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Product Overview
LUTHIONE Inj. is a South Korean prescription injectable pharmaceutical product containing reduced glutathione (GSH), manufactured by Daehan Nupharm Co., Ltd. Available in 600 mg and 1200 mg strengths, LUTHIONE is supplied as a white to off-white lyophilized powder in individual vials. Both formulations are registered in South Korea for the prevention of neurological disorders associated with cisplatin or similar chemotherapy agents.
Reduced glutathione is a naturally occurring tripeptide composed of glutamate, cysteine, and glycine. It plays an important role in intracellular antioxidant defense, redox homeostasis, and cellular detoxification processes.
LUTHIONE 600 mg and 1200 mg contain the same active pharmaceutical ingredient but differ in the amount of reduced glutathione per vial. Both formulations are supplied in manufacturer-documented boxes of 10 vials and are intended for administration by appropriately qualified healthcare professionals.
This TEOSQUARE product page covers both LUTHIONE strengths, providing professional buyers with information about their composition, pharmaceutical characteristics, packaging, approved indication, and storage requirements.
Key Features
- Reduced Glutathione: Contains glutathione in its reduced form (GSH), a naturally occurring tripeptide involved in cellular antioxidant defense and redox regulation.
- Two Available Strengths: LUTHIONE is available in 600 mg and 1200 mg formulations, with the labeled strength indicating the quantity of reduced glutathione per vial.
- Lyophilized Pharmaceutical Formulation: Supplied as a white to off-white freeze-dried powder for preparation as an injectable solution under the official prescribing instructions.
- 10-Vial Packaging: Both strengths are registered in standard commercial packages containing 10 vials per box.
- South Korean Prescription Medicine: Manufactured by Daehan Nupharm Co., Ltd., with separate South Korean pharmaceutical authorizations for the 600 mg and 1200 mg formulations.
Composition & Specifications
LUTHIONE contains reduced glutathione as its active pharmaceutical ingredient. Both strengths are single-active-ingredient formulations containing sodium bicarbonate as an excipient.
The labeled milligram strength represents the total quantity of reduced glutathione in each vial, not the concentration of the prepared injectable solution.
| Specification | Details |
|---|---|
| Brand | LUTHIONE |
| Official Product Name | LUTHIONE Injection / LUTHIONE Inj. 1200mg |
| Korean Product Name | 루치온주 / 루치온주1200mg |
| Product Category | Prescription Glutathione Injectable Pharmaceutical |
| Active Ingredient | Reduced Glutathione (GSH) |
| Available Strengths | 600 mg / 1200 mg |
| Active Ingredient per Vial | 600 mg or 1200 mg Reduced Glutathione |
| Excipient | Sodium Bicarbonate |
| Formulation | Lyophilized Powder for Injection |
| Appearance | White to Off-White Porous Freeze-Dried Material |
| Container Type | Vial |
| Standard Packaging | 10 Vials per Box |
| Approved Korean Indication | Prevention of Neurological Disorders Associated with Cisplatin or Similar Chemotherapy Agents |
| Approved Administration Routes | Intramuscular Injection or Intravenous Infusion |
| Manufacturer | Daehan Nupharm Co., Ltd. |
| Country of Origin | South Korea |
| Storage Temperature | 1–30°C |
| Storage Container | Tightly Closed Container |
| Regulatory Classification | Prescription Medicine in South Korea |
Reduced Glutathione (GSH)
Glutathione is a tripeptide composed of three amino acids: glutamate, cysteine, and glycine. It is naturally synthesized in human cells and is present in both reduced (GSH) and oxidized (GSSG) forms.
Reduced glutathione contains a reactive sulfhydryl group on its cysteine residue. This chemical structure allows GSH to participate in oxidation-reduction reactions and serve as a substrate for several antioxidant and detoxification-related enzymes.
LUTHIONE contains reduced glutathione rather than oxidized glutathione. Both registered strengths use the same active ingredient, with different quantities per vial.
Sodium Bicarbonate
Sodium bicarbonate is listed as an excipient in the South Korean pharmaceutical registrations for LUTHIONE 600 mg and 1200 mg.
It contributes to the formulation's physicochemical characteristics. Its presence should not be interpreted as an additional therapeutic active ingredient.
The registered formulation information refers to the original pharmaceutical products manufactured by Daehan Nupharm. Exact packaging accessories and market-specific labeling should be verified against the supplied presentation.
How Reduced Glutathione Works
Reduced glutathione is an essential component of the cellular antioxidant defense system. It participates in redox reactions, detoxification pathways, and the maintenance of intracellular biochemical balance.
Glutathione and Cellular Antioxidant Defense
Cells continuously generate reactive oxygen species (ROS) during normal metabolic processes. Excessive oxidative stress can damage proteins, lipids, and nucleic acids.
Glutathione participates in antioxidant reactions, including those catalyzed by glutathione peroxidase. In these reactions, reduced glutathione serves as an electron donor and is converted into oxidized glutathione.
Glutathione reductase helps regenerate reduced glutathione from its oxidized form using NADPH, supporting the cellular GSH/GSSG redox cycle.
Cellular Detoxification Pathways
Glutathione participates in enzymatic detoxification pathways involving glutathione S-transferases. These enzymes catalyze the conjugation of glutathione with certain electrophilic compounds, supporting their subsequent metabolism or elimination.
The biological role of glutathione in detoxification does not establish that intravenous glutathione provides general detoxification benefits, removes unspecified toxins, or improves overall wellness in otherwise healthy individuals.
Relationship with Chemotherapy-Induced Toxicity
Cisplatin and related platinum-based chemotherapy agents can cause neurological adverse effects through mechanisms involving cellular injury, oxidative stress, and other biological pathways.
Glutathione has been investigated in this therapeutic context because of its involvement in redox regulation and cellular protective mechanisms.
LUTHIONE's approved indication in South Korea is the prevention of neurological disorders associated with cisplatin or similar chemotherapy agents.
These explanations describe established glutathione biochemistry and the context of the registered pharmaceutical indication. They do not demonstrate additional clinical benefits for cosmetic whitening, anti-aging, fatigue recovery, or general wellness applications.
Available LUTHIONE Variants
LUTHIONE is available in two separately registered strengths: 600 mg and 1200 mg. Both formulations contain reduced glutathione and share the same general pharmaceutical characteristics.
The primary difference between the two products is the total quantity of reduced glutathione contained in each vial.
| Specification | LUTHIONE 600 mg | LUTHIONE 1200 mg |
|---|---|---|
| Active Ingredient | Reduced Glutathione | Reduced Glutathione |
| Strength per Vial | 600 mg | 1200 mg |
| Excipient | Sodium Bicarbonate | Sodium Bicarbonate |
| Formulation | Lyophilized Powder | Lyophilized Powder |
| Container | Vial | Vial |
| Standard Packaging | 10 Vials per Box | 10 Vials per Box |
| Storage Temperature | 1–30°C | 1–30°C |
| Manufacturer | Daehan Nupharm | Daehan Nupharm |
| Korean Authorization Date | July 13, 2012 | October 22, 2014 |
| Korean Product Authorization Code | 201206122 | 201404845 |
LUTHIONE Injection 600 mg
LUTHIONE Injection 600 mg contains 600 mg of reduced glutathione per vial. It is supplied as a white to off-white porous lyophilized formulation in a transparent vial.
The 600 mg formulation was authorized in South Korea on July 13, 2012, under product authorization code 201206122.
Its registered indication is the prevention of neurological disorders caused by cisplatin or similar chemotherapy agents. The formulation contains sodium bicarbonate as an excipient and is supplied in boxes containing 10 vials.
LUTHIONE Injection 1200 mg
LUTHIONE Injection 1200 mg contains 1200 mg of reduced glutathione per vial, providing twice the labeled active ingredient quantity of the 600 mg formulation.
The 1200 mg formulation received South Korean authorization on October 22, 2014, under product authorization code 201404845.
Like the 600 mg formulation, LUTHIONE 1200 mg is supplied as lyophilized material in a vial and contains sodium bicarbonate as an excipient. Its standard registered packaging consists of 10 vials per box.
The different vial strengths describe the amount of reduced glutathione contained in each product. They do not independently establish different indications, greater effectiveness, or a recommended administration quantity.
Packaging & Product Presentation
Both LUTHIONE formulations are supplied as freeze-dried pharmaceutical products in individual vials. The registered South Korean commercial packaging contains 10 vials per box for each strength.
| Packaging Component | LUTHIONE 600 mg | LUTHIONE 1200 mg |
|---|---|---|
| Active Ingredient per Vial | 600 mg | 1200 mg |
| Dosage Form | Lyophilized Powder | Lyophilized Powder |
| Container Type | Vial | Vial |
| Standard Box Quantity | 10 Vials | 10 Vials |
| Total Glutathione per Box | 6,000 mg | 12,000 mg |
| Storage Temperature | 1–30°C | 1–30°C |
| Country of Manufacture | South Korea | South Korea |
A solvent ampoule is documented for a specific export presentation of LUTHIONE 600 mg. However, the presence of a supplied solvent should not be assumed for every market version or for the 1200 mg formulation.
Buyers should verify the supplied product strength, number of vials, packaging accessories, manufacturer information, expiration date, and batch number.
The milligram strength indicates the amount of reduced glutathione in the unopened vial. It is not the final concentration or volume of a prepared injectable solution.
Storage & Handling
Daehan Nupharm's South Korean pharmaceutical registrations specify storage in tightly closed containers at room temperature between 1°C and 30°C for both LUTHIONE 600 mg and 1200 mg.
- Storage Temperature: Store between 1°C and 30°C according to the registered Korean labeling.
- Original Container: Maintain the product in its original tightly closed container and packaging.
- Packaging Integrity: Inspect the vial and packaging for visible damage before professional handling.
- Single-Use Handling: Follow the manufacturer's instructions for handling and disposal. The registered labeling requires prompt use after preparation.
- Product Traceability: Confirm the product name, labeled strength, batch number, expiration date, and applicable market-specific documentation.
The storage requirements above refer to unopened products. Preparation and post-preparation handling must comply with the official prescribing information and should be performed only by authorized healthcare professionals.
Safety & Regulatory Considerations
LUTHIONE is a prescription pharmaceutical product containing reduced glutathione. Its use requires medical supervision and compliance with the approved indications, prescribing information, and regulations of the destination country.
Reported Adverse Reactions
The South Korean product labeling identifies potential adverse reactions, including hypersensitivity reactions, skin rash, and gastrointestinal symptoms such as nausea, vomiting, abdominal discomfort, and loss of appetite.
Rare serious allergic reactions resembling anaphylaxis have also been reported. Symptoms may include facial pallor, decreased blood pressure, and abnormal pulse.
Prescription Medicine and Approved Indication
Both LUTHIONE 600 mg and 1200 mg are registered in South Korea for the prevention of neurological disorders associated with cisplatin or similar chemotherapy agents.
Although reduced glutathione is widely discussed in the medical aesthetics and wellness industries, its general antioxidant properties do not establish clinical effectiveness for cosmetic skin whitening, anti-aging, fatigue recovery, or general detoxification.
Cosmetic Whitening Claims
Glutathione has been studied in relation to melanogenesis and skin pigmentation. Certain experimental findings suggest that glutathione may influence oxidative pathways and melanin-related processes.
However, evidence from laboratory studies, oral supplements, or topical formulations cannot automatically establish the effectiveness or safety of intravenous glutathione for cosmetic skin lightening.
The South Korean registrations for LUTHIONE do not identify cosmetic skin whitening as an approved indication.
Regulatory Authorization
LUTHIONE 600 mg and 1200 mg have separate pharmaceutical registrations in South Korea. These registrations do not automatically establish marketing authorization, prescribing eligibility, or legal distribution in other countries.
Professional buyers must verify local regulatory approval, prescription requirements, import eligibility, and lawful distribution arrangements before procurement.
This information is intended for professional product identification and comparison. It does not constitute treatment guidance, establish patient suitability, or authorize unapproved cosmetic or wellness applications.
Frequently Asked Questions
What is the difference between LUTHIONE 600 mg and 1200 mg?
LUTHIONE 600 mg contains 600 mg of reduced glutathione per vial, while LUTHIONE 1200 mg contains 1200 mg. Both are lyophilized prescription formulations manufactured by Daehan Nupharm and are supplied in standard packages containing 10 vials.
What is the active ingredient in LUTHIONE?
The active ingredient is reduced glutathione (GSH), a naturally occurring tripeptide composed of glutamate, cysteine, and glycine. It participates in cellular antioxidant defense, redox regulation, and detoxification-related biochemical pathways.
Who manufactures LUTHIONE Injection?
LUTHIONE Injection is manufactured by Daehan Nupharm Co., Ltd., a South Korean pharmaceutical company. Both the 600 mg and 1200 mg formulations are separately registered as prescription medicines in South Korea.
How many vials are included in one box of LUTHIONE?
The registered standard packaging contains 10 vials per box for both LUTHIONE 600 mg and 1200 mg. The total reduced glutathione content is 6,000 mg per 600 mg box and 12,000 mg per 1200 mg box.
Is LUTHIONE approved for cosmetic skin whitening?
No cosmetic skin-whitening indication is listed in the South Korean pharmaceutical registrations for LUTHIONE. The approved indication is prevention of neurological disorders associated with cisplatin or similar chemotherapy agents. Ingredient-level pigmentation research does not establish approval or clinical effectiveness for cosmetic whitening.
How should LUTHIONE be stored?
Both LUTHIONE strengths should be stored in tightly closed containers at 1°C to 30°C according to their South Korean pharmaceutical registrations. The original manufacturer labeling should be followed for product handling and storage.