Oktolipen - instructions for use, doses, side effects, contraindications

Excipients: calcium hydrophosphate (calcium phosphate bis-substituted) - 23.7 mg. starch, pregelatinized starch 21.0 mg, silicon dioxide colloid (aerosil) 1.8 mg, magnesium stearate 3.5 mg, hard gelatin capsules 97.0 mg [titanium dioxide (E 171) 2.667% quinoline yellow (E 104) - 1.839%. dye sunset yellow (E110) - 0.0088%, gelatin medical - up to 100%].

Description:

Hard opaque gelatin capsules No. 0 of yellow color.

The contents of the capsules are a powder of light yellow or yellow color. Blotches of white are allowed.

Pharmacotherapeutic group:Metabolic means

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. Helps reduce blood glucose and increase glycogen content in the liver, as well as overcome insulin resistance. By the nature of the biochemical action 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 conductivity, reduces the manifestations of diabetic and alcoholic polyneuropathy.

Pharmacokinetics:

With intravenous administration, the maximum concentration is 25-38 μg / ml, the area under the concentration-time curve is about 5 μg h / ml. The volume of distribution is about 450 ml / kg.

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. Time to reach the maximum concentration in the plasma (TCam) - 25-60 min. Metabolized in the liver by side chain oxidation and conjugation.

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

Indications:

- Diabetic polyneuropathy;

- alcoholic polyneuropathy.

Contraindications:

Hypersensitivity (to tioctic acid and the components of the drug), pregnancy and the period of breastfeeding (lack of sufficient experience of the drug), children under 18 years of age (efficacy and safety not established).

Pregnancy and lactation:

The drug is contraindicated for use in pregnant women because of the lack of sufficient experience in the use of thioctic acid in pregnancy.

If you need to use the drug during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Capsules are taken orally, 600 mg (2 capsules) once a day. Take on an empty stomach, 30 minutes before the first meal, without chewing and washing down with a sufficient amount of water.The duration of the course of treatment is determined by the doctor.

Side effects:

Allergic reactions are possible: urticaria, systemic allergic reactions (up to the development of anaphylactic shock). Perhaps the development of symptoms of hypoglycemia (in connection with improving the absorption of glucose).

When ingestion, dyspepsia may occur, including nausea, vomiting, heartburn.

Overdose:

Symptoms: headache, nausea, vomiting.

Treatment: symptomatic. There is no specific antidote.

Interaction:

Thioctic acid (in the form of a solution for infusions) leads to a decrease in the effect of cisplatin.

When used simultaneously with insulin and / or oral hypoglycemic agents, an increase in the hypoglycemic effect is observed.

Thioctic acid forms hardly soluble complex compounds with sugar molecules. The prepared solution is incompatible with glucose solution, levulose, Ringer's solution, as well as with compounds (including their solutions) reacting with disulfide and SH-groups.

After the morning reception of thioctic acid, it is recommended to take iron, magnesium, and also dairy products (because of the calcium contained in them) after dinner or in the evening.

Ethanol reduces the therapeutic efficacy of thioctic acid.

Special instructions:

In patients with diabetes, especially at the beginning of treatment, frequent monitoring of the concentration of glucose in the blood. In some cases, a reduction in the dose of hypoglycemic agents is required.

During treatment, it is necessary to strictly refrain from drinking alcohol, because when the effect of alcohol therapeutic effect of thioctic acid is weakened.

Effect on the ability to drive transp. cf. and fur:

Data on the effect of the drug on the ability to drive vehicles and mechanisms are absent.

Form release / dosage:

Capsules of 300 mg.

Packaging:

10 capsules per contour cell package.

3 or 6 contour packs with instructions for use in a pack of cardboard.

Storage conditions:

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

Keep out of the reach of children.

Shelf life:

2 years. Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002211/07

Date of registration:15.08.2007 / 12.05.2015

Expiration Date:Unlimited

The owner of the registration certificate:PHARMSTANDART-FORESTRY, OJSC PHARMSTANDART-FORESTRY, OJSC Russia

Manufacturer: & nbsp

PHARMSTANDART-FORESTRY, OJSC Russia

Information update date: & nbsp29.05.2017

Illustrated instructions

Instructions

Octolip® (Octolipen)