Rose bengal sodium

Rose bengal sodium
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: Rabin Bista, M.B.B.S. [2]

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Overview

Rose bengal sodium is a Diagnostic Agent that is FDA approved for the diagnosis of keratoconjunctivitis sicca, keratitis, abrasions or corrosions and routine ocular examinations. Common adverse reactions include stinging, irritation, discomfort.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

Rose Bengal ophthalmic strips are used as a diagnostic agent in routine ocular examinations or when superficial conjunctiva or corneal tissue change is suspected. Rose Bengal ophthalmic strips can also serve as an effective aid in the diagnosis of keratoconjunctivitis sicca, keratitis, abrasions or corrosions as well as the detection of foreign bodies.

Direction

To ensure optimal staining and patient comfort, the GloStrip impregnated tip should be moistened with one or two drops of sterile, isotonic saline or irrigating solution before application. Shake off excess solution and touch conjunctiva or fornix as required with moistened tip. It is recommended that the patient blink several times after application.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Rose bengal sodium in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Rose bengal sodium in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Rose bengal sodium in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Rose bengal sodium in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Rose bengal sodium in pediatric patients.

Contraindications

• Known hypersensitivity to Rose Bengal.

Warnings

The contents may not be sterile if the individual strip package has been damaged or previously opened. This product is intended for external use only. Keep out of reach of children

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Clinical Trial Experience of Rose bengal sodium 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

Postmarketing Experience

stinging, irritation, discomfort

Drug Interactions

There is limited information regarding Rose bengal sodium Drug Interactions in the drug label.

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 Rose bengal sodium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Rose bengal sodium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Rose bengal sodium with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Rose bengal sodium with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Rose bengal sodium with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Rose bengal sodium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Rose bengal sodium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Rose bengal sodium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Rose bengal sodium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Rose bengal sodium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Rose bengal sodium in patients who are immunocompromised.

Administration and Monitoring

Administration

• Ophthalmic

Monitoring

There is limited information regarding Monitoring of Rose bengal sodium in the drug label.

IV Compatibility

There is limited information regarding IV Compatibility of Rose bengal sodium in the drug label.

Overdosage

There is limited information regarding Overdose of Rose bengal sodium in the drug label.

Pharmacology

There is limited information regarding Rose bengal sodium Pharmacology in the drug label.

Mechanism of Action

• As a vital stain, Rose Bengal stains both the nuclei and cell walls of dead or degenerated epithelial cells of the cornea and conjunctiva. Rose Bengal will also stain the mucus of the precorneal tear film.

Structure

• Rose Bengal Ophthalmic Strips

diagnostic agent is for professional use only

Each strip is impregnated with 1.3 mg of Rose Bengal.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Rose bengal sodium in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Rose bengal sodium in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Rose bengal sodium in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Rose bengal sodium in the drug label.

How Supplied

• Dispenser carton containing 100 sterile strips.

Storage

Store below 30°C. Take care not to stain clothing.

Images

Drug Images

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Package and Label Display Panel

PRINCIPAL DISPLAY PANEL - 100 STRIP CARTON

File:Rose bengal sodium01.png

This image is provided by the National Library of Medicine.

File:Rose bengal sodium01.png

This image is provided by the National Library of Medicine.

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Patient Counseling Information

INSTRUCTIONS FOR USE

File:Rose bengal sodium01.png

This image is provided by the National Library of Medicine.

Precautions with Alcohol

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

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

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

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