| FIELD OF APPLICATION | DETAILS |
|---|---|
| Generic Name | Glutathione disulfide |
| Active Ingredient | Glutathione disulfide |
| Drug Category | Ophthalmology |
| Drug Class | Palliative treatment, Immunosuppressive therapy |
| Brand Names | BSS Plus, Amo Endosol Extra, Navstel |
| Dosage Forms | Concentrate, Solution, Liquid, Powder for solution |
| Route of Administration | Ophthalmic, Intraocular, Irrigation |
| FDA Approval Status | FDA Approved (October 1981) Approved |
Glutathione disulfide: Overview
Glutathione disulfide is a dimer tripeptide formed by a disulfide bond between cysteine sulfhydryl side chains used in intraocular irrigation solutions. It is administered intraocularly as a reconstituted sterile irrigating solution under brand names like BSS Plus, Amo Endosol Extra, and Navstel to protect corneal endothelial cell junctional integrity, maintain corneal detumescence, preserve retinal electrical activity, and irrigate ocular segments during surgical procedures including phacoemulsification, vitrectomy, and cataract extraction.
What Is Glutathione disulfide & How Does It Work?
Glutathione disulfide, or oxidized glutathione, is a dimer tripeptide. In ocular surgery, the corneal endothelium maintains transparency via fluid transport. Prolonged surgery, trauma, and perfusion expose endothelial cells to oxidative stress, disrupting tight junctions and inducing corneal swelling.
Glutathione disulfide works through endothelial membrane stabilization, pump protection, glutathione replenishment, and corneal detumescence. Following irrigation, Glutathione disulfide enters endothelial cells as a substrate for glutathione reductase. Enzymatic reduction converts Glutathione disulfide into reduced glutathione, replenishing antioxidant capacity and scavenging reactive oxygen species. Restored glutathione preserves cell membranes, tight junctions, and fluid transport pumps. Preserving fluid transport prevents stromal fluid accumulation, maintaining corneal clarity during perfusion.
Is Glutathione disulfide FDA Approved?
Glutathione disulfide received US FDA approval as an active ingredient in prescription intraocular irrigating solutions for ophthalmic surgery.
The FDA approved Glutathione disulfide in combination with electrolytes, bicarbonate, and dextrose under the brand name BSS Plus under NDA 018469 in October 1981. The FDA approves Glutathione disulfide as a component of irrigating solutions during procedures requiring prolonged perfusion. Although standalone Glutathione disulfide solutions are not marketed separately, the co-formulated solution remains an approved prescription entity. Glutathione disulfide is classified as FDA Approved.
What Is Glutathione disulfide Used For?
- Intraocular irrigation during cataract extraction and lens implantation (FDA Approved).
- Intraocular perfusion during vitrectomy and posterior segment surgery (FDA Approved).
- Irrigation during anterior segment reconstruction and corneal transplant (FDA Approved).
- Preservation of corneal endothelial junctional integrity and detumescence during perfusion (FDA Approved).
- Irrigation in specialized anterior chamber procedures requiring endothelial protection (Off-label use).
- Research evaluating endothelial pump survival and retinal electrical activity (Unapproved; research use).
Before Taking Glutathione disulfide: Contraindications & Precautions
Evaluating ocular tissue integrity, solution reconstitution integrity, and patient sensitivity is essential before administering Glutathione disulfide. Specific clinical conditions dictate surgical irrigation safety.
Who Should Not Take Glutathione disulfide?
Glutathione disulfide is contraindicated in patients with severe hypersensitivity to Glutathione disulfide, oxidized glutathione, or formulation components.
It is strictly contraindicated for intravenous infusion, subcutaneous injection, or topical self-administration, as the formulation is intended exclusively for intraocular irrigation by ophthalmic surgeons.
Glutathione disulfide: Pregnancy & Fertility
Animal reproduction studies evaluating intraocular Glutathione disulfide irrigation have not been conducted, as systemic absorption is negligible. Glutathione disulfide should be used during pregnancy only when clearly needed.
It is unknown whether intraocular Glutathione disulfide is excreted in human breast milk. Caution is advised when performing surgery on nursing mothers. Fertility studies demonstrate no documented reproductive impairment.
Tell Your Doctor Before Taking Glutathione disulfide
Tell your surgeon if you have a history of corneal dystrophy, corneal edema, or intraocular surgical complications. Disclose active intraocular inflammation or uveitis.
Inform your doctor if you wear contact lenses or have retinal disease. Disclose concurrent medications, particularly topical corticosteroids or glaucoma drops.
Glutathione disulfide: Dosage & Administration
Proper administration and preparation depend on surgical irrigation protocols and strict aseptic reconstitution procedures. Strict adherence to preparation guidelines prevents intraocular solution contamination.
Standard Glutathione disulfide Dosing
For intraocular irrigation during ophthalmic surgery, the reconstituted irrigating solution contains 0.184 mg/mL Glutathione disulfide.
The volume of irrigating solution used depends on the surgical procedure, duration of intraocular perfusion, and clinical judgment of the surgeon.
How Glutathione disulfide Is Administered
Glutathione disulfide is supplied as a sterile concentrate vial (Part II) reconstituted with Part I diluent prior to surgery.
Reconstitute BSS Plus using aseptic technique. Mix Part II concentrate into Part I and invert gently to dissolve. Administer reconstituted solution via intraocular irrigation tubing attached to surgical instruments. Discard unused solution 6 hours after preparation. Do not use if discolored or containing particulate matter.
Glutathione disulfide: Clinical Efficacy & Research
Clinical trials established that intraocular irrigation with Glutathione disulfide enriched solution maintains better corneal endothelial cell density and corneal thickness compared to standard saline.
Research confirmed that Glutathione disulfide acts as a substrate for endothelial enzymatic pathways, maintaining pump function during vitrectomy. Studies in human in vitro perfused cornea models demonstrated that Glutathione disulfide preserves endothelial junctional integrity, preventing corneal swelling.
Glutathione disulfide: Side Effects & Safety Profile
This medication does not have an official US FDA Black Box Warning. As an approved component of prescription intraocular irrigating solutions, formal Black Box safety labeling was not issued. Ophthalmic surgeons emphasize maintaining strict solution sterility, ensuring proper Part I and Part II reconstitution, and discarding unused solution 6 hours after preparation.
Clinical use of Glutathione disulfide requires monitoring for post-operative intraocular inflammation, corneal edema, and intraocular pressure changes following surgical procedures.
Common Glutathione disulfide Side Effects
- Localized ocular symptoms including transient post-operative corneal haze, conjunctival hyperemia, and ocular discomfort.
- Surgical surface symptoms including mild intraocular inflammation, corneal punctate changes, and tearing.
- Visual symptoms including temporary blurred vision and light sensitivity during post-operative recovery.
- Post-procedural symptoms including mild transient elevation of intraocular pressure.
Serious Glutathione disulfide Adverse Events
- Severe post-operative corneal edema, endothelial decompensation, and persistent corneal clouding.
- Severe intraocular inflammatory reactions, sterile endophthalmitis, or fibrinous exudate.
- Toxic anterior segment syndrome resulting from improper reconstitution or contaminated instruments.
- Bacterial or fungal endophthalmitis secondary to compromised solution sterility.
Managing Glutathione disulfide Side Effects
If mild post-operative corneal haze or inflammation occurs, administer topical corticosteroids as prescribed.
If severe corneal edema, vision loss, or signs of intraocular infection develop, perform comprehensive ophthalmic evaluation immediately. Manage severe inflammation with topical or intracameral corticosteroids and antibiotics.
Glutathione disulfide: Interactions & What to Avoid
Glutathione disulfide exhibits minimal potential for systemic drug interactions due to localized intraocular administration during surgery. Safe intraocular irrigation requires careful preparation.
Glutathione disulfide: Interactions
Co-administration of Glutathione disulfide enriched solution with unbuffered intraocular additives can cause precipitation or endothelial toxicity.
Co-administration with intracameral medications like acetylcholine, carbachol, or epinephrine should follow surgical compatibility protocols. Flush intraocular lines when switching irrigation media.
Glutathione disulfide: Food & Alcohol
Intraocular administration of Glutathione disulfide during surgery is not affected by oral food intake.
Alcohol consumption should be avoided prior to elective ophthalmic surgery, as alcohol can alter intraocular pressure and impair surgical recovery.
Glutathione disulfide: Missed Dose, Overdose & Storage
Strict adherence to surgical reconstitution protocols and sterile hospital storage maintains solution safety and prevents intraocular toxicity. Clear guidelines for handling solution preparation ensure patient safety.
Missed Dose of Glutathione disulfide
Because Glutathione disulfide is administered continuously during intraocular surgery by ophthalmic surgeons, routine daily missed doses do not apply.
If irrigation is interrupted during surgery, the surgical team immediately restores irrigation flow using freshly reconstituted sterile solution.
Glutathione disulfide: Overdose & Emergency
Glutathione disulfide has no pharmacological toxicity, and accidental over-irrigation does not produce systemic drug overdose.
Excessive intraocular irrigation can cause mechanical corneal endothelial trauma or intraocular pressure elevation. Manage excessive intraocular perfusion by minimizing surgical manipulation time and monitoring post-operative corneal endothelial health.
How to Store Glutathione disulfide
Store un-reconstituted Glutathione disulfide Part I and Part II packages at room temperature between 2 degrees Celsius and 25 degrees Celsius (36 degrees Fahrenheit to 77 degrees Fahrenheit).
Protect from heat and light. Do not freeze. Discard solution 6 hours after mixing.
Glutathione disulfide: Patient Management & Monitoring
Routine pre-operative patient evaluation and post-operative corneal monitoring optimize surgical outcomes while safeguarding endothelial health.
Tests Before Starting Glutathione disulfide
- Pre-operative ophthalmic examination, including slit-lamp evaluation of the cornea and specular microscopy in high-risk patients.
- Baseline measurement of intraocular pressure and corneal thickness.
- Screening for pre-existing corneal endothelial dystrophy or active intraocular infection.
Monitoring During Glutathione disulfide Treatment
- Continuous intraoperative observation of corneal clarity and anterior chamber depth during perfusion.
- Post-operative slit-lamp evaluation of corneal endothelial integrity and inflammation.
- Post-operative monitoring of intraocular pressure and visual acuity recovery.
Glutathione disulfide: Do’s and Don’ts
- Do ensure Part I and Part II components are fully reconstituted using sterile aseptic technique prior to use.
- Do discard reconstituted irrigating solution 6 hours after preparation.
- Don’t use the solution if it appears cloudy, discolored, or contains particulate matter.
- Don’t use the solution for intravenous infusion or systemic injection.
Frequently Asked Questions
What is Glutathione disulfide used for in eye surgery?
Glutathione disulfide is a component of intraocular irrigating solutions used to preserve corneal endothelial cell integrity during eye surgery.
How does Glutathione disulfide protect the cornea?
Glutathione disulfide is reduced to glutathione in endothelial cells, scavenging free radicals and maintaining corneal detumescence.
Is Glutathione disulfide FDA approved?
Yes, Glutathione disulfide received US FDA approval as an active ingredient in irrigating solutions under NDA 018469.
How is Glutathione disulfide administered during surgery?
Glutathione disulfide is administered as a reconstituted sterile intraocular irrigating solution perfused through the eye during surgery.
What are the common side effects of Glutathione disulfide irrigation?
Common side effects include mild post-operative corneal haze, conjunctival redness, temporary blurred vision, and eye discomfort.
Can Glutathione disulfide cause corneal edema?
While Glutathione disulfide protects endothelial cells, surgical trauma or compromised sterility can occasionally result in corneal edema.
How long is reconstituted Glutathione disulfide solution usable?
Reconstituted Glutathione disulfide solution must be used within 6 hours of preparation and discarded thereafter.
References
- Official FDA Prescribing Information: BSS PLUS (Intraocular Irrigating Solution), Application No. NDA 018469.
- DrugBank Online: Glutathione Disulfide (DB03310) Profile and Pharmacological Data.
- National Center for Biotechnology Information PubChem Compound Summary: Glutathione Disulfide.
Legal Disclaimer
The information provided is for educational purposes only and does not constitute medical advice. Always consult a qualified healthcare provider at any hospital or clinic before starting or stopping any medication.

























