Rose bengal sodium

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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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-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.

## 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

## 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 30C.
- Take care not to stain clothing.

# Images

## Drug Images

## Package and Label Display Panel

### PRINCIPAL DISPLAY PANEL - 100 STRIP CARTON

### Ingredients and Appearance

# Patient Counseling Information

### INSTRUCTIONS FOR USE

# 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
- GLOSTRIPS

# Look-Alike Drug Names
- There is limited information regarding the look alike drug names

# Drug Shortage Status

# Price