Bismuth Salts

Drug class: Antineoplastic Agents

Usage of Bismuth Salts

Diarrhea

Bismuth subsalicylate used as self-medication in children and adults for symptomatic control of acute nonspecific diarrhea and travelers’ diarrhea.

Bismuth subsalicylate has been used in adults for prevention of travelers’ diarrhea† [off-label]; however, less effective than anti-infective agents.

Helicobacter pylori Infection and Duodenal Ulcer Disease

Bismuth subsalicylate used for treatment of Helicobacter pylori infection and duodenal ulcer disease (active disease or history of duodenal ulcer); eradication of H. pylori shown to reduce the risk of duodenal ulcer recurrence.

Bismuth subsalicylate used in multiple-drug regimens that also include metronidazole, tetracycline hydrochloride, and a histamine H2-receptor antagonist or proton-pump inhibitor (quadruple therapy); such drug combinations recommended by the American College of Gastroenterology (ACG) as first-line treatment option for eradication of H. pylori infection. ACG recommends consideration of such quadruple-drug regimens in penicillin-allergic patients and those who have previously received a macrolide antibiotic. If the initial 14-day regimen does not eradicate H. pylori, retreat with multiple-drug regimen that does not include metronidazole to avoid possible development of metronidazole resistance.

Multiple-drug regimens including bismuth subsalicylate, metronidazole, tetracycline hydrochloride, and a proton-pump inhibitor (instead of a histamine H2-receptor antagonist) may be more effective against metronidazole-resistant strains of H. pylori; such regimens recommended by ACG as acceptable treatment option for persistent H. pylori infection (“salvage” treatment).

Fixed combination containing BCitrate potassium, metronidazole, and tetracycline" href="/drugs/bismuth-subcitrate-potassium-metronidazole-and-tetracycline-1919/">Bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride (Pylera) used in conjunction with omeprazole for the treatment of H. pylori infection and duodenal ulcer (active ulcer or history of duodenal ulcer within past 5 years).

Flatulence or Stool Odor

Bismuth subgallate used as self-medication in children and adults for the reduction of flatulence or stool odor from a colostomy or ileostomy.

Bismuth subgallate has been used as self-medication for reduction of odor from fecal incontinence† [off-label], irritable bowel syndrome† [off-label], or bariatric surgery† [off-label].

Bismuth subgallate not expected to be effective for reduction of odor from faulty personal hygiene† [off-label].

Dyspepsia (Upset Stomach)

Bismuth subsalicylate used as self-medication in children and adults for symptomatic relief of dyspepsia (e.g., upset stomach, nausea, heartburn, fullness, belching, gas) secondary to overindulgence in food and drink.

Effectiveness of bismuth salts in the treatment of nonulcer dyspepsia† uncertain. Not recommended as first-line therapy because of potential risk of neurotoxicity with long-term use; may be useful as second-line agents.

Relate drugs

How to use Bismuth Salts

Administration

Oral Administration

Capsules

Bismuth subgallate: Administer orally up to 4 times daily with meals. Swallow capsule whole.

Bismuth subcitrate potassium in fixed combination with metronidazole and tetracycline hydrochloride (Pylera): Administer orally 4 times daily after meals and at bedtime; give omeprazole concomitantly as part of regimen. (See Fixed Combination Containing Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride [Pylera] under Dosage.) Swallow capsule whole. Administer with full glass (240 mL) of water, particularly with bedtime doses, to reduce risk of esophageal irritation and ulceration by tetracycline hydrochloride component. If a dose of Pylera is missed, take next dose at regularly scheduled time; do not double the dose. Contact clinician if >4 doses are missed.

Suspension

Bismuth subsalicylate: Shake suspension well prior to administration. Use dose cup provided by manufacturer for accurate dosing. For Diotame, twist off lid and dispense appropriate dose by squeezing tube.

Chewable Tablets

Bismuth subgallate: Administer orally up to 4 times daily with meals. Chew or swallow whole.

Bismuth subsalicylate: Chew or dissolve in mouth and swallow.

Bismuth subsalicylate (with metronidazole and tetracycline hydrochloride in Helidac Therapy kit): Administer each component orally 4 times daily with meals and at bedtime. Chew and swallow bismuth subsalicylate tablets. Administer tetracycline hydrochloride and metronidazole components with full glass (240 mL) of water, particularly with bedtime doses, to reduce risk of esophageal irritation and ulceration by tetracycline hydrochloride component. If a dose of Helidac Therapy is missed, take next dose at regularly scheduled time; do not double the dose. If >4 doses are missed, contact clinician.

Conventional Tablets

Bismuth subsalicylate (e.g., Pepto-Bismol Easy-to-Swallow Caplets): Swallow with water; do not chew.

Dosage

Available as bismuth subgallate, bismuth subcitrate potassium, and bismuth subsalicylate; dosages expressed in terms of the salts.

Bismuth subcitrate potassium available in fixed combination with metronidazole and tetracycline hydrochloride (Pylera); dosage of Pylera expressed as number of capsules.

Pediatric Patients

Acute Nonspecific Diarrhea and Travelers’ Diarrhea Bismuth Subsalicylate Oral

Children ≥12 years of age: 525 mg every 30–60 minutes or 1.05 g every hour as needed, not to exceed 4.2 g in a 24-hour period. Use until diarrhea stops, but not >2 days.

Children ≥12 years of age: Alternatively, administer 1.05 g every 30 minutes† to every hour as needed, not to exceed 4.2 g in a 24-hour period.

Flatulence or Stool Odor Bismuth Subgallate Oral

Children ≥12 years of age: 200–400 mg up to 4 times daily.

Dyspepsia (Upset Stomach) Bismuth Subsalicylate Oral

Children ≥12 years of age: 525 mg every 30–60 minutes as needed, not to exceed 4.2 g in a 24-hour period. Do not use for >2 days.

Children ≥12 years of age: Alternatively, administer 1.05 g every 30–60 minutes† as needed, not to exceed 4.2 g in a 24-hour period.

Adults

Acute Nonspecific Diarrhea and Travelers’ Diarrhea Bismuth Subsalicylate Oral

525 mg every 30–60 minutes or 1.05 g every hour as needed, not to exceed 4.2 g in a 24-hour period. Use until diarrhea stops, but not >2 days.

Alternatively, administer 1.05 g every 30 minutes† to every hour as needed, not to exceed 4.2 g in a 24-hour period.

Prevention of Travelers’ Diarrhea† Bismuth Subsalicylate Oral

525 mg 4 times daily has been recommended.

Helicobacter pylori Infection and Duodenal Ulcer Disease Bismuth subsalicylate, metronidazole, and tetracycline Hydrochloride Regimen Oral

525 mg of bismuth subsalicylate in conjunction with metronidazole (250 mg) and tetracycline hydrochloride (500 mg) 4 times daily for 10–14 days; give concomitantly with ranitidine (150 mg) twice daily or usual dosage of a proton-pump inhibitor once or twice daily.

Salvage therapy for persistent H. pylori infection: Administer for 7–14 days.

Bismuth Subsalicylate (with Metronidazole and Tetracycline Hydrochloride) in Helidac Therapy Kit Oral

525 mg of bismuth subsalicylate in conjunction with metronidazole (250 mg) and tetracycline hydrochloride (500 mg) 4 times daily (at meals and at bedtime) for 14 days; give concomitantly with usual dosage of H2-receptor antagonist.

Fixed Combination Containing Bismuth Subcitrate Potassium, Metronidazole, and Tetracycline Hydrochloride (Pylera) Oral

3 capsules 4 times daily (after meals and at bedtime) for 10 days; give concomitantly with omeprazole 20 mg twice daily (after morning and evening meal) for 10 days.

Flatulence or Stool Odor Bismuth Subgallate Oral

200–400 mg up to 4 times daily.

Dyspepsia (Upset Stomach) Bismuth Subsalicylate Oral

525 mg every 30–60 minutes as needed, not to exceed 4.2 g in a 24-hour period. Do not use for >2 days.

Alternatively, administer 1.05 g every 30–60 minutes† as needed, not to exceed 4.2 g in a 24-hour period.

Prescribing Limits

Pediatric Patients

Acute Nonspecific Diarrhea and Travelers’ Diarrhea Bismuth Subsalicylate Oral

Children ≥12 years of age: Maximum 4.2 g in a 24-hour period. Self-medication should not exceed 2 days.

Dyspepsia (Upset Stomach) Bismuth Subsalicylate Oral

Children ≥12 years of age: Maximum 4.2 g in a 24-hour period. Self-medication should not exceed 2 days.

Adults

Acute Nonspecific Diarrhea and Travelers’ Diarrhea Bismuth Subsalicylate Oral

Maximum 4.2 g in a 24-hour period. Self-medication should not exceed 2 days.

Dyspepsia (Upset Stomach) Bismuth Subsalicylate Oral

Maximum 4.2 g in a 24-hour period. Self-medication should not exceed 2 days.

Special Populations

No special population dosage recommendations at this time. (See Geriatric Use and also see Renal Impairment, under Cautions.)

Warnings

Contraindications

  • Helidac Therapy (kit containing bismuth subsalicylate, metronidazole, tetracycline hydrochloride) contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or renal impairment, patients with known allergy to aspirin or salicylates, and those with known hypersensitivity to any component of the kit.
  • Pylera (fixed-combination capsule containing bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or renal impairment, and those with known hypersensitivity to any ingredient in the capsule.

    • Warnings/Precautions

    Warnings

    GI Disorders

    Do not use bismuth subsalicylate (e.g., Maalox Total relief) for self-medication in patients with an ulcer, bleeding disorder, or bloody or black stools.

    Reye’s Syndrome

    Risk of Reye’s syndrome with bismuth subsalicylate in children or adolescents who have or are recovering from varicella or influenza-like symptoms. (See Pediatric Use under Cautions.)

    Neurotoxicity

    Neurotoxicity associated with excessive doses of bismuth salts reported rarely; reversible following discontinuance of drug.

    Discoloration of Tongue and/or Stool

    Possible transient and harmless darkening of tongue and/or black stool; do not confuse stool darkening with melena.

    Lead Content

    Bismuth mined from the ground, and commercially available Pepto-Bismol preparations, may contain small amounts of naturally occurring lead. Amounts of lead in Pepto-Bismol preparations are low compared with average daily lead exposure. Pepto-Bismol preparations not intended for chronic use.

    Sensitivity Reactions

    Hypersensitivity

    Bismuth subsalicylate contains salicylate; do not use in patients allergic to salicylates (including aspirin).

    General Precautions

    Selection and Use of Anti-infectives in H. pylori Regimens

    To reduce development of drug-resistant bacteria and maintain effectiveness of Helidac Therapy, Pylera, and other anti-infective agents, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria.

    When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy.

    Phenylketonuria

    Diotame chewable tablets contain aspartame (NutraSweet), which is metabolized in the GI tract to phenylalanine following oral administration.

    Use of Fixed Combinations or Multiple-Drug Kits

    When the fixed-combination preparation containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride (Pylera) or the kit containing bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (Helidac Therapy) is used for the treatment of H. pylori infection and duodenal ulcer disease, the cautions, precautions, and contraindications associated with metronidazole and tetracycline hydrochloride must be considered in addition to those associated with bismuth subcitrate potassium or bismuth subsalicylate.

    Medication Errors

    Serious medication errors have been reported to FDA in which consumers used Maalox Total Relief (bismuth subsalicylate) when they intended to use traditional Maalox liquid antacid products containing aluminum hydroxide, magnesium hydroxide, and simethicone (e.g., Maalox Advanced Regular Strength, Maalox Advanced Maximum Strength). Because of the potential for serious adverse effects associated with accidental use of bismuth subsalicylate (which is chemically related to aspirin), the manufacturer of Maalox Total Relief initially agreed to change the trade name of the product to one that did not include “Maalox”; however, the manufacturer instead discontinued the bismuth subsalicylate preparation in the summer of 2010.

    Specific Populations

    Pregnancy

    Bismuth subsalicylate: Category C (Category D in 3rd trimester).

    Helidac Therapy, Pylera: Category D.

    Helidac Therapy, Pylera: Effect on labor and delivery unknown.

    Lactation

    Bismuth subsalicylate: Use with caution.

    Helidac Therapy, Pylera: Discontinue nursing or the drug.

    Pediatric Use

    Do not use bismuth subsalicylate in children or adolescents who have or are recovering from varicella or influenza-like symptoms. Changes in behavior accompanied by nausea and vomiting in children or adolescents taking the drug may be an early sign of Reye’s syndrome.

    Safety and efficacy of the commercially available Helidac Therapy kit or the fixed-combination preparation Pylera in pediatric patients infected with H. pylori not established. Pylera or the Helidac Therapy kit should not be used in children <8 years of age. (See Contraindications under Cautions.)

    Geriatric Use

    Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults to the commercially available Helidac Therapy kit or the fixed-combination preparation or Pylera for treatment of H. pylori infection and duodenal ulcer disease.

    Consider age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.

    Hepatic Impairment

    Accumulation of bismuth salts may occur in patients with severe hepatic disease. The commercially available Helidac Therapy kit and the fixed-combination preparation Pylera are contraindicated in patients with hepatic impairment. (See Contraindications under Cautions and also see Special Populations under Pharmacokinetics.)

    Renal Impairment

    Use bismuth subsalicylate with caution, if at all, in patients with renal impairment. The commercially available Helidac Therapy kit and the fixed-combination preparation Pylera are contraindicated in patients with renal impairment. (See Contraindications under Cautions.)

    Common Adverse Effects

    Bismuth: Transient and harmless darkening of the tongue and/or black stools, decreased peristalsis (with bismuth subgallate).

    Helidac Therapy: Nausea, diarrhea, abdominal pain, melena, upper respiratory infection.

    Pylera: Stool abnormality, diarrhea, dyspepsia, abdominal pain, nausea, headache, flu syndrome, taste perversion, asthenia, vaginitis, dizziness.

    What other drugs will affect Bismuth Salts

    Specific Drugs and Laboratory Tests

    Drug or Test

    Interaction

    Comments

    Anticoagulants

    Salicylate salts (e.g., bismuth subsalicylate) may increase risk of bleeding with concomitant anticoagulant therapy

    Monitor anticoagulant therapy; adjust anticoagulant dosage as needed

    Antidiabetic agents

    Possibly enhanced hypoglycemic effects with concomitant salicylate salt therapy

    Use with caution

    Aspirin

    Use with caution

    Ciprofloxacin

    Bismuth subsalicylate slightly decreases peak plasma concentrations and AUC of ciprofloxacin

    Not considered clinically important

    Doxycycline

    Bismuth subsalicylate may decrease absorption of doxycycline

    Avoid using bismuth subsalicylate for self-medication in travelers taking doxycycline for malaria prophylaxis

    Methotrexate

    Avoid using bismuth subsalicylate for self-medication concomitantly with methotrexate

    Omeprazole

    Omeprazole increases extent of absorption of bismuth from Pylera capsules following concomitant administration

    Probenecid

    Use concomitantly with caution, if at all

    Radiographic imaging (radiographs)

    Bismuth absorbs x-rays; may interfere with radiographic diagnostic procedures of GI tract

    Salicylates

    Do not use bismuth subsalicylate for self-medication concomitantly with other salicylate drugs

    Sulfinpyrazone

    Use concomitantly with caution

    Tests for occult blood

    Darkening of stool from bismuth salts does not interfere with tests for occult blood

    Tetracycline

    Bismuth and/or Calcium carbonate (excipient of bismuth subsalicylate tablets) reduces systemic absorption of tetracycline; clinical importance unknown since relative contribution of systemic versus local antimicrobial activity against H. pylori not determined

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