Tiotriazolin - instructions for use, dose, side effects, contraindications

Active substanceMorpholinium-methyl-triazolyl-thioacetateMorpholinium-methyl-triazolyl-thioacetate

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Tiotriazolin®

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FARMACEUTICAL BALKANS dooNovi Bechei Republic of Serbia

Tiotriazolin®

pills inwards

FARMACEUTICAL BALKANS doo Novi Bechei Republic of Serbia

Dosage form: & nbspRAsterol for intravenous and intramuscular administration.

Composition:

In 1 ml of solution contains:

Active substance: morpholinium-triazolyl-methyl-thioacetate (thiotriazoline) 25 mg in terms of 100% substance.

Excipients: water for injection up to 1 ml.

Description:

Transparent, colorless or slightly yellowish liquid.

Pharmacotherapeutic group:antioxidant

ATX: & nbsp

A.05.B.A Preparations for the treatment of liver diseases

Pharmacodynamics:

The pharmacological effect is due to anti-ischemic, antioxidant, membrane-stabilizing and immunomodulating properties. Prevents the death of hepatocytes, reduces the degree of their fatty infiltration and the spread of centrolobular liver necrosis, promotes the regeneration of hepatocytes, normalizes protein, carbohydrate, lipid and pigment exchanges. Increases the amount of synthesis and excretion of bile, normalizes its chemical composition.

Thiotriazolin® compensatory increases activation of anaerobic glycolysis, inhibition reduces oxidation in the Krebs cycle preserving intracellular ATP fund.The drug activates the antioxidant system and inhibits the oxidation of lipids in the ischemic areas.

Improves rheological properties of blood (activates the fibrinolytic system).

Pharmacokinetics:

The maximum concentration of Tiotriasoline® in blood plasma with intramuscular injection is 399 μg / ml, the time to reach the maximum concentration is 0.84 hours, with intramuscular injection and 0.1 hour with intravenous administration, the volume of distribution is 318.0 ml, the degree of absolute bioavailability 34, 6%.

Indications:

Toxic liver damage, including: alcoholic, viral and medicinal origin (antibiotics, antitumor, antituberculosis, antiviral drugs, tricyclic antidepressants, oral contraceptives, etc.).

Chronic alcoholic hepatitis of minimal and moderate activity.

Chronic viral hepatitis, fatty liver, liver cirrhosis.

Contraindications:

- Hypersensitivity to the components of the drug;

- kidney failure;

- childhood;

- period of pregnancy and lactation.

Dosing and Administration:

With chronic hepatitis Tiotriazolin® in the first 5 days of the disease is administered intramuscularly 2 ml 2.5% solution 2-3 times a day (2-3 times 50 mg), or intravenously slowly, at a rate of 2 ml / min simultaneously 4 ml 2.5 % solution (100 mg) or drip at a rate of 20-30 drops per minute (2 ampules 2.5% solution dissolved in 150 - 250 ml of physiological solution). From the fifth to the twentieth day of treatment appoint Tiotriazoline® in tablets (100 mg 3 times a day).

The course of treatment is 20-30 days.

Side effects:

Tiotriazoline®, as a rule, is well tolerated.

In the clinical applications of Tiotriasbina®, the following adverse reactions are extremely rare:

from the gastrointestinal tract: nausea, dry mouth, bloating;

from the central and peripheral nervous system: general weakness, dizziness, tinnitus;

from the cardiovascular system: tachycardia, increased blood pressure, pain in the heart, arrhythmia;

from the respiratory system: very rarely - dyspnea, attacks of suffocation, synergistic reactions, hypersensitivity reactions, fever; very rarely - Quincke's edema;

from the skin: itching, skin hyperemia, urticaria;

local reactions: In rare cases, a tingling sensation and redness at the injection site.

Overdose:

Cases of overdose are unknown.

Special instructions:

None.

Form release / dosage:

Solution for intravenous and intramuscular administration, 25 mg / ml.

Packaging:

2 ml or 4 ml in ampoules glass colorless 1 class of hydrolytic stability or in ampoules glass colorless 1 class of hydrolytic stability with a ring of kink red color or in ampoules glass colorless 1 class of hydrolytic stability with a break point of 2 ml or 5 ml respectively. For 10 ampoules with a capacity of 2 ml in a contour mesh package made of a polyvinyl chloride film.

One outline cell pack together with the instruction for use and the ampoule scarifier is put into the pack.

Or 5 ampoules with a capacity of 5 ml per contour cell pack of a polyvinyl chloride film. Two contour mesh packages together with instructions for use and a scapegrator ampoule in a pack.

When using ampoules with a ring or fracture point, the imposition of scarifiers is not provided.

Storage conditions:

Store in a dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

4 years.

Do not use the product after the expiry date printed on the package.

Terms of leave from pharmacies:On prescription

Registration number:LSR-002170/10

Date of registration:17.03.2010 / 14.01.2016

Expiration Date:Unlimited

The owner of the registration certificate:FARMACEUTICAL BALKANS doo Novi BecheiFARMACEUTICAL BALKANS doo Novi Bechei Republic of Serbia

Manufacturer: & nbsp

GALICHFARM, PAO Ukraine

Representation: & nbspARTERIUM Corporation ARTERIUM Corporation Ukraine

Information update date: & nbsp30.12.2016

Illustrated instructions

Instructions

Tiotriazolin® (Thiotriasoline®)