Brilliant Blue G Ophthalmic Solution
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Omid Afkhami-Ardakani
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Overview
Brilliant Blue G Ophthalmic Solution is a Disclosing Agent that is FDA approved for the procedure of staining the internal limiting membrane (ILM) during ophthalmic surgery.. Common adverse reactions include {{{adverseReactions}}}.
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Inject TissueBlue 0.025% directly into a Balanced Salt Solution (BSS)-filled vitreous cavity. Excess TissueBlue should be removed from the vitreous cavity.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Brilliant Blue G Ophthalmic Solution in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Brilliant Blue G Ophthalmic Solution in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Brilliant Blue G Ophthalmic Solution in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Brilliant Blue G Ophthalmic Solution in pediatric patients.
Contraindications
There is limited information regarding Brilliant Blue G Ophthalmic Solution Contraindications in the drug label.
Warnings
Excessive Staining: Excess TissueBlue 0.025% should be removed from the eye immediately after staining.
Use of the Syringe: Ensure the plunger moves smoothly before injecting the solution. Do not use the product if the plunger does not move smoothly to prime the cannula.
Adverse Reactions
Clinical Trials Experience
Adverse reactions reported in procedures that included the use of TissueBlue 0.025% have often been associated with the surgical procedure. Complications include retinal break, tear, hemorrhage, detachment, and cataracts.
Postmarketing Experience
There is limited information regarding Brilliant Blue G Ophthalmic Solution Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Brilliant Blue G Ophthalmic Solution Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Brilliant Blue G Ophthalmic Solution in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Brilliant Blue G Ophthalmic Solution in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Brilliant Blue G Ophthalmic Solution during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Brilliant Blue G Ophthalmic Solution in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Brilliant Blue G Ophthalmic Solution in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Brilliant Blue G Ophthalmic Solution in geriatric settings.
Gender
There is no FDA guidance on the use of Brilliant Blue G Ophthalmic Solution with respect to specific gender populations.
Race
There is no FDA guidance on the use of Brilliant Blue G Ophthalmic Solution with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Brilliant Blue G Ophthalmic Solution in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Brilliant Blue G Ophthalmic Solution in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Brilliant Blue G Ophthalmic Solution in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Brilliant Blue G Ophthalmic Solution in patients who are immunocompromised.
Administration and Monitoring
Administration
Inject TissueBlue 0.025% directly into a Balanced Salt Solution (BSS)-filled vitreous cavity using a blunt cannula attached to the pre-filled syringe, without allowing the cannula to contact the retina or allowing TissueBlue to get under the retina.
Sufficient staining is expected within a few seconds.
Following staining, all excess dye should be removed from the vitreous cavity.
Monitoring
Monitor for signs of excessive staining and ensure complete removal of the dye after the procedure.
IV Compatibility
Not applicable – drug is not administered intravenously.
Overdosage
There is limited information regarding Brilliant Blue G Ophthalmic Solution overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Brilliant Blue G Ophthalmic Solution Pharmacology in the drug label.
Mechanism of Action
Brilliant Blue G selectively binds to the internal limiting membrane (ILM) of the retina, enhancing its visualization during ophthalmic surgery. The exact mechanism of this selectivity is not fully understood, but it facilitates safer and more effective membrane peeling.
Structure
There is limited information regarding Brilliant Blue G Ophthalmic Solution Structure in the drug label.
Pharmacodynamics
The dye provides a clear contrast between the ILM and underlying retinal structures, aiding surgeons in distinguishing and removing the membrane with precision.
Pharmacokinetics
Due to its localized intraocular application and subsequent removal during surgery, systemic absorption of Brilliant Blue G is negligible.
Nonclinical Toxicology
There is limited information regarding Brilliant Blue G Ophthalmic Solution Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Brilliant Blue G Ophthalmic Solution Clinical Studies in the drug label.
How Supplied
Form: Sterile, single-dose ophthalmic solution.
Strength: 0.025% Brilliant Blue G (0.25 mg/mL).
Packaging: Supplied in a 2.25 mL glass syringe pre-filled to 0.5 mL, packaged in a pre-formed polypropylene blister pouch sealed with a Tyvek® lid.
Storage
Store at 15°C to 25°C (59°F to 77°F). Protect from light, frost, and moisture.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
Procedure Explanation: Inform patients that TissueBlue is used during eye surgery to enhance visualization of specific retinal membranes, aiding in their removal.
Safety Profile: Reassure patients that the dye is removed during the procedure, minimizing systemic exposure and associated risks.
Potential Risks: Discuss the rare but possible complications associated with the surgical procedure, such as retinal tears or detachment, and cataract formation.
Precautions with Alcohol
Alcohol-Brilliant Blue G Ophthalmic Solution interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
TissueBlue® Manufacturered by Dutch Ophthalmic Research Center (DORC).
Look-Alike Drug Names
There is limited information regarding Brilliant Blue G Ophthalmic Solution Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.