Bismuth Subsalicylate

Pronunciation: BISS-muth sub-suh-LIS-ih-late
Class: Antidiarrheal

Trade Names

Bismatrol
- Tablets, chewable, oral 262 mg
- Suspension, oral 262 mg/15 mL

Bismatrol Maximum Strength
- Suspension, oral 525 mg/15 mL

Diotame
- Tablets, chewable, oral 262 mg

Kaopectate
- Suspension, oral 262 mg/15 mL

Kaopectate Extra Strength
- Suspension, oral 525 mg/15 mL

Kola-Pectin DS
- Suspension, oral 525 mg/15 mL

Pepto-Bismol Maximum Strength
- Liquid, oral 525 mg/15 mL

Pepto-Bismol
- Suspension 262 mg/15 mL
- Tablets, chewable, oral 262 mg
- Tablets, oral 262 mg

Pharmacology

Produces antisecretory and antimicrobial effects; may have anti-inflammatory effect.

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Pharmacokinetics

Absorption

In the GI tract, bismuth subsalicylate undergoes chemical dissociation to yield bismuth and salicylate. Bismuth absorption is negligible, and plasma levels of the salicylate are similar to levels achieved after a comparable dose of aspirin.

Metabolism

Chemical dissociation in the GI tract.

Elimination

Greater than 90% of salicylate is recovered in urine.

Indications and Usage

Treatment of indigestion without causing constipation, nausea, abdominal cramps; relief of nausea and/or upset stomach; control of heartburn and diarrhea, including traveler's diarrhea.

Unlabeled Uses

Treatment of recurrent ulcers, chronic infantile diarrhea, gastroenteritis associated with Norwalk virus; prevention of traveler's diarrhea.

Contraindications

None well documented.

Dosage and Administration

PO 2 tablets (262 mg each) or 30 mL suspension every 30 to 60 min as needed (max, 8 doses/day).

PO 30 mL every h as needed (max, 120 mL/24 h).

PO 1 tablet or 15 mL suspension every 30 to 60 min as needed (max, 8 doses/day).

PO 2/ 3  tablet or 10 mL suspension every 30 to 60 min as needed (max, 8 doses/day).

PO 1/ 3 tablet or 5 mL suspension every 30 to 60 min as needed (max, 8 doses/day).

Consult health care provider.

General Advice

• For oral use.
• Shake suspension well before use.
• Use until diarrhea stops, but not more than 2 days.

Storage/Stability

Store at room temperature. Protect from light and freezing. Avoid excessive heat (higher than 104°F [40°C].

Drug Interactions

May cause salicylate toxicity. Avoid concurrent use.

May decrease effectiveness.

Drug may increase glucose-lowering effect of insulin.

Drug may increase effects and toxicity of methotrexate.

Drug may interfere with diuretic effect.

Drug may interfere with uricosuric effect.

Bismuth subsalicylate may reduce GI absorption of tetracyclines and diminish their effectiveness.

Drug may increase free fraction of valproic acid, leading to toxicity.

Laboratory Test Interactions

Bismuth subsalicylate is radiopaque and may interfere with radiologic examination of GI tract.

Adverse Reactions

EENT

Tinnitus; discoloration of tongue.

GI

Discoloration of stools; impaction.

Precautions

Pregnancy

Category C .

Lactation

Excreted in breast milk.

Children

May cause impaction. Consult a health care provider before using in children younger than 12 y; children and/or teenagers who have or are recovering from chicken pox or flu-like symptoms should not use these products.

Hypersensitivity

Do not use in patients allergic to salicylates, including aspirin.

Special Risk Patients

Do not use in patients with bloody or black stools, ulcers, or in patients with bleeding problems.

Debilitated patients

May cause impaction.

Reye syndrome

If changes in behavior with nausea and vomiting occur, it could be an early sign of Reye syndrome, a rare but serious condition.

Overdosage

Symptoms

Ringing in ears, respiratory alkalosis, nausea, vomiting, hypokalemia, neurologic abnormalities (eg, disorientation, seizures), dehydration, hyperthermia, unusual bleeding or bruising.

Patient Information

• Counsel patient to maintain adequate fluid intake (2 to 3 L/day) to prevent dehydration.
• Instruct patient to notify health care provider if diarrhea is accompanied by high fever or continues for longer than 2 days or if abdominal pain occurs.
• Advise patient not to use medication if concurrent viral illness is present.
• Instruct patient to consult health care provider before taking drug if concurrently taking other salicylates, anticoagulants or medications for arthritis, diabetes, or gout.
• Instruct patient to inform health care provider regarding bismuth subsalicylate administration before any scheduled radiologic studies or stool examinations.
• Inform patient of possibility of salicylate toxicity and associated symptoms (eg, ringing in the ears or loss of hearing), and instruct patient to notify health care provider if these symptoms occur.
• Explain that stools may become black or gray and tongue may darken.

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