Trypan blue is an ophthalmic solution of an acid di-azo group diagnostic dye and selective tissue staining agent indicated for use as a medical aid in ophthalmic surgery by staining the anterior capsule of the lens. An anterior capsulotomy can then be performed. Discoloration of high water content hydrogen intraocular lenses and inadvertent staining of the posterior lens capsule and vitreous face have been reported after use of trypan blue. To prevent excessive staining, all excess dye is to be immediately removed from the eye through irrigation of the anterior chamber.
General Administration Information
For storage information, see the specific product information within the How Supplied section.
Route-Specific Administration
Ophthalmic Administration
-Trypan blue is supplied in a single-patient-use syringe to which a blunt cannula has to be attached.
-After opening the eye, an air bubble is injected into the anterior chamber of the eye in order to minimize dilution of trypan blue by the aqueous.
-Carefully apply trypan blue onto the anterior lens capsule using a blunt cannula. Sufficient staining is achieved as soon as the dye has contacted the capsule.
-Immediately irrigate the anterior chamber with balanced salt solution to remove all excess dye.
Discoloration of high water content hydrogen intraocular lenses and inadvertent staining of the posterior lens capsule and vitreous face have been reported after use of trypan blue. Staining of the posterior lens capsule or staining of the vitreous face is generally self-limited, lasting up to 1 week.
Trypan blue is contraindicated when a non-hydrated hydrophilic acrylic intraocular lens is planned to be inserted into the eye, as the dye may be absorbed by the intraocular lens and stain it.
There are no available data on the use of trypan blue 0.06% in pregnancy to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic absorption of trypan blue 0.06% is expected to be negligible after injection and removal of the medication at the completion of surgical procedures. Maternal use of trypan blue 0.06% is not expected to result in fetal exposure to the medication and risk of teratogenic effects based on negligible human systemic exposure when used as recommended. Teratogenicity was observed with trypan blue in various animal models at doses of 800-fold and more than the maximum recommended human dose, based on body surface area (BSA).
The presence of trypan blue in human milk after intraocular administration has not been evaluated. There are no data available regarding the effects of trypan blue on milk production. Breast-feeding is not expected to result in exposure of the child to trypan blue based on negligible systemic exposure of trypan blue in humans after injection and subsequent removal of the medication at the completion of surgical procedures.
For use as a visualization aid during ophthalmic surgery:
Ophthalmic dosage (0.06% ophthalmic solution):
Adults: 0.5 mL applied onto the anterior lens capsule of the affected eye(s) as a single dose.
Infants, Children, and Adolescents: 0.5 mL applied onto the anterior lens capsule of the affected eye(s) as a single dose.
Maximum Dosage Limits:
-Adults
0.5 mL of 0.06% ophthalmic solution/procedure.
-Geriatric
0.5 mL of 0.06% ophthalmic solution/procedure.
-Adolescents
0.5 mL of 0.06% ophthalmic solution/procedure.
-Children
0.5 mL of 0.06% ophthalmic solution/procedure.
-Infants
0.5 mL of 0.06% ophthalmic solution/procedure.
-Neonates
Safety and efficacy have not been established.
Patients with Hepatic Impairment Dosing
Specific guidelines for dosage adjustments in hepatic impairment are not available; it appears that no dosage adjustments are needed.
Patients with Renal Impairment Dosing
Specific guidelines for dosage adjustments in renal impairment are not available; it appears that no dosage adjustments are needed.
*non-FDA-approved indication
There are no drug interactions associated with Trypan blue products.
Trypan blue selectively stains connective tissue structures in the human eye such as the anterior lens capsule of the human crystalline lens. Trypan blue stains any portion of the anterior lens capsule which comes in contact with the dye. Excess dye is washed out of the anterior chamber. The dye does not penetrate the capsule, permitting visualization of the anterior capsule in contrast to the non-stained lens cortex and inner lens material.
Trypan blue is applied directly on the anterior lens capsule of the eye. Significant staining is achieved as soon as the dye has contacted the capsule. The dye does not penetrate the capsule.
Affected cytochrome P450 isoenzymes and drug transporters: none