TyBlue

Approved Indications:

• Ophthalmic Surgery (Capsular Staining):
• Visualization of the anterior capsule during cataract surgery (especially in mature or white cataracts).
• Assists in capsulorhexis during phacoemulsification or extracapsular cataract extraction (ECCE).
• Posterior Capsule Visualization:
• Used intraoperatively to delineate the posterior capsule, especially in cases of posterior capsule rupture or pediatric cataract surgery.
• Corneal Epithelium Assessment:
• Topical use in ophthalmic examination to stain devitalized corneal epithelial cells, assisting in diagnosis of ocular surface disorders (rare clinical use).

Important Off-Label or Investigational Uses:

• Retinal Surgery:
• Occasionally used to stain the internal limiting membrane (ILM) or epiretinal membranes during vitreoretinal surgery (though Brilliant Blue G or Indocyanine Green is more common).

Ophthalmic Surgical Use (Capsular Staining):

• Adults & Elderly:
• Inject 0.05 to 0.2 mL of 0.06% trypan blue solution directly into the anterior chamber after anterior capsulotomy.
• Allow contact for 10–30 seconds, then wash out completely with balanced salt solution (BSS) before proceeding with surgery.
• Pediatric Use:
• Use with caution; dosage individualized depending on the size of the eye and surgical context.

Topical Diagnostic Use:

• A drop of 0.06% trypan blue solution applied to the conjunctival sac; wait 10–20 seconds before rinsing.

Administration Route:

• Intracameral (intraocular) injection during surgery.
• Topical (diagnostic use) on the ocular surface.

Dose Adjustments:

• No specific adjustments for renal or hepatic impairment due to localized administration.
• Avoid systemic exposure.

Trypan Blue is a vital dye that selectively stains non-viable or degenerative cells and structures. In ophthalmic surgery, it binds preferentially to the anterior lens capsule, enhancing visualization by providing contrast between transparent ocular tissues and the dye-stained regions. It improves the safety and accuracy of capsulorhexis, particularly in complicated cataracts. The dye does not penetrate viable cells, allowing for targeted staining of extracellular matrix and dead or damaged tissue.

Absorption:

• Minimal systemic absorption when administered intracamerally or topically.

Distribution:

• Confined to the anterior chamber of the eye; no systemic distribution expected when used properly.

Metabolism:

• Not systemically metabolized due to minimal absorption.

Excretion:

• Excess dye is removed via irrigation with balanced salt solution during surgery.

Bioavailability:

• Not applicable (localized intraocular action).

Half-life:

• Not clinically relevant; eliminated by surgical aspiration or irrigation.

Active Metabolites:

• None.

Pregnancy:

• FDA Category C (formerly): Risk not ruled out.
• No adequate or well-controlled studies in pregnant women; use only if clearly needed and the benefits outweigh the potential risks.

Lactation:

• Unknown whether trypan blue is excreted in human breast milk.
• Given minimal systemic absorption, significant exposure to nursing infants is unlikely.
• Caution advised in breastfeeding mothers undergoing surgery.

• Vital Stain
• Subclass: Ophthalmic Surgical Dye

• Known hypersensitivity to trypan blue or any component of the formulation
• Use in non-intact ocular structures where dye may leak into systemic circulation
• Systemic injection or ingestion (toxic and contraindicated)
• Presence of active ocular infection

• Potential toxicity with prolonged exposure; wash dye promptly after staining.
• Risk of endothelial toxicity or increased intraocular pressure if not fully aspirated.
• Use with caution in pediatric patients due to limited safety data.
• Avoid use in eyes with compromised corneal endothelium.
• Monitor for signs of inflammation or delayed visual recovery postoperatively.
• Prevent accidental systemic exposure or inappropriate administration routes.

Common Adverse Effects (Ocular):

• Transient blurring of vision
• Mild ocular discomfort or foreign body sensation
• Temporary intraocular pressure elevation

Less Common / Serious Side Effects:

• Corneal endothelial toxicity
• Intraocular inflammation or uveitis
• Toxic anterior segment syndrome (TASS)
• Posterior capsule staining (unintended)
• Retinal toxicity (if inadvertently used in vitreous cavity at high doses)

Onset:

• Immediate to short-term post-administration

Severity:

• Mostly mild and self-limiting when used properly; severe reactions are rare

• No significant systemic drug interactions due to minimal absorption.
• Do not mix with other intraocular solutions unless compatibility is confirmed.
• Avoid simultaneous use with other intraocular dyes without clinical justification.

Enzyme Systems:

• Not metabolized via CYP450 enzymes; no enzyme interaction risk.

• No recent changes in FDA or EMA labeling.
• Still widely recommended in cataract surgery protocols for enhanced visualization.
• Preference for Brilliant Blue G in retinal surgeries has reduced its off-label use in posterior segment applications.

• Store at 15°C to 25°C (59°F to 77°F)
• Protect from light and freezing
• Do not use if solution is discolored or contains particulate matter
• Single-use vials should be discarded after opening
• Shake well before use if suspension appears settled