Diarrhea/dyspepsia: Oral: ~524 mg every 30 to 60 minutes or 1,050 mg every 60 minutes as needed for up to 2 days (maximum: ~4,200 mg/24 hours).
Helicobacter pylori eradication (off-label use):
American College of Gastroenterology guidelines (Chey 2007; Chey 2017): Bismuth quadruple therapy: Oral: 300 mg 4 times daily in combination with tetracycline 500 mg 4 times daily, either metronidazole 500 mg 3 or 4 times daily or 250 mg 4 times daily, and standard-dose proton pump inhibitor twice daily; continue regimen for 10 to 14 days.
Travelers' diarrhea, prophylaxis (off-label use): Oral: ~524 mg 4 times daily with meals and at bedtime during period of risk (ACG [Riddle 2016]; CDC 2020). Note: Safety has not been established for periods >3 weeks (CDC 2020); some experts do not recommend use for trips exceeding 2 weeks in duration (ACG [Riddle 2016]).
Travelers' diarrhea, treatment: Oral: ~524 mg every 30 to 60 minutes or 1,050 mg every 60 minutes as needed (maximum: ~4,200 mg/24 hours) (ACG [Riddle 2016]; manufacturer's labeling).
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer’s labeling; use with caution.
There are no dosage adjustments provided in the manufacturer’s labeling.
(For additional information see "Bismuth subsalicylate: Pediatric drug information")
Note: Multiple concentrations of oral liquid formulations exist; close attention must be paid to the concentration when ordering or administering. Children and adolescents who have or are recovering from chicken pox or flu-like symptoms should not use bismuth subsalicylate due to the association with Reye syndrome. Refer to product-specific labeling for approved pediatric ages. Dosing presented as mg of bismuth subsalicylate.
Diarrhea, chronic (Gryboski 1985; Gryboski 1990): Limited data available: Oral liquid:
Infants ≥2 months: Oral: 44 mg every 4 to 6 hours.
Children <2 years: Oral: 44 mg every 4 hours or 87 mg every 6 hours.
Children 2 to <3 years: Oral: 87 mg every 4 to 6 hours.
Children 3 to <4 years: Oral: 87 mg every 4 hours.
Children 4 to 6 years: Oral: 175 mg every 4 hours.
Dosing based on 2 studies; the first was a prospective, double-blind, placebo-controlled clinical trial of 29 infants and children with chronic diarrhea (>6 weeks); after 7 days of bismuth therapy, patients in the treatment group (n=15, age 2 to 30 months) gained significantly more weight and had significantly improved stool characteristics (consistency/frequency) compared to placebo; to prevent recurrence of symptoms, the authors also suggested tapering the medication at the end of therapy (Gryboski 1985). A second study compared bismuth subsalicylate with cholestyramine; patients were treated with bismuth (n=19) for 7 days; bismuth was found to be as effective as cholestyramine in binding of bile acids and at decreasing stool frequency (Gryboski 1990).
Diarrhea, dyspepsia, acute (gas, upset stomach, indigestion, heartburn, nausea): OTC labeling:
Children ≥12 years and Adolescents: Oral: 524 mg every 30 to 60 minutes or 1,050 mg every 60 minutes as needed for up to 2 days. Maximum daily dose: 4,200 mg/day.
Helicobacter pylori eradication: Limited data available: Note: Use as part of an appropriate combination regimen; usual duration of therapy is 14 days (NASPGHAN/ESPGHAN [Jones 2017]).
Children and Adolescents (NASPGHAN/ESPGHAN [Jones 2017]):
<10 years: Oral: 262 mg 4 times daily.
≥10 years: Oral: 524 mg 4 times daily.
Traveler's diarrhea (Gal 2007; Leung 2019; manufacturer's labeling): Limited data available in children <12 years:
Children 3 to <6 years: Oral: 87 mg every 30 to 60 minutes as needed; do not exceed 8 doses per 24 hours.
Children 6 to <9 years: Oral: 175 mg every 30 to 60 minutes as needed; do not exceed 8 doses per 24 hours.
Children 9 to <12 years: Oral: 262 mg every 30 to 60 minutes as needed; do not exceed 8 doses per 24 hours.
Children ≥12 years and Adolescents: Oral: 524 mg every 30 to 60 minutes or 1,050 mg every 60 minutes as needed; maximum dose: 4,200 mg per 24 hours.
Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.
There are no dosage adjustments provided in the manufacturer's labeling; use with caution.
There are no dosage adjustments provided in the manufacturer's labeling.
Refer to adult dosing.
Excipient information presented when available (limited, particularly for generics); consult specific product labeling. [DSC] = Discontinued product
Suspension, Oral:
Bismatrol Maximum Strength: 525 mg/15 mL (236 mL [DSC]) [contains benzoic acid, d&c red #22 (eosine), saccharin sodium; wintergreen flavor]
Diotame InstyDose: 262 mg/15 mL (30 mL) [contains benzoic acid, d&c red #22 (eosine), saccharin sodium, salicylic acid]
Geri-Pectate: 262 mg/15 mL (355 mL [DSC]) [contains fd&c red #40 (allura red ac dye)]
GoodSense Stomach Relief: 525 mg/30 mL (236 mL) [contains benzoic acid, d&c red #22 (eosine), saccharin sodium, salicylic acid]
GoodSense Stomach Relief: 1050 mg/30 mL (236 mL) [contains benzoic acid, d&c red #22 (eosine), saccharin sodium]
Pepto-Bismol: 262 mg/15 mL (118 mL) [contains benzoic acid, d&c red #22 (eosine), saccharin sodium; original flavor]
Pink Bismuth: 262 mg/15 mL (473 mL [DSC]) [contains benzoic acid, d&c red #22 (eosine), saccharin sodium]
Stomach Relief: 525 mg/15 mL (237 mL) [contains d&c red #22 (eosine), saccharin sodium]
Stomach Relief: 525 mg/30 mL (237 mL) [alcohol free, sugar free; contains benzoic acid, d&c red #22 (eosine)]
Stomach Relief Extra Strength: 525 mg/15 mL (237 mL) [alcohol free, sugar free; contains benzoic acid, d&c red #22 (eosine)]
Stomach Relief Plus: 525 mg/15 mL (240 mL, 480 mL)
Generic: 525 mg/30 mL (30 mL [DSC])
Suspension, Oral, as subsalicylate:
Bismatrol: 262 mg/15 mL (236 mL [DSC]) [contains benzoic acid, d&c red #22 (eosine), saccharin sodium; wintergreen flavor]
Geri-Pectate: 262 mg/15 mL (355 mL [DSC])
Kao-Tin: 262 mg/15 mL (236 mL [DSC], 473 mL [DSC]) [contains fd&c red #40 (allura red ac dye), saccharin sodium, sodium benzoate]
Pepto-Bismol: 262 mg/15 mL (473 mL) [contains benzoic acid, d&c red #22 (eosine), saccharin sodium]
Pink Bismuth: 262 mg/15 mL (236 mL)
Pink Bismuth: 262 mg/15 mL (237 mL [DSC]) [contains benzoic acid, d&c red #22 (eosine), saccharin sodium]
Stomach Relief: 527 mg/30 mL (240 mL, 480 mL)
Tablet Chewable, Oral:
Stomach Relief: 262 mg [contains aspartame]
Generic: 262 mg
Tablet Chewable, Oral, as subsalicylate:
Bismatrol: 262 mg [contains saccharin sodium]
Peptic Relief: 262 mg [DSC] [contains saccharin sodium]
Pepto-Bismol To-Go: 262 mg [sugar free; contains fd&c red #40(allura red ac)aluminum lake, saccharin sodium; cherry flavor]
Generic: 262 mg
Yes
Oral: Shake liquids well prior to use. Chew tablets thoroughly or allow to dissolve in the mouth before swallowing. Nonchewable tablets should be swallowed whole with a full glass of water.
Oral:
Liquid: Shake well before using.
Tablets, chewable: Chew or allow to dissolve in mouth before swallowing.
Tablets, nonchewable caplets: Swallow whole with a full glass of water.
Diarrhea: Relief of diarrhea.
Dyspepsia: Relief of upset stomach, including belching, fullness, gas, indigestion, heartburn, and nausea.
Travelers’ diarrhea, treatment: Relief of travelers’ diarrhea.
Helicobacter pylori eradication; Travelers' diarrhea, prophylaxis
Kaopectate may be confused with Kayexalate
KIDs List: Salicylates, when used in pediatric patients <18 years of age with suspicion of viral illness (influenza, chickenpox), are identified on the Key Potentially Inappropriate Drugs in Pediatrics (KIDs) list and should be used with caution due to risk of Reye syndrome (weak recommendation; very low quality of evidence) (PPA [Meyers 2020]).
Canadian formulation of Kaopectate does not contain bismuth; the active ingredient in the Canadian formulation is attapulgite.
There are no adverse reactions listed in the manufacturer's labeling.
Postmarketing:
Gastrointestinal: Esophagitis (acute esophageal necrosis) (Abed 2014), melena (Bierer 1990), melanoglossia (Bierer 1990), staining of tooth (Borbinha 2019)
Hypersensitivity: Anaphylaxis (More 2002)
Nervous system: Encephalopathy (Borbinha 2019)
Otic: Tinnitus (Castelli 2006)
OTC labeling: When used for self-medication, do not use if you are allergic to salicylates (including aspirin) or are taking other salicylates; have an ulcer, bleeding problem or bloody/black stool.
Concerns related to adverse effects:
• Neurotoxicity: Bismuth products may be neurotoxic with very large doses.
Dosage forms
• Benzyl alcohol and derivatives: Some dosage forms may contain sodium benzoate/benzoic acid; benzoic acid (benzoate) is a metabolite of benzyl alcohol; large amounts of benzyl alcohol (≥99 mg/kg/day) have been associated with a potentially fatal toxicity (“gasping syndrome”) in neonates; the “gasping syndrome” consists of metabolic acidosis, respiratory distress, gasping respirations, CNS dysfunction (including convulsions, intracranial hemorrhage), hypotension and cardiovascular collapse (AAP ["Inactive" 1997]; CDC 1982); some data suggests that benzoate displaces bilirubin from protein binding sites (Ahlfors 2001); avoid or use dosage forms containing benzyl alcohol derivative with caution in neonates. See manufacturer's labeling.
Other warnings/precautions:
• Diagnostic GI procedures: Bismuth absorbs x-rays and may interfere with diagnostic procedures of GI tract.
• Self-medication (OTC use): Pediatric patients who have or are recovering from chickenpox or flu-like symptoms should not use subsalicylate. Changes in behavior (along with nausea and vomiting) may be an early sign of Reye syndrome; patients should be instructed to contact their health care provider if these occur. A temporary harmless darkening of the stool and/or tongue may occur with use. Contact a health care provider before use if fever or mucus in the stool occurs. Discontinue use and contact health care provider if any of the following occur: diarrhea lasts >2 days, diarrhea with a fever, symptoms get worse, hearing loss, or ringing in the ears.
Do not use aspirin-containing products in children and adolescents who have or who are recovering from chickenpox or flu symptoms (due to the association with Reye syndrome); when using aspirin, changes in behavior (along with nausea and vomiting) may be an early sign of Reye syndrome; instruct patients and caregivers to contact their health care provider if these symptoms occur.
None known.
Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.
Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Risk C: Monitor therapy
Agents with Blood Glucose Lowering Effects: Salicylates may enhance the hypoglycemic effect of Agents with Blood Glucose Lowering Effects. Risk C: Monitor therapy
Ajmaline: Salicylates may enhance the adverse/toxic effect of Ajmaline. Specifically, the risk for cholestasis may be increased. Risk C: Monitor therapy
Ammonium Chloride: May increase the serum concentration of Salicylates. Risk C: Monitor therapy
Angiotensin-Converting Enzyme Inhibitors: Salicylates may enhance the nephrotoxic effect of Angiotensin-Converting Enzyme Inhibitors. Salicylates may diminish the therapeutic effect of Angiotensin-Converting Enzyme Inhibitors. Risk C: Monitor therapy
Anticoagulants: Salicylates may enhance the anticoagulant effect of Anticoagulants. Risk C: Monitor therapy
Benzbromarone: Salicylates may diminish the therapeutic effect of Benzbromarone. Risk C: Monitor therapy
Bismuth Subcitrate: Bismuth-Containing Compounds may enhance the neurotoxic effect of Bismuth Subcitrate. Risk X: Avoid combination
Carbonic Anhydrase Inhibitors: Salicylates may enhance the adverse/toxic effect of Carbonic Anhydrase Inhibitors. Salicylate toxicity might be enhanced by this same combination. Management: Avoid these combinations when possible.Dichlorphenamide use with high-dose aspirin as contraindicated. If another combination is used, monitor patients closely for adverse effects. Tachypnea, anorexia, lethargy, and coma have been reported. Risk D: Consider therapy modification
Corticosteroids (Systemic): Salicylates may enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Risk C: Monitor therapy
Dexketoprofen: Salicylates may enhance the adverse/toxic effect of Dexketoprofen. Dexketoprofen may diminish the therapeutic effect of Salicylates. Salicylates may decrease the serum concentration of Dexketoprofen. Management: The use of high-dose salicylates (3 g/day or more in adults) together with dexketoprofen is inadvisable. Consider administering dexketoprofen 30-120 min after or at least 8 hrs before cardioprotective doses of aspirin to minimize any possible interaction. Risk X: Avoid combination
Ginkgo Biloba: May enhance the anticoagulant effect of Salicylates. Management: Consider alternatives to this combination of agents. Monitor for signs and symptoms of bleeding (especially intracranial bleeding) if salicylates are used in combination with ginkgo biloba. Risk D: Consider therapy modification
Herbal Products with Anticoagulant/Antiplatelet Effects (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Salicylates. Bleeding may occur. Risk C: Monitor therapy
Hyaluronidase: Salicylates may diminish the therapeutic effect of Hyaluronidase. Risk C: Monitor therapy
Influenza Virus Vaccine (Live/Attenuated): May enhance the adverse/toxic effect of Salicylates. Specifically, Reye's syndrome may develop. Risk X: Avoid combination
Loop Diuretics: Salicylates may diminish the diuretic effect of Loop Diuretics. Loop Diuretics may increase the serum concentration of Salicylates. Risk C: Monitor therapy
Methotrexate: Salicylates may increase the serum concentration of Methotrexate. Salicylate doses used for prophylaxis of cardiovascular events are not likely to be of concern. Management: Consider avoiding coadministration of methotrexate and salicylates. If coadministration cannot be avoided, monitor for increased toxic effects of methotrexate. Salicylate doses used for prophylaxis of cardiovascular events are not likely to be of concern. Risk D: Consider therapy modification
Nonsteroidal Anti-Inflammatory Agents (Nonselective): May enhance the adverse/toxic effect of Salicylates. An increased risk of bleeding may be associated with use of this combination. Nonsteroidal Anti-Inflammatory Agents (Nonselective) may diminish the cardioprotective effect of Salicylates. Salicylates may decrease the serum concentration of Nonsteroidal Anti-Inflammatory Agents (Nonselective). Management: Nonselective NSAIDs may reduce aspirin's cardioprotective effects. Administer ibuprofen 30-120 minutes after immediate-release aspirin, 2 to 4 hours after extended-release aspirin, or 8 hours before aspirin. Risk D: Consider therapy modification
Nonsteroidal Anti-Inflammatory Agents (Topical): May enhance the adverse/toxic effect of Salicylates. Specifically, the risk of gastrointestinal (GI) toxicity is increased. Management: Coadministration of salicylates and topical NSAIDs is not recommended. If salicylates and topical NSAIDs are coadministered, ensure the benefits outweigh the risks and monitor for increased NSAID toxicities. Risk D: Consider therapy modification
Potassium Phosphate: May increase the serum concentration of Salicylates. Risk C: Monitor therapy
PRALAtrexate: Salicylates may increase the serum concentration of PRALAtrexate. Salicylate doses used for prophylaxis of cardiovascular events are unlikely to be of concern. Management: Consider avoiding concomitant use of salicylates and pralatrexate. If coadministered, monitor for increased pralatrexate adverse effects. Salicylate doses used for prophylaxis of cardiovascular events are not likely to be of concern. Risk D: Consider therapy modification
Probenecid: Salicylates may diminish the therapeutic effect of Probenecid. Risk X: Avoid combination
Salicylates: May enhance the anticoagulant effect of other Salicylates. Risk C: Monitor therapy
Sulfinpyrazone: Salicylates may decrease the serum concentration of Sulfinpyrazone. Risk X: Avoid combination
Tetracyclines: Bismuth Subsalicylate may decrease the serum concentration of Tetracyclines. Management: Consider dosing tetracyclines 2 hours before or 6 hours after bismuth. The need to separate doses during Helicobacter pylori eradication regimens is questionable. Risk D: Consider therapy modification
Thrombolytic Agents: Salicylates may enhance the adverse/toxic effect of Thrombolytic Agents. An increased risk of bleeding may occur. Risk C: Monitor therapy
Valproate Products: Salicylates may increase the serum concentration of Valproate Products. Risk C: Monitor therapy
Varicella Virus-Containing Vaccines: Salicylates may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. Specifically, the risk for Reye's syndrome may increase. Risk X: Avoid combination
Vitamin K Antagonists (eg, warfarin): Salicylates may enhance the anticoagulant effect of Vitamin K Antagonists. Management: Avoid as needed use of salicylates in patients taking vitamin K antagonists. Aspirin (80 to 325 mg/day) may be used with warfarin for prevention of cardiovascular events. If coadministering salicylates and vitamin K antagonists, monitor for bledding. Risk D: Consider therapy modification
Bismuth subsalicylate is converted to bismuth and salicylic acid in the GI tract. Following oral administration, salicylates cross the placenta. Very little bismuth is systemically absorbed from this preparation (Bierer 1990; Lione 1988).
Following ingestion of bismuth subsalicylate, plasma salicylate concentrations may be comparable to those following ingestion of aspirin (Bierer 1990; Lione 1988). Refer to the aspirin monograph for additional information related to salicylates and pregnancy.
Bismuth subsalicylate should not be used in pregnant patients for the treatment of dyspepsia or acute diarrhea (Body 2016) and current guidelines do not recommend use for the treatment or prevention of travelers' diarrhea in pregnancy (CDC 2020).
Salicylates enter breast milk (Bar-Oz 2003). Following ingestion of bismuth subsalicylate, plasma salicylate concentrations may be comparable to those following ingestion of aspirin (Bierer 1990). Refer to the aspirin monograph for additional information related to salicylates and breastfeeding.
It is not known if bismuth is present in breast milk; however, absorption is limited following oral administration of this preparation at usual doses (Bierer 1990).
A case report describes bowel obstruction in a breastfed infant whose mother applied a bismuth-containing ointment to her nipples prior to breastfeeding (Ingestion of bismuth-containing 1974).
Drink plenty of fluids to help prevent dehydration caused by diarrhea. Some products may contain phenylalanine, potassium, and/or sodium.
Bismuth subsalicylate exhibits both antisecretory and antimicrobial action. This agent may provide some anti-inflammatory action as well. The salicylate moiety provides antisecretory effect and the bismuth exhibits antimicrobial directly against bacterial and viral gastrointestinal pathogens.
Absorption: Bismuth: <1%; Subsalicylate: >80%
Distribution: Salicylate: Vd: 170 mL/kg
Protein binding, plasma: Bismuth and salicylate: >90%
Metabolism: Bismuth subsalicylate is converted to bismuth and salicylic acid in the GI tract.
Half-life elimination: Terminal: Bismuth: 21 to 72 days; Salicylate: 2 to 5 hours
Excretion: Bismuth: Urine and biliary; Salicylate: Urine (10% excreted unchanged)
Chewable (Bismuth Subsalicylate Oral)
262 mg (per each): $0.06 - $0.08
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