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

Excipients:
core: giprolose low-substituted (low-substituted hydroxypropyl cellulose) 108,880 mg, giprolose (hydroxypropylcellulose 28,040 mg, croscarmellose (croscarmellose sodium) 24,030 mg, silicon colloidal dioxide 20,025 mg, magnesium stearate 20,025 mg;

shell: Opadray Yellow (OPADRY 03F220017 Yellow) - 28,000 mg [hypromellose (hydroxyiropyl methylcellulose) - 15,800 mg, macrogol-6000 (polyethylene glycol 6000) - 4.701 mg, titanium dioxide - 5.270 mg, talc - 2.019 mg, quinoline yellow aluminum lacquer (E 104) - 0.162 mg, the iron dye oxide is yellow (E 172) - 0.048 mg].

Description:

The tablets covered with a film membrane from light yellow to yellow color, oval, biconcave with risk on one side. At the break from light yellow to yellow.

Pharmacotherapeutic group:Metabolic means

ATX: & nbsp

A.16.A.X.01 Thioctic acid

Pharmacodynamics:

Thioctic acid (alpha-lipoic acid) in the body is a coenzyme mitochondrial multi-enzyme complexes,

participating at oxidative decarboxylation of pyruvic acid and alpha-keto acids. It is an endogenous antioxidant: binds free radicals, restores the intracellular level of glutathione, increases activity of superoxide dismutase. Improves trophism of neurons and axonal conduction. The nature biochemical actions thioctic acid similar to Group B vitamins.

It plays an important role in energy exchange. Participates in the regulation of lipid and carbohydrate exchanges, stimulates the exchange of cholesterol. Helps reduce blood glucose levels, increase glycogen content in the liver, insulin resistance decrease.

Has lipotropic effect, improves liver function.Has a detoxifying effect in case of poisoning with salts of heavy metals and with other intoxications.

Pharmacokinetics:

When ingested quickly and fully absorbed in the gastrointestinal tract, taking with food simultaneously reduces the absorption of the drug. Biodostuity - 30-60% due to the effect of "first passage" through the liver. The time to reach the maximum plasma concentration (TC_max) - 25-60 min.

Metabolized in the liver by side chain oxidation and conjugation. The volume of distribution is 450 ml / kg. Total plasma clearance - 10-15 ml / min.

Thioctic acid and its metabolites are excreted by the kidneys (80-90%). Half-life (T_1/2) - 25 min.

Indications:

Diabetic polyneuropathy, alcoholic polyneuropathy.

Contraindications:

Hypersensitivity (to tioctic acid and components of the drug), pregnancy and the period of breastfeeding (there is insufficient experience in using the drug), children under 18 years of age (efficacy and safety not established).

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 did not reveal any risks with respect to fertility, effects on fetal development and any embryotoxic properties of the drug.

The use of the drug Oktalipen® during lactation is contraindicated because there is no data on the penetration of thioctic acid into breast milk.

Dosing and Administration:

Inside, on an empty stomach, 30 minutes before a meal, without chewing, squeezed enough liquid, 1 tablet (600 mg) 1 time per day.

It is possible to perform step therapy: oral tablet administration

begin after a 2-4 week course of parenteral administration of thioctic acid. The maximum course of taking tablets is 3 months. In some cases, taking the drug involves a longer application, the timing of which is determined by the doctor.

Side effects:

Possible side effects with Oktalipen are given in the descending incidence frequency: very often (1 ≥ 1/10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10000, <1/1000), very rarely (<1/10000). Correlations in the incidence of side effects with the sex and age of patients are not observed.

From the nervous system:

Very rarely: change or violation of taste sensations;

From the gastrointestinal tract:

Very rarely: nausea, vomiting, heartburn, abdominal pain, diarrhea;

From the side of metabolism:

Rarely: decrease in concentration

glucose in the blood (due to improved glucose uptake); perhaps development of hypoglycemia, the symptoms of which include dizziness, increased sweating, headache, impaired vision.

From the immune system:

Very rarely: allergic reactions, such as a skin rash, hives, itching.

Overdose:

Symptoms:

Headache, nausea, vomiting.

In severe cases (when taking tioctic acid in a dose of 10-40 g or more 10 tablets at 600 mg for adults, or at a dose> 50 mg / kg of body weight in children): psychomotor agitation or blurred vision, generalized convulsions, severe acid disturbances alkalinity with lactic acidosis, hypoglycemia (up to the development of coma), acute necrosis of skeletal muscles, hemolysis, DIC syndrome, suppression of bone marrow activity, multiple organ failure.

Treatment: If you suspect a significant overdose of the drug, immediate hospitalization and the application of measures are recommended in accordance with the general principles adopted in case of accidental poisoning (vomiting, gastric lavage,reception of activated carbon, etc.). Treatment of generalized seizures, lactic acidosis and other life-threatening consequences of intoxication should be conducted in accordance with the principles of modern intensive care and should be symptomatic. There is no specific antidote. Hemodialysis, hemoperfusion or filtration methods with forced removal of thioctic acid from the body are not effective.

Interaction:

Enhances anti-inflammatory effect of glucocorticosteroids.

Reduces the effectiveness of cisplatin.

Strengthens the action of insulin and oral hypoglycemic

(correction of their dose is necessary, as well as regular monitoring of glucose concentration in the blood to avoid hypoglycemia).

Simultaneous administration of the drug Oktalipen® and preparations of iron, magnesium and calcium is not recommended (due to the formation of a complex with metals).

When taking Oktalipen®, the use of dairy products is not recommended (because of the calcium content in them). The interval between the reception should be at least 2 hours.

Ethanol and its metabolites weaken the therapeutic activity of thiectic acid.

Special instructions:

During the treatment period (especially at the initial stage), regular monitoring of blood glucose concentration in patients with diabetes mellitus is necessary. In some cases, it may be necessary to reduce the dose of insulin or an oral hypoglycemic agent in order to avoid the development of hypoglycemia. Patients receiving

the need to reduce the dose of insulin or oral hypoglycemic agent in order to avoid the development of hypoglycemia. Patients receiving preparation Oktolipen, follows refrain from drinking alcohol.

Simultaneous food intake can inhibit the absorption of the drug.

Effect on the ability to drive transp. cf. and fur:The effect on the ability to drive vehicles and mechanisms has not been specially studied. Care must be taken when driving vehicles and engaging in potentially hazardous activities that require a high concentration of attention and speed of psychomotor reactions

Form release / dosage:Film-coated tablets, 600 mg.

Packaging:

For 10 tablets in a contour squeeze box made of PVC or PVC / PVDC film, or PVC / Polyethylen / PVDC and foil of aluminum printed varnished.

3, 6, 10 contour mesh packages together with the instruction for use will be prevented in a pack of cardboard.

Storage conditions:

At a temperature of no higher than 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years. Do not use after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LP-001863

Date of registration:28.09.2012 / 18.12.2015

Expiration Date:28.09.2017

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

Manufacturer: & nbsp

PHARMSTANDART-TOMSKHIMFARM, OJSC Russia

Information update date: & nbsp26.05.2017

Illustrated instructions

Instructions

Octolip® (Octolipen®)