Yes

Antidiarrheal

Symptomatic treatment of mild, nonspecific diarrhea; indigestion, nausea, control of traveler's diarrhea (enterotoxigenic Escherichia coli); an adjunct with other agents such as metronidazole, tetracycline, and an H₂-antagonist in the treatment of Helicobacter pylori-associated duodenal ulcer disease

C (D in 3rd trimester)

Do not use subsalicylate in patients with influenza or chickenpox because of risk of Reye's syndrome; do not use in patients with known hypersensitivity to salicylates; history of severe GI bleeding; history of coagulopathy

Subsalicylate should be used with caution if patient is taking aspirin; use with caution in children, especially those <3 years of age and those with viral illness; may be neurotoxic with very large doses

>10%: Gastrointestinal: Discoloration of the tongue (darkening), grayish black stools

<1%: Anxiety, confusion, slurred speech, headache, mental depression, impaction may occur in infants and debilitated patients, muscle spasms, weakness, hearing loss, tinnitus

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)

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.

Symptoms of toxicity: Bismuth: Rare with short-term administrations of bismuth salts; encephalopathy, methemoglobinemia, seizures

Treatment: Gastrointestinal decontamination; 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: Minimally (<1%) absorbed across the GI tract while the salt (eg, salicylate) may be readily absorbed (80%); bismuth subsalicylate is rapidly cleaved to bismuth and salicylic acid in the stomach

Distribution: Salicylate: Volume of distribution: 170 mL/kg

Protein binding, plasma: Bismuth and salicylate: >90%

Metabolism: Bismuth salts undergo chemical dissociation after oral administration; salicylate is extensively metabolized in the liver

Half-life: Bismuth: Terminal: 21-72 days; Salicylate: Terminal: 2-5 hours

Elimination: Bismuth: Renal, biliary; clearance: 50 mL/minute; Salicylate: Only 10% excreted unchanged

Oral:

Children: Up to 8 doses/24 hours:

3-6 years: 1/3 tablet or 5 mL every 30 minutes to 1 hour as needed

6-9 years: 2/3 tablet or 10 mL every 30 minutes to 1 hour as needed

9-12 years: 1 tablet or 15 mL 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

Subgallate: 1-2 tablets 3 times/day with meals

Helicobacter pylori: Chew 2 tablets 4 times/day with meals and at bedtime with other agents in selected regiment (eg, an H₂-antagonist, tetracycline and metronidazole) for 14 days

Dosing adjustment in renal impairment: Should probably be avoided in patients with renal failure

uric acid, 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 anticoagulants

Liquid, as subsalicylate (Pepto-Bismol®, Bismatrol®): 262 mg/15 mL (120 mL, 240 mL, 360 mL, 480 mL); 524 mg/15 mL (120 mL, 240 mL, 360 mL)

Tablet:

Chewable, as subsalicylate (Pepto-Bismol®, Bismatrol®): 262 mg

Chewable, as subgallate (Devrom®): 200 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.