Thiolepta, 300 mg 30 pcs

Pharmacodynamics

Thioctic acid (alpha-lipoic acid) is an endogenous antioxidant (binds free radicals), in the body is formed during oxidative decarboxylation of alpha-keto acids. As a coenzyme of mitochondrial multienzyme complexes it participates in oxidative decarboxylation of pyruvic acid and alpha-keto acids. By the nature of its biochemical action is close to the B vitamins.

It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic action. Helps to reduce blood glucose and increase glycogen in the liver, as well as reducing insulin resistance. Participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function. It improves the trophism of neurons. Use of meglumine salt of thioctic acid (which has a neutral reaction) reduces the severity of adverse reactions.

Pharmacokinetics

When taken orally, it is quickly and completely absorbed from the gastrointestinal tract (ingestion with food reduces absorption). Time to reach maximum concentration – 40-60 minutes. Bioavailability – 30%.

It has the effect of “first passage” through the liver. Formation of metabolites occurs as a result of side chain oxidation and conjugation.

The volume of distribution is about 450 ml/kg. Thioctic acid and its metabolites are excreted by the kidneys (80-90%). Half-life is 20-50 min. Total plasma clearance is 10-15 ml/min.

Indications

Type 2 diabetes

Diabetic and alcoholic polyneuropathy.

Active ingredient

Thioctic acid

Composition

1 film-coated tablet contains:

the active ingredient:

thioctic acid – 300 mg;

excipients:

potato starch,

aerosil A-300 (colloidal silicon dioxide),

primellose (croscarmellose sodium),

calcium stearate,

milk sugar (lactose),

microcrystalline cellulose,

castor oil,

selecote AQ -01812 (hydroxypropyl methylcellulose (hypromellose),

polyethylene glycol 400 (macrogol 400),

polyethylene glycol 6000 (macrogol 6000),

titanium dioxide,

iron oxide yellow,

quinoline yellow.

How to take, the dosage

Prescribe orally in 600 mg (2 tablets) once a day.

Tiolepta tablets are taken on an empty stomach about 30 minutes before the first meal, without chewing and with a small amount of liquid.

The duration of treatment is determined by the doctor.

Interaction

Thioleptic acid reacts with ionic metal complexes (e.g., with cisplatin), so when using Thiolepta simultaneously, it may reduce the effect of cisplatin. After taking Thiolepta in the morning, it is recommended to use preparations of iron, magnesium, and dairy products (due to their calcium content) in the afternoon or evening.

Tiolepta increases the effect of insulin and oral hypoglycemic agents when used concomitantly.

Alcohol (ethanol) reduces the therapeutic activity of thioctic acid.

Special Instructions

In diabetic patients, continuous monitoring of blood glucose concentrations is necessary, especially in the initial phase of therapy. In some cases, it is necessary to reduce the dose of insulin or oral hypoglycemic drug to avoid the development of hypoglycemia.

At the time of treatment, patients should refrain from drinking alcohol and exercise caution when driving vehicles and engaging in other potentially dangerous activities requiring increased attention and rapid mental and motor reactions.

Contraindications

• High sensitivity to the components of the drug Tiolepta.
• Pregnancy, breastfeeding (there is not enough experience in using the drug).
• Childhood (effectiveness and safety of use have not been established).

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Side effects

Thiolepta is usually well tolerated.

Possible dyspepsia, including nausea, vomiting, heartburn.

In some cases there may be skin allergic reactions (urticaria).

Possible development of hypoglycemia (due to improved glucose absorption).

Overdose

Symptoms: headache, nausea, vomiting.

Treatment: conducting symptomatic therapy. There is no specific antidote.

Similarities

Berlithione 300, Berlithione 300 oral, Thioctacid BV, Tiogamma, Octolipen, Berlithione, Thioctic acid