OCTOLIPEN PILLS 600MG

Indications

- diabetic polyneuropathy;

- alcoholic polyneuropathy.

Dosage and administration

The drug is taken orally, on an empty stomach, 30 minutes before a meal. pills should be swallowed whole, without chewing, with a sufficient amount of liquid.

The recommended dose is 1 tab. (600 mg) 1 time / day.

It is possible to conduct stepwise therapy: oral administration of the drug begins after a 2-4-week course of parenteral administration of thioctic acid. The maximum course of taking pills - 3 months. In some cases, drug therapy Octolipen ® involves longer use. The duration of treatment is determined by the attending physician.

Side effect

Possible side effects when using the drug Octolipen® are given on the descending frequency of occurrence: very often (1≥1 / 10), often (≥1 / 100, <1/10), infrequently (≥1 / 1000, <1/100), rarely (≥1 / 10 000, <1/1000), very rarely (<1/10 000). There is no correlation between the incidence of side effects and gender and age of patients.

From the side of the central nervous system: very rarely - a change or a violation of taste.

Gastrointestinal: very rarely - nausea, vomiting, heartburn, abdominal pain, diarrhea.

Metabolism: very rarely, a decrease in blood glucose (due to improved glucose uptake); hypoglycemia may develop, the symptoms of which include dizziness, increased sweating, headache, visual disturbances.

On the part of the immune system: very rarely - allergic reactions such as skin rashes, urticaria, itching.

Contraindications

- pregnancy;

- lactation period (breastfeeding);

- children's and teenage age up to 18 years (efficiency and safety are not established);

- hypersensitivity to thioctic acid and components of the drug.

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 in pregnant women. Reproductive toxicity studies did not reveal risks in terms of fertility, the impact on the development of the fetus and any embryotoxic properties of the drug.

Use of the drug Octolipen® during lactation is contraindicated due to the lack of data on the penetration of thioctic acid in breast milk.

Use in children

The use of the drug in children and adolescents under the age of 18 years is contraindicated (efficacy and safety have not been established).

Special notes

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

Patients taking the drug Octolipen®should refrain from drinking alcohol.

A simultaneous meal can interfere with the absorption of the drug.

When taking the drug Octolipen® consumption of dairy products is not recommended (due to their Calcium content). The interval between doses should be at least 2 hours.

Influence on ability to drive motor transport and control mechanisms

The effect on the ability to drive vehicles and mechanisms has not been specifically studied. Required
observe caution when driving and engaging in potentially hazardous activities that require increased concentration and psychomotor speed.

Overdosage

Symptoms: headache, nausea, vomiting. In severe cases (when taking thioctic acid at a dose of 10-40 g or more than 10 tablets. 600 mg for adults, or at a dose of> 50 mg / kg of body weight in children): psychomotor agitation or clouding of consciousness, generalized convulsions, pronounced disorders acid-base balance with lactic acidosis, hypoglycemia (up to the development of coma), acute skeletal muscle necrosis, hemolysis, DIC, bone marrow suppression, multiple organ failure.

Treatment: if a substantial overdose of the drug is suspected, immediate hospitalization and application of measures in accordance with the general principles adopted in case of accidental poisoning (induction of vomiting, gastric lavage, administration of Activated carbon, etc.) is recommended. Treatment of generalized seizures, lactic acidosis and other life-threatening consequences of intoxication is symptomatic, it should be carried out in accordance with the principles of modern intensive care. There is no specific antidote. Hemodialysis, hemoperfusion or filtration methods with the forced elimination of thioctic acid from the body are not effective.

Drug interaction

Enhances the anti-inflammatory effect of SCS.

Reduces the effectiveness of Cisplatin.

Enhances the action of insulin and oral hypoglycemic drugs (correction of their dose is necessary, as well as regular monitoring of blood glucose in order to avoid hypoglycemia).

Simultaneous administration of the drug Octolipen® and preparations of iron, Magnesium and calcium are not recommended (due to the formation of a complex with metals). The interval between doses should be at least 2 hours.

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

Terms and conditions of storage

The drug should be stored out of the reach of children at a temperature not higher than 25 ° C.