Arsenic trioxide and bismuth subnitrate

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NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

# Overview
Arsenic trioxide and bismuth subnitrate is an antiemetic that is FDA approved for the treatment of motion sickness and nausea.   Common adverse reactions include hypersensitivity.

# Adult Indications and Dosage

## FDA-Labeled Indications and Dosage (Adult)
- Relieves motion sickness and nausea.

## Off-Label Use and Dosage (Adult)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Arsenic trioxide and bismuth subnitrate in adult patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Arsenic trioxide and bismuth subnitrate in adult patients.

# Pediatric Indications and Dosage

## FDA-Labeled Indications and Dosage (Pediatric)
There is limited information regarding Arsenic trioxide and bismuth subnitrate FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

## Off-Label Use and Dosage (Pediatric)

### Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Arsenic trioxide and bismuth subnitrate in pediatric patients.

### NonGuideline-Supported Use
There is limited information regarding Off-Label NonGuideline-Supported Use of Arsenic trioxide and bismuth subnitrate in pediatric patients.

# Contraindications
There is limited information regarding Arsenic trioxide and bismuth subnitrate Contraindications in the drug label.

# Warnings
- If pregnant or breast feeding ask a health professional before use.

# Adverse Reactions

## Clinical Trials Experience
There is limited information regarding Arsenic trioxide and bismuth subnitrate Clinical Trials Experience in the drug label.

## Postmarketing Experience
- Hypersensitivity

# Drug Interactions
There is limited information regarding Arsenic trioxide and bismuth subnitrate Drug Interactions in the drug label.

# Use in Specific Populations

### Pregnancy
Pregnancy Category (FDA): 
There is no FDA guidance on usage of Arsenic trioxide and bismuth subnitrate in women who are pregnant.
Pregnancy Category (AUS): 
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Arsenic trioxide and bismuth subnitrate in women who are pregnant.

### Labor and Delivery
There is no FDA guidance on use of Arsenic trioxide and bismuth subnitrate during labor and delivery.

### Nursing Mothers
There is no FDA guidance on the use of Arsenic trioxide and bismuth subnitrate in women who are nursing.

### Pediatric Use
There is no FDA guidance on the use of Arsenic trioxide and bismuth subnitrate in pediatric settings.

### Geriatic Use
There is no FDA guidance on the use of Arsenic trioxide and bismuth subnitrate in geriatric settings.

### Gender
There is no FDA guidance on the use of Arsenic trioxide and bismuth subnitrate with respect to specific gender populations.

### Race
There is no FDA guidance on the use of Arsenic trioxide and bismuth subnitrate with respect to specific racial populations.

### Renal Impairment
There is no FDA guidance on the use of Arsenic trioxide and bismuth subnitrate in patients with renal impairment.

### Hepatic Impairment
There is no FDA guidance on the use of Arsenic trioxide and bismuth subnitrate in patients with hepatic impairment.

### Females of Reproductive Potential and Males
There is no FDA guidance on the use of Arsenic trioxide and bismuth subnitrate in women of reproductive potentials and males.

### Immunocompromised Patients
There is no FDA guidance one the use of Arsenic trioxide and bismuth subnitrate in patients who are immunocompromised.

# Administration and Monitoring

### Administration
- Oral

### Monitoring
There is limited information regarding Arsenic trioxide and bismuth subnitrate Monitoring in the drug label.

# IV Compatibility
There is limited information regarding the compatibility of Arsenic trioxide and bismuth subnitrate and IV administrations.

# Overdosage
There is limited information regarding Arsenic trioxide and bismuth subnitrate overdosage.  If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

# Pharmacology
There is limited information regarding Arsenic trioxide and bismuth subnitrate Pharmacology in the drug label.

## Mechanism of Action
There is limited information regarding Arsenic trioxide and bismuth subnitrate Mechanism of Action in the drug label.

## Structure
There is limited information regarding Arsenic trioxide and bismuth subnitrate Structure in the drug label.

## Pharmacodynamics
There is limited information regarding Arsenic trioxide and bismuth subnitrate Pharmacodynamics in the drug label.

## Pharmacokinetics
There is limited information regarding Arsenic trioxide and bismuth subnitrate Pharmacokinetics in the drug label.

## Nonclinical Toxicology
There is limited information regarding Arsenic trioxide and bismuth subnitrate Nonclinical Toxicology in the drug label.

# Clinical Studies
There is limited information regarding Arsenic trioxide and bismuth subnitrate Clinical Studies in the drug label.

# How Supplied
There is limited information regarding Arsenic trioxide and bismuth subnitrate How Supplied in the drug label.

## Storage
There is limited information regarding Arsenic trioxide and bismuth subnitrate Storage in the drug label.

# Images

## Drug Images

## Package and Label Display Panel

# Patient Counseling Information
There is limited information regarding Arsenic trioxide and bismuth subnitrate Patient Counseling Information in the drug label.

# Precautions with Alcohol
Alcohol-Arsenic trioxide and bismuth subnitrate interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

# Brand Names
- BIRIN 40 (NUMBER 79)

# Look-Alike Drug Names
There is limited information regarding Arsenic trioxide and bismuth subnitrate Look-Alike Drug Names in the drug label.

# Drug Shortage Status

# Price