Dialipon (capsules)

General characteristics. Structure:

Active ingredient: thioctic acid;

1 capsule contains alpha lipoic acid 0,300 g;

excipients: lactoses monohydrate, cellulose microcrystallic, gipromeloz (gidroksipropilmetiltsellyuloz) of E15, silicon dioxide colloid anhydrous (aerosil), magnesium stearate.

Pharmacological properties:

Pharmacodynamics. Alpha lipoic acid is synthesized in an organism and acts as coenzyme in oxidizing decarboxylation of  ketonic acids; plays an important role in energy balance of a cell. In an amide form (липоамид) is an essential cofactor of the multienzymatic complexes catalyzing decarboxylation of  ketonic acids of a tricarbonic acid cycle. Anti-toxic and antioxidant properties are inherent in alpha lipoic acid, it is also capable to recover other antioxidants, for example at a diabetes mellitus. At patients with a diabetes mellitus alpha lipoic acid reduces resistance to insulin and slows down development of peripheral neuropathy. Promotes decrease in content of glucose in blood and to accumulation of a glycogen in a liver. Alpha lipoic acid influences cholesterol exchange, takes part in regulation of lipidic and carbohydrate metabolism, improves function of a liver (owing to hepatoprotective, antioxidant, disintoxication action).

Pharmacokinetics. At oral administration alpha lipoic acid quickly and almost is completely absorbed from digestive tract, metabolized generally in a liver by oxidation of side chains and conjugation. Drug is removed through kidneys (93-97%), mainly in the form of metabolites. An elimination half-life – 10-20 min.

Pharmaceutical characteristics.

 

Main physical and chemical properties: solid gelatin capsules; the case and a lid of the capsule of color of ivory, capsule contents – the powdery granulated mix of yellow color.

Indications to use:

As a part of complex therapy of diabetic polyneuropathy, a liver disease (hepatitis, cirrhosis), at chronic intoxications (for example, salts of heavy metals, mushrooms).

Route of administration and doses:

Drug is used orally in doses of 600 mg of 1 times a day. Drug is accepted without chewing, washing down with a small amount of liquid, in the morning in 30-45 min. prior to food.

In cases of the heavy disturbances of sensitivity connected with diabetic polyneuropathy, treatment it is desirable to begin with parenteral administration of alpha lipoic acid (Dialipon® solution for injections) for 2-4 weeks. Afterwards it is necessary to continue oral administration of drug in a dose of 600 mg of 1 times a day.

Duration of treatment depends on character and the course of a disease and the doctor defines.

Features of use:

At treatment of patients with a diabetes mellitus frequent control of level of glucose of blood is necessary. In some cases it is necessary to correct doses of antihyperglycemic means for the prevention of a hypoglycemia.

During treatment of polyneuropathy, thanks to regeneration processes, perhaps short-term strengthening of sensitivity which is followed by paresthesia with feeling of "crawling of goosebumps".

Constant alcohol intake is risk factor of development of polyneuropathy and can reduce efficiency of Dialipona®. Therefore it is recommended to refrain from alcohol intake during treatment by drug. Thioctic acid connects ions of metals therefore it is not necessary to appoint Dialipon® along with the drugs containing metals (iron preparations, magnesium, calcium), and also with dairy products.

Ability to influence speed of response at control of motor transport or work with other mechanisms. Drug does not influence speed of response at control of motor transport or work with other mechanisms, but in case of signs of side effect of drug (see. "Side reactions") it is necessary to refrain from control of motor transport and work with other mechanisms.

Side effects:

General reactions of an organism: hot inflows, perspiration, breath difficulty.

From the central nervous system: headache, dizziness, change or disturbance of flavoring perception, vision disorder.

From the alimentary system: development of dyspepsia (heartburn, nausea, vomiting, moderate abdominal pains, diarrhea) which pass if to accept drug in time or after food is in some cases possible.

Disbolism: a hypoglycemia (owing to glucose utilization improvement).

Allergic reactions: a skin itch, an erythema, a small tortoiseshell, petekhialny rashes, dermatitis, eczema, it is rare - system allergic reactions, up to an acute anaphylaxis.

Interaction with other medicines:

Strengthening of hypoglycemic effect at reception of insulin or peroral antihyperglycemic means is possible. Reacts with ionic complexes of metals, for example Cisplatinum, can reduce its efficiency and lead to loss of activity of Cisplatinum. With molecules of sugar forms tyazhelorastvorimy complexes. Is a metal helator therefore it is impossible to apply with iron preparations.

Contraindications:

Hypersensitivity to alpha lipoic acid and other components of drug.

Hereditary intolerance of a galactose, deficit of lactase, syndrome of glyukozo-galaktozny malabsorption.

Pregnancy and period of feeding by a breast.

 

There is no sufficient clinical experience of use of drug at pregnancy and during feeding by a breast therefore   this category of patients is not recommended to appoint it.

Children.

 

Диалипон® children are not recommended to appoint up to 18 years due to the lack of clinical experience of use of drug for this category of patients.

Overdose:

About cases of specific intoxication by alpha lipoic acid it was not reported, besides, considering pharmacological effect of substance, it should not be expected. At overdose nausea, vomiting, a headache are possible.

At use of very high doses of alpha lipoic acid (from 10 to 40 g) in combination with alcohol, heavy intoxication is observed that can lead to death. Clinical signs of intoxication were shown in the form of psychomotor disturbance or a faint with the subsequent generalized spasms and development of a lactacidemia. Alpha lipoic acid the hypoglycemia, shock, рабдомиолиз, hemolysis, the disseminated intravascular coagulation, oppression of marrow and organ insufficiency are a consequence of intoxication.

At acute poisoning with alpha lipoic acid immediate hospitalization with holding all-therapeutic actions of a detoxication of an organism is shown (an artificial respiration, vomiting, a gastric lavage, absorbent carbon, etc.). For treatment of generalized spasms, a lactacidemia and other effects of intoxication it is necessary to be guided by means of a modern intensive care and symptomatic approach for acceleration of removal of alpha lipoic acid. Symptomatic further treatment.

Use during pregnancy and feeding by a breast.

 

There is no sufficient clinical experience of use of drug at pregnancy and during feeding by a breast therefore this category of patients is not recommended to appoint it.

Children.

 

Диалипон® children are not recommended to appoint up to 18 years due to the lack of clinical experience of use of drug for this category of patients.

Storage conditions:

Period of validity. 2 years. Not to use drug after the termination of the period of validity specified on packaging. To store in protected from light and the place, unavailable to children, at a temperature not above 25 °C.

Issue conditions:

According to the recipe

Packaging:

On 10 capsules in the blister. On 3 or 6 blisters enclosed in a pack.