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Октолипен®

Препарат Октолипен®. ОАО "Фармстандарт" Россия


Producer: JSC Pharmstandart Russia

Code of automatic telephone exchange: A05BA

Release form: Firm dosage forms. Capsules.

Indications to use: Diabetic neuropathy. Alcoholic polyneuropathy.


General characteristics. Structure:

Active agent: thioctic acid (α-lipoic acid acid) - 300 mg
Excipients: calcium phosphate disubstituted (calcium hydrophosphate), starch prezhelatinizirovanny, aerosil (silicon dioxide colloid), magnesium stearate for pharmaceutical industry.

Structure of the capsule:
the case and lid – gelatin medical, titanium dioxide (Е 171), quinolinic yellow (Е 104), dye a sunset yellow (Е 110).

Description
Solid opaque gelatin capsules No. 0 of yellow color.

Contents of capsules – powder of light yellow or yellow color. Impregnations of white color are allowed.




Pharmacological properties:

Thioctic acid (alpha lipoic acid) – endogenous antioxidant (connects free radicals), in an organism is formed at oxidizing decarboxylation of alpha ketonic acids. As coenzyme of mitochondrial multifermental complexes participates in oxidizing decarboxylation of pyruvic acid and alpha ketonic acids. Promotes decrease in concentration of glucose in blood and to increase in maintenance of a glycogen in a liver, and also to overcoming insulin resistance. On character of a biochemical effect it is close to group B vitamins. Participates in regulation of lipidic and carbohydrate metabolism, stimulates cholesterol exchange, improves function of a liver. Renders hepatoprotective, hypolipidemic, gipokholesterinemichesky,  hypoglycemic action. Improves a trophicity of neurons and axonal conductivity, reduces displays of diabetic and alcoholic polyneuropathy.

Pharmacokinetics. At intake it is quickly and fully soaked up, reception along with food reduces absorption. Bioavailability – 30-60% owing to effect of "the first passing" through a liver. Time of achievement of the maximum concentration in plasma (TCmax) – 25-60 min. It is metabolized in a liver by oxidation of a side chain and a konjyugirovaniye. Thioctic acid and its metabolites are removed by kidneys (80-90%). An elimination half-life - 20-50 min. The general plasma clearance - 10-15 ml/min.


Indications to use:

  • diabetic polyneuropathy;
  • alcoholic polyneuropathy.

Route of administration and doses:

Inside, on 600 mg (2 capsules) once a day. To accept on an empty stomach, in 30 minutes prior to the first meal, without chewing and washing down with enough water. Duration of a course of treatment is determined by the doctor.


Features of use:

At patients with a diabetes mellitus, especially in an initiation of treatment, frequent control of concentration of glucose in blood is necessary. In some cases the dose decline of hypoglycemic means is required.

During treatment it is necessary to abstain from alcohol intake as at alcohol influence the therapeutic effect of thioctic acid is weakened strictly.


Side effects:

Allergic reactions are possible: a small tortoiseshell, system allergic reactions (up to development of an acute anaphylaxis).

Development of symptoms of a hypoglycemia is possible (in connection with improvement of digestion of glucose).

At intake the dispepsichesky phenomena, including nausea, vomiting, heartburn are possible.


Interaction with other medicines:

At simultaneous use with insulin and other peroral hypoglycemic means strengthening of hypoglycemic effect is observed.

After morning reception of thioctic acid to accept iron preparations, magnesium, and also it is recommended to use dairy products (because of the calcium which is contained in them) after a lunch or in the evening.

Ethanol reduces a therapeutic effectiveness of thioctic acid


Contraindications:

  • hypersensitivity to drug components;
  • children's age up to 18 years (efficiency and safety of use are not established);
  • pregnancy and period of breastfeeding.

Overdose:

Symptoms: headache, nausea, vomiting.
Treatment: symptomatic. There is no specific antidote.


Storage conditions:

In the dry place protected from light at a temperature from 15 to 25 ° C.
To store in the place, unavailable to children.

Period of validity - 2 years. Not to use after a period of validity.


Issue conditions:

According to the recipe


Packaging:

Capsules on 300 mg.
On 10 capsules in a blister strip packaging.
3 or 6 planimetric packagings with the application instruction in a pack from a cardboard.



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