Bismuth Subsalicylate (Oral-Local)


VA CLASSIFICATION
Primary: GA208

Commonly used brand name(s): Bismatrol; Bismatrol Extra Strength; Bismed; PMS-Bismuth Subsalicylate; Pepto-Bismol; Pepto-Bismol Easy-to-Swallow Caplets; Pepto-Bismol Maximum Strength.

Note: For a listing of dosage forms and brand names by country availability, see Dosage Forms section(s).



Category:


Antidiarrheal(antisecretory)—

antacid—

antiulcer agent{02}{08}{09}{30}{35}

Indications

Note: Bracketed information in the Indications section refers to uses that are not included in U.S. product labeling.

Accepted

Diarrhea (treatment)—Bismuth subsalicylate is indicated for the symptomatic treatment of nonspecific diarrhea. {01} {02} {21} {32}

Gastric distress (treatment)—Bismuth subsalicylate is indicated for the symptomatic relief of upset stomach, including heartburn, acid indigestion, and nausea. {01} {03} {21} {32} {38}

[Traveler's diarrhea (prophylaxis)]1—Bismuth subsalicylate is used for the prevention of secretory diarrhea produced by enterotoxigenic Escherichia coli (traveler's diarrhea) and viral infections. {02} {03} {12} {13} {14} {15} {16} {17} {18} {19} {20} {22} {23} {31} {36}

[Ulcer, duodenal, Helicobacter pylori –associated (treatment adjunct)]1or
[Gastritis, Helicobacter pylori –associated (treatment adjunct)]1—Bismuth subsalicylate is used, in combination with oral antibiotic therapy, in the treatment of Helicobacter pylori –associated gastritis and duodenal ulcer. {25} {26} {27} {28} {29}

1 Not included in Canadian product labeling.



Pharmacology/Pharmacokinetics

Physicochemical characteristics:
Molecular weight—
    362.09 {06}

Mechanism of action/Effect:

Antidiarrheal—Exact mechanism has not been determined. Bismuth subsalicylate may exert its antidiarrheal action not only by stimulating absorption of fluid and electrolytes across the intestinal wall (antisecretory action) but also, when hydrolyzed to salicylic acid, by inhibiting synthesis of a prostaglandin responsible for intestinal inflammation and hypermotility. In addition, bismuth subsalicylate binds toxins produced by Escherichia coli . Both bismuth subsalicylate and the intestinal reaction products, bismuth oxychloride and bismuth hydroxide, are believed to have bactericidal action. {02} {15} {18} {23}

Antacid—Bismuth has weak antacid properties. {08} {10}

Absorption:

Following oral administration, absorption of the salicylate component from the small intestine is generally rapid and complete (>90%). In contrast to the salicylate, the amount of bismuth absorbed is negligible(<0.005%). {04} {08} {18} {22}

Protein binding:

Salicylate—High (to albumin). {04}

Biotransformation:

Based on in vitro dissociation data and in vivo animal data, bismuth subsalicylate is believed to be largely hydrolyzed in the stomach to bismuth oxychloride and salicylic acid. In the small intestine, nondissociated bismuth subsalicylate reacts with other anions (bicarbonate and phosphate) to form insoluble bismuth salts. In the colon, nondissociated bismuth subsalicylate and other bismuth salts react with hydrogen sulfide to produce bismuth sulfide, a highly insoluble black salt responsible for the darkening of the stools. {22} {23}

Elimination:
    Bismuth—Fecal (>99% of the bismuth present in an oral dose); renal. {09} {22}
    Salicylate—Renal (primarily excreted as free salicylic acid and conjugated metabolites). {04} {22}


Precautions to Consider

Cross-sensitivity and/or related problems

Patients sensitive to salicylates including methyl salicylate(oil of wintergreen), or to other nonsteroidal anti-inflammatory drugs (NSAIDs), may be sensitive to bismuth subsalicylate also.

Pregnancy/Reproduction

The occasional use of bismuth subsalicylate during pregnancy is not likely to result in adverse effects on the fetus or newborn; however, based on what is known about salicylates, the following information should be considered with higher doses and longer therapy. {40}
Fertility—
Salicylates have caused increased numbers of fetal resorptions in animal studies. {04}

Pregnancy—
First trimester: Salicylates readily cross the placenta. Studies in animals have shown that salicylates cause birth defects including fissure of the spine and skull; facial clefts; eye defects; and malformations of the central nervous system (CNS), viscera, and skeleton (especially the vertebrae and ribs). It has been reported that salicylate use during pregnancy may increase the risk of birth defects in humans.

Third trimester: Chronic, high-dose salicylate therapy may result in prolonged gestation, increased risk of postmaturity syndrome (fetal damage or death due to decreased placental function if pregnancy is greatly prolonged), and increased risk of maternal antenatal hemorrhage. Also, ingestion of salicylates during the last 2 weeks of pregnancy may increase the risk of fetal or neonatal hemorrhage. The possibility that regular use late in pregnancy may result in constriction or premature closure of the fetal ductus arteriosus, possibly leading to persistent pulmonary hypertension and heart failure in the neonate, must also be considered. {04}


Labor and delivery—

Chronic, high-dose salicylate therapy late in pregnancy may result in prolonged labor, complicated deliveries, and increased risk of maternal or fetal hemorrhage. {04}

Breast-feeding

Problems in humans have not been documented. However, salicylate is distributed into breast milk; with chronic, high-dose use, intake by the infant may be high enough to cause adverse effects. {04}

Pediatrics

In infants and children up to 3 years of age with diarrhea, caution is recommended because of the risk of fluid and electrolyte loss; these patients should be referred to a physician.

Pediatric patients, especially those with fever and dehydration, may be more susceptible to the toxic effects of salicylates. {04} {17}

Although no cases have been documented with the use of bismuth subsalicylate, {18} {40} recent studies indicate that use of aspirin, a salicylate, may be associated with the development of Reye's syndrome in children with acute febrile illnesses, especially influenza and varicella. There is insufficient data to establish an association between the use of nonaspirin salicylates, such as bismuth subsalicylate, and the occurrence of Reye's syndrome. However, it is recommended that children and adolescents who have or are recovering from influenza or varicella not be given bismuth subsalicylate to treat nausea or vomiting. Since nausea or vomiting could be an early sign of Reye's syndrome, these patients should be referred to a physician. {01} {04} {21} {24} {32}

Bismuth is more likely to cause impaction in children. {01} {02} {03}


Geriatrics


In geriatric patients with diarrhea, caution is recommended because of the risk of fluid and electrolyte loss; these patients should be referred to a physician.

Also, elderly patients are more likely to have age-related renal function impairment, which may increase the risk of salicylate toxicity. Dosage reduction may be required to prevent accumulation of the medication. {04}

Bismuth is more likely to cause impaction in elderly patients. {01} {02} {03}

Drug interactions and/or related problems
The following drug interactions and/or related problems have been selected on the basis of their potential clinical significance (possible mechanism in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):


Note: Although significant interactions are unlikely with usual doses of bismuth subsalicylate in the treatment of diarrhea and for occasional relief of gastric distress, the higher doses and the longer therapy used in the prophylaxis of traveler's diarrhea increase the potential for significant drug interactions.
Combinations containing any of the following medications, depending on the amount present, may also interact with this medication.

» Anticoagulants, coumarin- or indandione-derivative or
» Heparin or
» Thrombolytic agents, such as:
Alteplase (tissue-type plasminogen activator, recombinant)
Anistreplase
Streptokinase
Urokinase    (increased risk of bleeding may occur when these medications are used concurrently with salicylates {01} {04} {21} {32})


» Antidiabetic agents, oral or
Insulin    (large doses of salicylate may enhance the hypoglycemic effect of these medications; dosage adjustment may be necessary {04} {21} {22} {32})


» Probenecid or
» Sulfinpyrazone    (concurrent use of salicylates is not recommended when these medications are used to treat hyperuricemia or gout because uricosuric effects of these medications may be decreased by doses of salicylates that produce serum salicylate concentrations above 50 mcg per mL {21} {22} {32})

    (probenecid may decrease renal clearance and increase plasma concentrations and toxicity of salicylates {04})


» Salicylates, other    (ingestion of large repeated doses of bismuth subsalicylate, as for traveler's diarrhea, may produce substantial plasma salicylate concentrations thus increasing the risk of salicylate toxicity during concurrent use with other salicylates {01} {04} {23} {32})


» Tetracyclines, oral    (calcium carbonate contained in the tablet dosage form may decrease gastrointestinal absorption and bioavailability of tetracyclines; patients should be advised not to take bismuth subsalicylate tablets within 1 to 3 hours of oral tetracyclines {01} {02} {22} {32})



Laboratory value alterations
The following have been selected on the basis of their potential clinical significance (possible effect in parentheses where appropriate)—not necessarily inclusive (» = major clinical significance):

With diagnostic test results {04}
Copper sulfate urine sugar tests    (false-positive results may occur with chronic use of high doses of salicylate)


Gerhardt test for urine aceto-acetic acid    (may be interfered with because reaction of salicylate with ferric chloride produces a reddish color that persists after boiling)


Glucose enzymatic urine sugar tests    (false-negative results may occur with chronic use of high doses of salicylate)


Radiological examination of gastrointestinal tract    (radiopacity of bismuth may interfere with radiologic examination of the gastrointestinal tract {02})


Serum uric acid determinations    (falsely increased values may occur with colorimetric assay methods when plasma salicylate concentrations exceed 130 mcg per mL; the uricase assay method is not affected)


Thyroid imaging, radionuclide    (chronic salicylate administration may decrease thyroidal uptake of iodide I 131 or of pertechnetate ion because of depressed thyroid function; salicylate therapy should be discontinued at least 1 week prior to administration of the radiopharmaceutical; however, a rebound effect may occur following discontinuation of salicylate therapy, resulting in a period of 3 to 10 days of increased thyroidal uptake {39})


Urine vanillylmandelic acid (VMA) concentrations    (salicylate may falsely increase or decrease VMA concentrations, depending on method used)

With physiology/laboratory test values
Liver function tests, including:
Serum alanine aminotransferase(ALT [SGPT]) and
Serum alkaline phosphatase and
Serum aspartate aminotransferase (AST [SGOT])    (abnormalities may occur, especially in patients with juvenile rheumatoid arthritis, systemic lupus erythematosus, or history of liver disease, or when plasma salicylate concentrations exceed 250 mcg per mL)


Prothrombin time    (may be prolonged with large doses of salicylates, especially if plasma concentrations exceed 300 mcg per mL)


Serum potassium concentrations    (may be decreased because of increased potassium excretion caused by direct effect of salicylate on renal tubules)


Serum thyroxine (T 4) concentrations and
Serum triiodothyronine (T 3) concentrations    (large doses of salicylate may decrease serum T 4 and T 3 concentrations when determined by radioimmunoassay)


Serum uric acid concentrations    (may be increased or decreased, depending on salicylate dosage; plasma salicylate concentrations below 100 to 150 mcg per mL increase serum uric acid concentrations; salicylate concentrations above 100 to 150 mcg per mL decrease uric acid concentrations)


T 3 resin uptake    (may be increased with large doses of salicylate)


Urine phenolsulfonphthalein (PSP) concentrations    (may be decreased because of competition of salicylate with PSP for renal tubular secretion)


Medical considerations/Contraindications
The medical considerations/contraindications included have been selected on the basis of their potential clinical significance (reasons given in parentheses where appropriate)— not necessarily inclusive (» = major clinical significance).


Risk-benefit should be considered when the following medical problems exist
» Bleeding ulcers or
» Hemorrhagic states, other active    (may be exacerbated by the salicylate {04} {07})


» Dehydration    (rehydration therapy is essential if signs of dehydration, such as dry mouth, excessive thirst, wrinkled skin, decreased urination, dizziness or lightheadedness, are present with the diarrhea; fluid loss may have serious consequences, such as circulatory collapse and renal failure, especially in young children {34})


» Dysentery, acute, characterized by bloody stools and elevated temperature    (sole treatment with bismuth subsalicylate may be inadequate; antibiotic therapy may be required {35})


Gout    (salicylates may have variable dose-dependent effects on serum uric acid concentrations; also, salicylates may interfere with efficacy of uricosuric antigout agents {01} {04})


» Hemophilia    (salicylate may increase risk of hemorrhage {04})


Renal function impairment    (increased risk of bismuth and salicylate toxicity because of decreased excretion)


Sensitivity to bismuth subsalicylate


Side/Adverse Effects
The following side/adverse effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:

Those indicating need for medical attention
Incidence rare
—reported with higher-than-recommended doses and/or chronic dosing; may also be signs of overdose    
Bismuth encephalopathy {09}{11}{18}(anxiety; confusion; difficulty in speaking or slurred speech; severe and/or continuing headache; mental depression; muscle spasms, especially of face, neck, and back; muscle weakness; trembling; uncontrolled body movements)
    
constipation, severe{01}
    
salicylism, symptoms of {04}{07}{09}{23}(any loss of hearing; confusion; severe or continuing diarrhea; dizziness or lightheadedness; severe drowsiness; fast or deep breathing; severe or continuing headache; increased sweating; increased thirst; severe or continuing nausea or vomiting; continuing ringing or buzzing in ears; severe or continuing stomach pain; uncontrollable flapping movements of the hands, especially in elderly patients; vision problems)



Those not indicating need for medical attention
Incidence more frequent
    
Discoloration produced by bismuth {01}{02}{03}{05}{08}{21}{22}{23}{31}{32}(darkening of tongue or grayish black stools)





Overdose
For specific information on the agents used in the management of bismuth subsalicylate overdose, see:
   • Charcoal, Activated (Oral-Local) monograph;
   • Acetazolamide in Carbonic Anhydrase Inhibitors (Systemic) monograph; and/or
   • Vitamin K (Systemic) monograph.
For more information on the management of overdose or unintentional ingestion, contact a Poison Control Center (see Poison Control Center Listing ).

Clinical effects of overdose
The following effects have been selected on the basis of their potential clinical significance (possible signs and symptoms in parentheses where appropriate)—not necessarily inclusive:
    
Bismuth encephalopathy {09}{11}{18}(anxiety; confusion; difficulty in speaking or slurred speech; severe and/or continuing headache; mental depression; muscle spasms, especially of face, neck, and back; muscle weakness; trembling; uncontrolled body movements)
    
symptoms of salicylism (any loss of hearing; confusion; severe or continuing diarrhea; dizziness or lightheadedness; severe drowsiness; fast or deep breathing; severe or continuing headache; increased sweating; increased thirst; severe or continuing nausea or vomiting; continuing ringing or buzzing in ears; severe or continuing stomach pain; uncontrollable flapping movements of the hands, especially in elderly patients; vision problems){04}{07}{09}{23}


Treatment of overdose
Recommended treatment of overdose may include: {04}



• To decrease absorption—Emptying the stomach via induction of emesis or gastric lavage; administering activated charcoal.


• To enhance elimination—Institution of exchange transfusion, hemodialysis, peritoneal dialysis, or hemoperfusion as needed in severe overdose.


• Specific treatment—Monitoring serum salicylate concentration until it is apparent that the concentration is decreasing to the nontoxic range. Salicylate concentrations of 500 mcg per mL 2 hours after ingestion indicate serious toxicity; salicylate concentrations above 800 mcg per mL 2 hours after ingestion indicate possible fatality. In addition, prolonged monitoring may be necessary in massive overdosage because absorption may be delayed.Inducing forced alkaline diuresis to increase salicylate excretion. However, bicarbonate should not be administered orally for this purpose because salicylate absorption may be increased. Also, if acetazolamide is used, the increased risk of severe metabolic acidosis and salicylate toxicity (caused by increased penetration of salicylate into the brain because of metabolic acidosis) must be considered. It is recommended that acetazolamide be given concurrently with an alkaline intravenous solution, e.g., one that contains sodium bicarbonate or sodium lactate.Administering blood or vitamin K 1 if necessary to treat hemorrhaging.


• Monitoring—Monitoring and supporting vital functions; monitoring for pulmonary edema and convulsions and instituting appropriate therapy if required.


• Supportive care—Correcting hyperthermia; fluid, electrolyte, and acid-base imbalances; ketosis; and plasma glucose concentration as needed. Patients in whom intentional overdose is confirmed or suspected should be referred for psychiatric consultation.


Patient Consultation
As an aid to patient consultation, refer to Advice for the Patient, Bismuth Subsalicylate (Oral).

In providing consultation, consider emphasizing the following selected information (» = major clinical significance):

Before using this medication
»   Conditions affecting use, especially:
Allergies to salicylates or other nonsteroidal anti-inflammatory drugs

Pregnancy—Salicylates cross the placenta; concern only with high doses and long-term therapy because of salicylate effects





Breast-feeding—Concern only with high doses and chronic use because of salicylate intake by infant





Use in children—Risk of fluid and electrolyte loss due to diarrhea; increased susceptibility to toxic effects of salicylates if fever and dehydration present; risk of impaction due to bismuth






Use in the elderly—Risk of fluid and electrolyte loss due to diarrhea; increased susceptibility to toxic effects of salicylates possibly due to decreased renal function; risk of impaction due to bismuth
Other medications, especially anticoagulants, heparin, or thrombolytic agents; antidiabetic agents; probenecid or sulfinpyrazone; other salicylates; or oral tetracyclines (for tablet dosage form)
Other medical problems, especially bleeding ulcers or other active hemorrhagic states, acute dysentery, dehydration, or hemophilia

Proper use of this medication
Following physician's or manufacturer's instructions

» Not giving to children with symptoms of influenza or varicella without first checking with physician
Missed dose: If on a regular schedule—Taking as soon as possible; not taking if almost time for next dose; not doubling doses
» For use in treatment of diarrhea—Importance of maintaining adequate hydration and proper diet {34}

» Proper dosing

» Proper storage

Precautions while using this medication
» Caution if other medications containing aspirin or other salicylates are used {23}

Diabetics:

Possibility of false urine sugar test results with prolonged use

Checking with health care professional, if changes in urine sugar test results occur, or if any other questions, especially if diabetes is not well-controlled

» Suspected overdose: Getting emergency help immediately

For antidiarrheal use
Checking with physician if—

Symptoms do not improve within 2 days or become worse

Diarrhea is accompanied by high fever


Side/adverse effects
May cause encephalopathy, severe constipation, and/or salicylism with higher-than-recommended doses and/or chronic use

Dark tongue or grayish black stools may be alarming to patient although medically insignificant


Oral Dosage Forms

Note: Bracketed uses in the Dosage Forms section refer to categories of use and/or indications that are not included in U.S. product labeling.

BISMUTH SUBSALICYLATE ORAL SUSPENSION

Usual adult and adolescent dose {01} {05}
Diarrhea (treatment); or
Gastric distress (treatment)
Oral, 524 or 528 mg every half-hour to one hour or 1048 or 1056 mg every hour if needed. {01} {05} {21} {32} {38}

[Traveler's diarrhea (prophylaxis)]1
Oral, 524 or 528 mg four times a day, starting one day prior to departure and continuing for two days after returning, but not to exceed three weeks of continued use. {31} {34}

[Ulcer, duodenal, Helicobacter pylori –associated (treatment adjunct)]1 ; or
[Gastritis, Helicobacter pylori –associated(treatment adjunct)]1
Dosage has not been established. However, in one study, 525 mg was administered orally three times a day one hour before meals, in conjunction with 500 mg of amoxicillin and 500 mg of metronidazole administered three times a day after meals, for one to two weeks. {25} {26} {27} {28} {29}


Usual adult prescribing limits
4.2 grams in twenty-four hours. {21} {32}

Usual pediatric dose {01} {05}
Diarrhea (treatment); or
Gastric distress (treatment)


Children up to 3 years of age:


According to weight as follows (may be repeated every four hours if needed, but not to exceed six doses in a day)——
Children weighing 6.4 to 13 kg: Oral, 44 mg. {01}

Children weighing over 13 kg: Oral, 88 mg. {01}




Children 3 to 6 years of age:
Oral, 88 mg every half-hour to one hour but not to exceed 704 mg in a day. {21} {32}



Children 6 to 9 years of age:
Oral, 174.6 or 176 mg every half-hour to one hour but not to exceed 1.4 grams in a day. {21} {32}



Children 9 to 12 years of age:
Oral, 262 or 264 mg every half-hour to one hour but not to exceed 2.1 grams in a day. {21} {32}



Usual geriatric dose
See Usual adult and adolescent dose .

Note: Geriatric patients with reduced renal function may be more sensitive to the effects of the usual adult dose and may require lower doses.


Strength(s) usually available
U.S.—


262 mg per 15 mL (OTC) [Pepto-Bismol (salicylate 130 mg) ( sodium <3 mg)][Generic]


525 mg per 15 mL (OTC) [Bismatrol Extra Strength] [Pepto-Bismol Maximum Strength (salicylate 236 mg) ( sodium <5 mg)]

Canada—


264 mg per 15 mL (OTC) [Bismed (alcohol 2%) ( sodium <18 mg)] [Pepto-Bismol (sodium <1.3 mg)]


525 mg per 15 mL (OTC) [PMS-Bismuth Subsalicylate]

Packaging and storage:
Store below 40 °C (104 °F), {21} {32} preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer. Protect from freezing. {21} {32}

Auxiliary labeling:
   • Shake well.
   • May cause darkening of tongue and/or stools.


BISMUTH SUBSALICYLATE TABLETS

Usual adult and adolescent dose
Diarrhea (treatment); or
Gastric distress (treatment)
Oral, 524 or 600 mg every half-hour to one hour or 1050 or 1200 mg every hour if needed. {01} {05} {21} {32}

[Traveler's diarrhea (prophylaxis)]1
Oral, 524 or 600 mg four times a day, starting one day prior to departure and continuing for two days after returning, but not to exceed three weeks of continued use. {18} {19} {23} {29} {31} {34}

[Ulcer, duodenal, Helicobacter pylori –associated (treatment adjunct)]1
[Gastritis, Helicobacter pylori –associated (treatment adjunct)]1
Dosage has not been established. However, in one study, 525 mg was administered orally three times a day one hour before meals, in conjunction with 500 mg of amoxicillin and 500 mg of metronidazole administered three times a day after meals, for one to two weeks. {25} {26} {27} {28} {29}


Usual adult prescribing limits
4.8 grams in twenty-four hours. {21} {32}

Usual pediatric dose
Diarrhea (treatment); or
Gastric distress (treatment)
Children up to 9 years of age: The available strength of the tablet may not conform to the recommended dose for children up to 9 years of age; the bismuth subsalicylate oral suspension is the preferred dosage form for this age group.

Children 9 to 12 years of age: Oral, 262 or 300 mg every half-hour to one hour but not to exceed 2.4 grams in a day. {21} {32}


Usual geriatric dose
See Usual adult and adolescent dose.

Note: Geriatric patients with reduced renal function may be more sensitive to the effects of the usual adult dose and may require lower doses.


Strength(s) usually available
U.S.—


262 mg (OTC) [Pepto-Bismol Easy-to-Swallow Caplets (salicylate 99 mg)]

Canada—
Not commercially available.

Packaging and storage:
Store below 40 °C (104 °F), {21} preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Swallow with water. Do not chew.
   • May cause darkening of tongue and/or stools.


BISMUTH SUBSALICYLATE CHEWABLE TABLETS

Usual adult and adolescent dose
See Bismuth Subsalicylate Tablets.

Usual pediatric dose
See Bismuth Subsalicylate Tablets.

Usual geriatric dose
See Bismuth Subsalicylate Tablets .

Strength(s) usually available
U.S.—


262 mg (OTC) [Bismatrol] [Pepto-Bismol (salicylate 102 mg) (sodium <2 mg) (calcium carbonate 350 mg)][Generic]

Canada—


262 mg (OTC) [Pepto-Bismol (sodium <2 mg) (calcium carbonate 350 mg)]


300 mg (OTC) [Bismed (calcium carbonate 350 mg)] [PMS-Bismuth Subsalicylate (calcium carbonate 350 mg)]

Packaging and storage:
Store below 40 °C (104 °F), {21} {32} preferably between 15 and 30 °C (59 and 86 °F), unless otherwise specified by manufacturer.

Auxiliary labeling:
   • Chew or allow to disintegrate in mouth before swallowing.
   • May cause darkening of tongue and/or stools.



Revised: 09/01/1994



References
  1. Product labeling.
  1. AMA Drug evaluations. 6th ed. Chicago: American Medical Association, September 1986: 963-64.
  1. Olin BR, editor. Drug facts and comparisons. St. Louis: Facts and Comparisons Inc, 1987: 324d.
  1. Salicylates (Systemic), USP–DI 1988, 8th ed.
  1. Fed Regist 1986; 51: 16143.
  1. Fleeger CA, editor. USAN 1994. USAN and the USP dictionary of drug names. Rockville, MD: The United States Pharmacopeial Convention, Inc., 1993: 89.
  1. F–D–C– Reports, Aug 17, 1987: 8.
  1. Feldman EG, Blockstein WL, editors. Handbook of nonprescription drugs. 8th ed. Washington, DC: American Pharmaceutical Association, 1986: 31.
  1. Dukes MNG, editor. Meyler's side effects of drugs. An encyclopedia of adverse reactions and interactions. 10th ed. Amsterdam: Elsevier, 1984: 338-91.
  1. Gilman AG, Goodman LS, Rall TW, Murad F, editors. Goodman and Gilman's the pharmacological basis of therapeutics. 7th ed. New York: Macmillan, 1985: 988.
  1. Physician's Drug Alert April 1983: 29.
  1. Scott D. Traveler's diarrhea: must it spoil the patient's trip? Postgrad Med 1982; 71: 244.
  1. Weiss BD. Preventing traveler's diarrhea. Am Fam Physician 1981; 24: 169-70.
  1. DuPont HL, et al. Prevention of traveler's diarrhea—Prophylactic administration of subsalicylate bismuth. JAMA 1980; 243: 237-41.
  1. Review article. Am J Med 1985; 78: 81-90.
  1. Graham DY. Double-blind comparison of bismuth subsalicylate and placebo in the prevention and treatment of enterotoxigenic Eschericia coli–induced diarrhea in volunteers. Gastroenterology 1983; 85: 1017-22.
  1. Weiss BD. Traveler's diarrhea: update 1983. Am Fam Physician 1983; 27: 193-5.
  1. DuPont HL. Bismuth subsalicylate in the treatment and prevention of diarrheal disease. Drug Intell Clin Pharm 1987; 21: 687-93.
  1. DuPont HL, et al. Prevention of traveler's diarrhea by the tablet formulation of bismuth subsalicylate. JAMA 1987; 257: 1347-50.
  1. Steffen R, et al. Prevention of traveler's diarrhea by the tablet form of bismuth subsalicylate. Antimicrob Agents Chemother 1986; 29: 625-7.
  1. Pepto-Bismol product labeling. (Proctor & Gamble—US).
  1. Bierer DW. Bismuth subsalicylate: History, chemistry, and safety. Rev Infect Dis 1990; 12(S1): S3-S7.
  1. DuPont HL, Ericsson CD, Johnson PC, et al. Use of bismuth subsalicylate for the prevention of traveler's diarrhea. Rev Infect Dis 1990; 12: S64-S67.
  1. U.S. Food and Drug Administration. Labeling for oral and rectal over-the-counter aspirin and aspirin-containing products: Reye syndrome warning. Fed Regist 1988; 53: 21633-7.
  1. McNulty CAM, Gearty JC, Crump B, et al. Campylobacter pyloridis and associated gastritis: investigator blind, placebo controlled trial of bismuth salicylate and erythromycin ethylsuccinate. Br Med J 1986; 293: 645-9.
  1. Eberhardt R, Kasper G. Effect of oral bismuth subsalicylate on Campylobacter pylori and on healing and relapse rate of peptic ulcer. Rev Infect Dis 1990; 12: S115-S119.
  1. McNulty CAM. Bismuth subsalicylate in the treatment of gastritis due to Campylobacter pylori. Rev Infect Dis 1990; 12: S94-S98.
  1. Ormand JE, Talley NJ. Helicobacter pylori: controversies and an approach to management. Mayo Clin Proc 1990; 65: 414-26.
  1. Panel comment, 5/90.
  1. Carmichael JM. Helicobacter pylori: are ulcers an infectious disease? Am Drug 5/90.
  1. Ericsson CD, DuPont HL. Travelers' diarhea: approaches to prevention and treatment. Clin Infect Dis 1993; 16: 216-26.
  1. Pepto-Bismol(Proctor & Gamble). In: Krogh CME, editor. CPS Compendium of pharmaceuticals and specialties. 29th ed. Ottawa: Canadian Pharmaceutical Association, 1994: 1004.
  1. Soriano-Brücher HE, Avendaño P, O'Ryan M, et al. Use of bismuth subsalicylate in acute diarrhea in children. Rev Infect Dis 1990; 12: S51-S55.
  1. Reviewers' responses to Panel Memo of 5/90.
  1. DuPont HL. Using OTC drugs for acute diarrhea. Drug Ther 1983: 127-36.
  1. Wolfe MS. Acute diarrhea associated with travel. Am J Med 1990 Jun; 88(6A Suppl): 34S-37S.
  1. Not used.
  1. Berkowitz JM. The efficacy of bismuth subsalicylate in relieving gastro-intestinal discomfort following excessive alcohol and food intake. J Intl Med Res 1990; 18: 351-7.
  1. Sodium Iodide I 123 (Systemic), Sodium Iodide I 131 (Systemic), and Sodium Pertechnetate Tc 99m (Systemic) monographs in USP DI 1991.
  1. Panel comment, 1988.
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