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

Bismuth subnitrate is used as an over-the-counter (OTC) antacid and anti-diarrheic agent. Bismuth subnitrate is a homeopathic medication and lacks evaluation from the Food and Drug Administration (FDA) regarding its safety or efficacy. However, the use of bismuth substrate as an active ingredient in OTC antacids is approved by the FDA. Common adverse effects include headache, loss of appetite, and blue-gray skin discoloration.

Adult Indications and Dosage

Indications for Bismuth subnitrate use:

1. Palliative Cancer Treatment:
   • Used to prevent renal damage resulting from anti-cancer chemotherapy.
   • Aids in preventing bone marrow damage caused by radiation therapy.
2. Gastrointestinal Disorders:
   • Effective for treating duodenal ulcers, as part of triple-therapy for H. pylori infection.
   • Alleviates symptoms of diarrhea and vomiting.
3. Topical Use:
   • Acts as an astringent agent in the treatment of:
     • Wounds
     • Burns
     • Hemorrhoids
     • Other anorectal disorders.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium selenite in adult patients.

Pediatric Indications and Dosage

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

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

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Sodium selenite in adult patients.

Safety and effectiveness in pediatric patients have not been established.

Contraindications

Bismuth subnitrate is relatively contraindicated in patients with renal impairment and pregnant patients.

Adverse Reactions

Loss of appetite, headache, blue-gray discoloration of skin, or renal damage. It can also cause black spots on the tongue and a thin blue-black line along the gum margin.

Drug Interactions

There is limited information regarding drug interactions of Bismuth subnitrate.

Use in Specific Populations

Use of Bismuth subnitrate in pregnant population is relatively contraindicated, particularly in the third trimester.

Overdosage

Reported oral doses associated with moderate to potentially lethal toxicity in humans range from 0.5 to 5 grams per kilogram. Symptoms of bismuth toxicity include osteoarthropathy, nephropathy, colitis, gingivitis, stomatitis, and encephalopathy.

Package and Label Display Panel

Bismuth Subnitrate Package and Label Display Panel

Brand Names

Bismithum Subnitriticum

Antimonite Belladona powder

Look-Alike Drug Names

There is limited information regarding Look-Alike Drug Names.