Glathione (Powder) Instructions for Use

Marketing Authorization Holder

LASA Laboratorios, LLC (Russia)

Manufactured By

Shandong Luwei Pharmaceutical, Co.,Ltd (China)

ATC Code

V03AB32 (Glutathione)

Active Substance

Glutathione (BAN)

Dosage Forms

	Glathione	Powder for solution for intravenous and intramuscular administration 0.3 g: vial 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.
		Powder for solution for intravenous and intramuscular administration 0.6 g: vial 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.
		Powder for solution for intravenous and intramuscular administration 1.2 g: vial 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.
		Powder for solution for intravenous and intramuscular administration 1.8 g: vial 1, 2, 3, 4, 5, 6, 7, 8, 9 or 10 pcs.

Dosage Form, Packaging, and Composition

0.3 g – vials (1) – plastic trays (1) – cardboard packs.
0.3 g – vials (2) – plastic trays (1) – cardboard packs.
0.3 g – vials (3) – plastic trays (1) – cardboard packs.
0.3 g – vials (4) – plastic trays (1) – cardboard packs.
0.3 g – vials (5) – plastic trays (1) – cardboard packs.
0.3 g – vials (6) – plastic trays (1) – cardboard packs.
0.3 g – vials (7) – plastic trays (1) – cardboard packs.
0.3 g – vials (8) – plastic trays (1) – cardboard packs.
0.3 g – vials (9) – plastic trays (1) – cardboard packs.
0.3 g – vials (10) – plastic trays (1) – cardboard packs.

0.6 g – vials (1) – plastic trays (1) – cardboard packs.
0.6 g – vials (2) – plastic trays (1) – cardboard packs.
0.6 g – vials (3) – plastic trays (1) – cardboard packs.
0.6 g – vials (4) – plastic trays (1) – cardboard packs.
0.6 g – vials (5) – plastic trays (1) – cardboard packs.
0.6 g – vials (6) – plastic trays (1) – cardboard packs.
0.6 g – vials (7) – plastic trays (1) – cardboard packs.
0.6 g – vials (8) – plastic trays (1) – cardboard packs.
0.6 g – vials (9) – plastic trays (1) – cardboard packs.
0.6 g – vials (10) – plastic trays (1) – cardboard packs.

1.2 g – vials (1) – plastic trays (1) – cardboard packs.
1.2 g – vials (2) – plastic trays (1) – cardboard packs.
1.2 g – vials (3) – plastic trays (1) – cardboard packs.
1.2 g – vials (4) – plastic trays (1) – cardboard packs.
1.2 g – vials (5) – plastic trays (1) – cardboard packs.
1.2 g – vials (6) – plastic trays (1) – cardboard packs.
1.2 g – vials (7) – plastic trays (1) – cardboard packs.
1.2 g – vials (8) – plastic trays (1) – cardboard packs.
1.2 g – vials (9) – plastic trays (1) – cardboard packs.
1.2 g – vials (10) – plastic trays (1) – cardboard packs.

1.8 g – vials (1) – plastic trays (1) – cardboard packs.
1.8 g – vials (2) – plastic trays (1) – cardboard packs.
1.8 g – vials (3) – plastic trays (1) – cardboard packs.
1.8 g – vials (4) – plastic trays (1) – cardboard packs.
1.8 g – vials (5) – plastic trays (1) – cardboard packs.
1.8 g – vials (6) – plastic trays (1) – cardboard packs.
1.8 g – vials (7) – plastic trays (1) – cardboard packs.
1.8 g – vials (8) – plastic trays (1) – cardboard packs.
1.8 g – vials (9) – plastic trays (1) – cardboard packs.
1.8 g – vials (10) – plastic trays (1) – cardboard packs.

Clinical-Pharmacological Group

Hepatoprotective agent

Pharmacotherapeutic Group

Other therapeutic products; antidotes

Pharmacological Action

Glutathione is a linear tripeptide with a sulfhydryl group, consisting of L-glutamine, L-cysteine, and glycine.

It plays an important role in protecting the body’s cells, being a powerful antioxidant.

In the human body, a deficiency of glutathione leads to the occurrence of many diseases, such as Parkinson’s disease, tyrosinemia type I, alcohol poisoning, and others.

In vivo and in vitro experiments have shown that glutathione deficiency can lead to mitochondrial damage and cell death caused by an increase in the number of toxic oxygen species, leading to an increase in the number of free radicals.

Glutathione is able to prevent cell damage by binding to toxic substances and/or their metabolites.

Detoxification of xenobiotics by glutathione can be carried out in three different ways: by conjugation of the substrate with glutathione, as a result of nucleophilic substitution, and as a result of the reduction of organic peroxides to alcohols.

The detoxification system involving glutathione plays a unique role in the formation of the body’s resistance to a wide variety of influences and is the most important protective mechanism of the cell.

During the biotransformation of some xenobiotics with the participation of glutathione, thioethers are formed, which are then converted into mercaptans, among which toxic products have been found.

However, glutathione conjugates with most xenobiotics are less reactive and more hydrophilic than the original substances, and therefore less toxic and more easily excreted from the body.

Glutathione binds a huge number of lipophilic compounds (physical detoxification), preventing their penetration into the lipid layer of membranes and disruption of cell function.

Thus, Glutathione improves the stability of the cell membrane, protects the membrane of liver cells, increases the activity of liver enzymes, and promotes detoxification and restorative activity of the liver by eliminating free radicals.

Pharmacokinetics

Fifteen minutes after an intravenous infusion of 2 g of glutathione, the average concentration of glutathione in the blood is 444 mmol/L (average physiological concentration of glutathione in the blood is 6.9 mmol/L).

The volume of distribution is 15 L.

The half-life is 10 minutes.

Clearance is 850 ml/min.

It is excreted in the urine unchanged or as cysteine 90 minutes after the infusion.

Indications

• As part of complex therapy for liver diseases, such as acute and chronic hepatitis of various etiologies (viral, alcoholic, toxic), alcoholic cirrhosis, hepatic steatosis, liver fibrosis;
• Liver damage caused by the use of anti-tuberculosis, anticonvulsant drugs, herbal preparations, antibiotics, hypolipidemic drugs, NSAIDs, hormonal, psychotropic drugs and drugs for the treatment of gout;
• To reduce and prevent hepatotoxicity, nephrotoxicity and neuropathy when using chemotherapeutic drugs (cisplatin, cyclophosphamide, doxorubicin and bleomycin).

ICD codes

Dosage Regimen

For intravenous administration, the contents of the vial are dissolved in 250-500 ml of 0.9% sodium chloride solution.

The drug solution should be used immediately after preparation; re-use of the remaining solution is not allowed.

For severe forms of hepatitis of various etiologies – 1.2-2.4 g intravenously per day for 30 days as infusions.

For alcoholic hepatitis – 1.8 g intravenously per day for 14-30 days as infusions.

For alcoholic cirrhosis – 1.2 g intravenously per day for 30 days as infusions.

For hepatic steatosis – 1.8 g intravenously per day for 30 days as infusions.

For liver damage caused by medication use – 1.2-1.8 g intravenously per day for 14-30 days as infusions.

To reduce the toxicity of cisplatin, cyclophosphamide, doxorubicin and bleomycin, the initial dose is 1.5 g, diluted in 100 ml of 0.9% sodium chloride solution or 5% glucose solution for a 15-minute intravenous infusion, from the second to the fifth day – 600 mg per day intramuscularly.

When prescribing cisplatin, the dose of Glutathione should not exceed 35 mg of glutathione per 1 mg of cisplatin to prevent its effect on chemotherapy (except for appropriate doctor’s recommendations).

Intravenous infusion should be performed slowly.

For intramuscular administration: 0.3 g is diluted in 3 ml of 0.9% sodium chloride solution, 0.6 g is diluted in 4 ml of 0.9% sodium chloride solution.

The drug must be completely dissolved in the solvent.

The solution should be clear and colorless.

1.2 g and 1.8 g are not administered intramuscularly.

Adverse Reactions

Allergic reactions, decreased blood pressure, decreased or increased heart rate, palpitations, dyspeptic disorders are possible, which disappear after discontinuation of the drug.

Contraindications

• Childhood;
• Individual intolerance to the components of the drug.

With caution: elderly age (the drug should be prescribed in reduced doses with careful monitoring of the condition).

Use in Pregnancy and Lactation

Contraindicated for use during pregnancy and lactation.

If it is necessary to use the drug during lactation, breastfeeding should be discontinued.

Pediatric Use

Contraindicated in children.

Geriatric Use

Use with caution in the elderly.

Special Precautions

If symptoms of allergy appear, it is necessary to stop using the drug.

Effect on the ability to drive vehicles and operate machinery

Due to possible manifestations of side effects of the drug, it should be used with caution in persons driving vehicles and operating machinery.

Overdose

No cases of overdose have been recorded.

In case of overdose, symptomatic therapy should be applied.

Drug Interactions

Avoid concomitant use with menadione sodium bisulfite, cyanocobalamin, calcium pantothenate, sulfonamide drugs and tetracyclines.

Storage Conditions

In a dry place protected from light at a temperature of 15 to 25°C (77°F).

Keep out of reach of children.

Shelf Life

Shelf life – 2 years.

Dispensing Status

By prescription.

Important Safety Information

This information is for educational purposes only and does not replace professional medical advice. Always consult your doctor before use. Dosage and side effects may vary. Use only as prescribed.