG VEVWAG PHARMA GmbH & Co. KG Germany

Information update date: & nbsp07.09.2015

Illustrated instructions

Instructions

Tiogamma® (Thiogamma® )