Thioctic acid - instructions for use, dose, side effects, contraindications

Auxiliary substances (core): microcrystalline cellulose 165.0 mg, lactose monohydrate 60.0 mg, croscarmellose sodium 24.0 mg, povidone-K25 21.0 mg, silicon dioxide colloid 18.0 mg, magnesium stearate - 12.0 mg. Excipients (membrane): hypromellose 5.0 mg, giprolose 3.55 mg, macrogol 4000 4000 mg, titanium dioxide 4.25 mg, dye quinoline yellow 0.1 mg

Dosage 600 mg

Active substance: thioctic acid - 600 mg.

Auxiliary substances (core): microcrystalline cellulose 330.0 mg, lactose monohydrate 120.0 mg, croscarmellose sodium 48.0 mg, povidone-K25 42.0 mg, silicon dioxide colloid 36.0 mg, magnesium stearate - 24.0 mg.Auxiliary substances (membrane): hypromellose - 10.0 mg, giprolose - 7.1 s macrogol 4000 - 4.2 mg, titanium dioxide - 8.5 mg, dye quinoline yellow - 0.2 mg

Description:

Dosage of 300 mg

Round biconvex tablets covered with a film membrane from yellow to yellow-green in color, on the fracture - the core is from light yellow to yellow.

Dosage 600 mg

Oval biconvex tablets with a risk on one side, covered with a film coat from yellow to yellow-green, on the fracture - the core is from light yellow to yellow.

Pharmacotherapeutic group:metabolic

ATX: & nbsp

A.16.A.X.01 Thioctic acid

Pharmacodynamics:

Thioctic acid (alpha lipoic acid) - an endogenous antioxidant (binds free radicals), in the body is formed during the oxidative decarboxylation of alpha-keto acids. As a coenzyme mitochondrial multienzyme complexes is involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. By the nature of biochemical action thioctic acid is close to the vitamins of group B. It improves the trophism of neurons. Helps reduce blood glucose and increase glycogen content in the liver, as well as reduce insulin resistance.Participates in the regulation of lipid and carbohydrate metabolism, stimulates the exchange of cholesterol, improves liver function.

Pharmacokinetics:

When ingested quickly and fully absorbed in the gastrointestinal tract, taking with food simultaneously reduces absorption. The time to reach the maximum concentration is 40-60 minutes. Bioavailability is 30%.

Has the effect of "first pass" through the liver. Metabolized in the liver by side chain oxidation and conjugation.

The volume of distribution is about 450 ml / kg. The total plasma clearance is 10-15 ml / min. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). Half-life is 20-50 minutes.

Indications:

Diabetic polyneuropathy, alcoholic polyneuropathy.

Contraindications:

- Hypersensitivity to the components of the drug.

- Pregnancy, the period of breastfeeding (there is insufficient experience of the drug).

- Children under 18 years of age (efficacy and safety of use not established).

- Lactose intolerance, lactase deficiency, glucose-galactose malabsorption.

Pregnancy and lactation:

Admission of thioctic acid is contraindicated during pregnancy and during breastfeeding because of a lack of sufficient experience of use.

Dosing and Administration:

Apply inside 600 mg once a day.

Tablets are taken on an empty stomach, approximately 30 minutes before the first meal, without chewing and washing down with sufficient water. Treatment is started after a 2-4 week course of parenteral administration.

The minimum course of taking tablets is 3 months. In some cases, taking the drug involves a longer application, the timing of which is determined by the attending physician.

Side effects:

The incidence of side effects is aligned with the WHO classification: very often (^ 1/10); often 1/100 to <1/10); infrequently 1/1000 to <1/100); rarely (^ 1/10000 to <1/1000); very rarely (<1/10000).

On the part of the gastrointestinal tract, very rarely - nausea, heartburn, vomiting, diarrhea, abdominal pain.

From the immune system: very rarely - allergic reactions - urticaria, skin rash, itching; very rarely - systemic allergic reactions (up to the development of anaphylactic shock).

From the nervous system: very rarely - a change or violation of taste

sensations.

From the side of metabolism and nutrition: very rarely - the development of hypoglycemia (due to improved utilization of glucose), the symptoms of which include dizziness, increased sweating, headache, and visual disturbances.

Overdose:

Symptoms: headache, nausea, vomiting.

Treatment: symptomatic. There is no specific antidote.

In case of acute overdose (with application of 10-40 g), serious signs of intoxication can be noted (generalized convulsive seizures, severe acid-base balance disturbances leading to lactic acidosis, hypoglycemic coma, severe bleeding disorders, sometimes leading to fatal outcome).

If you suspect a significant overdose of the drug (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 (including gastric lavage, taking activated charcoal), if necessary, anticonvulsant therapy, measures to maintain vital functions.

Interaction:

With the simultaneous use of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin.

Thioctic acid binds metals, so it should not be used simultaneously with preparations containing metals (such as iron, magnesium, calcium), as well as dairy products (because of the calcium content in them); the interval between taking such drugs and thioctic acid should be at least 2 hours.

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

Enhances the anti-inflammatory effect of glucocorticosteroids.

Ethanol and its metabolites weaken the action of thioctic acid.

Special instructions:

Patients taking thiocy acid should refrain from drinking alcohol.

Patients with diabetes require constant monitoring of blood glucose concentrations, 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.

Effect on the ability to drive transp. cf. and fur:The drug does not affect the ability to drive vehicles and mechanisms that require increased attention.

Form release / dosage:

The tablets covered with a film membrane 300 mg and 600 mg.

For 10, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 10, 20, 30, 40, 50 or 100 tablets in cans of polymeric for medicines.One jar or 1, 2, 3, 4, 5 or 10 contour mesh packages together with the instruction for use are placed in a cardboard package (bundle).

Packaging:

For 10, 20, 30 tablets in a contour mesh box made of polyvinylchloride film and aluminum foil printed lacquered.

By 10, 20, 30, 40, 50 or 100 tablets in cans of polymeric for medicines. One jar or 1, 2, 3, 4, 5 or 10 contour mesh packages together with the instruction for use are placed in a cardboard package (bundle).

Storage conditions:

In the dark place at a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after the expiration date.

Terms of leave from pharmacies:On prescription

Registration number:LP-002355

Date of registration:31.01.2014

The owner of the registration certificate:ATOLL, LLC ATOLL, LLC Russia

Manufacturer: & nbsp

OZONE, LLC Russia

Information update date: & nbsp05.09.2015

Illustrated instructions

Instructions

Thioctic acid (Thioctic acid)