NOXIMED

INSTRUCTIONS FOR MEDICAL USE OF THE MEDICINAL PRODUCT NOXIMED NOXIMED

Composition:

Active substance: glutathione;

1 vial contains 643 mg of sodium glutathione, equivalent to 600 mg of glutathione.

1 ampoule of solvent contains 3 ml of water for injections.

Pharmaceutical form. Powder and solvent for solution for injection.

Main physicochemical properties: white hygroscopic powder; clear colorless odorless liquid.

Pharmacotherapeutic group. Antidotes. ATC code V03A B32.

Pharmacological Properties

Pharmacodynamics

Glutathione is a tripeptide that is a natural component of cells in all body tissues. Its widespread presence is associated with a broad spectrum of biological functions and is fundamental to numerous biochemical and metabolic processes.

The sulfhydryl groups of cysteine, a component of glutathione, are potent nucleophilic agents. Consequently, they become the primary target for electrophilic attack by chemical substances or their active metabolites, resulting in the inactivation of potentially toxic exogenous compounds. Thus, the drug exerts a protective effect on vital nucleophilic sites within cells, the attack on which initiates cellular damage.

Furthermore, glutathione (GSH), upon reduction following interaction with a large number of oxidized organic metabolites, forms less toxic conjugated compounds, which are then more easily metabolized and excreted as mercapturic acids.

Given these properties, glutathione is indicated in cases of hepatotoxic reactions, the development mechanisms of which may include ethyl or drug-induced hepatotoxicity, or pathogenetically determined hepatotoxicity associated with impaired detoxification mechanisms.

Pharmacokinetics

After intravenous administration, glutathione is predominantly distributed into erythrocytes, while in plasma it is rapidly degraded by gamma-glutamyl transpeptidase and gamma-glutamyl cyclotransferase. Thus, plasma levels of reduced glutathione remain low even after high doses (peak plasma concentration approximately 1 nmol/mL at 5 minutes after intravenous administration of 600 mg). The drug concentration in blood gradually decreases, returning to nearly baseline levels approximately 60 minutes after administration.

Clinical characteristics.

Indications.

Prevention of neuropathy induced by chemotherapy with cisplatin or similar agents.

Contraindications.

Hypersensitivity to the active substance or to any of the excipients.

Interaction with other medicinal products and other forms of interaction.

Unknown.

Special precautions for use.

The prepared solution must be clear, colorless, and free from any visible particles. It should be used for single, continuous administration only and immediately after preparation. After administration, any remaining medication should be disposed of according to local regulations.

Use during pregnancy or breastfeeding.

Pregnancy

There are no available data on potential harm caused by the medicinal product when used during pregnancy.

Breastfeeding

There are no available data on potential harm caused by the medicinal product when used during breastfeeding.

Fertility

There are no available data on potential harm to fertility caused by the use of this medicinal product. However, the medicinal product should not be used during pregnancy and breastfeeding unless there is a clear medical necessity, and only after careful assessment of the benefit-risk ratio.

Ability to affect reaction speed when driving or operating machinery.

Glutathione does not affect the ability to drive or operate machinery.

Administration and Dosage

For the most severe degree of injury: 600–1200 mg (1–2 vials) per day administered by intramuscular or slow intravenous injection.

For moderate degree of injury: half of the above-mentioned dose should be used.

Preparation of the drug for administration

For intramuscular administration, the drug should be completely dissolved directly in the vial using the solvent provided in the package.

For intravenous administration, the drug should be dissolved with the solvent from the package (water for injection) and administered either by direct slow injection or by infusion after adding the prepared solution to at least 20 mL of sterile infusion solution.

Children. The possibility of use in children has not been studied.

Overdose.

There is no information available regarding overdose.

Adverse Reactions.

In rare cases, nausea, vomiting, headache, hypersensitivity reactions, skin rashes, and urticaria may occur. These reactions usually resolve after discontinuation of therapy.

Shelf life. 3 years.

Storage conditions.

Store in the original packaging at a temperature not exceeding 25 ºC.

Keep out of reach of children.

Packaging.

Powder for solution for injection 600 mg in vials №10, supplied with solvent 3 ml in ampoules №10, in a cardboard box.

Prescription category.

Prescription only.

Marketing Authorisation Holder.

Laboratorio Italiano Biocomico Farmaceutico Lisapharma S.p.A.

Manufacturer.

Laboratorio Italiano Biocomico Farmaceutico Lisapharma S.p.A.

Address of manufacturer and place of business.

Via Lichinio, 11, 22036 Erba (CO), Italy.