Berlition 300 mg 30 pcs. film-coated tablets

Composition and release form

in brown glass ampoules of 12 ml; in a cardboard box there are 5, 10 or 20 ampoules.

in a blister pack 10 pcs.; There are 3, 6 or 10 packs in a cardboard box.

pharmachologic effect

Pharmacological action - hepatoprotective, hypolipidemic, hypocholesterolemic, hypoglycemic.

As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids. Helps reduce blood glucose and increase glycogen content in the liver, as well as overcome insulin resistance. By the nature of its biochemical action it is close to B vitamins. Participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function. The use of trometamol salt of thioctic acid (which has a neutral reaction) in solutions for intravenous administration can reduce the severity of adverse reactions.

Berlition 300 mg 30 pcs. film-coated tablets

pharmachologic effect

Metabolic agent.

Composition and release form Berlition 300 mg 30 pcs. film-coated tablets

Tablets - 1 tablet:

• Active ingredient: thioctic acid - 300 mg;
• Excipients: lactose monohydrate - 60.00 mg, croscarmellose sodium -24.00 mg, colloidal silicon dioxide - 18.00 mg, microcrystalline cellulose -165.00 mg, povidone (K = 30) - 21.00 mg, magnesium stearate - 12.00 mg;
• Film shell: Opadry OY-S-22898 yellow - 12.00 mg, consisting of: hypromellose - 6.5970 mg, titanium dioxide (E 171) - 3.9134 mg, sodium lauryl sulfate - 0.7096 mg, liquid paraffin - 0 .6760 mg, quinoline yellow dye (E 104) - 0.0750 mg, sunset yellow dye (E 110) - 0.0290 mg; liquid paraffin - 3.00 mg.

1, 2 or 4 cardboard contour packages with instructions for use of the drug in a cardboard box.

Film-coated tablets, 300 mg.

10 tablets in a blister pack (blister) [PVC/PVDC/aluminum foil]. 3, 6 or 10 blisters along with instructions for use are placed in a cardboard box.

Description of the dosage form

Round, biconvex, film-coated tablets, pale yellow in color, scored on one side.

Cross-sectional appearance: uneven, granular surface, light yellow in color.

Characteristic

Thioctic acid is an endogenous antioxidant (binds free radicals); it is formed in the body during the oxidative decarboxylation of alpha-keto acids.

Directions for use and doses

Take 2 tablets (600 mg) of Berlition® 300 orally once a day. Daily dose – 600 mg. The tablets are taken on an empty stomach, approximately 30 minutes before meals, without chewing, with a sufficient amount of liquid. Long-term use of the drug is possible.

The duration of the course of treatment and the possibility of its repetition is determined by the doctor.

Pharmacodynamics

Thioctic (alpha-lipoic) acid is an endogenous antioxidant with direct (binds free radicals) and indirect (restores intracellular glutathione levels, increases superoxide dismutase activity).

As a coenzyme of mitochondrial multienzyme complexes, it participates in the oxidative decarboxylation of pyruvic acid and alpha-keto acids.

Helps reduce the concentration of glucose in the blood and increase the concentration of glycogen in the liver, and also reduces insulin resistance.

Thioctic acid is an endogenous vitamin-like substance and, in terms of the nature of its biochemical action, is close to B vitamins.

Improves neuronal trophism, participates in the regulation of lipid and carbohydrate metabolism, stimulates cholesterol metabolism, and improves liver function.

Pharmacokinetics

When taken orally, it is quickly absorbed from the gastrointestinal tract (food intake reduces absorption).

The time to reach maximum concentration in blood plasma is 25-60 minutes.

The absolute bioavailability of thioctic acid when taken orally is 30%.

Has a “first pass” effect through the liver.

The formation of metabolites occurs as a result of side chain oxidation and conjugation.

Volume of distribution is about 450 ml/kg.

Thioctic acid and its metabolites are excreted by the kidneys (80-90%).

The half-life is 25 minutes.

Total plasma clearance is 10 - 15 ml/min/kg.

Indications for use Berlition 300 mg 30 pcs. film-coated tablets

• diabetic polyneuropathy;
• alcoholic polyneuropathy.

Contraindications

• hypersensitivity to thioctic acid or other components of the drug;
• lactase deficiency, hereditary lactose intolerance, glucose-galactose malabsorption syndrome;
• pregnancy, lactation period;
• children under 18 years of age (the effectiveness and safety of the drug have not been established).

Application of Berlition 300 mg 30 pcs. film-coated tablets during pregnancy and breastfeeding

The use of Berlition® 300 during pregnancy is contraindicated due to the lack of sufficient clinical experience with the use of thioctic acid during pregnancy.

Reproductive toxicity studies did not reveal any risks to fertility, effects on fetal development or any embryotoxic properties of the drug. The use of Berlition® 300 during lactation is contraindicated due to the lack of data on the penetration of thioctic acid into breast milk.

special instructions

In patients with diabetes mellitus taking insulin or oral hypoglycemic agents, constant monitoring of plasma glucose concentrations is necessary, especially at the initial stage of therapy. In some cases, it may be necessary to reduce the dose of insulin or oral hypoglycemic agent to avoid the development of hypoglycemia. Concomitant food intake may interfere with the absorption of the drug. Alcohol intake reduces the effectiveness of treatment with Berlition® 300, so patients during therapy with Berlition® 300 should refrain from drinking alcohol during the entire course of treatment, and also, if possible, in between courses.

The effect of the drug on the ability to drive vehicles and operate machinery

The effect of Berlition® 300 on the ability to drive vehicles and operate machinery has not been specifically studied, therefore, during treatment with Berlition® 300, care should be taken when driving vehicles and engaging in potentially hazardous activities that require increased concentration and speed of psychomotor reactions.

Storage conditions

Store at a temperature not exceeding 25°C.

Keep the medicine out of the reach of children!

Storage conditions:

Store at a temperature not exceeding 25° C.

Overdose

Symptoms: nausea, vomiting, headache. In severe cases (when taking more than 20 tablets of 300 mg for adults or at a dose of >50 mg/kg body weight in children): psychomotor agitation or clouding of consciousness, generalized convulsions, severe acid-base imbalance with lactic acidosis, hypoglycemia (up to development of coma), acute necrosis of skeletal muscles, hemolysis, disseminated intravascular coagulation syndrome, suppression of bone marrow activity, multiple organ failure. Treatment: If severe intoxication with thioctic acid is suspected, emergency hospitalization is recommended and the initiation of measures in accordance with the general principles adopted for accidental poisoning (inducing vomiting, gastric lavage, taking activated charcoal, etc.). Treatment of generalized seizures, lactic acidosis and other life-threatening consequences of intoxication should be carried out in accordance with the principles of modern intensive care and should be symptomatic. There is no specific antidote. Hemodialysis, hemoperfusion, or filtration methods with forced removal of thioctic acid are not effective.

Side effects Berlition 300 mg 30 pcs. film-coated tablets

Possible side effects when using the drug Berlition® 300 are listed below in descending frequency of occurrence: very often (1 >1/10), often (>1/100.1/1000.1/10000,

From the nervous system:

Very rare: change or disturbance of taste sensations;

From the gastrointestinal tract:

Very rare: nausea, vomiting, abdominal pain, diarrhea;

From the side of metabolism:

Very rare: decreased blood glucose concentration (due to improved glucose absorption); Complaints indicative of a hypoglycemic state, such as dizziness, increased sweating, headache and blurred vision, have been reported.

From the immune system:

Very rare: allergic reactions such as skin rash, urticaria (urticarial rash), itching, and in some cases anaphylactic shock.

Drug interactions

Concomitant use of Berlition® 300 with cisplatin reduces the effectiveness of the latter. The simultaneous use of Berlition® 300 and iron and magnesium preparations, as well as the consumption of dairy products (due to the calcium content in them) is not recommended (due to the formation of complexes with metals). The interval between doses should be at least 2 hours. The drug Berlition® 300 enhances the hypoglycemic effect of insulin and oral hypoglycemic agents.

Ethanol reduces the therapeutic activity of Berlition® 300.

Pharmacokinetics

When taken orally, it is quickly and completely absorbed from the gastrointestinal tract (taken with food reduces absorption). Time to reach Cmax is 40–60 minutes. Bioavailability - 30%. Has a “first pass” effect through the liver. The formation of metabolites occurs as a result of side chain oxidation and conjugation. Volume of distribution is about 450 ml/kg. The main metabolic pathways are oxidation and conjugation. Thioctic acid and its metabolites are excreted by the kidneys (80–90%). T1/2 - 20–50 min. Total plasma Cl - 10–15 ml/min.

Berlition 300, tablets 300 mg, 30 pcs.

Manufacturer

Berlin-Chemie/Menarini, Germany

Compound

Active ingredients: thioctic acid 300 mg. Excipients: 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: Opadry OY-S-22898 yellow - 12 mg (hypromellose - 6.597 mg, titanium dioxide (E171) - 3.9134 mg, sodium lauryl sulfate - 0.7096 mg, liquid paraffin - 0.676 mg, quinoline yellow dye (E104) -0.075 mg, sunset yellow dye (E110) - 0.029 mg, liquid paraffin - 3 mg).

pharmachologic effect

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

By the nature of its 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 effects.

Pharmacokinetics

Suction and distribution

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

Vd - about 450 ml/kg.

Metabolism and excretion

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 breastfeeding

The use of Berlition® 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 in using the drug); - breastfeeding (there is no sufficient experience in using the drug).

Side effects

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

Metabolism: hypoglycemia (due to improved glucose absorption).

Allergic reactions: in some cases - urticaria.

Interaction

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

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

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

When used simultaneously, Berlition® 300 enhances the hypoglycemic effect of insulin and oral hypoglycemic agents.

How to take, course of administration and dosage

Orally prescribed 600 mg (2 tablets) 1 time/day. The 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 drug solution should be protected from light, for example, using aluminum foil. The solution, protected from light, can be stored for approximately 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 oral hypoglycemic drug to avoid the development of hypoglycemia.

Patients taking Berlition® 300 should avoid drinking alcohol.

Release form

Film-coated tablets

Storage conditions

In a place protected from light, at a temperature not exceeding 25 °C

Best before date

2 years

Active substance

Thioctic acid

Conditions for dispensing from pharmacies

On prescription

Dosage form

pills

Purpose

For adults as prescribed by a doctor

Indications

Type 2 diabetes, Type 1 diabetes, Alcoholism

Information in the State Register of Medicines

Go

Barcode and weight

Barcode: 4630011650046, 4013054008652 Weight: 0.029 kg

Directions for use and doses

IV, inside. For severe forms of polyneuropathy, 12-24 ml (300-600 mg alpha-lipoic acid) per day for 2-4 weeks. To do this, 1–2 ampoules of the drug are diluted in 250 ml of physiological 0.9% sodium chloride solution and administered dropwise over approximately 30 minutes. Subsequently, they switch to maintenance therapy with Berlition 300 in the form of tablets at a dose of 300 mg per day.

For the treatment of polyneuropathy - 1 table. 1–2 times a day (300–600 mg alpha lipoic acid).