Berlition

Берлитион Drug photo

The description is actual on 10.06.2016

  • Latin name: Berlithion
  • ATH code: A16AX01
  • Active ingredient: Thioctic acid (Thioctic acid)
  • Producer: Jenahexal Pharma, EVER Pharma Jena GmbH, Haupt Pharma Wolfratshausen (Germany)

Structure

One ampoule can include 300 mg or 600 mg of thioctic acid. In addition: propylene glycol, ethylene diamine, injection water.

One capsule can include 300 mg or 600 mg of thioctic acid. In addition: solid fat, srednetsepochechny triglycerides, gelatin, sorbite solution, glycerin, amaranth, titanium dioxide.

One tablet includes 300 mg of thioctic acid. In addition: magnesium stearate, monohydrate of lactose, croscarmellose sodium, MKTs, colloid silicon dioxide, povidone, yellow Opadray of OY-S-22898 (as a cover).

Release form

Medicine Berlition is made in the form of the concentrated (concentrate) of infusion solution in ampoules on 12 ml for 300 mg and on 24 ml for 600 mg No. 5 or No. 10; in the form of capsules on 300 mg and 600 mg No. 15 or No. 30; in the form of tablets on 300 mg No. 30.

Pharmacological action

Gipokholesterinemichesky, gepatoprotektorny, hypolipidemic, hypoglycemic.

Pharmacodynamics and pharmacokinetics

Berlition includes as active ingredient thioctic acid (alpha lipoic acid) in the form of etilendiaminovy salt which is the endogenous antioxidant connecting free radicals with a coenzyme of processes of decarboxylation of alpha ketonic acids.

The carried-out treatment by Berlition promotes reduction of plasma content of glucose and increase in level of a hepatic glycogen, weakens an insulinorezistentnost, stimulates cholesteric, regulates lipidic and carbohydrate exchanges. Thioctic acid, thanks to antioxidant activity inherent in it, protects cells of a human body from the damage put with products of their disintegration.

At patients with a diabetes mellitus thioctic acid reduces allocation of end products of a proteinaceous glikirovaniye in nervous cells, increases microcirculation and improves an endoneural blood stream, increases physiological concentration of antioxidant of glutathione. Thanks to ability to reduce the plasma content of glucose makes impact on an alternative way of its metabolism.

Thioctic acid reduces cumulation of pathological poliolovy metabolites, thereby promoting decrease in puffiness of nervous tissue. Normalizes carrying out nervous impulses and energy balance. Participating in a fatty metabolism, increases biosynthesis of phospholipids owing to what the damaged structure of membranes of cells is reformed. Liquidates toxic influence of products of a metabolism of alcohol (pyruvic acid, acetic aldehyde), reduces excess allocation of molecules of free radicals of oxygen, reduces ischemia and an endoneural hypoxia, softening the polyneuropathy symptomatology which is shown in the form of paresthesias, a burning sensation, numbness and extremity pains.

Proceeding from the aforesaid, thioctic acid is characterized by the hypoglycemic, neurotrophic and antioxidant activity, and also the action improving a lipidic metabolism. Use in drug of active ingredient in the form of etilendiaminovy salt allows to reduce expressiveness of probable negative by-effects of thioctic acid.

At oral administration thioctic acid is quickly and entirely soaked up from a gastrointestinal tract (in parallel the eaten food reduces absorption a little). TCmax in plasma varies within 25-60 minutes (at in introduction of 10-11 minutes). Plasma Cmax makes 25-38 mkg/ml. Bioavailability about 30%; Vd about 450 ml/kg; AUC approximately 5 mkg/h/ml.

Thioctic acid is subject to effect of "the first passing" through a liver. Allocation of products of a metabolism becomes possible thanks to processes of conjugation and oxidation of a side chain. Excretion in the form of metabolites for 80-90% is carried out by kidneys. T1/2 takes about 25 minutes. The cumulative plasma clearance is equal to 10-15 ml/min.

Indications to Berlition's use

The indication to Berlition's use is treatment of alcoholic and diabetic polyneuropathy.

Contraindications

Berlition is contraindicated to patients till 18 years, the patient with personal hypersensitivity to active (thioctic acid) or to any of auxiliary ingredients of the medicinal odds of drug used in treatment, and also the feeding and pregnant women.

Tablets Berlition 300, in connection with existence in this dosage form of lactose, are contraindicated to patients with any hereditary intolerance of sugars.

Side effects

For all dosage forms of drug

In addition for parenteral forms of drug

  • diplopia;
  • burning in the area carrying out an injection;
  • spasms;
  • trombotsitopatiya;
  • purpura;
  • difficulty of breath and increase in intracranial pressure (were noted in cases fast in/in introductions and passed spontaneously).

In addition for peroral forms of drug

  • nausea/vomiting;
  • diarrhea (diarrhea);
  • feeling of abdominal pains.

Berlition, application instruction (Way and dosage)

The official application instruction Berlition 300 is identical to the application instruction Berlition 600 for all dosage forms of this drug (injection solution, capsules, tablets).

Medicine Berlition intended for preparation of infusions initially appoint in a daily dosage 300-600 mg which daily in/in is kapelno entered for at least 30 minutes, within 2-4 weeks. Just before carrying out infusion prepare drug solution by mixing of contents of 1 ampoule on 300 mg (12 ml) or 600 mg (24 ml) from 250 ml of injection Sodium chloride (0,9%).

In connection with a photosensitivity of the prepared infusion solution it needs to be protected from influence of light, having wound for example with aluminum foil. In such look solution can keep the properties for about 6 hours.

After carrying out 2-4-week therapy with use of infusions pass to treatment using peroral dosage forms of drug. Capsules or tablets Berlition appoint 300-600 mg in a daily maintenance dose and take on an empty stomach entirely approximately for half an hour to food, washing down 100-200 ml of water.

Duration of an infusional and peroral therapeutic course, as well as possibility of their repeated carrying out, the attending physician in an individual order defines.

Overdose

The negative symptomatology of moderate overdose by thioctic acid is shown by the nausea passing into vomiting and headaches.

In hard cases opacification of consciousness or psychomotor excitement, generalized spasms, a hypoglycemia (before forming of a coma), the expressed acid-base frustration with a lactacidemia, an acute necrosis of muscular tissue of a skeleton, multiorgan insufficiency, hemolysis, the IDCS, oppression of activity of marrow can be noted.

At suspicion on toxic effect of thioctic acid (for example, at reception more than 80 mg of a remedy on 1 kilogram of weight) recommend to carry out urgently hospitalization of the patient and to start immediately implementation of the standard measures of counteraction to accidental poisoning (cleaning of a gastrointestinal tract, reception of sorbents and so forth). Further carrying out symptomatic therapy is shown.

Treatment of a lactacidemia, generalized spasms and other potentially life-threatening the patient of painful states has to happen in an intensive care unit. The specific antidote is not revealed. Hemoperfusion, a hemodialysis and other methods of forced filtering are inefficient.

Interaction

For thioctic acid its interaction with the remedies including ionic complexes of metals is characteristic (for example, with platinum drug Cisplatinum). In this regard the combined Berlition's use and drugs of metals can lead to decrease in efficiency of the last.

Parallel reception of etanolsoderzhashchy medicines leads to reduction of therapeutic action of Berlition.

Thioctic acid increases hypoglycemic activity of oral hypoglycemic drugs and insulin that can demand correction of their dosing mode.

Berlition for injections is incompatible with the medicinal solutions which are used as bases for preparation of infusional mixes including Ringer's solution and the Dextrose, and also solutions reacting with disulfide bridges or SH groups.

Thioctic acid is capable to create almost insoluble complexes with molecules of sugars.

Terms of sale

All existing dosage forms of drug Berlition are prescription.

Storage conditions

Berlition's ampoules should be preserved in original cardboard packing in the dark place, at a temperature at most 25 °C. Capsules and tablets of drug demand the similar temperature of storage.

Period of validity

Injection Berlition on 300 mg and 600 mg it is possible to store for 3 years; capsules on 300 mg – 3 years, capsules on 600 mg – 2,5 years; tablets on 300 mg – 2 years.

Special instructions

The patients with a diabetes mellitus taking oral hypoglycemic medicine or insulin against therapy by Berlition demand continuous supervision over the plasma content of glucose (in particular at the beginning of carrying out treatment) and in need of correction (decrease) of the dosing mode of hypoglycemic drugs.

At use of injection dosage forms of Berlition emergence of the phenomena of hypersensitivity is possible. In case of the negative symptoms which are characterized by an itch, an indisposition, nausea Berlition's introduction it is necessary to stop immediately.

Freshly cooked infusion solution Berlition needs to be protected from influence of light.

At purpose of tablets Berlition the doctor has to consider contents in this dosage form of drug of lactose that can be important for patients with intolerance of sugars.

Analogs

Berlition's analogs similar to it the medical effects, are provided by various groups of drugs in this connection, the price of analogs of Berlition fluctuates in quite extensive limits from several tens to several thousand rubles.

The most known analogs are:

Zdravzona

  • Berlition the 300th concentrate for solution 25mgml 12 of ml No. 5 of an ampulyberlin-Hema of AG
  • Berlition of 300 mg No. 30 of a tabletkiberlin-Hema of AG
  • Berlition the 600th concentrate for solution 25mgml 24 of ml No. 5 of an ampoule

Drugstore of IFC

  • Berlition the 600th solution for in 600 mg 24 ml No. 5, Berlin-Chemie/Menarini Groupgermaniya
  • Berlition the 300th solution for in 300 mg 12 ml No. 5, Berlin-Chemie/Menarini Groupgermaniya
  • Berlition 300 tbl p / about 300 mg No. 30, Berlin-Chemie/Menarini Groupgermaniya
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Apteka24

  • Berlition30
  • Berlitionberlin-Chemie/Menarini Group (Germany)
  • Berlition of 600 PIECES a concentrate for preparation of infusion solution of 600 mg of an ampoule 24 мл№5Берлин-Хеми (Germany)
  • Berlition of 300 PIECES of a capsule soft 300 mg No. of a 30berlin-Hema (Germany)
  • Berlition oralberlin-Chemie/Menarini Group (Germany)

Paniapteka

  • Berlition of 300 PIECES kaps. soft 300 mg No. of a 30berlin-Hema
  • Berlition of 300 PIECES kaps. soft 300 mg No. of a 30berlin-Hema
  • Berlition of 300 PIECES kaps. soft 300 mg No. of a 30berlin-Hema
  • Berlition of 300 PIECES kaps. soft 300 mg No. of a 30berlin-Hema

BIOSPHERE

  • ÜÑÓ½¿Ô¿«¡® 600 mg / 24 ml No. 5 konts. for solution for inf.
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Section: Gastrointestinal
in more detail

Education: Graduated from the Vinnytsia national medical university of N. I. Pirogov, pharmaceutical faculty, the higher pharmaceutical education – the specialty "Pharmacist".

Experience: Work in Koneks and Bios-Media pharmacy chains as "Druggist". Work as "Pharmacist" in Avicenna pharmacy chain of the city of Vinnytsia.

PAY ATTENTION! Information on drugs on the website is help generalizing, collected from public sources and can form the basis for making decision on use of medicines it is not aware of treatment. Before medicine use Berlition surely consult with the attending physician.