bismuth subsalicylate

Bismuth subsalicylate is an over-the-counter medication used to treat and manage gastrointestinal discomfort, indigestion, traveler’s diarrhea and Helicobacter pylori infection. Bismuth subsalicylate has antimicrobial, anti-inflammatory and antisecretory properties. Bismuth subsalicylate is effective against both bacterial and viral gastrointestinal pathogens, but does not appear to affect normal gut flora.

Bismuth subsalicylate is a formulation of bismuth and an insoluble salt of salicylic acid that works in multiple ways. Bismuth subsalicylate is broken up in the stomach into salicylic acid and bismuth salts such as bismuth oxychloride, bismuth subcarbonate, bismuth phosphate and bismuth sulfide. Salicylic acid is nearly completely absorbed systemically, while very little of bismuth salts are absorbed. Bismuth subsalicylate works in the following ways in the treatment of diarrhea and H. pylori infection:

• Prevents the H. pylori bacteria from binding and growing on the mucous lining and also inhibits their enzyme activities which help them grow
• Inhibits intestinal secretions and fluid loss
• Promotes fluid and electrolyte reabsorption into the bloodstream
• Reduces inflammation which helps heal peptic ulcers
• The salicylate component adds to the anti-inflammatory effect by inhibiting enzymes known as cyclooxygenases required for synthesizing prostaglandin, a substance that promotes inflammation

Bismuth subsalicylate is used in the treatment of the following:

• Gas
• Upset stomach and indigestion
• Heartburn
• Nausea
• Diarrhea
• Traveler’s diarrhea caused by bacterial infections from contaminated food and drink
• Helicobacter pylori and associated peptic ulcers

• Do not take bismuth subsalicylate if you are hypersensitive to bismuth, salicylates, including aspirin, and any of the other components of bismuth subsalicylate
• Do not take bismuth subsalicylate if you have any of the following:
  • Infectious diarrhea
  • High fever
  • Bleeding disorders such as hemophilia or von Willebrand disease
  • Hemorrhage
  • GI ulcers
  • GI bleeding with black or bloody stool
  • Do not use in children and adolescents who have or who are recovering from chickenpox or flu; can increase the risk for Reye syndrome, a rare condition that damages the liver and the brain
• Some formulations may contain benzyl alcohol; do not use these products in newborn babies, can cause potentially fatal toxicity known as “gasping syndrome”
• Bismuth salts can cause temporary and harmless darkening of tongue and/or stools; exercise caution not to confuse dark stools from bismuth with tarry stools that result from upper GI bleeding (melena)
• Bismuth absorbs x-rays and can interfere with diagnostic procedures of the GI tract
• Large doses of bismuth products can be toxic to the nervous system

Common side effects of bismuth subsalicylate include:

• Nausea
• Diarrhea
• Abdominal pain
• Dark tarry stools (melena)

Less common side effects of bismuth subsalicylate include:

• Constipation
• Vomiting
• Loss of appetite (anorexia)
• Indigestion (dyspepsia)
• Stool abnormality
• Duodenal ulcer
• Anal discomfort
• Gray-black stool
• Discolored tongue
• Taste perversion
• Gas (flatulence)
• Gastrointestinal hemorrhage
• Fecal impaction
• Headache
• Dizziness
• Pain
• Weakness (asthenia)
• Upper respiratory tract infection
• Sinus inflammation (sinusitis)
• Abnormal skin sensations (paresthesia)
• Sleeplessness (insomnia)
• Anxiety
• Confusion
• Depression
• Ringing in the ears (tinnitus)
• Hearing loss
• Muscle spasm
• Neurotoxicity (rare)

This is not a complete list of all side effects or adverse reactions that may occur from the use of this drug.

Call your doctor for medical advice about serious side effects or adverse reactions. You may also report side effects or health problems to the FDA at 1-800-FDA-1088.

Tablet, chewable

• 262mg
• 525mg

Caplet

• 262mg

Oral suspension

• 262mg/15mL
• 525mg/15mL
• 525 mg/30 mL
• 1050 mg/30 mL

Adult:

Diarrhea, Gas, Upset Stomach, Indigestion, Heartburn, Nausea

• 2 tablets (262 mg/tab) or 30 mL (regular strength) orally every 30-60 minutes as needed; maximum daily dose: 8 regular-strength doses or 4 extra-strength doses

Traveler's Diarrhea

Prophylaxis

• 2 tablets (262 mg/tab) every 6 hours for up to 3 weeks

Helicobacter pylori infection

• 525 mg (2 regular-strength tablets or 1 extra-strength tablet) + 250 mg metronidazole + 500 mg tetracycline PO every 6 hours for 14 days, plus an H2 antagonist (Helidac Therapy pack)

Dosing Modifications

• Renal impairment: Overdose may cause nephrotoxicity

Administration

• Drink plenty of clear fluids to prevent dehydration caused by diarrhea
• Do not use for longer than 2 days
• Helidac Therapy pack: Bismuth subsalicylate tablets should be chewed and swallowed; if a dose is missed, double doses should not be taken

Pediatric:

Diarrhea, Gas, Upset Stomach, Indigestion, Heartburn, Nausea

• Children younger than 3 years: Safety and efficacy not established
• Children 3-6 years: 1/3 tablet or 5 mL (regular strength) or 2.5 mL (extra strength) orally every 30-60 minutes as needed
• Children 6-9 years: 2/3 tablet or 10 mL (regular strength) or 5 mL (extra strength) orally every 30-60 minutes as needed
• Children 9-12 years: 1 tablet or 15 mL (regular strength) or 7.5 mL (extra strength) orally every 30-60 minutes as needed
• Children older than 12 years: 2 tablets or 30 mL (regular strength) or 15 mL (extra strength) orally every 30-60 minutes as needed; maximum daily dose: 8 regular-strength doses or 4 extra-strength doses

Chronic Infantile Diarrhea

• Children younger than 2 years: 2.5 mL (regular strength) every 4 hours
• Children 2-4 years: 5 mL (regular strength) every 4 hours
• Children 4-6 years: 10 mL (regular strength) every 4 hours

• Overdose of bismuth subsalicylate can cause symptoms such as lethargy, drowsiness, anxiety, insomnia, tremor and seizures.
• There is no specific antidote for bismuth subsalicylate; overdose may be treated with symptomatic and supportive care.
• Activated charcoal may be administered to eliminate unabsorbed drug in the digestive tract, if possible within two hours. In case of overdose, seek medical help or contact Poison Control.

Inform your doctor of all medications you are currently taking, who can advise you on any possible drug interactions. Never begin taking, suddenly discontinue, or change the dosage of any medication without your doctor’s recommendation.

• Severe interactions of bismuth subsalicylate include:
  • dichlorphenamide
• Serious interactions of bismuth subsalicylate include:
  • demeclocycline
  • doxycycline
  • eluxadoline
  • minocycline
  • oxytetracycline
  • tetracycline
  • warfarin
• Moderate interactions of bismuth subsalicylate include:
  • acebutolol
  • atenolol
  • benazepril
  • betaxolol
  • bisoprolol
  • carvedilol
  • celiprolol
  • esmolol
  • labetalol
  • metoprolol
• Minor interactions of bismuth subsalicylate include:
  • aspirin
  • aspirin rectal
  • aspirin/citric acid/sodium bicarbonate
  • esomeprazole
  • omeprazole

The drug interactions listed above are not all of the possible interactions or adverse effects. For more information on drug interactions, visit the RxList Drug Interaction Checker.

It is important to always tell your doctor, pharmacist, or health care provider of all prescription and over-the-counter medications you use, as well as the dosage for each, and keep a list of the information. Check with your doctor or health care provider if you have any questions about the medication.

• Use bismuth subsalicylate with caution during pregnancy if the benefits outweigh potential risks. Avoid bismuth subsalicylate, or use only in life-threatening emergencies during the third trimester, as it can cause fetal harm
• Bismuth subsalicylate is present in breast milk. Use with caution in nursing mothers.

• Take bismuth subsalicylate exactly as per instructions on the label
• Store carefully out of reach of children
• Bismuth subsalicylate can temporarily darken tongue and/or stools which is harmless; if dark stools do not stop within a couple of days after discontinuation of the drug, seek medical help
• Discontinue bismuth subsalicylate and seek medical help if diarrhea does not stop within a couple of days of taking the drug and/or symptoms last longer than 14 days or worsen
• Check with your healthcare provider before taking bismuth subsalicylate if you have fever or mucus in the stool