neobookRx
DrugsLevel 4 LocalisationS2TABEML

Bismuth Subcitrate [Discontinued in SA Market]

BismuthAnti-ulcer agent

Indications

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market.

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.


  • Duodenal ulcers
  • Gastric ulcers
  • Gastritis

Cautions

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market.

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.


Contraindications

  • Hypersensitivity to the active ingredient or any of its excipients
  • Pregnancy
  • Lactation
  • Renal impairment
  • Patients on a low potassium diet
  • Patients who have colostomies or ileostomies

Cautions

  • Hepatic impairment
  • Elderly
  • Prolonged use
  • Controlled potassium diet

Adult dosage

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market.

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.


Duodenal ulcers
Gastric ulcers

  • Oral (tab): 240mg, 2-3 times a day on an empty stomach (half an hour before meals); Treatment duration: 4-8 weeks

Maintenance therapy is not recommended, although treatment may be resumed after a bismuth subcitrate -free interval of one month


Gastritis (additional agents required)
- Adjunct treatment of gastritis due to Helicobacter pylori

  • Oral (tab): 120mg, 4 times a day on an empty stomach (half an hour before meals); Treatment duration: 7 days

No liquid is to be taken 30 minutes before or after each dose

Swallow whole - Do not chew

Paediatric dosage

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market.

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.


No information available

Special populations

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market.

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.


Pregnancy

  • Contraindicated
  • Bismuth trioxide is contraindicated in pregnancy

Breastfeeding

  • Contraindicated
  • No information is available on excretion in breast milk. Safety in breastfeeding has not been established

Renal Impairment

  • Contraindicated

Hepatic Impairment

  • Caution; no information available

Elderly

  • Caution; no information available

Porphyria Information

  • Probably not porphyrinogenic (PNP)

Drugs in Sport

  • Permitted - No warnings

Adverse reactions

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market.

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.


Gastrointestinal Disorders

Very common

  • Blackening of stool and tongue

Uncommon

  • Nausea and vomiting
  • Constipation
  • Diarrhoea and pain

Skin and Subcutaneous Tissue Disorders

Uncommon

  • Rash
  • Pruritus

Immune, Blood and Lymphatic System Disorders

Frequency unknown

  • Anaphylactic reaction

Interactions

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market.

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.


  • Tetracyclines
  • Antacids

Other interactions

  • Alcohol
  • Food or drink
  • Milk
  • Fruit or fruit juices

Monitoring

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market.

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.


None routine

Mechanism of action

Please note that the products associated with this active ingredient monograph have all been discontinued in the South African market.

The information in this monograph has not been updated and remains on the EMGuidance platform for reference purposes only.


Tripotassium dicitrato bismuthate is a colloidal bismuth hydrosol which has the ability to combine with the necrotic protein material oozing from the ulcer bed and form a bismuth-protein chelate over the ulcer base (surface).

Dosage forms

  • Tablet

Formulation

Tablet 120mg

  • Denol (Astellas) originator - Discontinued

References

1. SAMF_12th Edition_Page 44 2. SmPC: DE-NOLTAB, Astellas Pharma:Last updated on eMC: 18 Sep 2012; Downloaded online 22 Jan 2019 [https://www.medicines.org.uk/emc/medicine/2254] 3. PI: Denol swallow tablets, Astellas Pharma:Date of registration: 7 Jun 2012 [https://drive.google.com/drive/folders/0BxqKo-EBYgZDcEloNE5LeFctVjA] 4. NAPOS: The Drug Database for Acute Porphyria: A02BX05 Bismuth subcitrate; Accessed online 22 Jan 2019 [http://www.drugs-porphyria.org/languages/UnitedKingdom/s3.php?atc_code=A02BX05&l=gbr] 5. South African Institute for Drug-Free Sport: Denol; Accessed online 22 Jan 2019 [http://www.drugfreesport.org.za/online-medication-check/]

Brands & products

1 product · cached snapshot
Trade names (1)
  • Denol

TABTablet· 1 product

from R274.33
ProductStrengthPackApplicantMin price
Denol Swallow Tabletsdiscontinued120 mg40Astellas Pharma (Pty) LtdR274.33

Medical aid coverage

data not yet integrated
Discovery Health
not yet integrated
  • Comprehensive Series—
  • Executive Plan—
  • KeyCare Series—
  • Priority Series—
  • Saver Series—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

Bonitas Medical Fund
not yet integrated
  • BonClassic—
  • BonComprehensive—
  • BonEssential—
  • BonFit Select—
  • BonSave—
  • BonStart—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

GEMS — Government Employees Medical Scheme
not yet integrated
  • Beryl—
  • Emerald—
  • Onyx—
  • Ruby—
  • Sapphire—
  • Tanzanite One—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

POLMED — Police Medical Aid Scheme
not yet integrated
  • Aquarium Option—
  • Efficiency Option—
  • Marine Option—

Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.

NeoHealth® ID 15767 · updated 3/8/2024