Trypan Blue: Difference between revisions

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|authorTag={{KS}}
|authorTag={{KS}}
|genericName=trypan blue
|genericName=trypan blue
|aOrAn=a
|aOrAn=an
|indicationType=treatment
|drugClass=Ophthalmologic agent
|hasBlackBoxWarning=Yes
|indicationType=procedure
|adverseReactions=<!--Black Box Warning-->
|indication=ophthalmic posterior surgery and facilitates removal of epiretinal tissue.
|adverseReactions=discoloration of high water content hydrogen intraocular lenses and inadvertent staining of the posterior lens capsule and vitreous face
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningTitle=<span style="color:#FF0000;">ConditionName: </span>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
|blackBoxWarningBody=<i><span style="color:#FF0000;">ConditionName: </span></i>
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|fdaLIADAdult===Indications==
|fdaLIADAdult===Indications==
* 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.
* 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.


==Dosage==
==Dosage==


* 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.
* 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™ 0.15% perform a ‘fluid-air exchange’, i.e. filling the entire vitreous cavity with air, to prevent aqueous dilution of MembraneBlue™ 0.15%. MembraneBlue™ 0.15% is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlue™ 0.15% 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.
 
* Before injection of MembraneBlue™ 0.15% perform a ‘fluid-air exchange’, i.e. filling the entire vitreous cavity with air, to prevent aqueous dilution of MembraneBlue™ 0.15%. MembraneBlue™ 0.15% is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlue™ 0.15% 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™ 0.15% 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™ 0.15% 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.
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* MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.
* MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.
|offLabelAdultGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.
|offLabelAdultNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in adult patients.


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<!--FDA-Labeled Indications and Dosage (Pediatric)-->
<!--FDA-Labeled Indications and Dosage (Pediatric)-->
|fdaLIADPed======Condition1=====
|fdaLIADPed===Indications==


* Dosing Information
* 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.


:* Dosage
==Dosage==


=====Condition2=====
* 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.


There is limited information regarding <i>FDA-Labeled Use</i> of {{PAGENAME}} in pediatric patients.
* Before injection of MembraneBlue™ 0.15% perform a ‘fluid-air exchange’, i.e. filling the entire vitreous cavity with air, to prevent aqueous dilution of MembraneBlue™ 0.15%. MembraneBlue™ 0.15% is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlue™ 0.15% 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.


<!--Off-Label Use and Dosage (Pediatric)-->
* MembraneBlue™ 0.15% 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.


<!--Guideline-Supported Use (Pediatric)-->
* MembraneBlue™ 0.15% 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.
|offLabelPedGuideSupport======Condition1=====


* Developed by:
==DOSAGE FORMS AND STRENGTH==


* Class of Recommendation:
* MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.
 
|offLabelPedGuideSupport=* There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
* Strength of Evidence:
|offLabelPedNoGuideSupport=* There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Non–Guideline-Supported Use (Pediatric)-->
|offLabelPedNoGuideSupport======Condition1=====
 
* Dosing Information
 
:* Dosage
 
=====Condition2=====
 
There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of {{PAGENAME}} in pediatric patients.
 
<!--Contraindications-->
|contraindications=* MembraneBlue™ 0.15% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye. The dye may be absorbed by the IOL and stain it.
|contraindications=* MembraneBlue™ 0.15% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye. The dye may be absorbed by the IOL and stain it.
|warnings='''Excessive staining''':
|warnings='''Excessive staining''':
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|clinicalTrials=* Adverse reactions reported following use of MembraneBlue™ 0.15% include discoloration of high water content hydrogen intraocular lenses  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.
|clinicalTrials=* Adverse reactions reported following use of MembraneBlue™ 0.15% include discoloration of high water content hydrogen intraocular lenses  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.
|postmarketing=* There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|postmarketing=* There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.
|useInPregnancyFDA=* '''Teratogenic Effects: Pregnancy Category C'''. 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. These doses are approximately 4,000- and 2,000-fold the maximum recommended human dose of 0.75 mg per injection based in a 60 kg person, assuming that the whole dose is completely absorbed. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality, and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 4,000-fold maximum recommended human dose of 0.75 mg per injection, assuming total absorption). There are no adequate and well-controlled studies in pregnant women. Trypan blue should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
|useInPregnancyFDA=* '''Teratogenic Effects: Pregnancy Category C'''. 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. These doses are approximately 4,000- and 2,000-fold the maximum recommended human dose of 0.75 mg per injection based in a 60 kg person, assuming that the whole dose is completely absorbed. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality, and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 4,000-fold maximum recommended human dose of 0.75 mg per injection, assuming total absorption). There are no adequate and well-controlled studies in pregnant women. Trypan blue should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.
|useInPregnancyAUS=* There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInPregnancyAUS=* There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of {{PAGENAME}} in women who are pregnant.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInLaborDelivery=There is no FDA guidance on use of {{PAGENAME}} during labor and delivery.
|useInNursing=* It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trypan blue is administered to a nursing woman.
|useInNursing=* It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trypan blue is administered to a nursing woman.
|useInPed=* The safety and effectiveness of trypan blue have been established in pediatric patients. Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients.
|useInPed=* The safety and effectiveness of trypan blue have been established in pediatric patients. Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients.
|useInGeri=* No overall differences in safety and effectiveness have been observed between elderly and younger patients.
|useInGeri=* No overall differences in safety and effectiveness have been observed between elderly and younger patients.
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|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInReproPotential=There is no FDA guidance on the use of {{PAGENAME}} in women of reproductive potentials and males.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
|useInImmunocomp=There is no FDA guidance one the use of {{PAGENAME}} in patients who are immunocompromised.
 
|administration=* Intravenous
 
|administration=* Oral
 
* Intravenous
|monitoring=* There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|monitoring=* There is limited information regarding <i>Monitoring</i> of {{PAGENAME}} in the drug label.
|IVCompat=* There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|IVCompat=* There is limited information regarding <i>IV Compatibility</i> of {{PAGENAME}} in the drug label.
|overdose=* There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.
|overdose=* There is limited information regarding <i>Chronic Overdose</i> of {{PAGENAME}} in the drug label.


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<!--Drug box 2-->
<!--Drug box 2-->
|drugBox=[[File:Trypan blue wikipedia.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
|mechAction=* MembraneBlue™ 0.15% selectively stains membranes in the human eye during posterior surgery, such as epiretinal membranes (ERM) and Internal Limiting Membranes (ILM).
|mechAction=* MembraneBlue™ 0.15% selectively stains membranes in the human eye during posterior surgery, such as epiretinal membranes (ERM) and Internal Limiting Membranes (ILM).
|structure=* MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is a sterile solution of trypan blue (an acid di-azo group dye). MembraneBlue™ 0.15% selectively stains epiretinal membranes during ophthalmic surgical vitrectomy procedures.
|structure=* MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is a sterile solution of trypan blue (an acid di-azo group dye). MembraneBlue™ 0.15% selectively stains epiretinal membranes during ophthalmic surgical vitrectomy procedures.
Line 129: Line 94:
* 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 C34H24N6Na4O14S4, and has the following chemical structure:
* 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 C34H24N6Na4O14S4, and has the following chemical structure:


[[File:XXXXX.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
[[File:Trypan blue structure.png|thumb|none|600px|This image is provided by the National Library of Medicine.]]
 
 
|PD=* There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PD=* There is limited information regarding <i>Pharmacodynamics</i> of {{PAGENAME}} in the drug label.
|PK=* There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|PK=* There is limited information regarding <i>Pharmacokinetics</i> of {{PAGENAME}} in the drug label.
|nonClinToxic=* Trypan blue is carcinogenic in rats. Wister/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total dose approximately 100,000-fold the maximum recommended human dose of 0.75 mg per injection in a 60 kg person, assuming total absorption).  
|nonClinToxic=* Trypan blue is carcinogenic in rats. Wister/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total dose approximately 100,000-fold the maximum recommended human dose of 0.75 mg per injection in a 60 kg person, assuming total absorption).  


* Trypan blue was mutagenic in the Ames test and caused DNA strand breaks in vitro.
* Trypan blue was mutagenic in the Ames test and caused DNA strand breaks in vitro.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
|clinicalStudies=There is limited information regarding <i>Clinical Studies</i> of {{PAGENAME}} in the drug label.
<!--How Supplied-->
|howSupplied=*MembraneBlue™ 0.15% is supplied as follows:
|howSupplied=*MembraneBlue™ 0.15% is supplied as follows:


:*0.5 mL of MembraneBlue™ 0.15% in a sterile single-use Luer Lok, 2.25 mL glass syringe, grey rubber plunger stopper and tip cap with polypropylene plunger rod in a peel pouch. Five pouched products are packed in one distribution box.
:*0.5 mL of MembraneBlue™ 0.15% in a sterile single-use Luer Lok, 2.25 mL glass syringe, grey rubber plunger stopper and tip cap with polypropylene plunger rod in a peel pouch. Five pouched products are packed in one distribution box.
|storage=* MembraneBlue™ 0.15% is stored at 15-25ºC (59-77ºF). Protect from direct sunlight.
|storage=* MembraneBlue™ 0.15% is stored at 15-25ºC (59-77ºF). Protect from direct sunlight.
|packLabel=[[File:XXXXX.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|packLabel=[[File:Trypan blue indgredients and appearance.png|thumb|none|400px|This image is provided by the National Library of Medicine.]]
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
|fdaPatientInfo=There is limited information regarding <i>Patient Counseling Information</i> of {{PAGENAME}} in the drug label.
<!--Precautions with Alcohol-->
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
|alcohol=* Alcohol-{{PAGENAME}} interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
<!--Brand Names-->
|brandNames=* MEMBRANEBLUE®<ref>{{Cite web |title =MEMBRANEBLUE - trypan blue injection, solution  | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0364aceb-dd3f-4bac-b468-25379a07ccfc#section-8 }}</ref>
|brandNames=* MEMBRANEBLUE®<ref>{{Cite web |title =MEMBRANEBLUE - trypan blue injection, solution  | url =http://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=0364aceb-dd3f-4bac-b468-25379a07ccfc#section-8 }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|lookAlike=* A® — B®<ref name="www.ismp.org">{{Cite web  | last =  | first =  | title = http://www.ismp.org | url = http://www.ismp.org | publisher =  | date =  }}</ref>
|drugShortage=
|drugShortage=
}}
}}
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<!--Category-->
<!--Category-->


[[Category:Azo dyes]]
[[Category:Drug]]
[[Category:Drug]]

Latest revision as of 17:22, 20 August 2015

Trypan Blue
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Kiran Singh, M.D. [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Trypan Blue is an Ophthalmologic agent that is FDA approved for the procedure of ophthalmic posterior surgery and facilitates removal of epiretinal tissue.. Common adverse reactions include discoloration of high water content hydrogen intraocular lenses and inadvertent staining of the posterior lens capsule and vitreous face.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

  • 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.

Dosage

  • 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™ 0.15% perform a ‘fluid-air exchange’, i.e. filling the entire vitreous cavity with air, to prevent aqueous dilution of MembraneBlue™ 0.15%. MembraneBlue™ 0.15% is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlue™ 0.15% 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™ 0.15% 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™ 0.15% 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.

DOSAGE FORMS AND STRENGTH

  • MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Trypan Blue in adult patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Trypan Blue in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

Indications

  • 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.

Dosage

  • 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™ 0.15% perform a ‘fluid-air exchange’, i.e. filling the entire vitreous cavity with air, to prevent aqueous dilution of MembraneBlue™ 0.15%. MembraneBlue™ 0.15% is carefully applied to the retinal membrane using a blunt cannula attached to the MembraneBlue™ 0.15% 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™ 0.15% 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™ 0.15% 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.

DOSAGE FORMS AND STRENGTH

  • MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

  • There is limited information regarding Off-Label Guideline-Supported Use of Trypan Blue in pediatric patients.

Non–Guideline-Supported Use

  • There is limited information regarding Off-Label Non–Guideline-Supported Use of Trypan Blue in pediatric patients.

Contraindications

  • MembraneBlue™ 0.15% is contraindicated when a non-hydrated (dry state), hydrophilic acrylic intraocular lens (IOL) is planned to be inserted into the eye. The dye may be absorbed by the IOL and stain it.

Warnings

Excessive staining:

  • It is recommended that after injection all excess MembraneBlue™ 0.15% be immediately removed from the eye.

Priming of the syringe:

  • 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

Clinical Trials Experience

  • Adverse reactions reported following use of MembraneBlue™ 0.15% include discoloration of high water content hydrogen intraocular lenses 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.

Postmarketing Experience

  • There is limited information regarding Postmarketing Experience of Trypan Blue in the drug label.

Drug Interactions

There is limited information regarding Trypan Blue Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

  • Teratogenic Effects: Pregnancy Category C. 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. These doses are approximately 4,000- and 2,000-fold the maximum recommended human dose of 0.75 mg per injection based in a 60 kg person, assuming that the whole dose is completely absorbed. Characteristic anomalies included neural tube, cardiovascular, vertebral, tail, and eye defects. Trypan blue also caused an increase in post-implantation mortality, and decreased fetal weight. In the monkey, trypan blue caused abortions with single or two daily doses of 50 mg/kg between 20th to 25th days of pregnancy, but no apparent increase in birth defects (approximately 4,000-fold maximum recommended human dose of 0.75 mg per injection, assuming total absorption). There are no adequate and well-controlled studies in pregnant women. Trypan blue should be given to a pregnant woman only if the potential benefit justifies the potential risk to the fetus.


Pregnancy Category (AUS):

  • There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trypan Blue in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Trypan Blue during labor and delivery.

Nursing Mothers

  • It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when trypan blue is administered to a nursing woman.

Pediatric Use

  • The safety and effectiveness of trypan blue have been established in pediatric patients. Use of trypan blue is supported by evidence from an adequate and well-controlled study in pediatric patients.

Geriatic Use

  • No overall differences in safety and effectiveness have been observed between elderly and younger patients.

Gender

There is no FDA guidance on the use of Trypan Blue with respect to specific gender populations.

Race

There is no FDA guidance on the use of Trypan Blue with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Trypan Blue in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Trypan Blue in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Trypan Blue in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Trypan Blue in patients who are immunocompromised.

Administration and Monitoring

Administration

  • Intravenous

Monitoring

  • There is limited information regarding Monitoring of Trypan Blue in the drug label.

IV Compatibility

  • There is limited information regarding IV Compatibility of Trypan Blue in the drug label.

Overdosage

  • There is limited information regarding Chronic Overdose of Trypan Blue in the drug label.

Pharmacology

This image is provided by the National Library of Medicine.

Mechanism of Action

  • MembraneBlue™ 0.15% selectively stains membranes in the human eye during posterior surgery, such as epiretinal membranes (ERM) and Internal Limiting Membranes (ILM).

Structure

  • MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is a sterile solution of trypan blue (an acid di-azo group dye). MembraneBlue™ 0.15% 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 (Na2HPO4.2H2O); 0.3 mg sodium di-hydrogen orthophosphate (NaH2PO4.2H2O); 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 C34H24N6Na4O14S4, and has the following chemical structure:
This image is provided by the National Library of Medicine.

Pharmacodynamics

  • There is limited information regarding Pharmacodynamics of Trypan Blue in the drug label.

Pharmacokinetics

  • There is limited information regarding Pharmacokinetics of Trypan Blue in the drug label.

Nonclinical Toxicology

  • Trypan blue is carcinogenic in rats. Wister/Lewis rats developed lymphomas after receiving subcutaneous injections of 1% trypan blue dosed at 50 mg/kg every other week for 52 weeks (total dose approximately 100,000-fold the maximum recommended human dose of 0.75 mg per injection in a 60 kg person, assuming total absorption).
  • Trypan blue was mutagenic in the Ames test and caused DNA strand breaks in vitro.

Clinical Studies

There is limited information regarding Clinical Studies of Trypan Blue in the drug label.

How Supplied

  • MembraneBlue™ 0.15% is supplied as follows:
  • 0.5 mL of MembraneBlue™ 0.15% in a sterile single-use Luer Lok, 2.25 mL glass syringe, grey rubber plunger stopper and tip cap with polypropylene plunger rod in a peel pouch. Five pouched products are packed in one distribution box.

Storage

  • MembraneBlue™ 0.15% is stored at 15-25ºC (59-77ºF). Protect from direct sunlight.

Images

Drug Images

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Package and Label Display Panel

This image is provided by the National Library of Medicine.

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Trypan Blue in the drug label.

Precautions with Alcohol

  • Alcohol-Trypan Blue interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

  • MEMBRANEBLUE®[1]

Look-Alike Drug Names

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

  1. ↑ "MEMBRANEBLUE - trypan blue injection, solution".
  2. ↑ "http://www.ismp.org". External link in |title= (help)

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