Glutathione Injection
200 mg/mL
Size: 30 mLGlutathione is an endogenous tripeptide composed of glutamate, cysteine, and glycine. It is a principal intracellular thiol compound involved in cellular redox regulation, peroxide metabolism, protection of protein sulfhydryl groups, and conjugation of selected endogenous and exogenous compounds [1–3].
Sterile Glutathione Injection is supplied as a concentrated 200 mg/mL solution in a 30 mL multiple-dose vial for intravenous or intramuscular administration by licensed healthcare professionals. The presentation is designed for office or clinical use under appropriate medical supervision.
Published human evidence concerning parenteral glutathione remains indication-specific. Dose, route, administration rate, frequency, and treatment duration should be individualized according to the clinical objective, patient condition, and applicable institutional protocol. The biochemical functions of endogenous glutathione should not be interpreted as establishing a specific clinical outcome from an injected dose [1–3].
More About This Product
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• Concentration: 200 mg/mL
• Volume: 30 mL multi-dose vial
• Route of administration: Intravenous (IV) or intramuscular (IM)
• Dosage form: Sterile injectable solution
• Administration setting: Office or clinical use; for administration by licensed healthcare professionals
Verify the prescribed dose, route, concentration, and corresponding administration volume before use. For intravenous administration, dilution, compatible infusion solution, administration rate, and infusion duration should follow the product-specific label and validated institutional procedures.
Do not administer glutathione concurrently through the same intravenous line with another medication unless compatibility has been established for the specific drug, concentration, diluent, and administration conditions. Published testing has identified physical incompatibilities with selected intravenous drugs [3]. For intramuscular administration, select an appropriate injection site and rotate sites when repeated administration is required.
Inspect the solution and container before each administration. Do not use if the solution contains visible particulate matter, precipitation, cloudiness, unexpected discoloration, or if the vial or closure is damaged. Use strict aseptic technique during every vial entry, withdrawal, and administration.
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Glutathione exists primarily in reduced and oxidized forms, abbreviated GSH and GSSG. Reduced glutathione serves as a substrate for glutathione peroxidases, which reduce hydrogen peroxide and lipid hydroperoxides. Glutathione reductase uses reducing equivalents from NADPH to convert GSSG back to GSH [1].
Glutathione also participates in glutathione S-transferase-mediated conjugation of selected electrophilic compounds and in reversible protein S-glutathionylation. These processes contribute to redox regulation, protection of protein thiol groups, and metabolism of selected endogenous and exogenous compounds [1,2].
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Contraindications: Do not administer to patients with known hypersensitivity to glutathione or any component of the formulation.
Hypersensitivity: Observe patients for rash, urticaria, facial or airway swelling, bronchospasm, respiratory difficulty, hypotension, or other evidence of a serious reaction. Discontinue administration immediately and initiate appropriate medical treatment if a serious reaction occurs.
Formulation-specific precautions: Verify intravenous compatibility before concurrent administration with another injectable product. Stop administration and evaluate the patient if fever, severe chills, persistent vomiting, marked hypotension, respiratory difficulty, or other unexpected systemic symptoms occur.
Clinical monitoring: Safety, efficacy, optimal dosing, and treatment duration have not been established uniformly across clinical applications. Treatment protocols should be individualized according to patient condition, organ function, concurrent therapies, and clinical response [1–3].
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Formal interaction studies have not been conducted for this compounded parenteral formulation. Concurrent medications should be reviewed according to the patient’s clinical condition and the applicable administration protocol.
Do not combine glutathione with another medication, vitamin, mineral, amino acid, antioxidant, or compounded preparation in the same syringe, vial, infusion container, or intravenous line unless physical and chemical compatibility has been established [3].
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Reported or clinically relevant reactions may include:
Hypersensitivity: Rash, pruritus, urticaria, facial swelling, bronchospasm, dyspnea, hypotension, or anaphylaxis
Injection site: Pain, tenderness, erythema, swelling, induration, or local irritation
Gastrointestinal: Nausea, vomiting, or abdominal discomfort
Neurologic: Headache, dizziness, or lightheadedness
General: Flushing, chills, fatigue, malaise, or body aches
Cardiovascular: Hypotension associated with a serious acute or hypersensitivity reaction
Fever, rigors, persistent vomiting, marked hypotension, respiratory compromise, or cardiovascular instability requires immediate discontinuation and medical evaluation.
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Pregnancy: Adequate controlled studies of parenteral glutathione administration during pregnancy are not available. Administer only when the prescribing healthcare professional determines that the potential benefit justifies the potential risk.
Lactation: Clinical data concerning parenteral glutathione administration during lactation are insufficient. Consider maternal clinical need together with potential exposure of the breastfed infant.
Pediatric use: Safety and dosing have not been established specifically for this 200 mg/mL, 30 mL presentation. Pediatric administration requires precise calculation and independent dose verification.
Older adults and organ impairment: Consider renal and hepatic function, concurrent medical conditions, concomitant medications, and the limited clinical evidence supporting repeated parenteral administration.
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Store refrigerated at 2°C to 8°C (36°F to 46°F).
Protect from light. Do not freeze. Discard the vial if it has been frozen.
Inspect the solution and container before each use. Do not use if the solution contains visible particulate matter, precipitation, cloudiness, or unexpected discoloration.
Use strict aseptic technique during vial entry and product withdrawal. Record the date of initial puncture and follow the product-specific label and applicable facility procedures for the permitted post-puncture period, beyond-use dating, and disposal.
Keep out of the reach of children.
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[1] Averill-Bates DA. The antioxidant glutathione. Vitam Horm. 2023;121:109–141. doi:10.1016/bs.vh.2022.09.002.
[2] Aebi S, Assereto R, Lauterburg BH. High-dose intravenous glutathione in man: pharmacokinetics and effects on cysteine in plasma and urine. Eur J Clin Invest. 1991;21(1):103–110. PMID:1907548.
[3] Wu R, Zhu G, Ju Y, et al. Physical compatibility of reduced glutathione for injection with 44 intravenous drugs during simulated Y-site administration. Clin Ther. 2024;46(10):785–790. doi:10.1016/j.clinthera.2024.08.002.
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This information is intended for licensed healthcare professionals and is provided for product-information purposes only. Refer to the product-specific label, lot-specific Certificate of Analysis, applicable institutional protocols, and independent clinical judgment before ordering, preparing, or administering this compounded drug product.
