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Bismuth


General


Pronunciation

(BIZ muth)


Indications


Use: Labeled Indications

Subsalicylate formulation: Symptomatic treatment of mild, nonspecific diarrhea; control of travelers diarrhea (enterotoxigenic Escherichia coli); as part of a multidrug regimen for H. pylori eradication to reduce the risk of duodenal ulcer recurrence


Contraindications


OTC labeling: When used for self-medication, do not use if you have an ulcer, bleeding problem or bloody/black stool


Dosing and Administration


Dosing: Adult

Treatment of nonspecific diarrhea, control/relieve travelers diarrhea: Subsalicylate: Oral: 524 mg every 30 minutes to 1 hour as needed up to 8 doses/24 hours

Helicobacter pylorieradication: Oral: Subsalicylate: 524 mg 4 times/day with meals and at bedtime; requires combination therapy


Dosing: Geriatric

Refer to adult dosing.


Dosing: Pediatric

Nonspecific diarrhea, control/relieve travelers diarrhea: Subsalicylate: Oral: Children >12 years: Refer to adult dosing.


Dosing: Renal Impairment

Bismuth has been associated with nephrotoxicity in overdose (Leussnik, 2002); although there are no specific recommendations by the manufacturer, consider using with caution in patients with renal impairment.


Administration

Liquids must be shaken prior to use. Chewable tablets should be chewed thoroughly. Nonchewable caplets should be swallowed whole with a full glass of water.


Dietary Considerations

Drink plenty of fluids to help prevent dehydration caused by diarrhea. Some products may contain potassium and/or sodium.


Dosage Forms/Strengths


Drug Interactions

ACE Inhibitors: Salicylates may diminish the antihypertensive effect of ACE Inhibitors. They may also diminish other beneficial pharmacodynamic effects desired for the treatment of CHF. The effects are likely dose-related. 100 mg doses aspirin appear to cause no problems, whereas 300 mg doses appear to significantly affect ACE Inhibitor efficacy. Monitor therapy

Agents with Antiplatelet Properties (e.g., P2Y12 inhibitors, NSAIDs, SSRIs, etc.): May enhance the adverse/toxic effect of Salicylates. Increased risk of bleeding may result. Monitor therapy

Ammonium Chloride: May increase the serum concentration of Salicylates. Monitor therapy

Anticoagulants: Salicylates may enhance the anticoagulant effect of Anticoagulants. Monitor therapy

Blood Glucose Lowering Agents: Salicylates may enhance the hypoglycemic effect of Blood Glucose Lowering Agents. Monitor therapy

Calcium Channel Blockers (Nondihydropyridine): May enhance the anticoagulant effect of Salicylates. Exceptions: Bepridil [Off Market]. Monitor therapy

Carbonic Anhydrase Inhibitors: Salicylates may enhance the adverse/toxic effect of Carbonic Anhydrase Inhibitors. Salicylate toxicity might be enhanced by this same combination. Exceptions: Brinzolamide; Dorzolamide. Consider therapy modification

Corticosteroids (Systemic): Salicylates may enhance the adverse/toxic effect of Corticosteroids (Systemic). These specifically include gastrointestinal ulceration and bleeding. Corticosteroids (Systemic) may decrease the serum concentration of Salicylates. Withdrawal of corticosteroids may result in salicylate toxicity. Monitor therapy

Dexketoprofen: Salicylates may enhance the adverse/toxic effect of Dexketoprofen. Dexketoprofen may diminish the therapeutic effect of Salicylates. Salicylates may decrease the serum concentration of Dexketoprofen. Management: The use of high-dose salicylates (3 g/day or more) together with dexketoprofen is inadvisable. Consider administering dexketoprofen 30-120 min after or at least 8 hrs before cardioprotective doses of aspirin to minimize any possible interaction. Avoid combination

Ginkgo Biloba: May enhance the anticoagulant effect of Salicylates. Management: Consider alternatives to this combination of agents. Monitor for signs and symptoms of bleeding (especially intracranial bleeding) if salicylates are used in combination with ginkgo biloba. Consider therapy modification

Herbs (Anticoagulant/Antiplatelet Properties) (eg, Alfalfa, Anise, Bilberry): May enhance the adverse/toxic effect of Salicylates. Bleeding may occur. Consider therapy modification

Hyaluronidase: Salicylates may diminish the therapeutic effect of Hyaluronidase. Management: Patients receiving salicylates (particularly at larger doses) may not experience the desired clinical response to standard doses of hyaluronidase. Larger doses of hyaluronidase may be required. Consider therapy modification

Influenza Virus Vaccine (Live/Attenuated): May enhance the adverse/toxic effect of Salicylates. Specifically, Reyes syndrome may develop. Avoid combination

Loop Diuretics: Salicylates may diminish the diuretic effect of Loop Diuretics. Loop Diuretics may increase the serum concentration of Salicylates. Monitor therapy

Methotrexate: Salicylates may increase the serum concentration of Methotrexate. Salicylate doses used for prophylaxis of cardiovascular events are not likely to be of concern. Consider therapy modification

NSAID (Nonselective): May enhance the adverse/toxic effect of Salicylates. An increased risk of bleeding may be associated with use of this combination. NSAID (Nonselective) may diminish the cardioprotective effect of Salicylates. Salicylates may decrease the serum concentration of NSAID (Nonselective). Consider therapy modification

Potassium Acid Phosphate: May increase the serum concentration of Salicylates. Monitor therapy

PRALAtrexate: Salicylates may increase the serum concentration of PRALAtrexate. Salicylate doses used for prophylaxis of cardiovascular events are unlikely to be of concern. Consider therapy modification

Probenecid: Salicylates may diminish the therapeutic effect of Probenecid. Monitor therapy

Salicylates: May enhance the anticoagulant effect of other Salicylates. Monitor therapy

Tetracycline Derivatives: Bismuth may decrease the serum concentration of Tetracycline Derivatives. Management: Consider dosing tetracyclines 2 hours before, or 6 hours after, bismuth. The need to separate doses during Helicobacter pylori eradication regimens is questionable. Consider therapy modification

Thrombolytic Agents: Salicylates may enhance the adverse/toxic effect of Thrombolytic Agents. An increased risk of bleeding may occur. Monitor therapy

Treprostinil: May enhance the adverse/toxic effect of Salicylates. Bleeding may occur. Monitor therapy

Valproic Acid and Derivatives: Salicylates may increase the serum concentration of Valproic Acid and Derivatives. Monitor therapy

Varicella Virus-Containing Vaccines: Salicylates may enhance the adverse/toxic effect of Varicella Virus-Containing Vaccines. Reye's Syndrome may develop. Consider therapy modification

Vitamin K Antagonists (eg, warfarin): Salicylates may enhance the anticoagulant effect of Vitamin K Antagonists. Consider therapy modification


Lab Test Interferences


Test Interactions

Increased uric acid, increased AST; bismuth absorbs x-rays and may interfere with diagnostic procedures of GI tract


Adverse Reactions


Frequency not defined; subsalicylate formulation:

Central nervous system: Anxiety, confusion, depression, headache, slurred speech

Gastrointestinal: Fecal discoloration (grayish black; impaction may occur in infants and debilitated patients), tongue discoloration (darkening)

Neuromuscular & skeletal: Muscle spasm, weakness

Otic: Hearing loss, tinnitus


Warnings/Precautions


Concerns related to adverse effects:

- Neurotoxicity: Bismuth products may be neurotoxic with very large doses.

Concurrent drug therapy issues:

- Aspirin: Bismuth subsalicylate should be used with caution if patient is taking aspirin.

Other warnings/precautions:

- Self-medication (OTC use): Children and teenagers who have or are recovering from chickenpox or flu-like symptoms should not use subsalicylate. Changes in behavior (along with nausea and vomiting) may be an early sign of Reyes syndrome; patients should be instructed to contact their healthcare provider if these occur. Patients should be instructed to contact healthcare provider for diarrhea lasting >2 days, hearing loss, or ringing in the ears. Not labeled for OTC use in children <12 years of age.


Pregnancy Considerations

Following oral administration, bismuth and salicylates cross the placenta. The use of salicylates in pregnancy may adversely affect the newborn (Lione, 1988). Use during pregnancy is not recommended (Mahadevan, 2007).


Actions


Pharmacology

Bismuth subsalicylate exhibits both antisecretory and antimicrobial action. This agent may provide some anti-inflammatory action as well. The salicylate moiety provides antisecretory effect and the bismuth exhibits antimicrobial directly against bacterial and viral gastrointestinal pathogens.


Absorption

Bismuth: <1%; Subsalicylate: >90%


Metabolism

Bismuth subsalicylate is converted to salicylic acid and insoluble bismuth salts in the GI tract.


Excretion

Bismuth: Urine and feces; Salicylate: Urine


Half-Life Elimination

Terminal: Bismuth: Highly variable


Patient and Family Education


Patient Education

- Discuss specific use of drug and side effects with patient as it relates to treatment. (HCAHPS: During this hospital stay, were you given any medicine that you had not taken before? Before giving you any new medicine, how often did hospital staff tell you what the medicine was for? How often did hospital staff describe possible side effects in a way you could understand?)

- Patient may experience tongue discoloration or stool discoloration. Have patient report immediately to prescriber tinnitus, hearing impairment, severe constipation, ecchymosis, or hemorrhaging (HCAHPS).

- Educate patient about signs of a significant reaction (eg, wheezing; chest tightness; fever; itching; bad cough; blue skin color; seizures; or swelling of face, lips, tongue, or throat). Note: This is not a comprehensive list of all side effects. Patient should consult prescriber for additional questions.

Intended Use and Disclaimer: Should not be printed and given to patients. This information is intended to serve as a concise initial reference for healthcare professionals to use when discussing medications with a patient. You must ultimately rely on your own discretion, experience and judgment in diagnosing, treating and advising patients.

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