Bismuth Salts

Bismuth Salts are antimicrobial agents and used to treat peptic ulcer, indigestion, nausea, diarrhea; to relieve stomach cramps and to prevent traveler's diarrhea.

Bismuth Salts is primarily indicated in conditions like Duodenal ulcer, Peptic ulcer, Upset stomach, Nausea, Diarrhea, Gas, Indigestion, Traveler's diarrhea, H.Pylori.

Bismuth Salts is contraindicated in conditions like Renal failure. Hypersensitivity to Bismuth, Aspirin, other salicylates.

Bismuth Salts produces potentially life-threatening effects which include Encephalopathy, Diarrhea, Melena, which are responsible for the discontinuation of Bismuth Salts therapy.The symptomatic adverse reactions produced by Bismuth Salts are more or less tolerable and if they become severe, they can be treated symptomatically, these include Ammonical odor, Stool darkening, Tongue darkening., Anorexia, Asthenia, Headache, Dizziness, Taste perversions, Anal discomfort

Do not use bismuth subsalicylate (e.g., Maalox Total relief) for self-medication in patients with an ulcer, bleeding disorder, or bloody or black stools. Risk of Reye’s syndrome with bismuth subsalicylate in children or adolescents who have or are recovering from varicella or influenza-like symptoms. (See Pediatric Use under Cautions.) Neurotoxicity associated with excessive doses of bismuth salts reported rarely; reversible following discontinuance of drug. Possible transient and harmless darkening of tongue and/or black stool; do not confuse stool darkening with melena. Bismuth mined from the ground, and commercially available Pepto-Bismol preparations, may contain small amounts of naturally occurring lead. Amounts of lead in Pepto-Bismol preparations are low compared with average daily lead exposure. Pepto-Bismol preparations not intended for chronic use. Bismuth subsalicylate contains salicylate; do not use in patients allergic to salicylates (including aspirin). To reduce development of drug-resistant bacteria and maintain effectiveness of Helidac Therapy, Pylera , and other anti-infective agents, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria. When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy. Diotame chewable tablets contain aspartame (NutraSweet ), which is metabolized in the GI tract to phenylalanine following oral administration. When the fixed-combination preparation containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride (Pylera ) or the kit containing bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (Helidac Therapy) is used for the treatment of H. pylori infection and duodenal ulcer disease, the cautions, precautions, and contraindications associated with metronidazole and tetracycline hydrochloride must be considered in addition to those associated with bismuth subcitrate potassium or bismuth subsalicylate. Serious medication errors have been reported to FDA in which consumers used Maalox Total Relief (bismuth subsalicylate) when they intended to use traditional Maalox liquid antacid products containing aluminum hydroxide, magnesium hydroxide, and simethicone (e.g., Maalox Advanced Regular Strength, Maalox Advanced Maximum Strength). Because of the potential for serious adverse effects associated with accidental use of bismuth subsalicylate (which is chemically related to aspirin), the manufacturer of Maalox Total Relief initially agreed to change the trade name of the product to one that did not include “Maalox”; however, the manufacturer instead discontinued the bismuth subsalicylate preparation in the summer of 2010. Bismuth subsalicylate: Category C (Category D in 3rd trimester). Helidac Therapy, Pylera : Category D. Helidac Therapy, Pylera : Effect on labor and delivery unknown. Bismuth subsalicylate: Use with caution. Helidac Therapy, Pylera : Discontinue nursing or the drug. 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 Therapy kit or the fixed-combination preparation Pylera in pediatric patients infected with H. pylori not established. Pylera or the Helidac Therapy kit should not be used in children <8 years of age. (See Contraindications under Cautions.) Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults to the commercially available Helidac Therapy kit or the fixed-combination preparation or Pylera 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. Accumulation of bismuth salts may occur in patients with severe hepatic disease. The commercially available Helidac Therapy kit and the fixed-combination preparation Pylera are contraindicated in patients with hepatic impairment. (See Contraindications under Cautions and also see Special Populations under Pharmacokinetics.) Use bismuth subsalicylate with caution, if at all, in patients with renal impairment. The commercially available Helidac Therapy kit and the fixed-combination preparation Pylera are contraindicated in patients with renal impairment. (See Contraindications under Cautions.)

Do not use bismuth subsalicylate (e.g., Maalox Total relief) for self-medication in patients with an ulcer, bleeding disorder, or bloody or black stools. Risk of Reye’s syndrome with bismuth subsalicylate in children or adolescents who have or are recovering from varicella or influenza-like symptoms. (See Pediatric Use under Cautions.) Neurotoxicity associated with excessive doses of bismuth salts reported rarely; reversible following discontinuance of drug. Possible transient and harmless darkening of tongue and/or black stool; do not confuse stool darkening with melena. Bismuth mined from the ground, and commercially available Pepto-Bismol preparations, may contain small amounts of naturally occurring lead. Amounts of lead in Pepto-Bismol preparations are low compared with average daily lead exposure. Pepto-Bismol preparations not intended for chronic use. Bismuth subsalicylate contains salicylate; do not use in patients allergic to salicylates (including aspirin). To reduce development of drug-resistant bacteria and maintain effectiveness of Helidac Therapy, Pylera , and other anti-infective agents, use only for treatment or prevention of infections proven or strongly suspected to be caused by susceptible bacteria. When selecting or modifying anti-infective therapy, use results of culture and in vitro susceptibility testing. In the absence of such data, consider local epidemiology and susceptibility patterns when selecting anti-infectives for empiric therapy. Diotame chewable tablets contain aspartame (NutraSweet ), which is metabolized in the GI tract to phenylalanine following oral administration. When the fixed-combination preparation containing bismuth subcitrate potassium, metronidazole, and tetracycline hydrochloride (Pylera ) or the kit containing bismuth subsalicylate, metronidazole, and tetracycline hydrochloride (Helidac Therapy) is used for the treatment of H. pylori infection and duodenal ulcer disease, the cautions, precautions, and contraindications associated with metronidazole and tetracycline hydrochloride must be considered in addition to those associated with bismuth subcitrate potassium or bismuth subsalicylate. Serious medication errors have been reported to FDA in which consumers used Maalox Total Relief (bismuth subsalicylate) when they intended to use traditional Maalox liquid antacid products containing aluminum hydroxide, magnesium hydroxide, and simethicone (e.g., Maalox Advanced Regular Strength, Maalox Advanced Maximum Strength). Because of the potential for serious adverse effects associated with accidental use of bismuth subsalicylate (which is chemically related to aspirin), the manufacturer of Maalox Total Relief initially agreed to change the trade name of the product to one that did not include “Maalox”; however, the manufacturer instead discontinued the bismuth subsalicylate preparation in the summer of 2010. Bismuth subsalicylate: Category C (Category D in 3rd trimester). Helidac Therapy, Pylera : Category D. Helidac Therapy, Pylera : Effect on labor and delivery unknown. Bismuth subsalicylate: Use with caution. Helidac Therapy, Pylera : Discontinue nursing or the drug. 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 Therapy kit or the fixed-combination preparation Pylera in pediatric patients infected with H. pylori not established. Pylera or the Helidac Therapy kit should not be used in children <8 years of age. (See Contraindications under Cautions.) Insufficient experience in those ≥65 years of age to determine whether they respond differently than younger adults to the commercially available Helidac Therapy kit or the fixed-combination preparation or Pylera 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. Accumulation of bismuth salts may occur in patients with severe hepatic disease. The commercially available Helidac Therapy kit and the fixed-combination preparation Pylera are contraindicated in patients with hepatic impairment. (See Contraindications under Cautions and also see Special Populations under Pharmacokinetics.) Use bismuth subsalicylate with caution, if at all, in patients with renal impairment. The commercially available Helidac Therapy kit and the fixed-combination preparation Pylera are contraindicated in patients with renal impairment. (See Contraindications under Cautions.)

120 mg (120 (120)) 6 hourly PO — For 4-8 weeks. Should be taken before food.

( ) — Not recommended in this age group

( ) — Not recommended in this age group

No data regarding the interactions of Bismuth Salts was found.

Paste Store in refrigerator.