Bismuth Subcitrate [Discontinued in SA Market]
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- Denol
TABTablet· 1 product
from R274.33| Product | Strength | Pack | Applicant | Min price |
|---|---|---|---|---|
| Denol Swallow Tabletsdiscontinued | 120 mg | 40 | Astellas Pharma (Pty) Ltd | R274.33 |
Medical aid coverage
data 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.
- BonClassic—
- BonComprehensive—
- BonEssential—
- BonFit Select—
- BonSave—
- BonStart—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Beryl—
- Emerald—
- Onyx—
- Ruby—
- Sapphire—
- Tanzanite One—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.
- Aquarium Option—
- Efficiency Option—
- Marine Option—
Formulary scraper pending — coverage tier, co-pay and authorisation requirements will appear here once data is ingested.