>10%: Gastrointestinal: Discoloration of the tongue (darkening), grayish black stools
<1%: Anxiety, confusion, headache, hearing loss, impaction may occur in infants and debilitated patients, mental depression, muscle spasms, slurred speech, tinnitus, weakness
Symptoms of toxicity:
Subsalicylate: Hyperpnea, nausea, vomiting, tinnitus, hyperpyrexia, metabolic acidoses/respiratory alkalosis, tachycardia, and confusion; seizures in severe overdose, pulmonary or cerebral edema, respiratory failure, cardiovascular collapse, coma, and death. Note: Each 262.4 mg tablet of bismuth subsalicylate contains an equivalent of 130 mg aspirin (150 mg/kg of aspirin is considered to be toxic; serious life-threatening toxicity occurs with >300mg/kg)
Bismuth: Rare with short-term administrations of bismuth salts; encephalopathy, methemoglobinemia, seizures
Treatment: Gastrointestinal decontamination (activated charcoal for immediate release formulations (10 x dose of ASA in g), whole bowel irrigation for enteric coated tablets or when serially increasing ASA plasma levels indicate the presence of an intestinal bezoar), supportive and symptomatic treatment with emphasis on correcting fluid, electrolyte, blood glucose and acid-base disturbances; elimination is enhanced with urinary alkalinization (sodium bicarbonate infusion with potassium), multiple dose activated charcoal, and hemodialysis. Chelation with dimercaprol in doses of 3 mg/kg or penicillamine 100 mg/kg/day for 5 days can hasten recovery from bismuth-induced encephalopathy; methylene blue 1-2 mg/kg in a 1% sterile aqueous solution I.V. push over 4-6 minutes for methemoglobinemia. This may be repeated within 60 minutes if necessary, up to a total dose of 7 mg/kg. Seizures usually respond to I.V. diazepam.
Decreased effect: Tetracyclines and uricosurics
Increased toxicity: Aspirin, warfarin, hypoglycemics
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. Bismuth has some antacid properties.Absorption: Minimal (<1%) across GI tract, salt (eg, salicylate) may be readily absorbed (80%); bismuth subsalicylate is rapidly cleaved to bismuth and salicylic acid in the stomach
Distribution: Salicylate: Vd: 170 mL/kg
Protein binding, plasma: Bismuth and salicylate: >90%
Metabolism: Bismuth: Oral: Salts undergo chemical dissociation; Salicylate: Extensively hepatic
Half-life elimination: Terminal: Bismuth: 21-72 days; Salicylate: 2-5 hours
Excretion: Bismuth: Urine and feces; Salicylate: 10% (as unchanged drug)
Clearance: Bismuth: 50 mL/minute
Nonspecific diarrhea: Subsalicylate:
Children: Up to 8 doses/24 hours:
3-6 years: 1/3 tablet or 5 mL (regular strength) every 30 minutes to 1 hour as needed
6-9 years: 2/3 tablet or 10 mL (regular strength) every 30 minutes to 1 hour as needed
9-12 years: 1 tablet or 15 mL (regular strength) every 30 minutes to 1 hour as needed
Adults: 2 tablets or 30 mL every 30 minutes to 1 hour as needed up to 8 doses/24 hours
Prevention of traveler's diarrhea: 2.1 g/day or 2 tablets 4 times/day before meals and at bedtime
Helicobacter pylori eradication: 524 mg 4 times/day with meals and at bedtime; requires combination therapy
Control of fecal odor in ileostomy or colostomy: Subgallate: 1-2 tablets 3 times/day with meals (maximum: 5 tablets/day)
Dosing adjustment in renal impairment: Should probably be avoided in patients with renal failure
Increased uric acid, increased AST; bismuth absorbs x-rays and may interfere with diagnostic procedures of GI tract Chew tablet well or shake suspension well before using; may darken stools; if diarrhea persists for more than 2 days, consult a physician; can turn tongue black; tinnitus may indicate toxicity and use should be discontinued Seek causes for diarrhea; monitor for tinnitus; may aggravate or cause gout attack; may enhance bleeding if used with anticoagulantsMental Health: Effects on Mental Status
May rarely cause anxiety, confusion, or depressionMental Health: Effects on Psychiatric Treatment
None reportedLiquid, as subsalicylate: 262 mg/15 mL (240 mL, 360 mL, 480 mL); 525 mg/15 mL (240 mL, 360 mL)
Bismatrol®: 262 mg/15 mL (240 mL)
Diotame®: 262 mg/15 mL (30 mL)
Pepto-Bismol®: 262 mg/15 mL (120 mL, 240 mL, 360 mL, 480 mL) [wintergreen flavor]
Pepto-Bismol® Maximum Strength: 525 mg/15 mL (120 mL, 240 mL, 360 mL) [wintergreen flavor]
Tablet, as subgallate (Colo-FreshTM): 324 mg
Tablet, chewable, as subsalicylate (Diaotame®, Bismatrol®, Pepto-Bismol®): 262 mg
Drumm B, Sherman P, Karmali M, et al, "Treatment of Campylobacter pylori-associated Antral Gastritis in Children With Bismuth Subsalicylate and Ampicillin,"J Pediatr, 1988, 113(5):908-12.
Graham DY, Lew GM, Evans DG, et al, "Effect of Triple Therapy (Antibiotics Plus Bismuth) on Duodenal Ulcer Healing,"Ann Intern Med, 1991, 115(4):266-9.
Graham DY, Lew GM, Klein PD, et al, "Effect of Treatment of Helicobacter pylori Infection on the Long-Term Recurrence of Gastric or Duodenal Ulcer,"Ann Intern Med, 1992, 116(9):705-8.
Ormand JE and Talley NJ, "Helicobacter pylori: Controversies and an Approach to Management,"Mayo Clin Proc, 1990, 65(3):414-26.
Soriano-Brucher HE, Avendano P, O'Ryan M, et al, "Use of Bismuth Subsalicylate in Acute Diarrhea in Children,"Rev Infect Dis, 1990, 12(Suppl 1):S51-5.
Bismed liquid® (CA); Bismutsubsalicylat-Steigerwald® (DE); Dermatol® (DE, PL, TR); Jatrox® (DE); Pepto-Bismol® (CA); PMS-Bismuth Subsalicylate® (CA); Trigastronol® (ES); Ulcolind Wismut® (DE)