Bismuth Subsalicylate

Bismuth subsalicylate is an over-the-counter medication used for treatment of diarrhea, gas, upset stomach, indigestion, heartburn, nausea and as a prophylaxis for traveler's diarrhea. Bismuth subsalicylate is also used in conjunction with other medications to treat H. pylori.

• Bismuth subsalicylate is available under the following different brand names: Kaopectate, Pepto Bismol, Maalox Total Relief, Kaopectate Extra Strength, and Pepto-Bismol Maximum Strength.

Tablet, chewable

• 262 mg
• 525 mg

Caplet

• 262 mg

Oral suspension

• 262 mg/15 ml
• 525 mg/15 ml

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

Adult Dosing:

• 2 tablets (262 mg/tab) or 30 ml (regular strength) orally every ½-1 hour as needed; maximum daily dose: 8 regular-strength doses or 4 extra-strength doses

Pediatric Dosing:

• Children under 3: 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 ½-1 hour as needed
• Children 6-9 years: 2/3 tablet or 10 ml (regular strength) or 5 ml (extra strength) orally every ½-1 hour as needed
• Children 9-12 years: 1 tablet or 15 ml (regular strength) or 7.5 ml (extra strength) orally every ½-1 hour as needed
• Children over 12 years; 2 tablets or 30 ml (regular strength) or 15 ml (extra strength) orally every ½-1 hour 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

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

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

Chronic Infantile Diarrhea

• Children under 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

Dosing Modifications

• Renal impairment: Overdose may cause nephrotoxicity

Administration

• Drink plenty of clear fluids to prevent dehydration caused by diarrhea
• Do not use for more 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

Side effects of bismuth subsalicylate include:

• abdominal pain
• anal discomfort
• anxiety
• black or 'hairy' tongue
• clay-colored or gray-black stools
• cold symptoms (stuffy nose, sneezing, sore throat)
• confusion
• constipation (may be chronic)
• dark urine
• depression
• diarrhea (may be severe, watery, or bloody)
• dizziness
• sores in the stomach lining
• indigestion
• gas (flatulence)
• gastrointestinal bleeding
• headache (may be severe)
• difficulty falling asleep (insomnia)
• itching
• loss of appetite
• dark sticky feces
• lightheadedness
• metallic taste in your mouth
• mild diarrhea
• mouth pain
• muscle spasm
• nausea
• damage to the brain or nervous system
• pain
• pain behind your eyes
• pale skin
• numbness and tingling
• rapid heart rate
• ringing in your ears (tinnitus)
• seizure (convulsions)
• severe allergic reaction
• shortness of breath
• sinusitis
• stomach pain
• swollen tongue
• taste perversion
• trouble concentrating
• trouble swallowing
• upper respiratory tract infection
• vaginal itching or discharge
• vision problems
• vomiting
• weakness
• yellowing of the skin or eyes (jaundice)

This document does not contain all possible side effects and others may occur. Check with your physician for additional information about side effects.

If your doctor has directed you to use this medication, your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor, health care provider, or pharmacist first.

• Severe interactions of bismuth subsalicylate include:
  • dichlorphenamide
• Serious interactions of bismuth subsalicylate include:
  • demeclocycline
  • doxycycline
  • eluxadoline
  • lymecycline
  • minocycline
  • oxytetracycline
  • tetracycline
• Moderate interactions of bismuth subsalicylate include:
  • acebutolol
  • atenolol
  • benazepril
  • betaxolol
  • bisoprolol
  • carvedilol
  • celiprolol
  • esmolol
  • labetalol
  • metoprolol
  • nadolol
  • nebivolol
  • penbutolol
  • pindolol
  • propranolol
  • sotalol
  • timolol
  • tobramycin (inhaled)
• Minor interactions of bismuth subsalicylate include:
  • aspirin
  • aspirin (rectal)
  • aspirin/citric acid/sodium bicarbonate
  • esomeprazole
  • omeprazole

This information does not contain all possible interactions or adverse effects. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share this information with your doctor and pharmacist. Check with your health care professional or doctor for additional medical advice, or if you have health questions, concerns, or for more information about this medicine.

Warnings

This medication contains bismuth subsalicylate. Do not take Kaopectate, Pepto Bismol, Maalox Total Relief, Kaopectate Extra Strength, or Pepto-Bismol Maximum Strength if you are allergic to bismuth subsalicylate or any ingredients contained in this drug.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center immediately.

Contraindications

• Hypersensitivity to bismuth, aspirin, other salicylates.
• Infectious diarrhea, high fever, von Willebrand disease, hemorrhage, ulcer or gastrointestinal bleeding with black or bloody stool, hemophilia.
• In pediatric patients, chickenpox or influenza (risk of Reye's syndrome); changes in behavior with nausea and vomiting may be an early sign of Reye's syndrome.

Effects of Drug Abuse

• No information available

Short-Term Effects

• See "What Are Side Effects Associated with Using Bismuth Subsalicylate?"

Long-Term Effects

• See "What Are Side Effects Associated with Using Bismuth Subsalicylate?"

Cautions

• May cause a black tongue and/or black stool.
• May interfere with gastrointestinal radiographic tests.

Pregnancy and Lactation

• Use bismuth subsalicylate with caution during pregnancy if the benefits outweigh the risks. Animal studies show risk and human studies are not available or neither animal nor human studies were done. During the third trimester, use bismuth subsalicylate only in LIFE-THREATENING emergencies when no safer drug is available. There is positive evidence of human fetal risk.
• Salicylates enter breast milk; use bismuth subsalicylate with caution if breastfeeding.