Bismuth subsalicylate

What is Bismuth subsalicylate?

• Bismuth subsalicylate is an antacid elixir medication, antidiarrheal agent used to treat temporary discomforts of the stomach and gastrointestinal tract, such as nausea, heartburn, indigestion, upset stomach, and diarrhea.
• One off-label indication for BSS use is to eradicate Helicobacter pylori (H. pylori) gastrointestinal tract infection.

Bismuth subsalicylate

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What are the uses of this medicine?

Bismuth subsalicylate is used for:

• travelers’ diarrhea
• diarrhea
• upset stomach due to overindulgence in food and drink, including:
• heartburn
• indigestion
• nausea
• gas
• belching
• fullness

How does this medicine work?

• Bismuth subsalicylate is in a class of medications called antidiarrheal agents.
• Bismuth subsalicylate (BSS) exhibits many of its properties due to its formulation as an insoluble salt of salicylic acid and trivalent bismuth.
• The mechanism of action through which BSS works is complex.
• In the stomach, BSS hydrolyzes into two compounds, bismuth and salicylic acid.
• The salicylate compound is almost completely absorbed into the bloodstream, while bismuth salt is minimally absorbed.
• The bismuth that remains in the gastrointestinal tract forms other bismuth salts.
• These bismuth salts contain bactericidal and antimicrobial activity and prevent bacteria from binding and growing on the mucosal cells of the stomach.
• Furthermore, the prevention of bacterial binding to the mucosal cells provides many benefits, including preventing intestinal secretion, promoting fluid absorption, reducing inflammation, and promoting the healing of any present ulcer in the stomach.

• It appears as though BSS does not alter the normal flora of the stomach; however, its antimicrobial and antisecretory properties play a significant role in combating diarrhea.

The antidiarrheal effect of BSS is most likely due to:

• The reduction in prostaglandin formation, as BSS inhibits cyclooxygenase. Prostaglandin induces inflammation and hypermotility.
• The stimulation of reabsorption of fluids, sodium, and chloride - this action helps decrease fluid loss.
• The inhibition of intestinal secretions.

• While, in peptic ulcer disease, the likely mechanism of BSS involves its cytoprotective and demulcent activity.
• In H. pylori specifically, BSS blocks the adhesion of the bacteria to the gastric epithelial cells.
• Additionally, BSS inhibits H. pylori's enzyme activities, including phospholipase, protease, and urease.

Who Should Not Use this medicine ?

This medicine cannot be used in patients:

• Children and teenagers who have or are recovering from chicken pox or flu-like symptoms
• Children less than 12 years of age
• who are allergic to salicylates (including aspirin)
• who are taking other salicylate products
• with an ulcer
• with a bleeding problem
• with bloody or black stool
• undergoing oral treatments for gastric and intestinal conditions with anticoagulants, sulfinpyrazone, probenecid, methotrexate, or any medication with high salicylate concentrations

What drug interactions can this medicine cause?

• Tell your doctor and pharmacist what other prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take.

Be sure to mention any of the following:

• anticoagulants ('blood thinners') such as warfarin (Coumadin); a daily aspirin; or medication for diabetes, arthritis or gout

• If you are taking tetracycline antibiotics such as demeclocycline (Declomycin), doxycycline (Doryx, Vibramycin), minocycline (Dynacin, Minocin), and tetracycline (Sumycin), take them at least 1 hour before or 3 hours after taking bismuth subsalicylate.

Is this medicine FDA approved?

• The combination of bismuth subsalicylate and zinc salts for astringency with salol (phenyl salicylate) appears to have begun in the US in the early 1900s as a remedy for life-threatening diarrhea in infants with cholera.

How should this medicine be used?

Recommended dosage:

For Diarrhea/Dyspepsia Adult dose:

• 524 mg every 30 minutes to 1 hour as needed (regular strength) or 1050 mg every 60 minutes (maximum strength) for up to 2 days (maximum dose of approximately 4,200 mg)

Pediatric dose:

• Adolescents ≥ 12 years: same as adult dosing
• 9 to <12 years: 262 mg every 30 minutes to 1 hour as needed
• 6 to 9 years: 175 mg every 30 minutes to 1 hour as needed
• 3 to <6 years: 87 mg every 30 minutes to 1 hour as needed

For Traveler's Diarrhea:

• Prophylaxis for traveler's diarrhea adults dose (off-label use): 524 mg four times daily with meals and at bedtime during the time of risk (recommendation is limited for trips less than two weeks of duration).
• Treatment of traveler's diarrhea adults dose (off-label use): 524 mg every 30 minutes to 1 hour as needed (maximum of 8 doses/24 hours).

Administration:

• Bismuth subsalicylate comes as a liquid, tablet, or chewable tablet to be taken by mouth, with or without food
• Swallow the tablets whole; do not chew them.
• Shake the liquid well before each use to mix the medication evenly.
• use until diarrhea stops but not more than 2 days.

What are the dosage forms and brand names of this medicine?

This medicine is available in fallowing doasage form:

• As a liquid, tablet, or chewable tablet

This medicine is available in fallowing brand namesː

• Bismusal
• Kaopectate
• Peptic Relief
• Pepto-Bismol
• Pink Bismuth
• Stomach Relief

What side effects can this medication cause?

The most common side effects of this medicine include:

• nausea
• bitter taste
• diarrhea
• dark/black stools
• blackening of the tongue and teeth
• fatigue
• mood changes
• deterioration of mental status

What special precautions should I follow?

• When using this product a temporary but harmless darkening of the stool and/or tongue may occur.

Stop use and ask a doctor if:

• symptoms get worse or last more than 2 dyas.
• ringing in the ears or loss of hearing occurs.
• diarrhea lasts more than 2 days.
• Ask your doctor before taking this medication if you have ever had an ulcer, bleeding problem, stools that are bloody or blackened, or kidney disease.
• Ask your doctor before taking bismuth subsalicylate if you have a fever or mucus in your stool.
• If you will be giving bismuth subsalicylate to a child or teenager, tell the child's doctor if the child has any of the following symptoms before he or she receives the medication: vomiting, listlessness, drowsiness, confusion, aggression, seizures, yellowing of the skin or eyes, weakness, or flu-like symptoms. Also tell the child's doctor if the child has not been drinking normally, has had excessive vomiting or diarrhea, or appears dehydrated.

What to do in case of emergency/overdose?

Symptoms of overdosage may include:

• blackening of the tongue and teeth
• impaired cognition
• tremors
• lethargy
• somnolence
• insomnia
• delirium
• myoclonus
• seizures
• depressed mood
• anxiety

Management of overdosage:

• In case of overdose, call the poison control helpline of your country. In the United States, call 1-800-222-1222.

• Overdose related information is also available online at poisonhelp.org/help.
• In the event that the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services. In the United States, call 911.
• If a patient is experiencing bismuth toxicity, they should discontinue BSS use and seek medical attention.
• Fortunately, there is little evidence to suggest that bismuth subsalicylate can be fatal, although there have been a few reported cases.
• In more severe cases and with the presence of altered mental status and metabolic acidosis, hemodialysis may be an option.
• If the patient is not able to maintain their airway and intubation is required, precautions should be taken to avoid severe acidosis.
• It is recommended to closely follow up with arterial blood gases and maintain the pre-intubation minute ventilation and low PCO2.
• Other laboratory parameters that are recommended to be collected include hepatic panel, INR/PTT, CBC, electrolytes, and serum creatinine (renal function tests).

Can this medicine be used in pregnancy?

• If pregnant or breast-feeding, ask a health professional before use.

Can this medicine be used in children?

• Children less than 12 years of age
• There is limited data for BSS use in children under the age of 12 years old; other treatment options may be preferable.

What are the active and inactive ingredients in this medicine?

Active ingredient:

• Bismuth subsalicylate

Inactive ingredients:

• croscarmellose sodium, crospovidone, hypromellose, magnesium stearate, microcrystalline cellulose, mineral oil, povidone, silica, sodium lauryl sulfate, stearic acid, talc, titanium dioxide, triacetin

Who manufactures and distributes this medicine?

Distributed by:

• CVS Pharmacy, Inc.

What should I know about storage and disposal of this medication?

• store at room temperature, in a dry place.

• Dailymed label info on Bismuth subsalicylate
• FDA Bismuth subsalicylate

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