Trypan Blue: Difference between revisions

Trypan Blue
	Black Box Warning
	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

VisualWikitext

Revision as of 15:47, 2 April 2015

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

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Black Box Warning

ConditionName:

See full prescribing information for complete Boxed Warning.

ConditionName:

Content

Overview

Trypan Blue is a {{{drugClass}}} that is FDA approved for the treatment of {{{indication}}}. There is a Black Box Warning for this drug as shown here. Common adverse reactions include .

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

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

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)

Condition1

Dosing Information

Dosage

Condition2

There is limited information regarding FDA-Labeled Use of Trypan Blue in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

Condition1

Developed by:

Class of Recommendation:

Strength of Evidence:

Dosing Information

Dosage

Condition2

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

Non–Guideline-Supported Use

Condition1

Dosing Information

Dosage

Condition2

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

ConditionName:

See full prescribing information for complete Boxed Warning.

ConditionName:

Content

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.

Body as a Whole

Cardiovascular

Digestive

Endocrine

Hematologic and Lymphatic

Metabolic and Nutritional

Musculoskeletal

Neurologic

Respiratory

Skin and Hypersensitivy Reactions

Special Senses

Urogenital

Miscellaneous

Drug Interactions

Drug

Description

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

Pregnancy Category

Pregnancy Category (AUS):

Australian Drug Evaluation Committee (ADEC) Pregnancy Category

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

There is no FDA guidance on the use of Trypan Blue with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Trypan Blue with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Trypan Blue with respect to geriatric 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

Oral

Intravenous

Monitoring

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

Description

IV Compatibility

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

Overdosage

Acute Overdose

Signs and Symptoms

Description

Management

Description

Chronic Overdose

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

Pharmacology

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

Mechanism of Action

Structure

File:Trypan Blue01.png

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

There is limited information regarding Nonclinical Toxicology of Trypan Blue in the drug label.

Clinical Studies

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

How Supplied

Storage

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

Images

Drug Images

{{#ask: Page Name::Trypan Blue |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Trypan Blue |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

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

®^[1]

Look-Alike Drug Names

A® — B®^[2]

Drug Shortage Status

Price

References

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

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[1] Empty citation (help)

[www.ismp.org-2] "http://www.ismp.org". External link in |title= (help)

[1]

[2]

@@ Line 1: / Line 1: @@
 {{DrugProjectFormSinglePage
+|authorTag={{KS}}
+|genericName=trypan blue
 |aOrAn=a
 |indicationType=treatment
@@ Line 12: / Line 14: @@
 <!--FDA-Labeled Indications and Dosage (Adult)-->
-|fdaLIADAdult======Condition1=====
+|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.
-* Dosing Information
+==Dosage==
-:* Dosage
-=====Condition2=====
-* Dosing Information
-:* Dosage
-=====Condition3=====
-* Dosing Information
-:* 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.
-=====Condition4=====
+* 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.
-* Dosing Information
+* 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
+==DOSAGE FORMS AND STRENGTH==
-<!--Off-Label Use and Dosage (Adult)-->
+* MembraneBlue™ 0.15% (trypan blue ophthalmic solution) is supplied in 2.25 mL syringes filled to a volume of 0.5 mL.
-<!--Guideline-Supported Use (Adult)-->
 |offLabelAdultGuideSupport======Condition1=====
@@ Line 110: / Line 101: @@
 <!--Contraindications-->
-|contraindications=* Condition1
+|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-->
-|warnings=* Description
-====Precautions====
-* Description
-<!--Adverse Reactions-->
-<!--Clinical Trials Experience-->
-|clinicalTrials=There is limited information regarding <i>Clinical Trial Experience</i> of {{PAGENAME}} in the drug label.
-=====Body as a Whole=====
-=====Cardiovascular=====
-=====Digestive=====
-=====Endocrine=====
-=====Hematologic and Lymphatic=====
-=====Metabolic and Nutritional=====
-=====Musculoskeletal=====
-=====Neurologic=====
-=====Respiratory=====
-=====Skin and Hypersensitivy Reactions=====
-=====Special Senses=====
-=====Urogenital=====
+* 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.
+|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.
-=====Miscellaneous=====
-<!--Postmarketing Experience-->
 |postmarketing=There is limited information regarding <i>Postmarketing Experience</i> of {{PAGENAME}} in the drug label.