Maalox Total Relief (Bismuth) (bismuth subsalicylate)
Last reviewed · Source: First Databank (FDB) drug data
Overview
Bismuth subsalicylate is an antidiarrheal agent and antidyspepsia agent; bismuth subgallate is an internal deodorant.
Bismuth subcitrate potassium and bismuth subsalicylate are antiulcer agents (used as part of multiple-drug regimens for Helicobacter pylori infection).
Bismuth subsalicylate may protect gastric mucosa, bind to ulcer base and mucosa, bind bile acids, and decrease endogenous prostaglandin and bicarbonate secretion.
Bismuth subsalicylate reduces number of bowel movements, aids in firming stool, normalizes fluid movement via antisecretory mechanisms, binds bacterial toxins, and exhibits antimicrobial activity in patients with diarrhea.
Mechanism of antibacterial action of bismuth salts not fully elucidated.
Bismuth salts may exert bactericidal action by complexing in bacterial wall and periplasmic space, inhibiting urease, catalase and lipase/phospholipase, ATP synthesis, and H. pylori adherence.
Multiple-drug regimen of bismuth subsalicylate, metronidazole, and tetracycline hydrochloride and the fixed-combination preparation containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride (Pylera(R)) active against most strains of H. pylori in vitro and in clinical infections.
Bismuth subgallate may reduce number of odor-producing anaerobic intestinal microbes and/or directly interact with sulfur-containing compounds; reduces flatulence odor but not flatulence itself.
Each 262.4-mg tablet of bismuth subsalicylate contains an amount of salicylate comparable to that in approximately 130 mg of aspirin.
USES: This medication is used to treat occasional upset stomach, heartburn, and nausea. It is also used to treat diarrhea and help prevent travelers' diarrhea. It works by helping to slow the growth of bacteria that might be causing the diarrhea.
This product should not be used to self-treat diarrhea if you also have a fever or blood/mucus in the stools. These could be signs of a serious health condition. Consult your doctor promptly for proper evaluation and treatment if you have these symptoms.
This medication is used under a doctor's direction with other medication to treat stomach ulcers caused by a certain bacteria (Helicobacter pylori). Do not use this medication to self-treat ulcers. Bismuth subsalicylate is a salicylate.
Salicylates can cause serious bleeding problems when used alone in patients with ulcers. Check the ingredients on the label even if you have used the product before. The manufacturer may have changed the ingredients.
Also, products with similar names may contain different ingredients meant for different purposes. Taking the wrong product could harm you.
Generic name: bismuth subsalicylate
Pronunciation: (BIZ-muth SUB-sa-LIS-i-late)
Reference product & biosimilars
No reference, biosimilar or interchangeable associated with this drug.
Today’s intelligence on Maalox Total Relief (Bismuth)
Indications
The following indications are listed for Maalox Total Relief (Bismuth):
- Diarrhea
- Dyspepsia
Also known as: Functional Dyspepsia.
Dosing
Bismuth salts are available as bismuth subgallate, bismuth subcitrate potassium, and bismuth subsalicylate; dosages are expressed in terms of the salts.
Bismuth subcitrate potassium is available in fixed combination with metronidazole and tetracycline hydrochloride (Pylera(R)); dosage of Pylera(R) is expressed as number of capsules.
No dosing information is available for this tab.
No dosing information is available for this tab.
No dosing information is available for this tab.
Drug interactions
There is no enhanced messaging for this drug.
There are no contraindication interactions for this drug.
There are no severe interactions for this drug.
There are no moderate interactions for this drug.
Contraindications
Helidac(R) Therapy (kit containing bismuth subsalicylate, metronidazole, tetracycline hydrochloride) is contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or renal impairment, patients with known allergy to aspirin or salicylates, and those with known hypersensitivity to any component of the kit.
Pylera(R) (fixed-combination capsule containing bismuth subcitrate potassium, metronidazole, tetracycline hydrochloride) is contraindicated in pregnant or nursing women, pediatric patients, patients with hepatic or renal impairment, and those with known hypersensitivity to any ingredient in the capsule.
There are no contraindication contraindications for this drug.
There are no severe contraindications for this drug.
There are no moderate contraindications for this drug.
Adverse reactions
Bismuth: Transient and harmless darkening of the tongue and/or black stools, decreased peristalsis (with bismuth subgallate).
Helidac(R) Therapy: Nausea, diarrhea, abdominal pain, melena, upper respiratory infection.
Pylera(R): Stool abnormality, diarrhea, dyspepsia, abdominal pain, nausea, headache, flu syndrome, taste perversion, asthenia, vaginitis, dizziness.
There are no severe adverse reactions for this drug.
There are no less severe adverse reactions for this drug.
Precautions
No enhanced messaging available.
Do not use bismuth subsalicylate in children or adolescents who have or are recovering from varicella or influenza-like symptoms. Changes in behavior accompanied by nausea and vomiting in children or adolescents taking the drug may be an early sign of Reye's syndrome.
Safety and efficacy of the commercially available Helidac(R) Therapy kit or the fixed-combination preparation Pylera(R) in pediatric patients infected with H. pylori have not been established. Pylera(R) or the Helidac(R) Therapy kit should not be used in children younger than 8 years of age. (See Contraindications under Cautions.)
Bismuth subsalicylate: Category C (Category D in third trimester). (See Users Guide.)
Helidac(R) Therapy, Pylera(R): Category D. (See Users Guide.)
Helidac(R) Therapy, Pylera(R): Effect on labor and delivery unknown.
Bismuth subsalicylate: Use with caution.
Helidac(R) Therapy, Pylera(R): Discontinue nursing or the drug.
There is insufficient experience in patients 65 years of age or older to determine whether they respond differently than younger adults to the commercially available Helidac(R) Therapy kit or the fixed-combination preparation Pylera(R) for treatment of H. pylori infection and duodenal ulcer disease.
Consider age-related decreases in hepatic, renal, and/or cardiac function and concomitant disease and drug therapy.
ICD codes
No ICD codes are available for this drug.
Formulary status
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Last reviewed · Source: First Databank (FDB) drug data
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