Lisathyone Glutathione Injection 600 mg/3 ml – 10 Vials + Solvent Ampoules

Lisathyone® 600 mg/3 mL – Glutathione for Injection

Product Description
Lisathyone contains glutathione sodium salt, equivalent to 600 mg of glutathione per vial. It is supplied as a powder and solvent for solution for injection. Glutathione (GSH) is a physiological tripeptide made of glutamic acid, cysteine, and glycine. It plays a crucial role in detoxification, cellular defense against oxidative stress, and protection from xenobiotics and free radicals.

Therapeutic Indications

• Prophylaxis of neuropathies associated with chemotherapy using cisplatin or cisplatin analogues.

• Protective antioxidant action in patients undergoing chemotherapy to reduce oxidative damage and related side effects.

Dosage and Administration

• Posology: 1–2 vials per day, administered intramuscularly, by slow intravenous injection, or by intravenous infusion.

• The dosage depends on patient’s age, body weight, clinical condition, and chemotherapy protocol.

• For IV infusion, the reconstituted solution should be further diluted in at least 20 mL of water for injectables.

• The solution must be prepared immediately before use and administered 15–30 minutes prior to chemotherapy.

• Pediatric use: Safety and efficacy in children have not been established.

Contraindications

• Hypersensitivity to glutathione or any excipients.

Special Warnings & Precautions

• Use only for single, uninterrupted administration. Any remaining solution must be discarded.

• The product must not be used during pregnancy and lactation unless strictly necessary after benefit/risk evaluation.

• No evidence of pharmacological interactions with other medicinal products, but monitoring is advised.

Undesirable Effects

• Gastrointestinal: nausea, vomiting.

• Immune system: hypersensitivity reactions, skin rash, urticaria.

• Nervous system: headache.

• General/administration site: febrile reactions, infusion site pain, venous thrombosis, phlebitis, extravasation, possible extravascular diffusion.

Overdose

• No cases reported. Symptomatic treatment should be considered if needed.

Pharmacological Properties

• Pharmacodynamics: Glutathione participates in detoxification, reduction of oxidative stress, and protection against xenobiotics. It shields cells by neutralizing reactive metabolites and supports immune defense.

• Pharmacokinetics: After IV administration, glutathione is rapidly metabolized, with plasma half-life ~14 minutes. Metabolites include cysteine and mixed disulfides, excreted mainly via urine.

• Preclinical Data: Studies show no significant toxicity at therapeutic doses. High-dose studies in animals confirm safety with no organ damage, reproductive toxicity, or carcinogenic effects observed.

Storage

• Store below 25°C.

• Reconstituted solution must be used immediately after preparation.