Octolipen for infusions 30mg/ml 10ml #10

Octolipen for infusions instruction for use

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The composition of one ampoule

Active ingredient: thioctic acid (a-lipoic acid) - 300 mg
Excipients: Ethylenediamine -87.4 mg; disodium edetate (disodium salt of ethylenediaminetetraacetic acid) - 1 mg; water for injection up to 10ml
Description: clear greenish yellow liquid
Pharmacotherapeutic group - metabolic agent
ATH code: A16AH01

Pharmacological properties

Thioctic acid (alpha-lipoic acid) - an endogenous antioxidant (binds free radicals), is formed in the body during the oxidative decarboxylation of alpha-keto acids. As a coenzyme, mitochondrial multienzyme complexes are involved in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. It helps to reduce the concentration of glucose in the blood and increase the glycogen content in the liver, as well as to overcome insulin resistance. By the nature of the biochemical action is close to the vitamins of group B. Participates in the regulation of lipid and carbohydrate metabolism, stimulates the exchange of cholesterol, improves liver function.
It has a hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect. It improves neuronal trophism and axonal conductivity, reduces manifestations of diabetic and alcoholic polyneuropathy.

Pharmacokinetics

When administered intravenously, 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.
Metabolized in the liver by side chain oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The half-life is 20-50 minutes. Total plasma clearance - 10-15 ml / min.

Indications for use

    diabetic polyneuropathy;
    alcoholic neuropathy.

Contraindications

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

Dosage and administration

For the preparation of an infusion solution of 1 -2 ampoules (300-600 mg) of Octolipen for infusions is diluted in 50-250 ml of 0.9% sodium chloride solution. The finished solution is administered intravenously. Apply 300-600 mg 1 time per day for 2-4 weeks. In the future, switch to oral therapy.
Octolipen for infusions has a photosensitivity, so the ampoule should be taken out of the packaging just before use. It is advisable to protect the vial with the solution from light during the infusion (you can use light-protective bags, aluminum foil). The prepared solution should be stored in a dark place and used for a maximum of 6 hours after preparation.

Side effects of Octolipen for infusions

Allergic reactions are possible: urticaria, systemic allergic reactions (up to the development of anaphylactic shock).
Perhaps the development of symptoms of hypoglycemia (due to improved glucose uptake).
With intravenous administration, seizures and diplopia are very rare; point hemorrhages in mucous membranes, skin; thrombocytopathy; hemorrhagic rash (purpura), thrombophlebitis.
With the rapid introduction may increase intracranial pressure (the appearance of a feeling of heaviness in the head); difficulty breathing.
These side effects are their own.

Overdose

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

Interaction with other drugs

Thioctic acid (as an infusion solution) reduces the effect of cisplatin.
With simultaneous use with insulin and / or oral hypoglycemic agents, there is an increase in the hypoglycemic effect.
Thioctic acid forms difficultly soluble complex compounds with sugar molecules. The prepared solution is incompatible with a solution of glucose, levulose, Ringer's solution, as well as with compounds (including their solutions) that react with disulfide and SH-groups.

special instructions for Octolipen for infusions

In patients with diabetes mellitus, especially at the beginning of treatment, frequent monitoring of glucose concentration in the blood is necessary. In some cases, a reduction in the dose of hypoglycemic agents is required.
During treatment, it is necessary to strictly abstain from alcohol because the therapeutic effect of thioctic acid is weakened when exposed to alcohol.
Ethanol reduces the therapeutic efficacy of thioctic acid.

Release form

Concentrate for preparation of solution for infusions of 30 mg / ml.
On 10 ml in ampoules from light-protective glass.
On 5 ampoules in a blister strip packaging without foil.
1 or 2 blister packs with instructions for use in a pack of cardboard.

Storage conditions

In the 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 expiration date.

Pharmacy sales terms

You can buy Octolipen for infusions without a prescription.