Bismuth Subcitrate Equ. To Bismuth Oxide

What it is and how it works

Tripotassium dicitratobismuthate (bismuth subcitrate) forms a protective precipitate on ulcer craters, stimulates mucosal prostaglandin and bicarbonate secretion, inhibits pepsin, and has a direct bactericidal effect on Helicobacter pylori.

Indications

Benign gastric and duodenal ulcer; as part of bismuth-containing quadruple therapy for eradication of Helicobacter pylori.

Dosage and administration (summary)

Oral (120 mg tablets, expressed as Bi2O3): 240 mg twice daily or 120 mg four times daily, taken half an hour before meals, for 4–8 weeks; for H. pylori eradication used in combination regimens for 10–14 days. Maximum course length usually 8 weeks.

Contraindications

Severe renal impairment; hypersensitivity; pregnancy.

Warnings and precautions

Darkening of the tongue and blackening of the stools are expected and harmless. Prolonged use or high doses can cause bismuth accumulation and encephalopathy, particularly in renal impairment, so courses should not be repeated without a drug-free interval. Avoid taking milk, antacids or food within 30 minutes of a dose; it reduces absorption of tetracyclines.

Pregnancy

Contraindicated in pregnancy.

Storage and supply

Store below 25 °C, protected from moisture.

Source: reference summary prepared from the EU SmPC/EPAR, BNF and WHO Model Formulary. The approved product information in Iran governs.