Indications:
Bismuth tripotassium dicitrate is indicated for adults in the following cases:
Treatment of peptic ulcers.
Support for eradication of Helicobacter pylori in combination with other drugs.
Gastritis accompanied by digestive disorders when attemping to eradicate Helicobacter pylori.
Administration, dosage:
Administration: Swallow the tablet whole with a sufficient amount of water.
Dosage:
The following treatment regimens are recommended:
- 1 tablet x 4 times/day on an empty stomach (half an hour before main meals and before bedtime), or
- 2 tablets x 2 times/day on an empty stomach (half an hour before breakfast and dinner or before bedtime).
The maximum duration of treatment is 2 months. Discontinue taking medicine at least 2 months before starting a new treatment with bismuth-containing drugs.
For the treatment of gastric or duodenal ulcers, the treatment duration is 4 – 8 weeks.
For the eradication of Helicobacter pylori, combination therapy selection and the treatment duration (7 – 14 days) should consider each patient’s drug tolerance and be carried out in accordance with regional resistance patterns and treatment guidelines.
Children: The safety and efficacy of bismuth tripotassium dicitrate in children aged 0 – 18 years have not been established. No data available.
Contraindications:
Hypersensitivity to bismuth tripotassium dicitrate or to any of the excipients of the medicine.
Severe kidney failure.
Warnings and precautions for use:
Long-term use of high doses of bismuth compounds is not recommended due to resulting reversible encephalopathy. If bismuth is taken at the recommended dose, the likelihood of this occurring is very low. It is not recommended to take other drugs containing bismuth.
This medicine contains potassium, caution should be exercised in patients with impaired kidney function or on a potassium-controlled diet.
This medicine contains lactose, patients with rare hereditary problems of galactose intolerance, Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine.
Pregnancy and lactation:
Pregnancy: There is no evidence of harmful effects in animal studies. There are insufficient data to assess the harmful effects of bismuth tripotassium dicitrate in pregnant women. Therefore, bismuth tripotassium dicitrate should not be used during pregnancy.
Lactation: There are insufficient data to assess the harmful effects of bismuth tripotassium dicitrate in breastfeeding women.
Effects on ability to drive and use machines:
There is no information on the effect of the drug on the ability to drive. However, it is unlikely to affect the ability to drive and use machines.
Interactions, incompatibilities of medicine:
Interaction of the drug with other drugs and other types of interactions:
Other medications, especially antacids, food or drinks, milk, fruits, and fruit juices should not be taken within 30 minutes before or after taking bismuth as they can affect its efficacy.
Bismuth reduces the absorption of tetracycline when given concomitantly.
Incompatibilities:
Because there are no studies of drug incompatibility, do not mix this drug with other drugs.
Undesirable effects:
Side effects are classified according to frequency: Very common (ADR ≥ 1/10), common (1/100 ≤ ADR < 1/10), uncommon (1/1,000 ≤ ADR < 1/100), rare (1/10,000 ≤ ADR < 1/1,000), very rare (ADR < 1/10,000); can not be estimated from the available data “Not known”.
Very common, ADR ≥ 1/10
Digestive disorders: Black stools.
Uncommon, 1/1,000 ≤ ADR < 1/100
Gastrointestinal disorders: Nausea, vomiting, constipation, diarrhea.
Skin and subcutaneous tissue disorders: Rash, pruritus.
Very rare, ADR < 1/10,000
Immune system disorders: Anaphylactic reaction.
Overdose and management:
Overdose:
Acute and severe overdose can lead to kidney failure with an incubation period of up to 10 days.
Management:
After a single dose of a very high dose, the treatment consists in gastric lavage, followed by doses of activated charcoal and osmotic laxatives. Generally, this therapy reduces the absorption of bismuth, so additional measures are not necessary.
The concentration of bismuth in the blood and urine should be determined in acute and chronic intoxication in order to identify the connection of any symptoms with an increased bismuth exposure. Chelate therapy with dimercaptosuccinic acid (DMSA) or dimercaptopropane sulphonic acid (DMPS) is used if symptoms are caused by acute or chronic overdose of bismuth. In case of severe renal failure, chelation therapy should be accompanied by hemodialysis.
Pharmacodynamics:
Pharmacotherapeutic group: Other drugs against peptic ulcer and gastroesophageal reflux disease.
ATC code: A02BX05.
Mechanism of action:
Under the effect of gastric acid, a precipitate is formed from bismuth tripotassium dicitrate, which adheres primarily to the ulcerated area and inhibits the activity of pepsin. Bismuth tripotassium dicitrate also protects the mucosa by stimulating the synthesis and secretion of endogenous prostaglandins, hence increasing bicarbonate and mucin production. In addition, bismuth tripotassium dicitrate has antibacterial activity against Helicobacter pylori. The elimination of this bacterium leads to histological improvement and symptom relief.
Pharmacodynamic effects:
Bismuth tripotassium dicitrate contributes to the healing of a high percentage of gastric and duodenal ulcers. Its antibacterial effect is associated with a lower frequency of ulcer recurrence in the first year after treatment discontinuation compared to some other drugs.
Pharmacokinetics:
Absorption: Bismuth tripotassium dicitrate exerts a local action. However, small amount of bismuth is absorbed (less than 0.2% of the dose) during therapy.
Distribution: Bismuth is distributed mainly into the kidneys. Only small amount can be detected in other organs.
Biotransformation: Under the action of gastric acid, bismuth tripotassium dicitrate precipitates locally to form insoluble compounds, possibly bismuth oxychloride and bismuth citrate.
Elimination: Most of bismuth is excreted in the feces. Of the small amount absorbed, urinary clearance is approximately 50 ml/min. A 3-compartment model is needed to describe the excretion of bismuth over time. The half life is 5 – 11 days.
