Registered Malawi · PMRA

WW BIS SUP COMBINATION PRODUCT SUPPOSITORIES

COMPOUND BISMUTH SUBGALLATE

PMPB/PL381/59 SUPPOSITORIES INN generic

What it does

Bismuth is a substance that can help protect the stomach lining and reduce symptoms of upset stomach.

Commonly used for: stomach upset, indigestion, diarrhea, gastrointestinal discomfort

Read more in plain English ↓

Plain-language summary for general understanding - not medical advice. Always follow your pharmacist/doctor.

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Registration & product details

Registration no.
PMPB/PL381/59
Registration date
17/04/2015
Expiry date
31/03/2025
Status
Registered
Active ingredient
COMPOUND BISMUTH SUBGALLATE
Dosage form
SUPPOSITORIES
Strength
-
Pack size
-
Therapeutic class
-
RxNorm RxCUI
1599
Manufacturer / MAH
-
Applicant / LTR
-
Country of origin
-

Source: Pharmacy and Medicines Regulatory Authority · fetched 2026-04-21 17:37:42 · updated 2026-09-29 04:33:05

Disclaimer: This information is sourced from Pharmacy and Medicines Regulatory Authority (Malawi). Always consult a qualified healthcare professional before using any medication.

About bismuth

Bismuth is a substance that can help protect the stomach lining and reduce symptoms of upset stomach.

What it treats

  • stomach upset
  • indigestion
  • diarrhea
  • gastrointestinal discomfort

How it works

Bismuth works by forming a protective layer on the stomach lining and reducing inflammation.

Who it's for

Bismuth is for adults and children experiencing stomach-related issues.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About compound

Compound is a medication used for various conditions.

How it works

The exact way compound works is not specified, but it is used to help manage certain health issues.

Who it's for

This medication can be prescribed to individuals with specific medical conditions as determined by a healthcare professional.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

About subgallate

Subgallate is a medication that may be used in specific medical situations. It's important to know its uses and any precautions associated with it.

How it works

The exact way subgallate works is not clearly defined in the available information.

Who it's for

Subgallate may be suitable for certain patients, but specific conditions are not detailed.

AI-assisted summary grounded in BNF data - general information only, not medical advice. Always confirm with your pharmacist or doctor.

Clinical monograph: bismuth

BNF-referenced

Bismuth is a heavy metal that has been used in various medicinal formulations, particularly for its gastrointestinal protective properties. It is often found in preparations for treating conditions such as diarrhea, dyspepsia, and gastritis. Bismuth compounds, notably bismuth subsalicylate, are known for their ability to coat the gastrointestinal mucosa, providing both protective and anti-inflammatory effects.

Indications

  • Diarrhea
  • Dyspepsia
  • Gastritis
  • Peptic ulcer disease
  • Helicobacter pylori eradication

Dosage

Children: Refer to the BNF for Children for specific dosing recommendations.

Adults: Refer to the BNF for specific dosing recommendations.

Mechanism of action

Bismuth exerts its therapeutic effects primarily by coating the mucosal lining of the gastrointestinal tract, which protects it from irritants and helps to reduce inflammation. It also has antimicrobial properties that may help to eradicate Helicobacter pylori, a bacterium associated with peptic ulcers. The exact mechanisms at the molecular level include the formation of a protective barrier and the inhibition of bacterial growth.

Pharmacodynamics

Bismuth compounds demonstrate a protective effect on the gastric mucosa, promoting healing in ulcerative and inflammatory conditions. The antimicrobial properties of bismuth also contribute to its efficacy in treating gastrointestinal infections, particularly those caused by H. pylori. Additionally, bismuth exhibits mild antisecretory effects, which can help to alleviate symptoms of diarrhea.

Pharmacokinetics

Bismuth is poorly absorbed from the gastrointestinal tract, which allows it to exert its effects locally while minimizing systemic exposure. Following oral administration, it travels through the gastrointestinal system, where it is primarily retained in the gut. Any absorbed bismuth is excreted through the kidneys, and its half-life is relatively short due to minimal systemic absorption.

Contra-indications

  • Hypersensitivity to bismuth or any of its components
  • Active gastrointestinal bleeding
  • Severe renal impairment

Adverse effects

  • Constipation
  • Darkening of the tongue
  • Stool discoloration
  • Nausea
  • Vomiting
  • Abdominal pain

Interactions

  • Bismuth subsalicylate + aspirin: Severe (increases risk of adverse effects)
  • Bismuth subsalicylate + drugs with anticoagulant effects: Unknown (increases risk of bleeding events)
  • Bismuth subsalicylate + see table P: Unknown (increases risk of bleeding events)

Precautions

  • Use with caution in patients with renal impairment
  • Avoid use in patients with a history of gastrointestinal ulcers or bleeding
  • Not recommended for use in children with viral infections (risk of Reye's syndrome)

Pregnancy

Use with caution. Consult with a healthcare professional prior to use.

Breast-feeding

Considered compatible with breastfeeding but should be used only if necessary.

Storage

Store in a cool, dry place away from direct sunlight. Keep out of reach of children.

Formulations

  • Bismuth subsalicylate oral suspension
  • Bismuth subsalicylate chewable tablets

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: compound

Compound refers to a formulation that consists of two or more active ingredients, often used to enhance therapeutic efficacy or to target multiple pathways in disease management. The specific effects and uses of a compound can vary widely based on the active ingredients included, as well as the condition being treated.

Dosage

Children: Refer to specific product guidelines or BNF for Children for accurate dosing information based on the formulation and indication.

Adults: Refer to specific product guidelines or BNF for accurate dosing information based on the formulation and indication.

Mechanism of action

The mechanism of action of compounds varies depending on their specific components. Generally, compounds can work through synergistic effects where the combined action of the ingredients leads to enhanced therapeutic outcomes. This may involve interactions at specific receptor sites, modulation of enzyme activity, or alteration of physiological pathways.

Pharmacodynamics

Pharmacodynamics of compounds is dependent on the individual pharmacological properties of each active ingredient within the formulation. This can include effects on receptor binding, ion channel modulation, and influence on neurotransmitter levels, leading to a range of therapeutic effects such as analgesia, anti-inflammatory action, or antimicrobial activity.

Pharmacokinetics

Pharmacokinetics of a compound involves the absorption, distribution, metabolism, and excretion of the active ingredients. Depending on their chemical nature, some compounds may exhibit rapid absorption, while others may have prolonged release characteristics. The bioavailability and half-life of each component can differ significantly, affecting overall efficacy and safety profiles.

Pregnancy

Use only if clearly needed, as safety in pregnancy is not established.

Breast-feeding

Caution is advised, as it is not known if the drug is excreted in human milk.

Storage

Store in a cool, dry place away from light. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Clinical monograph: subgallate

Subgallate, also known as bismuth subgallate, is a compound derived from bismuth and gallic acid. It is primarily used for its astringent properties and is commonly employed in the management of gastrointestinal disorders, particularly diarrhea. Subgallate acts by reducing gastrointestinal motility and enhancing the absorption of fluids and electrolytes, thereby alleviating symptoms associated with diarrhea.

Indications

  • Acute diarrhea
  • Chronic diarrhea
  • Gastrointestinal upset
  • Mild gastrointestinal inflammation

Dosage

Children: Refer to BNF for Children for specific dosing guidance.

Adults: Refer to BNF for specific dosing guidance.

Mechanism of action

Subgallate exerts its effects mainly through its astringent action, which leads to the precipitation of proteins in the gastrointestinal tract. This process results in the formation of a protective barrier that helps to reduce fluid secretion, enhances mucosal integrity, and decreases stool frequency. It also promotes the absorption of fluids and electrolytes, aiding in the management of diarrhea.

Pharmacodynamics

The pharmacodynamics of subgallate involve its ability to bind to proteins and mucins in the gastrointestinal lining, thereby providing a protective effect against irritants and inflammatory agents. Its astringent properties help reduce secretions and increase the absorption of fluids in the intestines. Subgallate may also have mild antibacterial effects, contributing to its efficacy in treating certain types of diarrhea.

Pharmacokinetics

Subgallate is not extensively absorbed systemically and primarily acts locally within the gastrointestinal tract. After administration, it exerts its therapeutic effects directly where it is required. The onset of action is relatively rapid, and the duration of effect can vary depending on the formulation and individual patient factors. Metabolism and excretion details for subgallate are limited, but it is generally eliminated from the gastrointestinal tract without significant systemic absorption.

Pregnancy

Subgallate may be used during pregnancy if the potential benefit justifies the potential risk to the fetus. Consult healthcare professionals for specific guidance.

Breast-feeding

It is unknown whether subgallate is excreted in human milk. Caution should be exercised when administering to breastfeeding women.

Storage

Store in a cool, dry place, away from direct sunlight. Keep out of reach of children.

AI-synthesized from BNF references - general information only, not a substitute for professional medical advice or the current BNF. Verify doses with a pharmacist.

Molecular reference: bismuth

PubChem CID 5359367

Molecular formula: Bi

Source: PubChem (NCBI) · pathways from PathBank, Reactome, WikiPathways & PharmGKB.

This drug in other countries

The same active ingredient registered across other registries we cover - including different brands.