Espa-Lipon - instructions for use, dose, side effects, contraindications

Additives: lactose monohydrate 289.0 mg, povidone (collidon 25) 29.5 mg, microcrystalline cellulose 33.0 mg, cellulose powder 22.0 mg, silicon colloidal dioxide 11.0 mg, silicon dioxide - 27.5 mg, sodium carboxymethyl starch 44.0 mg, magnesium stearate 44.0 mg;

membrane film: hypromellose - 4.5 mg, macrogol-6000 - 0.5 mg, talc - 1.395 mg, titanium dioxide (E 171) -1,125 mg, dye quinoline yellow (E 104) - 0.225 mg.

Description:

Biconvex oblong tablets, covered with a film coating of yellow color, with a risk on one side.

Pharmacotherapeutic group:metabolic

ATX: & nbsp

A.16.A.X.01 Thioctic acid

Pharmacodynamics:

The coenzyme of mitochondrial multienzyme complexes participating in the oxidative decarboxylation of pyruvic acid and alpha-keto acids plays an important role in the energy balance of the organism. By the nature of the biochemical action, thioktovaya (alpha-lipoic) acid is similar to the vitamins of group B. It is an endogenous antioxidant. Participates in the regulation of lipid and carbohydrate metabolism, has a lipotropic effect, affects cholesterol metabolism, improves liver function, has a detoxification effect in poisoning with salts of heavy metals and other intoxications. The effect on carbohydrate metabolism is expressed in a decrease in the concentration of glucose in the blood and in the increase in glycogen in the liver, as well as in overcoming insulin resistance. Improves trophic neurons.

Pharmacokinetics:

When ingested quickly and completely absorbed in the gastrointestinal tract, simultaneous intake with food reduces absorption. Bioavailability - 30-60% due to the effect of "first passage" through the liver. The time to reach the maximum concentration (TCmax) is 25-60 min. Metabolized in the liver by side chain oxidation and conjugation.The volume of distribution is 450 ml / kg. The total clearance is 10-15 ml / min. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). The half-life (T1 / 2) is 20-50 min.

Indications:

diabetic polyneuropathy;

alcoholic polyneuropathy.

Contraindications:

Hypersensitivity; pregnancy, the period of breastfeeding (there is insufficient experience in using the drug); children under 18 years of age (efficacy and safety of use not established); hereditary intolerance of galactose, deficiency of lactase or glucose-galactose malabsorption.

Dosing and Administration:

The drug is taken orally 600 mg once a day on an empty stomach, 30 minutes before a meal (breakfast), without chewing and washing down with water. Treatment is started after a 2-4-week course of parenteral administration.

The minimum 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 attending physician.

Side effects:

Very rarely (<1 / 10,000), the following side effects occur: nausea, heartburn,

vomiting, diarrhea, abdominal pain, allergic reactions (including urticaria, cutaneous

rash, itching).Perhaps the development of hypoglycemia (due to improved glucose utilization), the symptoms of which include dizziness, increased sweating, headache, impaired vision.

Overdose:

Symptoms: headache, nausea, vomiting.

Treatment: symptomatic. There is no specific antidote.

In case of acute overdose (with application of 10-40 g), serious signs of intoxication can be noted (generalized convulsive seizures, severe acid-base balance disturbances leading to lactic acidosis, hypoglycemic coma, severe bleeding disorders, sometimes leading to fatal outcome).

If you suspect a significant overdose of the drug (doses equivalent to more than 10 tablets for an adult or more than 50 mg / kg of body weight for a child), immediate hospitalization is necessary.

Treatment: symptomatic, if necessary - anticonvulsant therapy, measures to maintain vital functions.

Interaction:

Enhances the anti-inflammatory effect of glucocorticoid agents.

With the simultaneous administration of thioktovyh kilo and cisplatin, there is a decrease in the effectiveness of cisplatin.

Thioctic acid binds metals, so it should not be prescribed simultaneously with preparations containing metals (for example, preparations of iron, magnesium, calcium) - the interval between the intake should be at least 2 hours.

With the simultaneous use of thioctic acid and insulin or oral hypoglycemic drugs, their effect may be enhanced.

Ethanol and its metabolites weaken the action of thioctic acid.

Special instructions:

Patients taking the drug Espa-Lipon, should refrain from drinking alcohol. During the treatment period, regular monitoring of glucose concentration (especially at the beginning of therapy) in patients with diabetes mellitus is necessary. In some

it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia.

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

The drug does not affect the ability to drive vehicles and work with mechanisms that require increased attention.

Form release / dosage:

Film coated tablets 600 mg.

For 10 tablets in a blister of PVC / A1 foil. By 3, 6 or 10 blisters together with instructions for use in cardboard pack.

Packaging:

Film coated tablets 600 mg.

For 10 tablets in a blister of PVC / A1 foil. By 3, 6 or 10 blisters together with instructions for use in cardboard pack.

Storage conditions:

At a temperature of no higher than 25 ° C in a dark place.

Keep out of the reach of children.

Shelf life:

3 years.

Do not use after expiry date.

Terms of leave from pharmacies:On prescription

Registration number:П N012834 / 01

Date of registration:14.02.2011

The owner of the registration certificate:Esparma GmbHEsparma GmbH Germany

Manufacturer: & nbsp

ESPARMA, GmbH Germany

Representation: & nbspESPARMA GmbH ESPARMA GmbH Germany

Information update date: & nbsp07.09.2015

Illustrated instructions

Instructions

Espa Lipon (Espa-lipon®)