Berlition 300 tablets 300 mg, 30 pcs. (thioctic acid)

Release form

Film-coated tablets.

Packing

30 pcs

Pharmacological action

Pharmacodynamics

Thioctic ( -lipoic) acid - an endogenous antioxidant (binds free radicals), is formed in the body by oxidative decarboxylation of -keto acids. As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative carboxylation of pyruvic acid and β-keto acids. Helps reduce blood glucose and increase glycogen content in the liver, as well as overcome insulin resistance. By the nature of the biochemical action, it is close to B vitamins. Participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function. It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effect.

Pharmacokinetics

Absorption and distribution of

After oral administration, thioctic ( -lipoic) acid is rapidly and completely absorbed from the gastrointestinal tract. Intake with food reduces absorption. The time to reach Cmax is 40-60 minutes. Bioavailability is 30%.

Vd - about 450 ml / kg.

Metabolism and excretion

Has the effect of first passing through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation.

Thioctic acid and its metabolites are excreted in the urine (80-90%). T1 / 2 - 20-50 minutes. The total plasma clearance is 10-15 ml / min.

Indications

Diabetic polyneuropathy. Alcoholic polyneuropathy.

Contraindications

- Hypersensitivity to the components of the drug

- children's age (efficacy and safety have not been established)

- pregnancy (lack of sufficient experience with the drug)

- breastfeeding (lack of sufficient experience with the drug).

Use during pregnancy and lactation

UseBerlition 300 during pregnancy and lactation is contraindicated due to the lack of sufficient clinical data confirming the safety and effectiveness of the drug in this category of patients.

Dosage and administration

Inside, 600 mg (2 tablets) are prescribed once a day. The tablets are taken on an empty stomach, approximately 30 minutes before the first meal, without chewing and drinking plenty of fluids.

The duration of treatment is determined by the doctor individually.

Side effects

From the digestive system: possible (after oral administration) - dyspepsia, incl. nausea, vomiting, heartburn.

From the side of metabolism: hypoglycemia (due to improved glucose uptake).

Allergic reactions: in some cases - urticaria.

Drug Interaction

In vitro thioctic ( -lipoic) acid interacts with metal ion complexes (e.g. with cisplatin). Therefore, the simultaneous administration may reduce the effect of cisplatin.

After taking Berlition® 300 in the morning, iron, magnesium and dairy products (due to calcium content) are recommended in the afternoon or evening.

Ethanol and its metabolites may reduce the therapeutic activity of thioctic ( -lipoic) acid when used together.

When used with Berlition® 300, it enhances the hypoglycemic action of insulin and oral hypoglycemic agents.

Overdose

Symptoms: headache, nausea, vomiting.

Treatment: symptomatic. There is no specific antidote.

Storage conditions

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

Expiration

2 years.

dosage form

dosage form

tablets

Berlin-Chemie / Menarini Germany



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