Thiogamma coated pills 600mg N30
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Active ingredients
Thioctic acid
Release form
Pills
Composition
1 tab. thioctic acid 600 mg. Excipients: hypromellose - 25 mg, colloidal silicon dioxide - 25 mg, microcrystalline cellulose - 49 mg, lactose monohydrate - 49 mg, carmellose sodium - 16 mg, talc - 36.
Pharmacological effect
Metabolic drug. Thioctic (α-lipoic) acid is an endogenous antioxidant (binds free radicals), is synthesized in the body during the oxidative decarboxylation of alpha keto acids. As a coenzyme, mitochondrial multienzyme complexes are involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. It helps to reduce the concentration of glucose in the blood and increase the glycogen content in the liver, as well as to overcome insulin resistance. It participates in the regulation of lipid and carbohydrate metabolism, affects cholesterol metabolism, improves liver function, and has a detoxification effect in case of poisoning with heavy metal salts and other intoxications. It has a hepatoprotective, hypolipidemic, hypocholesterolemic and hypoglycemic effect. Improves trophism of neurons. In diabetes mellitus, thioctic acid improves endoneural blood flow, increases glutathione content to a physiological value, which results in an improvement in the functional state of peripheral nerve fibers in diabetic polyneuropathy.
Pharmacokinetics
Absorption: After oral administration, thioctic acid is rapidly and almost completely absorbed from the gastrointestinal tract. When taken with food absorption decreases. The time to reach Cmax (4 mcg / ml) is about 30 minutes. Bioavailability - 30-60% due to the effect of "first pass" through the liver. Metabolism: Metabolized in the liver by side chain oxidation and conjugation. Excretion: Thioctic acid and its metabolites are excreted by the kidneys (80-90%), in a small amount - in unchanged form. T1 / 2 is 25 minutes.
Indications
- diabetic polyneuropathy - alcoholic polyneuropathy.
Contraindications
- pregnancy - lactation period (breastfeeding) - children under 18 years of age - hereditary intolerance to galactose, lactase deficiency or glucose-galactose malabsorption - hypersensitivity to thioctic acid or other components of the drug.
Use during pregnancy and lactation
The use of the drug Tiogamma is contraindicated during pregnancy and lactation (breastfeeding).
Dosage and administration
Assign inside 600 mg (1 tab.) 1 time / day. Tablets are taken on an empty stomach, without chewing, with a small amount of liquid. The duration of treatment is 30-60 days, depending on the severity of the disease. Possible repetition of treatment 2-3 times a year.
Side effects
The incidence of adverse reactions is given in accordance with the WHO classification: Very often, more than 1 in 10 undergoing treatment. Often less than 1 in 10, but more than 1 in 100 undergoing treatment. Not often less than 1 in 100, but more than. 1 in 1000 undergoing treatment Rarely less than 1 in 1000, but more than 1 in 10 000 undergoing treatment. Very rarely less than 1 in 10,000, including isolated cases. Very rarely (less than 1 / 10,000) the following side effects develop: On the part of the digestive system: nausea, vomiting, abdominal pain, diarrhea i. Allergic reactions: systemic reactions (up to the development of anaphylactic shock), skin rash, urticaria, itching. From the side of the central nervous system: a change or a violation of taste. On the part of the endocrine system: due to improved glucose uptake, a decrease in blood glucose concentration is possible. This may cause symptoms of hypoglycemia - dizziness, increased sweating, headache, visual disturbances.
Overdose
Symptoms: nausea, vomiting, headache. In the case of receiving from 10 to 40 g of thioctic acid in combination with alcohol, there were cases of intoxication, even death. Symptoms of acute overdose: psychomotor agitation or stupefaction, as a rule, with the subsequent development of generalized seizures and the formation of lactic acidosis. It also describes cases of hypoglycemia, shock, rhabdomyolysis, hemolysis, disseminated intravascular coagulation of blood, bone marrow suppression and multiorgan failure. Treatment: conduct symptomatic therapy. There is no specific antidote.
Interaction with other drugs
Thioctic acid enhances the anti-inflammatory effect of SCS. With the simultaneous appointment of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin. Thioctic acid binds metals, so it should not be prescribed simultaneously with drugs containing metals (for example, iron, magnesium, calcium) - the interval between doses should be at least 2 hours. While using thioctic acid and insulin or oral hypoglycemic drugs, their action may increase. Ethanol and its metabolites weaken the action of thioctic acid.
special instructions
Patients with rare hereditary fructose intolerance, glucose / galactose malabsorption syndrome, or glucose isomaltase deficiency should not take the drug Thiogamma. Patients with diabetes mellitus during the period of treatment with the drug Tiogamma, especially at the beginning of therapy, it is necessary to monitor the level of glucose in the blood. In some cases, it may be necessary to adjust the dose of insulin or oral hypoglycemic drug in order to avoid the development of hypoglycemia. Patients taking the drug Thiogamma, should refrain from alcohol. Alcohol consumption during treatment with Thiogamma reduces the therapeutic effect and is a risk factor contributing to the development and progression of neuropathy. 1 tablet of Thiogamma 600 mg contains less than 0.0041 XE. Influence on the ability to drive vehicles and control mechanisms The admission of the drug Tiogamma does not affect the ability to drive vehicles and work with other mechanisms.