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®

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FARMACEUTICAL BALKANS doo Novi Bechei Republic of Serbia

Dosage form: & nbspTabletki.

Composition:

One tablet contains:

active substance: morpholinium-methyl-triazolyl-thioacetate (thiotriazoline) 200 mg;

Excipients: Potato starch 16 mg Povidone low molecular 8 mg, 5.6 mg sucrose, microcrystalline cellulose 8 mg Calcium stearate 2.4 mg.

Description:Round, flat-cylindrical tablets of white or almost white color, with a facet and a risk.

Pharmacotherapeutic group:antioxidant

ATX: & nbsp

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

Pharmacodynamics:

Pharmacological effect morpholinium-triazolyl-methyl-thioacetate due antiischemic, membrane stabilizing, antihypoxic and immunomodulatory effects.

Exposure of the drug is realized by increasing the compensatory activation of anaerobic glycolysis and oxidation in the activation of Krebs cycle with preservation of intracellular adenosine triphosphate fund. The presence in the structure of the thiotriazoline molecule of thiol of sulfur,which is characterized by oxidation-reduction properties, and tertiary nitrogen, which binds excess hydrogen ions, causes the activation of the antioxidant system. The restorative properties of the needle group cause a reaction with the active forms of oxygen and lipid radicals. Reactivation of antiradical enzymes - superoxide dismutase, catalase and glutathione peroxidase - prevents the initiation of reactive oxygen species.

Tiotriazolin® is used in the treatment of liver diseases, taking into account its gethoprotective properties. The drug prevents the destruction of hepatocytes, reduces the degree of fatty infiltration and the spread of centrolobular liver necrosis, promotes the processes of reparative regeneration of hepatocytes, normalizes protein, carbohydrate, lipid and pigment metabolism in them. Increases the rate of synthesis and excretion of bile, normalizes its chemical composition.

The effect of morpholinium-methyl-triazolyl-thioacetate leads to inhibition of lipid oxidation in ischemic areas of the myocardium, a decrease in the sensitivity of the myocardium to catecholamines, prevention of progressive inhibition of the contractile function of the heart, stabilization and a decrease in the necrosis zone and myocardial ischemia, respectively.Improvement of rheological properties of blood is carried out due to the activation of the fibrinolytic system. Improves metabolic processes in the myocardium.

Reduces the number of angina attacks and the number of taken nitroglycerin tablets in order to stop angina attacks (according to the results of a clinical trial).

Pharmacokinetics:

After oral administration, morpholinium-methyl-triazolyl-thioacetate is rapidly absorbed in the gastrointestinal tract, its absolute bioavailability is 53%. The maximum concentration in the blood plasma is achieved through 1.6 hours after a single oral intake at a dose of 200 mg. The half-life is almost 8 hours. Morpholinium-methyl-triazolyl-thioacetate is excreted mainly by the kidneys.

Indications:

Toxic liver damage, incl. alcoholic, viral and medicinal origin (antibiotics, antitumoral, antitubercular, antiviral drugs, tricyclic antidepressants, oral contraceptives, etc.).

Chronic alcoholic hepatitis of minimal and moderate activity.

Chronic viral hepatitis, fatty liver, liver cirrhosis.

Ischemic heart disease: prevention of attacks of stable angina pectoris (as part of combination therapy).

Contraindications:

Hypersensitivity to morpholinium-methyl-triazolyl-thioacetate and other auxiliary components of the preparation; moderate and severe renal impairment (creatinine clearance (CK) <60 mL / min); children under 18 years of age (efficacy and safety not established).

Pregnancy and the period of breastfeeding.

Deficiency of sugar / isomaltase, intolerance to fructose, glucose-galactose malabsorption.

Carefully:

FROMdiabetes mellitus, renal dysfunction (KK> 60 ml / min) (experience of use is limited).

Pregnancy and lactation:

In pre-clinical studies, there is no teratogenic effect, but due to the lack of data on the use of the drug in pregnant women, administration of Tiotriazolin® during pregnancy is not recommended.

It is not known whether morpholinium-methyl-triazolyl-thioacetate is excreted in breast milk. If you need to use the drug Tiotrizolin® during lactation, breastfeeding should be discontinued.

Dosing and Administration:

Inside. Do not chew, squeezed water.

Toxic liver damage, chronic alcoholic hepatitis: Tiotriazolin® is prescribed 1 tablet 3-4 times a day.

Chronic viral hepatitis, fatty liver, liver cirrhosis: Tiotriazolin® is prescribed 1 tablet 3-4 times a day.

The course of treatment is 20-30 days.

The maximum daily dose is 800 mg.

Prevention of attacks of stable angina pectoris: Tiotriazolin® is prescribed 1 tablet 3 times a day. The course of treatment is 8 weeks.

The decision on the repeated course of treatment is determined by the doctor individually, depending on the severity and characteristics of the course of the disease.

Use in patients with impaired renal function

In patients with mild impairment of renal function (CK> 60 mL / min), dose adjustment is not required. In patients with moderate and severe renal dysfunction (CC <60 mL / min), the use of Tiotriazolin® is contraindicated (see "Contraindications").

Pediatric Use

Efficacy and safety in children under 18 years of age have not been established.

Use in elderly patients (over 65 years)

Correction of the dose is not required.

Side effects:

The frequency of adverse reactions was determined in accordance with the recommendations of the World Health Organization: very often (> 1/10); often (> 1/100.<1/10); uncommon (> 1/1000, <1/100, rare (> 1/10 000, <1/1000), very rare (<1/10 000), including isolated reports; not known frequency (frequency can not be calculated from the available data).

From the gastrointestinal tract: very rarely - nausea, dryness of the oral mucosa, bloating.

From the central and peripheral nervous system: very rarely - dizziness, noise in the ears.

From the side of the cardiovascular system: very rarely - tachycardia, increased arterial pressure, pain in the heart, arrhythmias.

From the respiratory system: very rarely - shortness of breath, bronchospasm.

Allergic reactions: very rarely - reactions of hypersensitivity, angioedema.

From the skin: very rarely - skin itching, skin hyperemia, urticaria.

Are common: very rarely - general weakness, fever.

Overdose:

Cases of overdose are unknown.

Symptoms: possibly increased side effects.

Treatment: When ingesting a large amount of the drug, it is necessary to rinse the stomach. Treatment is symptomatic. There is no specific antidote.

Interaction:

Thiotriazolin® can be used with standard therapy of hepatitis and stable angina (nitrates, angiotensin converting enzyme inhibitors, β- adrenoblockers, blockers of "slow" calcium channels, antiplatelet agents, angiotensin receptor antagonists II, inhibitors of HMG-CoA reductase (sateen)).

Special instructions:

Do not use to stop angina attacks!

The composition of the tablets includes sucrose - 5.6 mg in one tablet, i.e. in the maximum daily dose (4 tablets) contains 22.4 mg of sucrose, which should be taken into account in patients with diabetes.

The use of Tiotriazolin® in children under 18 years of age is not recommended (no experience is available).

When used in elderly patients (over 65 years of age), due to the age-related decrease in kidney function, periodic monitoring of creatinine, urea is necessary.

Effect on the ability to drive transp. cf. and fur:

The effect of the drug on the ability to drive vehicles and care with mechanisms has not been studied. However, given the possible risk of developing dizziness, care must be taken when driving vehicles and working with mechanisms.

Form release / dosage:Tablets, 200 mg.

Packaging:

10 tablets per contour cell packaging made of polyvinylchloride film and aluminum foil.

9 contour mesh packages together with the instruction for use are placed in a pack of cardboard.

Storage conditions:

In the dark place at a temperature of 15 to 25 ° C.

Keep out of the reach of children.

Shelf life:

2 years.

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

Terms of leave from pharmacies:On prescription

Registration number:LP-001998

Date of registration:08.02.2013 / 22.12.2015

Expiration Date:08.02.2018

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

Manufacturer: & nbsp

KIEVMEDPREPARAT, PAO Ukraine

Pharmaceutical balkans doo novi bečej Republic of Serbia

Representation: & nbspARTERIUM Corporation ARTERIUM Corporation Ukraine

Information update date: & nbsp03.01.2016

Illustrated instructions

Instructions

Tiotriazolin® (Thiotriasoline®)