Classes
DEA Class; OTC
Common Brand Names; Kaopectate, Pepto Bismol, Maalox Total Relief, Kaopectate Extra Strength, Pepto-Bismol Maximum Strength
- Antidiarrheals;
- H pylori Agents
Description
Antimicrobial anti-inflammatory action (bismuth); antisecretory effect (salicylate)
Indications
Indicated for Diarrhea, Gas, Upset Stomach, Indigestion, Heartburn, Nausea, Traveler’s Diarrhea, Helicobacter Pylori
Contraindications
Hypersensitivity to bismuth, aspirin, other salicylates
Infectious diarrhea, high fever, von Willebrand disease, hemorrhage, ulcer or GI bleeding with black or bloody stool, hemophilia
In pediatric patients, chicken pox or influenza (risk of Reye syndrome)
Adverse Effects
- Nausea (12%)
- Diarrhea (7%)
- Abdominal pain (7%)
- Melena (3%)
- Upper respiratory tract infection (2%)
- Constipation (2%)
- Anorexia (2%)
- Vomiting (2%)
- Asthenia (2%)
- Discolored tongue (2%)
- Headache (2%)
- Dyspepsia (2%)
- Dizziness (2%)
- Stool abnormality (1%)
- Duodenal ulcer (1%)
- Sinusitis (1%)
- Taste perversion (1%)
- Flatulence (1%)
- GI hemorrhage (1%)
- Pain (1%)
- Insomnia (1%)
- Anal discomfort (1%)
- Paresthesia (1%)
Warnings
Bismuth subcitrate potassium may cause temporary and harmless darkening of tongue and/or black stools, generally reversible within several days after treatment stopped; stool darkening should not be confused with melena
Bismuth absorbs x-rays and may interfere with x-ray diagnostic procedures of gastrointestinal tract
Cases of neurotoxicity associated with excessive doses of various bismuth-containing products reported; effects have been reversible with discontinuation of bismuth therapy
Not to be administered to children or teenagers recovering from flu-like symptoms or chickenpox; increased incidence of Reye syndrome, associated with salicylate products
Pregnancy and Lactation
Pregnancy category: C; D in 3rd trimester
Lactation: Salicylates enter breast milk; use with caution
Maximum Dosage
Diarrhea, Gas, Upset Stomach, Indigestion, Heartburn, Nausea
2 tablets (262 mg/tab) or 30 mL (regular strength) PO q½-1hr PRN; maximum daily dose: 8 regular-strength doses or 4 extra-strength doses
Traveler’s Diarrhea
Prophylaxis
2 tablets (262 mg/tab) q6hr for up to 3 weeks
Helicobacter Pylori
525 mg (2 regular-strength tablets or 1 extra-strength tablet) + 250 mg metronidazole + 500 mg tetracycline PO q6hr for 14 days, plus an H2 antagonist (Helidac Therapy pack)
How supplied
Bismuth subsalicylate
tablet, chewable
- 262mg
- 525mg
caplet
- 262mg
oral suspension
- 262mg/15mL
- 525mg/15mL
- 525 mg/30 mL
- 1050 mg/30 mL
