Thiogamma tab n / 600mg film about 60 pc

Description

Composition
Active substance:
Thioctic acid – 600 mg ;.
Excipients:
25.00 mg of Hypromellose, colloidal silicon dioxide 25.00 mg Microcrystalline cellulose 49.00 mg Lactose monohydrate 49.00 mg Croscarmellose sodium 16.00 mg Talc 36.364 mg, 3.636 mg Simethicone (dimethicone and silicon dioxide colloidal 94: 6) magnesium stearate 16.00 mg; sheath: Macrogol 6000 – 0.60 mg, 2.80 mg of hypromellose, 2.00 mg of talc, sodium lauryl sulfate 0,025 mg.
Description:
Oblong, biconvex film-coated membrane shell, with a smooth and slightly shiny surface with a break line on both sides, yellow with possible patches of white and dark yellow color.
Product form:
Tablets, coated membrane sheath 600 mg.
10 tablets are coated with a foil wrapper in a blister made of PVC / PVDC / Aluminum foil. At 3, 6 or 10 blisters together with instructions for use in a cardboard package.
Contraindications
Hypersensitivity to thioctic acid or other ingredients.
Children up to age 18 years.
Hereditary galactose intolerance, lactase deficiency or glucose-galactose malabsorption.
Pregnancy and breast-feeding. (See. Section “Pregnancy and lactation”.
Before taking this medication, you should consult with your doctor.
Dosage
600 mg
Indications
Diabetic polyneuropathy and alcoholic polyneuropathy.
Interaction with other drugs
Thioctic acid increases glucocorticosteroid antiinflammatory action means. When concomitant administration of cisplatin and thioctic acid is decreasing effectiveness of cisplatin.
Thioctic acid binds the metals, so it should not be administered concurrently with preparations containing metals (e.g., iron preparations, magnesium, calcium) – interval between doses should be at least 2 hours.
With simultaneous application thioctic acid and insulin or oral hypoglycemic agents their effect can be enhanced.
Ethanol and its metabolites weaken the effect of thioctic acid. • If you are already taking other medicines or are going to take them, before taking Tiogamma® medication should consult a physician.
Overdose
Symptoms include nausea, vomiting, headache.
In case of receiving doses of 10 to 40 g of thioctic acid in combination with alcohol intoxication cases were observed until death.
Symptoms of acute overdose: psychomotor agitation or dizziness, as a rule, with the subsequent development of generalized seizures, and the formation of lactic acidosis. cases of hypoglycaemia have also been described, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation, bone marrow depression, and multiorgan failure.
Treatment is symptomatic. No specific antidote.
pharmachologic effect
Pharmacological group:
Metabolic means.
Pharmacodynamics:
Thioctic acid – endogenous antioxidant (binds free radicals).
The body is formed by oxidative decarboxylation of alpha-keto acids.
As coenzyme mitochondrial multienzyme complexes involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Thereby reducing the concentration of glucose in blood and increasing in liver glycogen, and reduce insulin resistance.
Participates in the regulation of lipid and carbohydrate metabolism, influences the metabolism of cholesterol, improves liver function has a detoxication effect for poisoning by heavy metal salts and other intoxications. It has hepatoprotective, lipid-lowering, cholesterol-lowering, hypoglycemic effect. Improves trophic neurons.
In diabetes thioctic acid reduces the formation of advanced glycation end products, improves endoneurial blood flow, increases glutathione levels to physiological values ​​that results in the improvement of the functional status of peripheral nerve fibers in diabetic polyneuropathy.
Pharmacokinetics:
When ingestion rapidly and completely absorbed in the gastrointestinal tract, concomitant use with food reduces the absorption. Bioavailability – 30-60% due to the effect of “first pass” through the liver. The time to reach maximum concentration (4 mcg / ml) – 30 min. It is metabolized in the liver by the oxidation of side chain conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in small quantities – unchanged. The half-life of 25 min.
Pregnancy and breast-feeding
Use of the drug Tiogamma® during pregnancy and lactation is contraindicated. (See. See “Contraindications”).
Conditions of supply of pharmacies
On prescription.
side effects
The incidence of adverse reactions is given in accordance with the WHO classifications:
Very often, more than 1 out of 10 treated
Often less than 1 out of 10, but more than 1 out of 100 treated
In the case of less than 1 in 100, but more than 1 out of 1000 treated
Rarely less than 1 in 1,000, but more than 1 in 10,000 treated
Very rarely, in less than 1 in 10,000, including isolated cases
It is not known can not be established from the available data
Very rarely (
Disorders of the gastrointestinal tract (GIT): nausea, vomiting, abdominal pain, diarrhea.
Disorders of immune system: allergic reactions (up to the development of anaphylactic shock), skin rash, hives, itching; Insulin autoimmune syndrome (AIS) AIS clinical manifestations may include: dizziness, sweating, muscle tremors, heart palpitations, nausea, headache, confusion, impaired vision, loss of consciousness, coma.
Disorders of the nervous system: change or impaired sense of taste.
Violations by the Metabolism and nutrition: the improvement in glucose uptake may reduce the concentration of glucose in the blood. In this case, you may experience symptoms of hypoglycemia – dizziness, sweating, headache, visual disturbances.
Frequency not known (can not be established from the available data):
Violations of the skin and subcutaneous covers eczema.
If any of these instructions side effects are compounded, or if you notice any other side effects not mentioned in the instructions, tell your doctor.
special instructions
Patients with rare hereditary fructose intolerance, glucose-galactose malabsorption syndrome, or glucose-izomaltoznym deficiency should not take the drug Tiogamma®.
In patients with diabetes requires 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 oral hypoglycemic agents, in order to avoid hypoglycemia.
With the development of hypoglycemia should immediately stop taking the drug Tiogamma®.
When the hypersensitivity symptoms should immediately stop taking the drug Tiogamma®.
Patients taking the drug Tiogamma®, should refrain from drinking alcohol. The consumption of alcohol during therapy with Tiogamma® reduces the therapeutic effect and is a risk factor for the development and progression of neuropathy. 1 coated tablet shell membrane preparation Tiogamma® 600 mg Corn contains less than 0.0041 units.
There are cases of autoimmune insulin syndrome (AIS) during treatment with thioctic acid. The possibility of AIS is defined by the presence of patients alleles HLA-DRB1 * 04: 06 and HLA-DRB1 * 04: 03.
Effects on ability to drive vehicles and operate machinery:
Tiogamma® the drug does not affect the ability to drive vehicles and work with other mechanisms.
Storage conditions
Stored in a dry place at a temperature not exceeding 25 ° C. Keep out of reach of children.
Dosing and Administration
Assign inside of 600 mg (1 tablet) formulation Tiogamma® 1 time per day. Tablets are taken on an empty stomach, not liquid, squeezed small amounts of liquid.
The duration of treatment is 30 – 60 days depending on the severity of the disease. Possible repetition of the course of treatment 2-3 times a year.
Information
Appearance may differ from that depicted in the picture. There are contraindications. You need to read the manual or consult with a specialist