pharmacopeia

Trypan Blue

Other surgical aidsUS-FDASourced from openFDA
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Mechanism of action

Sourced from openFDA

MembraneBlue 0.15% - Mechanism of action section. MembraneBlue 0.15% selectively stains membranes in the human eye during posterior surgery, such as epiretinal membranes (ERM) and Internal Limiting Membranes (ILM).

Indications

Sourced from openFDA
  • MembraneBlue 0.15% - Indications & Usage Section MembraneBlue™ 0.15% is indicated for use as an aid in ophthalmic surgery by staining the epiretinal membranes during ophthalmic surgical vitrectomy procedures, facilitating removal of the tissue in adults and pediatric patients. These highlights do not include all the information needed to use MEMBRANEBLUE™ safely and effectively.

Contraindications

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  • MembraneBlue 0.15% - Contraindications section. MembraneBlue 0.15% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye.contraindicated

Dosage & administration

Sourced from openFDA

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 intended to be applied directly on the areas where membranes could be present, staining any portion of the membrane which comes in contact with the dye. The dye does not penetrate the membrane.

Warnings & precautions

Sourced from openFDA

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.

Adverse reactions

Sourced from openFDA

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.

Use in specific populations

Sourced from openFDA

MembraneBlue - Use in specific populations section MembraneBlue should not be given to pregnant women MembraneBlue - Pregnancy section Risk Summary There are no available data on the use of MembraneBlue 0.15% in pregnant women to inform a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes. Systemic absorption of MembraneBlue 0.15% in humans is expected to be negligible following injection and subsequent removal of the drug at the completion of surgical procedures. Adequate animal reproduction studies were not conducted with MembraneBlue 0.15%, however, trypan blue has been shown to be teratogenic in various animal models at doses 323-fold and greater than the maximum recommended human dose, based on body surface area (BSA). Due to the negligible human systemic exposure when used as recommended, it is not expected that maternal use of MembraneBlue will result in fetal exposure to the drug and risk of teratogenic effects. Data Animal Data Trypan blue is teratogenic in rats, mice, rabbits, hamsters, dogs, guinea pigs, pigs, and chickens. The majority of teratogenicity studies performed involve intravenous, intraperitoneal, or subcutaneous administration in the rat. The teratogenic dose is 50 mg/kg as a single dose or 25 mg/kg/day during embryogenesis in the rat.

Approval history

Sourced from openFDA
  • Dec 16, 2004NDANDA021670Dorc
  • Feb 20, 2009NDANDA022278Dorc

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
46 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Toxic Anterior Segment Syndrome2452%
  2. 2Blindness2248%
  3. 3Corneal Oedema1022%
  4. 4Product Quality Issue613%
  5. 5Cerebral Infarction36.5%
  6. 6Endophthalmitis36.5%
  7. 7Off Label Use36.5%
  8. 8Pigmentation Disorder36.5%
  9. 9Thyroid Disorder36.5%
  10. 10Condition Aggravated24.3%
  11. 11Vision Blurred24.3%
  12. 12Corneal Decompensation12.2%
  13. 13Corneal Degeneration12.2%
  14. 14Drug Interaction12.2%
  15. 15Eye Disorder12.2%

Literature

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Recent PubMed references pinned to Trypan Blue as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 21 ClinicalTrials.gov registrations naming Trypan Blue as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Trypan Blue work?
MembraneBlue 0.15% - Mechanism of action section. MembraneBlue 0.15% selectively stains membranes in the human eye during posterior surgery, such as epiretinal membranes (ERM) and Internal Limiting Membranes (ILM).
What is Trypan Blue used for?
According to FDA labeling, Trypan Blue carries indications including: MembraneBlue 0.15% - Indications & Usage Section MembraneBlue™ 0.15% is indicated for use as an aid in ophthalmic surgery by staining the epiretinal membranes during ophthalmic surgical vitrectomy procedures, facilitating removal of the tissue in adults and pediatric patients. These highlights do not include all the information needed to use MEMBRANEBLUE™ safely and effectively.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Trypan Blue?
Trypan Blue is classified as Other surgical aids.
What are the contraindications for Trypan Blue?
Trypan Blue labeling lists contraindications including: MembraneBlue 0.15% - Contraindications section. MembraneBlue 0.15% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye.. Always consult the full prescribing information and a clinician.
Note. Data for trypan-blue is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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