Octolipen pills 600mg, 30pcs

Composition

Active ingredient:

thioctic acid (a-lipoic acid) – 600 mg;

Auxiliary substances:

low-substituted hyprolose (low-substituted hydroxypropyl cellulose L-HPC LH-B1) – 120.90 mg;

hyprolose (hydroxypropyl cellulose (Klucel EF)) – 32.04 mg;

colloidal silicon dioxide (aerosil) – 24.03 mg;

magnesium stearate-24.03 mg;

Shell:

OPADRY yellow (OPADRY 03F220017 Yellow) – 28.00 mg [hypromellose (hydroxypropylmethylcellulose), macrogol-6000 (polyethylene glycol 6000), titanium dioxide, talc, quinoline yellow aluminum varnish (E 104), iron oxide yellow dye (E 172)

Pharmacological action

Pharmacotherapeutic group: metabolic agent.

ATX code: A 16AX01

Pharmacological properties

Pharmacodynamics :

Thioctic acid (alpha-lipoic acid) is found in the human body, where it serves as a coenzyme in the oxidative phosphorylation reactions of pyruvic acid and alpha-keto acids. Thioctic acid is an endogenous antioxidant. Thioctic acid helps protect the cell from the toxic effects of free radicals that occur in the metabolic processes; it also neutralizes exogenous toxic compounds. Thioctic acid increases the concentration of the endogenous antioxidant glutathione, which leads to a decrease in the severity of symptoms of polyneuropathy. The drug has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects; improves the trophic function of neurons. The result of the synergistic action of thioctic acid and insulin is an increase in glucose utilization.

Pharmacokinetics:

When taken orally, it is rapidly and completely absorbed in the gastrointestinal tract, taking it simultaneously with food can reduce the absorption of the drug. Taking the drug, according to the recommendations,30 minutes before meals allows you to avoid unwanted interaction with food, because the absorption of thioctic acid at the time of eating is already complete. The maximum concentration of thioctic acid in the blood plasma is reached 30 minutes after taking the drug and is 4 micrograms / ml. Thioctic acid has a “first pass” effect through the liver. The absolute bioavailability of thioctic acid is 20%. The main metabolic pathways are oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The elimination half-life (T 1/2) is 25 minutes.

Indications

Diabetic polyneuropathy; alcoholic polyneuropathy.

Use during 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 have not identified any risks in terms of fertility, effects on fetal development, or any embryotoxic properties of the drug. The use of Octolipen® during lactation is contraindicated due to the lack of data on the penetration of thioctic acid into breast milk.

Contraindications

Hypersensitivity to thioctic acid or other components of the drug.

Pregnancy, breast-feeding period (there is no sufficient experience of using the drug).

Children under 18 years of age (efficacy and safety have not been established).

Side effects

The frequency of side effects is defined as follows:

Very Common: > 1/10;>

Common: <1/10 > 1/100;<1/10 >

Infrequently: <1/100 > 1/1000;<1/100 >

Rare: <1/1000> 1/10000;<1/1000>

Very rare:

From the gastrointestinal tract: often-nausea; very rarely-vomiting, pain in the stomach and intestines, diarrhea, changes in taste sensations.

Allergic reactions: very rarely – skin rash, urticaria, pruritus, anaphylactic shock.

Nervous system and sensory disorders: often – dizziness.

General: very rare-due to improved glucose utilization, blood glucose levels may decrease and symptoms of hypoglycemia may appear (confusion, increased sweating, headache, visual disturbances).

Interaction

With simultaneous use of thioctic acid and cisplatin, there is a decrease in the effectiveness of cisplatin. Thioctic acid binds metals, so it should not be administered simultaneously with preparations containing metals (for example, preparations of iron, magnesium, calcium). According to the recommended method of use, Octolipen tablets are taken 30 minutes before breakfast, while preparations containing metals should be taken at lunch or in the evening. For the same reason, during the treatment period, it is recommended to eat dairy products only in the afternoon. Concomitant use of thioctic acid and insulin or oral hypoglycemic drugs may increase their effect, so regular monitoring of blood glucose levels is recommended, especially at the beginning of therapy with thioctic acid. In some cases, it is acceptable to reduce the dose of hypoglycemic drugs in order to avoid the development of symptoms of hypoglycemia. Ethanol and its metabolites weaken the effect of thioctic acid.

How to take, course of use and dosage

The recommended dose is 1 tablet (600 mg) once a day. The drug is used orally, on an empty stomach,30 minutes before breakfast, without chewing, washed down with water. In some (severe) cases, treatment begins with the appointment of the drug Octolipen® solution for intravenous use for 2-4 weeks, then transferred to treatment with the oral form of the drug Octolipen® (step therapy). The type and duration of the course of therapy are determined by the doctor.

Overdose

Symptoms: Headache, nausea, vomiting. In the case of taking thioctic (alpha-lipoic) acid in doses of 10-40 g, serious signs of intoxication may occur (generalized convulsions; severe violations of acid-base balance leading to lactic acidosis; hypoglycemia, up to hypoglycemic coma; severe blood clotting disorders, sometimes leading to death). If a significant overdose of the drug is suspected (doses equivalent to more than 10 tablets for an adult or more than 50 mg per kg of body weight for a child), immediate hospitalization is required. Treatment: There is no specific antidote. Treatment is symptomatic, if necessary – anticonvulsant therapy, measures to maintain the function of vital organs.

Special instructions

Patients taking Octolipen® should refrain from drinking alcoholic beverages, as alcohol consumption is a risk factor for developing polyneuropathy and may reduce the effectiveness of treatment.

Treatment of diabetic polyneuropathy should be carried out against the background of maintaining an optimal concentration of glucose in the blood.

Influence on the ability to drive vehicles and mechanisms

The effect on the ability to drive vehicles and mechanisms has not been specifically studied. Caution should be exercised when driving vehicles and engaging in potentially dangerous activities that require increased concentration of attention and speed of psychomotor reactions.

Form of production

Film-coated tablets,600 mg. 10 tablets in a contour cell package made of polyvinyl chloride or imported PVC film/PVDC, or PVC/Polyethylene/PVDC and aluminum foil printed varnished. 3,6,10 contour cell packages together with the instructions for use are placed in a pack of cardboard.

Storage conditions

Store at a temperature not exceeding 25 °C. Keep out of reach of children.

Shelf

life is 2 years. Do not use after the expiration date indicated on the package.

Active ingredient

Thioctic acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Polyneuropathy, Alcoholism, Type 1 Diabetes, Type 2 Diabetes