Berlithione 300, pills 300mg, 30pcs

Composition

Active ingredients: thioctic acid 300 mg. Auxiliary substances: lactose monohydrate – 60 mg, croscarmellose sodium-24 mg, colloidal silicon dioxide-18 mg, microcrystalline cellulose-165 mg, povidone (K-30) – 21 mg, magnesium stearate-12 mg. Shell composition: Opadray OY-S-22898 yellow – 12 mg (hypromellose-6.597 mg, titanium dioxide (E 171) – 3.9134 mg, sodium lauryl sulfate-0.7096 mg, liquid paraffin-0.676 mg, quinoline yellow dye (E 104) -0.075 mg, sunny sunset yellow dye (E 110) – 0.029 mg, liquid paraffin – 3 mg).

Pharmacological action

Pharmacodynamics

Thioctic (alpha-lipoic) acid is an endogenous antioxidant (binds free radicals), formed in the body during oxidative decarboxylation of alpha-keto acids. As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative carboxylation of pyruvic acid and alpha-keto acids. It helps to reduce blood glucose and increase liver glycogen, as well as to overcome insulin resistance.

By the nature of its biochemical action, it is close to vitamins of group B. It participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function. It has hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic effects.

Pharmacokinetics

Suction and distribution

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

Vd – about 450 ml / kg.

Metabolism and elimination

It has a “first pass” effect 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 min. Total plasma clearance is 10-15 ml/min.

Indications

Diabetic polyneuropathy. Alcoholic polyneuropathy.

Use during pregnancy and lactation

The use of Berlithione 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.

Contraindications

-Hypersensitivity to the components of the drug; – children’s age (efficacy and safety have not been established);- pregnancy (there is no sufficient experience of using the drug);- breast-feeding (there is no sufficient experience of using the drug).

Side effects

From the digestive system: possibly (after ingestion) – dyspepsia, including nausea, vomiting, heartburn.

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

Allergic reactions: in some cases – urticaria.

Composition

In vitro interaction thioctic (alpha-lipoic) acid interacts with metal ionic complexes (for example, with cisplatin). Therefore, when taken simultaneously, the effect of cisplatin may be reduced.

After taking Berlithione 300 in the morning, it is recommended to use iron and magnesium preparations, as well as to consume dairy products (due to their calcium content) in the afternoon or in the evening.

When used concomitantly, ethanol and its metabolites may reduce the therapeutic activity of thioctic (alpha-lipoic) acid.

When used concomitantly, Berlithione 300 enhances the hypoglycemic effect of insulin and oral hypoglycemic agents.

How to take, course of use and dosage

Inside,600 mg (2 tablets) is prescribed 1 time/day. Tablets are taken on an empty stomach, approximately 30 minutes before the first meal, without chewing and with a sufficient amount of liquid.

The duration of treatment is determined by the doctor individually.

Overdose

Symptoms: headache, nausea, vomiting.

Treatment: symptomatic. There is no specific antidote.

Special instructions

The solution of the drug should be protected from light, for example, using aluminum foil. Protected from light, the solution can be stored for about 6 hours. In patients with diabetes mellitus, constant monitoring of blood glucose concentration is necessary, especially at the initial stage of therapy. In some cases, it is necessary to reduce the dose of insulin or an oral hypoglycemic drug to avoid the development of hypoglycemia.

Patients taking Berlithione 300 should refrain from drinking alcohol.

Form of production

Film-coated tablets

Storage conditions

In a dark place, at a temperature not exceeding 25 °C

Shelf life

2 years

Active ingredient

Thioctic acid

Conditions of release from pharmacies

By prescription

Dosage form

Tablets

Description

For adults as directed by your doctor

Indications

Type 1 Diabetes, Type 2 Diabetes, Alcoholism