Action and Spectrum

Actions and Spectrum: 

The actions of bismuth subsalicylate include: 

• Antimicrobial activity: bismuth subsalicylate has antibacterial and antiviral properties, which help to reduce the number of harmful bacteria and viruses in the digestive tract. 
• Antidiarrheal activity: bismuth subsalicylate can help to reduce the frequency and severity of diarrhea by slowing down the movement of the intestines. 
• Anti-inflammatory activity: bismuth subsalicylate has anti-inflammatory properties, which can help to reduce inflammation in the digestive tract and relieve pain and discomfort. 

The spectrum of bismuth subsalicylate includes: 

• Treatment of diarrhea: bismuth subsalicylate is commonly used to treat acute diarrhea caused by bacterial or viral infections. 
• Relief of heartburn and indigestion: bismuth subsalicylate can help to relieve symptoms of heartburn and indigestion by reducing inflammation and protecting the lining of the digestive tract. 
• Prevention of traveler’s diarrhea: bismuth subsalicylate can be taken before traveling to prevent the onset of traveler’s diarrhea. 
• Treatment of Helicobacter pylori infection: bismuth subsalicylate is often used in combination with antibiotics to treat Helicobacter pylori infection, a bacterial infection that can cause ulcers in the stomach and small intestine. 
• Treatment of canker sores: bismuth subsalicylate can be applied topically to canker sores to help reduce pain and inflammation. 

Drug Interaction

Adverse Reaction

Frequency defined:

>10 % 

Nausea  

1-10% 

Diarrhea  

Abdominal pain 

Melena  

Upper respiratory tract infection  

Constipation  

Anorexia  

Vomiting  

Asthenia  

Discolored tongue  

Headache  

Dyspepsia  

Dizziness  

Stool abnormality  

Duodenal ulcer  

Sinusitis  

Taste perversion  

Flatulence  

GI hemorrhage  

Pain  

Insomnia  

Anal discomfort  

Paresthesia  

Frequency undefined: 

Anxiety 

Confusion 

Depression 

Tinnitus 

Gray-black stool 

Impaction 

Muscle spasm 

Neurotoxicity 

Black Box Warning

Contraindication / Caution

Contraindication/Caution: 

• Allergy: bismuth subsalicylate should not be taken by anyone with a known allergy to salicylates, such as aspirin. 
• Pregnancy and breastfeeding: bismuth subsalicylate should be avoided during pregnancy and breastfeeding due to the risk of harm to the developing fetus or infant. 
• Bleeding disorders: bismuth subsalicylate can increase the risk of bleeding in people with bleeding disorders or those taking blood-thinning medications. 
• Children and teenagers: bismuth subsalicylate should not be given to children or teenagers who are recovering from a viral infection, as it may increase the risk of Reye’s syndrome, a rare but serious condition. 
• Kidney disease: bismuth subsalicylate should be used with caution in people with kidney disease, as it can accumulate in the blood and cause toxicity. 
• Interactions with other medications: bismuth subsalicylate can interact with other medications, including anticoagulants, antibiotics, and methotrexate, so it’s important to talk to your doctor before taking it if you are on any other medications. 

Pregnancy / Lactation

Pregnancy consideration:  

bismuth subsalicylate comes under the C category for the 1st and 2nd trimesters and types under the D category in the 3rd semester. 

Breastfeeding warnings: Salicylates are secreted in breastmilk; hence gestating females should consult a physician. 

Pregnancy category: 

• Category A: Satisfactory and well-controlled studies show no risk to the fetus in the first or later trimester. 
• Category B: There is no affirmation of risk to the fetus found in animal reproduction studies, and there are not enough studies on pregnant women. 
• Category C: Adverse effects on the fetus found with evidence in animal reproduction studies and no adequate evidence for a product in humans; Pregnant women must take care of the potential risks. 
• Category D: There is adequate data available with sufficient evidence of human fetal risk from various platforms. However, despite potential dangers may be used only in emergency cases for potential benefits. 
• Category X: Drugs listed in this category outweigh risks over benefits. The drug is not for pregnant women. 
• Category N: No data is available for the drug under this category. 

Pharmacology

Pharmacology: 

• Antidiarrheal action: bismuth subsalicylate reduces the frequency and liquidity of stools by slowing down the movement of the gastrointestinal tract. It also acts by decreasing the secretion of water and electrolytes in the intestines. 
• Anti-microbial action: bismuth subsalicylate has bactericidal and bacteriostatic activity against several pathogens, including Escherichia coli, Salmonella, Shigella, and Helicobacter pylori. It disrupts the bacterial cell membrane, leading to bacterial death. 
• Anti-inflammatory action: bismuth subsalicylate has anti-inflammatory activity due to its salicylate component. Salicylate is a non-steroidal anti-inflammatory drug that inhibits the production of prostaglandins and other inflammatory mediators. 
• Protective action: bismuth subsalicylate forms a protective layer on the surface of the gastrointestinal tract, which helps to reduce irritation and inflammation. It also binds with toxins and other harmful substances, preventing their absorption by the body. 
• Mucosal healing action: bismuth subsalicylate stimulates the production of mucus in the gastrointestinal tract, which helps to protect the mucosal lining and promote healing. 

Pharmacodynamics: 

The pharmacodynamics of bismuth subsalicylate involve its interactions with various biological targets in the body. Some of the key pharmacodynamic effects of bismuth subsalicylate include: 

• Binding to bacterial cell membranes: bismuth subsalicylate binds to the cell membranes of bacteria such as Helicobacter pylori, leading to disruption of the membrane and ultimately, bacterial death. 
• Decreasing intestinal secretion: bismuth subsalicylate reduces the secretion of water and electrolytes in the intestines, which helps to reduce diarrhea. 
• Slowing intestinal motility: bismuth subsalicylate slows down the movement of the intestines, which helps to reduce diarrhea and allows more time for water and nutrients to be absorbed. 
• Anti-inflammatory effects: bismuth subsalicylate has anti-inflammatory effects due to its salicylate component, which inhibits the production of prostaglandins and other inflammatory mediators. 
• Barrier formation: bismuth subsalicylate forms a protective barrier on the surface of the gastrointestinal tract, which helps to reduce irritation and inflammation. 
• Mucosal healing: bismuth subsalicylate stimulates the production of mucus in the gastrointestinal tract, which helps to protect the mucosal lining and promote healing. 

Pharmacokinetics: 

The pharmacokinetics of bismuth subsalicylate can be described as follows: 

Absorption 

bismuth subsalicylate is poorly absorbed from the gastrointestinal tract, with only about 2-18% of the dose being absorbed. The absorption is affected by several factors, including the presence of food, pH of the stomach, and the presence of other drugs. 

Distribution 

bismuth subsalicylate is distributed throughout the body, with the highest concentrations found in the liver, kidneys, and spleen. Bismuth does not cross the blood-brain barrier, so it does not have any central nervous system effects. 

Metabolism 

bismuth subsalicylate is not metabolized by the liver or other organs. The salicylate component is hydrolyzed to salicylic acid, which is then metabolized by the liver and excreted in the urine. 

Elimination and Excretion 

bismuth subsalicylate is eliminated primarily in the feces, with only a small amount being excreted in the urine. The elimination half-life of bismuth subsalicylate is long, ranging from 5 to 12 days, which allows for prolonged activity. 

Adminstartion

Administration: 

bismuth subsalicylate is usually administered orally as a suspension or tablet. It is recommended to take it with a full glass of water, and to shake the suspension well before using it. The recommended dosage of bismuth subsalicylate may vary depending on the indication and the age of the patient. 

For the treatment of diarrhea, the usual adult dosage is 524 mg (two tablets or two tablespoons of the suspension) every 30-60 minutes as needed, up to a maximum of 8 doses in 24 hours. The usual pediatric dosage is 130 mg (half a tablet or half a tablespoon of the suspension) for every 30-60 minutes as needed, up to a maximum of 8 doses in 24 hours. 

For the prevention of traveler’s diarrhea, the usual adult dosage is 2 tablets or 30 mL of the suspension four times daily, taken with meals and at bedtime. The usual pediatric dosage is 130 mg (half a tablet or half a tablespoon of the suspension) four times daily, taken with meals and at bedtime. 

It is important to follow the instructions provided by the healthcare provider or on the label of the medication. It is not recommended to exceed the recommended dosage, as it may increase the risk of adverse effects. If the symptoms persist or worsen, it is important to seek medical attention. 

Patient Information Leaflet

Patient information leaflet 

Generic Name: bismuth subsalicylate 

Pronounced: bis-muth sub-saly-silate 

Why do we use bismuth subsalicylate? 

bismuth subsalicylate is used for the treatment of various gastrointestinal conditions, including: 

• Diarrhea: bismuth subsalicylate can help reduce the frequency and severity of diarrhea by decreasing intestinal secretion, slowing intestinal motility, and binding to bacterial cell membranes. 
• Peptic ulcers: bismuth subsalicylate can help treat and prevent peptic ulcers by forming a protective barrier on the surface of the gastrointestinal tract and reducing inflammation. 
• Gastroesophageal reflux disease (GERD): bismuth subsalicylate can help alleviate the symptoms of GERD, such as heartburn and acid reflux, by neutralizing stomach acid and reducing inflammation. 
• Helicobacter pylori infection: bismuth subsalicylate is used in combination with antibiotics to treat Helicobacter pylori infection, which is a common cause of peptic ulcers. 
• Traveler’s diarrhea: bismuth subsalicylate can help prevent and treat traveler’s diarrhea by reducing the frequency and severity of diarrhea and other gastrointestinal symptoms.