Thioctacide film coated pills 600mg N100
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Active ingredients
Thioctic acid
Release form
Pills
Composition
1 tablet contains: Tioktovaya (α-lipoic) acid 600 mg Supplementary substances: low substituted hyprolosis - 157 mg, hyprolosis - 20 mg, magnesium stearate - 24 mg - 4 mg, talc - 2.02 mg, aluminum lacquer based on quinoline yellow dye - 1.32 mg, aluminum lacquer based on indigo carmine - 0.16 mg.
Pharmacological effect
Metabolic drug. Thioctic (α-lipoic) acid is found in the human body, where it acts as a coenzyme in the reactions of oxidative phosphorylation of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant, according to the biochemical mechanism of action, it is close to the vitamins of group B. Thioctic acid contributes to the protection of cells from the toxic effects of free radicals that occur in metabolic processes; it also neutralizes exogenous toxic compounds that have entered the body. Thioctic acid increases the concentration of the endogenous antioxidant glutathione, which leads to a decrease in the severity of symptoms of polyneuropathy. The drug has a hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect; improves trophism of neurons. The result of the synergistic effect of thioctic acid and insulin is an increase in glucose utilization.
Pharmacokinetics
Absorption When taking the drug Thioctacid BV (rapid release) inside, thioctic acid is rapidly and completely absorbed from the gastrointestinal tract. Simultaneous food intake can reduce the absorption of the drug. Cmax in plasma is reached 30 minutes after administration and is 4 μg / ml. The absolute bioavailability of thioctic acid is 20%. Metabolism Exposed to the effect of the first passage through the liver. The main metabolic pathways are oxidation and conjugation. The T1 / 2 output is 25 minutes. Thioctic acid and its metabolites are excreted in the urine (80-90%).
Indications
- diabetic polyneuropathy; - alcoholic polyneuropathy.
Contraindications
- pregnancy (there is not enough experience in using the drug); - breastfeeding period (there is not enough experience in using the drug); - children and adolescents (there are no clinical data on the use of the drug in children and adolescents); - hypersensitivity to thioct (α-lipoic) acid and other components of the drug.
Precautionary measures
Alcohol consumption is a risk factor for the development of polyneuropathy and may reduce the efficacy of Thioctacid BV, therefore patients should refrain from taking alcoholic beverages both during drug treatment and during periods outside of treatment.
Use during pregnancy and lactation
The drug is contraindicated during pregnancy and lactation, because there is insufficient experience with the drug during these periods.
Dosage and administration
Inside appoint 600 mg (1 tab.) 1 time / day. Tablets are taken on an empty stomach, 30 minutes before breakfast, without chewing and drinking water.
Side effects
On the part of the digestive system: often - nausea; very rarely - vomiting, pain in the stomach and intestines, diarrhea, change in taste. Allergic reactions: very rare - skin rash, urticaria, itching, anaphylactic shock. On the nervous system: often - dizziness. On the whole body: very rarely - due to improved glucose utilization, blood glucose levels may decrease and symptoms of hypoglycemia appear (confusion, increased sweating, headache, visual disturbances).
Overdose
Symptoms: when taking thioctic (α-lipoic) acid in a dose of 10 g to 40 g, serious signs of intoxication (generalized convulsive seizures; marked CSR disorders (leading to lactic acidosis), hypoglycemic coma, severe bleeding disorders, sometimes leading to lethal outcome). Treatment: if a significant overdose of the drug is suspected (for example, more than 10 pills are taken by an adult or more than 50 mg / kg of body weight by a child), immediate hospitalization with symptomatic therapy is necessary, if necessary Odds - anticonvulsant therapy, measures to maintain the functions of vital organs.
Interaction with other drugs
With the simultaneous appointment of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin. Thioctic (α-lipoic) acid binds metals, therefore, it should not be administered simultaneously with preparations containing metals (for example, preparations of iron, magnesium, calcium). If BV Thioctacid is taken 30 minutes before breakfast, then preparations containing iron or magnesium can be taken day or evening. When using thioctic acid and insulin or oral hypoglycemic drugs at the same time, their effect may be enhanced, therefore regular monitoring of blood glucose is recommended, especially at the beginning of thioctic acid therapy.In some cases, it is possible to reduce the dose of hypoglycemic drugs in order to avoid the development of symptoms of hypoglycemia. Ethanol and its metabolites weaken the action of thioctic acid.
special instructions
Treatment of diabetic polyneuropathy should be carried out against the background of maintaining an optimal concentration of glucose in the blood. Due to the fact that thioctic acid binds metals, and pills Tioctacid BV taken 30 minutes before breakfast, preparations containing metals should be taken at lunch or in the evening. For the same reason, during the treatment period with BV Thioctacid, the consumption of dairy products is recommended only in the second half of the day.