Bismuth (Pepto Bismol, Kaopectate) Side Effects & Dosage (original) (raw)

• What is bismuth subsalicylate-oral, and how does it work (mechanism of action)?
• What are the side effects of bismuth subsalicylate-oral?
• What is the dosage for bismuth subsalicylate-oral?
• Which drugs or supplements interact with bismuth subsalicylate-oral?
• Is bismuth subsalicylate-oral safe to take if I'm pregnant or breastfeeding?
• What else should I know about bismuth subsalicylate-oral?

What is bismuth subsalicylate-oral, and how does it work (mechanism of action)?

Bismuth subsalicylate (BSS) is a commonly used over the counter medicine used to treat:

• diarrhea,
• upset stomach,
• nausea,
• indigestion, and
• heartburn.

Bismuth subsalicylate is also used to prevent traveler's diarrheaand to treat Helicobacter pylori (H. pylori) infection as part of a quadruple-drug therapy that also includes two antibiotics, and either a histamine-2 receptor antagonist or proton pump inhibitor.

Bismuth subsalicylate has various therapeutic benefits in the body including anti-bacterial, weak antacid, anti-inflammatory, and anti-secretory actions. After oral administration, bismuth subsalicylate is degraded in the stomach to produce salicylic acid. Salicylic acid inhibits the synthesis of prostaglandin, a chemical made in the body that plays an important role in contraction of smooth muscle and relaxation, dilation & constriction of blood vessels, blood pressure control, and modulation of inflammation.

The antidiarrheal benefits of bismuth subsalicylate may be due to the reduction in prostaglandin synthesis. Bismuth subsalicylate also prevents the attachment of bacteria to the walls of the intestine, inactivates enterotoxins (toxic chemicals made by bacteria), and has a direct inhibiting effect on bacteria.

Bismuth subsalicylate was first approved by the FDA in 1939.

What brand names are available for bismuth subsalicylate?

Bismatrol Maximum Strength, Pepto Bismol, Kaopectate, and many other brands

Is bismuth subsalicylate-oral available as a generic drug?

Yes

Do I need a prescription for bismuth subsalicylate?

No

What are the side effects of bismuth subsalicylate-oral?

Dark brown or black stools are common with use of bismuth subsalicylate. Tongue discoloration and constipation also may occur.

Other side effects associated with bismuth subsalicylate include:

• anxiety,
• confusion,
• depression,
• headache,
• slurred speech,
• muscle spasms,
• weakness,
• hearing loss,
• ringing in the ears,
• Reye's syndrome,
• abdominal pain,
• nausea, and
• vomiting.

QUESTION Pancreatitis is inflammation of an organ in the abdomen called the pancreas. See Answer

What is the dosage for bismuth subsalicylate-oral?

Over-the-counter treatment of nonspecific diarrhea in adults and adolescents (= 12 years):

• Chewable tablets, caplets, liquids containing 262 mg/15 ml: 524 mg by mouth every 30-60 minutes as needed. Not to exceed 8 doses in 24 hours.
• Liquids containing 525 mg/15 ml: 1050 mg by mouth every hour as needed. Not to exceed 4 doses in 24 hours.
• Over-the-counter treatment of upset stomach, heartburn, indigestion, nausea, and related symptoms in adults and adolescents (= 12 years):
• Chewable tablets, caplets, liquids containing 262 mg/15 ml: 524 mg by mouth every 30-60 minutes as needed. Not to exceed 8 doses in 24 hours.
• Liquids containing 525 mg/15 ml: 1050 mg by mouth every hour as needed. Not to exceed 4 doses in 24 hours.
• For the prevention of traveler's diarrhea due to Escherichia coli (E. coli) and viral infections in adults and adolescents (≥ 12 years):
• 524 mg by mouth four times daily, starting 1 day before departure and continuing for 2 days after returning. Generally, treatment duration should not exceed 3 weeks.
• For the eradication of helicobacter pylori as part of quadruple-drug regimen in adults and adolescents (≥ 12 years):
• 525 mg by mouth 4 times daily.

The safety and effectiveness of bismuth subsalicylate use in children <12 years has not been established.

Health News

Which drugs or supplements interact with bismuth subsalicylate-oral?

Combining bismuth subsalicylate with sulfinpyrazone (Anturane) or probenecidis not recommended because bismuth subsalicylate may suppress the therapeutic effects of both drugs.

Tetracycline and quinolone antibiotics may form insoluble complexes with bismuth subsalicylate. While bismuth subsalicylate should be avoided in patients taking these antibiotics if possible, separating administration by 2 hours may be sufficient to avoid this interaction.

Bismuth subsalicylate should be used cautiously in patients taking methotrexate (Trexall). Bismuth subsalicylate is broken down to salicylic acid which is known to increase blood levels of methotrexate. Patients especially at risk for this interaction include those on high-dose methotrexate therapy, elderly patients, and patients with reduced kidney function.

Bismuth subsalicylate is broken down to salicylic acid. Pediatric patients should not be given salicylates for 6 weeks after receiving the varicella-zoster virus live vaccine (Zostavax, Varivax) due to the risk of developing Reye's syndrome, a seriousliver disease.

Is bismuth subsalicylate-oral safe to take if I'm pregnant or breastfeeding?

Bismuth subsalicylate is known to cross the placenta following oral administration. Use of salicylates during pregnancy has been associated with adverse effects in the fetus. Therefore use of bismuth subsalicylate during pregnancy should be avoided. Bismuth subsalicylate is classified as FDA pregnancy risk category C (adverse effects in animals but inadequate human data).

Salicylates are excreted into human milk and can cause harm to the nursing infant. Bismuth subsalicylate is thought to be harmful to the nursing infant and should be avoided during breastfeeding.

What else should I know about bismuth subsalicylate-oral?

What preparations of bismuth subsalicylate-oral are available?

• Chewable tablets: 262, 525 mg
• Oral suspension: 262 mg/15 ml, maximum strength 525 mg/15 ml
• Caplets: 262 mg

How should I keep bismuth subsalicylate-oral stored?

Bismuth subsalicylate products should be stored at room temperature, between 59 F to 86 F (15 C to 30 C).

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Summary

Bismuth subsalicylate (Pepto Bismol, Kaopectate, Bismatrol Maximum Strength, and many other brands) is an over-the-counter (OTC) drug used to prevent traveler's diarrhea, and to treat diarrhea, upset stomach, nausea, indigestion, heartburn, and H. pylori infection. Side effects, drug interactions, dosage, storage, pregnancy and breastfeeding safety should be reviewed prior to taking this medication.

Related Disease Conditions

• Stool Color Changes Stool color changes can very from green, red, maroon, yellow, white, or black. Causes of changes of stool color can range from foods a person eats, medication, diseases or conditions, pregnancy, cancer, or tumors. Stool can also have texture changes such as greasy or floating stools. Stool that has a uncharacteristically foul odor may be caused by infections such as giardiasis or medical conditions.
• Diarrhea Diarrhea is a change in the frequency and looseness of bowel movements. Symptoms associated with diarrhea are cramping, abdominal pain, and the sensation of rectal urgency. Causes of diarrhea include viral, bacterial, or parasite infection, gastroenteritis, food poisoning, and drugs. Absorbents and anti-motility medications are used to treat diarrhea.
• Irritable Bowel Syndrome (IBS) Irritable bowel syndrome or IBS is a GI disorder with symptoms of constipation, abdominal pain, bloating, and gas. IBS treatment includes medications, dietary changes, and lifestyle changes.
• Dyspepsia (Indigestion) Indigestion (dyspepsia, upset stomach) can be caused by problems related to, or not related to the gastrointestinal tract. Signs and symptoms are upper abdominal pain, belching, nausea, vomiting, abdominal bloating, and abdominal distention. Treatment depends upon the cause.
• Helicobacter Pylori Helicobacter pylori (H. pylori) is a bacteria that causes chronic inflammation (gastritis) of the inner lining of the stomach and also is the most common cause of ulcers worldwide. About 50% of people in the world carry or are infected with H. pylori. Common symptoms of H. pylori infection are occasional abdominal discomfort, bloating, belching or burping, and nausea and vomiting. H. pylori infection is difficult to eradicate, and treatment is with two or more antibiotics.
• Traveler's Diarrhea Traveler's diarrhea is generally contracted by eating contaminated food or drinking contaminated water. Food is the primary source of traveler's diarrhea. Enterotoxigenic E. coli is the cause of up to 70% of all cases of traveler's diarrhea. Five unique classes of E. coli cause gastroenteritis. Other bacteria responsible for traveler's diarrhea include Campylobacter, jejuni, shigella, and salmonella. Viruses, such as rotavirus and Norwalk virus (norovirus), and giardia lamblia, a parasite, may cause traveler's diarrhea. Prevention is careful eating and drinking of water.
• Antiemetics Nausea and vomiting after eating are symptoms that may be caused by many conditions. Antiemetics are drugs that help get rid of nausea and vomiting. Though some antiemetics for motion sickness and mild nausea remedies are available over the counter (OTC), most require a medical evaluation and prescription. Read experts describing what causes nausea and how to stop nausea and vomiting.
• Is H. Pylori Contagious? H. pylori infection is caused by fecal contamination in either food or water and by poor hygiene practices such as not washing hands often. Common symptoms of H. pylori are discomfort or pain in the area of the stomach. Some individuals describe the pain as gnawing or burning. Treatment of H. pylori infection is antibiotic therapy.
• Microscopic Colitis Microscopic colitis (lymphocytic colitis and collagenous colitis) is a disease of inflammation of the colon. Microscopic colitis is only visible when the colon's lining is examined under a microscope. The cause of microscopic colitis is not known. Symptoms of microscopic colitis are chronic watery diarrhea and abdominal pain or cramps.
• Travel Medicine Travelers should prepare for their trip by visiting their physician to get the proper vaccinations and obtain the necessary medication if they have a medical condition or chronic disease. Diseases that travelers may pick up from contaminated water or food, insect or animal bites, or from other people include: malaria, meningococcal meningitis, yellow fever, hepatitis A, typhoid fever, polio, and cholera.

Treatment & Diagnosis

Medications & Supplements

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References

Medically reviewed by John P. Cunha, DO, FACOEP; Board Certified Emergency Medicine

REFERENCE:

FDA Prescribing Information.