Description

Tationil 600mg/4ml 10 ampoules + 10 flasks

Pharmacodynamics

Tationil Glutathione is a tripeptide composed of glutamic acid, cysteine, and glycine. It plays a crucial role in various biological processes and acts as a detoxifier, protecting cells against the harmful effects of xenobiotics, free radicals, and radiation. Preclinical and clinical studies have demonstrated the protective effects of glutathione in conditions that cause pathological cell damage, such as poisoning from substances like alcohol, paracetamol, salicylates, phenobarbital, tricyclic antidepressants, and organophosphate insecticides. Additionally, glutathione has been found to influence the activity of certain chemotherapeutic drugs, reducing oxidative stress associated with the tumor process. Glutathione is used to prevent neurotoxicity induced by chemotherapeutic drugs like cisplatin and its derivatives, which tend to accumulate in the peripheral nervous system.

Tationil Indications for Use

Glutathione serves multiple biochemical functions at the cellular level. Its sulfhydryl group, found in the cysteine component, is highly nucleophilic and acts as a target for electrophilic reactions involving certain chemicals and their active metabolites. This reaction helps protect key nucleophilic regions in cells, preventing damage. Glutathione also reacts with various organic oxidized metabolites, producing less toxic compounds that can be easily metabolized and excreted from the body. Decreased levels of glutathione in cells can occur due to malnutrition, illnesses, medications, or drugs. Glutathione plays a protective role in animals and humans, reducing the toxic effects of substances like salicylic acid, organophosphorus insecticides, antineoplastics, ethyl alcohol, and penicillic acid.

Dosage Form

Lyophilized powder for the preparation of an intravenous solution, containing 600 mg of glutathione sodium salt, and a solvent of 4 ml water for injection.

Description

The powder is a crystalline, hygroscopic substance ranging from white to yellowish in color. Once reconstituted, the solution appears as a clear, colorless, or light yellow liquid.

Pharmacotherapeutic Group

Antidotes with pharmacological properties.

Pharmacokinetics

Following intravenous infusion of 2 g/m² of glutathione, plasma concentrations of total glutathione significantly increase. The exogenous glutathione has a volume of distribution of 176 ± 107 ml/kg and a half-life of 14.1 ± 9.2 minutes. The infusion also leads to an increase in plasma cysteine concentration. Urinary excretion of glutathione and cysteine shows significant increases 90 minutes after injection.

Tationil Dosage and Administration

The recommended daily dose of TAD 600 for patients receiving cisplatin-based chemotherapy is usually 1.5 g/m² (equivalent to 2.5 g), administered via slow intravenous infusion. The dosage may vary based on factors such as age, weight, clinical condition, and the chemotherapy regimen. Glutathione should be infused 15-30 minutes prior to chemotherapy. In long-term treatment, the dose can be reduced to 600 mg or 300 mg, administered intramuscularly or slowly intravenously.

Tationil Contraindications

Hypersensitivity to the active ingredient.

Drug Interactions

No pharmacological interactions with glutathione have been reported in the literature. TAD 600, at recommended doses, does not interfere with the therapeutic activity of chemotherapy drugs.

Special Instructions

If adverse reactions occur following intravenous administration, the drug should be discontinued immediately. Prior to use, visually inspect the product for the presence of particles or deviations in color. Do not use if the solution is turbid or shows signs of precipitation.

Overdose

No cases of overdose have been reported. Symptomatic treatment may be administered if necessary.

Release Form and Packaging

The drug is supplied in transparent glass vials containing 0.646 g of powder, sealed with a rubber stopper and aluminum cap. Each vial is accompanied by a 4 ml solvent in a transparent glass bottle, also sealed with a rubber stopper and aluminum cap. A package contains 10 vials of the drug, 10 bottles of solvent, and instructions for medical use in both the state and Russian languages.

Storage Conditions

Store below 25 °C. Keep out of reach of children. Do not use after the expiration date.

Shelf Life

5 years. Do not use after the expiration date.

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Intravenous administration of glutathione protects parenchymal and non-parenchymal liver cells against reperfusion injury following rat liver transplantation