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THIOCTACID 600 HR film -coated tablets, 100 pcs
Areas of application:
Instructions for use Thioctacid bv 600mg 100 pcs. film-coated tablets
Composition, release form and packaging
Tablets – 1 tab.:
Active ingredient: thioctic acid (α-lipoic acid) – 600 mg;
Excipients: low-substituted hyprolose 157.00 mg, hyprolose 20.00 mg, magnesium stearate 24.00 mg;
Film shell: hypromellose 15.80 mg, macrogol 6000 4.70 mg, titanium dioxide 4.00 mg, talc 2.02 mg, aluminum varnish based on quinoline yellow dye 1.32 mg, aluminum varnish based on indigocarmine 0.16 mg.
Description of the dosage form
Biconvex oblong tablets coated with a light green film coating.
Pharmacotherapeutic group
A metabolic remedy.
Pharmacokinetics
When taking the drug orally, thioctic acid is rapidly and completely absorbed from the gastrointestinal tract. Taking the drug Thioctacid® BV simultaneously with meals can reduce the absorption of thioctic acid. Taking the drug according to the recommendations 30 minutes before meals avoids undesirable interaction with food, since the absorption of thioctic acid at the time of eating has already been completed. The maximum concentration of thioctic acid in the blood plasma is reached 30 minutes after taking the drug and is 4 micrograms / ml. Thioctic acid has a “first pass” effect through the liver. The absolute bioavailability of thioctic acid is 20%. The main metabolic pathways are oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The half-life is 25 minutes.
Pharmacodynamics
Thioctic (alpha-lipoic) acid is found in the human body, where it performs the function of a coenzyme in the reactions of oxidative phosphorylation of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant, and its biochemical mechanism of action is close to B vitamins.
Thioctic acid helps protect 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 the trophism of neurons. The result of the synergistic action of thioctic acid and insulin is an increase in glucose utilization.
Thioctacid® BV (rapid release) is an optimized dosage form for oral administration, which avoids high variability in the concentration of thioctic acid in blood plasma.
Indications for use
Diabetic and alcoholic polyneuropathy.
Contraindications to use
Hypersensitivity to thioctic acid or other components of the drug.
Pregnancy, breastfeeding (lack of sufficient experience with the drug).
There are no clinical data on the use of Thioctacid® 600 BV in children and adolescents, and therefore the drug cannot be prescribed to children and adolescents.
Side effects
The frequency of side effects is determined as follows: Very often – > 1/10; Often – <1/10 > 1/100; Infrequently – <1/100 > 1/1000; Rarely – <1/1000> 1/10000; Very rarely – <1/10000.
From the gastrointestinal tract: Often – nausea; very rarely – vomiting, pain in the stomach and intestines, diarrhea, changes in taste sensations.
Allergic reactions: Very rarely – skin rash, urticaria, itching, anaphylactic shock.
From the nervous system and sensory organs: Often – dizziness.
General: Very rarely – due to improved glucose utilization, blood glucose levels may decrease and symptoms of hypoglycemia may appear (confusion, increased sweating, headache, visual disturbances).
Interaction with medicines
With simultaneous administration 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 preparations containing metals (for example, preparations of iron, magnesium, calcium). According to the recommended method of administration, Thioctacid® 600 BV tablets are taken 30 minutes before breakfast, whereas preparations containing metals should be taken at lunch or in the evening. For the same reason, during treatment with Thioctacid® 600 BV, it is recommended to consume dairy products only in the afternoon.
With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may increase, therefore, regular monitoring of blood glucose levels is recommended, especially at the beginning of therapy with thioctic acid. In some cases, it is permissible to reduce the dose of hypoglycemic drugs in order to avoid the development of symptoms of hypoglycemia.
Ethanol and its metabolites weaken the effect of thioctic acid.
Method of administration and dosage
The drug is administered orally. The recommended dose is 1 tablet (600 mg) once a day. The drug is taken on an empty stomach, 30 minutes before breakfast, without chewing, with water.
In severe cases, treatment begins with the appointment of Thioctacid® 600 T solution for intravenous administration for 2 to 4 weeks, then the patient is transferred to treatment with Thioctacid® BV.
Overdose
Symptoms: In the case of taking thioctic (-lipoic) acid in doses of 10-40 g, serious signs of intoxication may be noted (generalized convulsive seizures; pronounced acid-base balance disorders leading to lactic acidosis; hypoglycemic coma; severe blood clotting disorders, sometimes fatal).
If a significant overdose of the drug is suspected (doses equivalent to more than 10 tablets for an adult or more than 50 mg / kg of body weight for a child), immediate hospitalization is necessary.
Treatment: symptomatic, if necessary – anticonvulsant therapy, measures to maintain the functions of vital organs.
Precautions and special instructions
Alcohol consumption is a risk factor for the development of polyneuropathy and may reduce the effectiveness of Thioctacid® BV, therefore, patients should refrain from taking alcoholic beverages both during treatment with the drug and during periods outside of treatment.
Treatment of diabetic polyneuropathy should be carried out against the background of maintaining an optimal concentration of glucose in the blood.
Storage conditions
Store at a temperature not exceeding 25 ° C
Conditions of release from pharmacies
By prescription
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