Composition, form of production and packaging
Capsules hard gelatinous, size No. 0, opaque, yellow; contents of capsules - powder of light yellow or yellow color; blotches of white are allowed.
1 caps.
Thioctic (? -lipoic) acid 300 mg
Auxiliary substances: calcium hydrophosphate (calcium phosphate disubstituted) - 23.7 mg, pregelatinized starch - 21 mg, silicon dioxide colloid (aerosil) - 1.8 mg, magnesium stearate - 3.5 mg, hard gelatin capsules - 97 mg (titanium dioxide (E171) - 2.667 %, quinoline yellow (E104) - 1.839%, dye sunset yellow (E110) - 0.0088%, gelatin medical - up to 100%).
10 pieces. - Packings contour mesh (3) - packs cardboard.
10 pieces. - packings contour mesh (6) - packs cardboard.
INSTRUCTION FOR THE SPECIALIST.
Description of the drug approved by the manufacturer for the printed edition of 2016.
PHARMACHOLOGIC EFFECT
Thioctic acid (? -lipoic acid) - an endogenous antioxidant (binds free radicals), in the body is formed during oxidative decarboxylation of? -keto acids. As a coenzyme mitochondrial multi-enzyme complexes involved in the oxidative decarboxylation of pyruvic acid and? -ketokislot. Helps reduce blood glucose and increase glycogen content in the liver, as well as overcome insulin resistance. By the nature of the biochemical effect, thioctic acid is close to the vitamins of group B. It participates in the regulation of lipid and carbohydrate metabolism, stimulates the exchange of cholesterol, improves liver function.
Has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic action. Improves trophic neurons and axonal conduction, reduces the manifestations of diabetic and alcoholic polyneuropathy.
PHARMACOKINETICS
Suction and distribution
When ingested quickly and fully absorbed, taking with food simultaneously reduces absorption. Bioavailability - 30-60% due to the effect of "first passage" through the liver. The time to reach C max is 25-60 min.
Metabolism and excretion
Metabolized in the liver by side chain oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). T 1/2 - 20-50 min. The total plasma clearance is 10-15 ml / min.
INDICATIONS
- diabetic polyneuropathy;
- alcoholic polyneuropathy.
DOSING MODE
The drug is taken orally, on an empty stomach, 30 minutes before the first meal, without chewing and washing down with a sufficient amount of water.
The recommended dose is 600 mg (2 capsules) 1 time / day.
The duration of the course of treatment is determined by the doctor.
SIDE EFFECT
Allergic reactions: possibly - hives, systemic allergic reactions (up to the development of anaphylactic shock).
From the side of metabolism: it is possible to develop symptoms of hypoglycemia (in connection with the improvement of glucose assimilation).
From the digestive system: dyspeptic phenomena are possible, incl. nausea, vomiting, heartburn.
CONTRAINDICATIONS
- Pregnancy (there is insufficient experience of using the drug);
- the period of breastfeeding (there is insufficient experience in using the drug);
- children and adolescents under 18 years of age (efficacy and safety of use not established);
- hypersensitivity to thioctic acid and the components of the drug.
PREGNANCY AND LACTATION
The use of the drug during pregnancy is contraindicated due to the lack of sufficient clinical experience with the use of thioctic acid during pregnancy.
Reproductive toxicity studies did not reveal any risks with respect to fertility, effects on fetal development and any embryotoxic properties of the drug.
The use of the drug Oktalipen В® during lactation is contraindicated because there is no data on the penetration of thioctic acid into breast milk.
APPLICATION FOR CHILDREN
The use of the drug in children and adolescents under the age of 18 is contraindicated (efficacy and safety not established).
SPECIAL INSTRUCTIONS
Patients with diabetes require frequent monitoring of blood glucose (especially at the beginning of treatment). In some cases, a reduction in the dose of hypoglycemic agents is required.
During treatment, you must strictly refrain from drinking alcohol, because when exposed to ethanol, the therapeutic effect of thioctic acid is weakened.
Impact on the ability to drive vehicles and manage mechanisms
The impact on the ability to drive vehicles and control mechanisms is not specifically studied. Care must be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.
OVERDOSE
Symptoms: headache, nausea, vomiting.
Treatment: symptomatic therapy. There is no specific antidote.
DRUG INTERACTION
With simultaneous use with insulin and oral hypoglycemic drugs, an increase in hypoglycemic effect is observed.
After the morning reception of thioctic acid, it is not recommended to take iron, magnesium or dairy products (because of the calcium contained in them), you should transfer their reception to a later time (after dinner or in the evening).
Ethanol reduces the therapeutic efficacy of thioctic acid.
TERMS OF RELEASE FROM PHARMACY
The drug is released by prescription.
TERMS AND CONDITIONS OF STORAGE
The drug should be stored in a dry, protected from light and out of reach of children at a temperature of 15 to 25 В° C. Shelf life - 2 years.
