Arsenic trioxide and bismuth subnitrate

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Arsenic trioxide and bismuth subnitrate
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: Ammu Susheela, M.D. [2]

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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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-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

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

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

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Package and Label Display Panel

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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)®[1]

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

References

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

  1. "BIRIN 40 (NUMBER 79)- arsenic trioxide and bismuth subnitrate pellet".

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