trypan blue · by dorc
MembraneBlue - Description. MembraneBlue™ (trypan blue ophthalmic solution) 0.15% is a sterile solution of trypan blue (an acid di-azo group dye) for intraocular ophthalmic use. MembraneBlue selectively stains epiretinal membranes during ophthalmic surgical vitrectomy procedures. Each mL of MembraneBlue 0.15% contains: 1.5 mg trypan blue; 1.9 mg sodium mono-hydrogen orthophosphate (Na 2 HPO 4 •2H 2 O); 0.3 mg sodium di-hydrogen orthophosphate (NaH 2 PO 4 •2H 2 O); 8.2 mg sodium chloride (NaCl); and water for injection. The pH is 7.3 - 7.6. The osmolality is 257 - 314 mOsm/kg. The drug substance trypan blue has the chemical name 3,3'-[(3,3'-dimethyl-4,4'-biphenylylene) bis (azo)] bis (5-amino-4-hydroxy-2,7-naphthalenedisulfonic acid) tetra sodium salt, a molecular weight of 960.8, a molecular formula of C 34 H 24 N 6 Na 4 O 14 S 4 , and has the following chemical structure: Chemical structure MembraneBlue
MembraneBlue 0.15% - Dosage & administration section MembraneBlue 0.15% is packaged in a single-patient-use syringe filled to a volume of 0.5 mL. Make sure the plunger moves smoothly before use. Prime the syringe prior to use by retracting the plunger before injecting the fluid. Alternatively, twist the plunger into the stopper in a clockwise motion until tight. Once tight, continue turning the plunger in a clockwise motion until the stopper rotates freely within the syringe, two or three rotations. The syringe is now primed and suitable for injection. Before injection of MembraneBlue perform a “fluid-air exchange” (i.e., filling the entire vitreous cavity with air, to prevent aqueous dilution of MembraneBlue). MembraneBlue is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlue syringe, without allowing the cannula to contact or damage the retina. Sufficient staining is expected on contact with the membrane. All excess dye should be removed from the vitreous cavity before performing an air-fluid exchange, to prevent unnecessary spreading of the dye. MembraneBlue can also be injected directly in a BSS filled vitreous cavity (instead of injecting under air). Clinical use demonstrated that, after complete vitreous and posterior hyaloid removal, sufficient staining is achieved after 30 seconds of application under BSS. MembraneBlue is…
MembraneBlue 0.15% - Adverse reactions section Adverse reactions reported following use of MembraneBlue 0.15% include discoloration of high water content hydrogen intraocular lenses [see Contraindications] and inadvertent staining of the posterior lens capsule and vitreous face. Staining of the posterior lens capsule or staining of the vitreous face is generally self limited, lasting up to one week. Most common adverse reactions include discoloration of high water content hydrogen intraocular lenses and inadvertent staining of the posterior lens capsule and vitreous face. To report SUSPECTED ADVERSE REACTIONS contact Dutch Ophthalmic, USA at 1-800-75-DUTCH or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Important safety information
MembraneBlue 0.15% - Warnings and precautions section Excessive Staining Excess MembraneBlue 0.15% should be immediately removed from the eye after staining. Priming of the Syringe To make sure the plunger moves smoothly before use, first retract the plunger or twist the plunger in a clockwise motion before injecting the fluid. Excessive Staining: Excess MembraneBlue 0.15% should be immediately removed from the eye after staining. Priming of the Syringe: To make sure the plunger moves smoothly before use, first retract the plunger or twist the plunger in a clockwise motion before injecting the fluid.
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Clinical content sourced from the FDA label via openFDA (U.S. FDA). Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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