Bismuth tripotassium dicitrate
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2019-09-19
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Clinical Pharmacology
De-Nol - gastroprotective, anti-ulcer, antibacterial.
Pharmacodynamics
Antiulcer agent with bactericidal activity againstHelicobacter pylori. It also has anti-inflammatory and astringent effects. In the acidic environment of the stomach, insoluble bismuth oxychloride and citrate precipitate, chelate compounds are formed with a protein substrate in the form of a protective film on the surface of ulcers and erosions. Increasing the synthesis of PGE, the formation of mucus and the secretion of bicarbonate, stimulates the activity of cytoprotective mechanisms, increases the resistance of the mucous membrane of the gastrointestinal tract to the effects of pepsin, hydrochloric acid, enzymes and bile salts. Leads to the accumulation of epidermal growth factor in the area of the defect. Reduces the activity of pepsin and pepsinogen.
Pharmacokinetics
Bismuth subcitrate is practically not absorbed from the gastrointestinal tract. Excreted mainly with feces. A small amount of bismuth entering the plasma is excreted by the kidneys.
Indications
- peptic ulcer and duodenal ulcer in the acute phase, including associated withHelicobacter pylori;
- chronic gastritis and gastroduodenitis in the acute phase, incl. associated withHelicobacter pylori;
- irritable bowel syndrome, occurring predominantly with diarrhea symptoms;
- functional dyspepsia, not associated with organic diseases of the gastrointestinal tract.
Composition
1 tablet contains:
Active substance: Bismuth tripotassium dicitrate 304.6 mg (in terms of bismuth oxide Bi2O3 - 120 mg);
Excipients: corn starch; Povidone K30; potassium polyacrylate; macrogol 6000; magnesium stearate;
Shell: Opadry OY-S-7366 (hypromellose, macrogol 6000).
Bismuth tripotassium dicitrate is marketed under different brands and generic names, and comes in different dosage forms:
| Brand name | Manufacturer | Country | Dosage form |
|---|---|---|---|
| De nol | pills | ||
| De nol | Astellas | the Netherlands, Netherlands, Russia | pills |
| Escap | Pharmstandard | Russia | pills |
| Ulcavis | Krka dd Novo mesto AO | Slovenia | pills |
| Novobismol | Pharmproject | Russia | pills |
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Dosage and Administration
For oral use washing it down with a little water.
Adults and children over 12 years old - 1 tablet 4 times a day, 30 minutes before meals and at night, or 2 pills 2 times a day, 30 minutes before meals.
Children from 8 to 12 years - 1 tablet 2 times a day 30 minutes before meals.
Children from 4 to 8 years - at a dose of 8 mg / kg / day; daily dosage divided into 2 doses. Take 30 minutes before meals.
Duration of treatment is 4–8 weeks. For the next 8 weeks, do not use bismuth-containing products.
For eradicationHelicobacter pylori appropriate use of De-Nol® in combination with other antibacterial agents with anti-helicobacter activity.
Adverse reactions
From the digestive system: possible nausea, vomiting, more frequent stools, constipation. These phenomena are not harmful to health and are temporary.
Allergic reactions: skin rash, itchy skin.
With prolonged use in high doses - encephalopathy associated with the accumulation of bismuth in the central nervous system.
Contraindications
- individual intolerance to the drug;
- severe renal impairment;
- pregnancy;
- breastfeeding period.
Drug interactions
Within half an hour before and after taking De-Nol® It is not recommended to use inside other drugs, as well as the ingestion of food and liquids, in particular antacids, milk, fruit and fruit juices. This is due to the fact that they, when taken simultaneously, can affect the effectiveness of De-Nol.®.
Pregnancy and Lactation
Contraindicated in pregnancy. At the time of treatment should stop breastfeeding.
Special instructions
The drug should not be used for more than 8 weeks. It is also not recommended during treatment to exceed the established daily doses for adults and children. During the treatment period De-Nol® do not use other preparations containing bismuth. At the end of the course of treatment with the drug in recommended doses, the concentration of the active active substance in the blood plasma does not exceed 3–58 mcg / l, and intoxication is observed only at concentrations above 100 mcg / l.
When using De-Nol® It is possible to stain feces in a dark color due to the formation of bismuth sulphide. Sometimes there is a slight darkening of the tongue.
Overdosage
Symptoms (with long-term doses higher than recommended): renal dysfunction. These symptoms are completely reversible when de-Nol is canceled.®.
Treatment: gastric lavage, the appointment of Activated charcoal and saline laxatives. Further treatment should be symptomatic. In the case of renal dysfunction, accompanied by a high level of bismuth in the blood plasma, the use of complexing agents - dimercaptosuccinic and dimercaptopropanesulfonic acids. In the case of pronounced renal impairment, hemodialysis is indicated.
- Brand name: De nol
- Active ingredient: Bismuth tripotassium dicitrate
- Dosage form: Coated pills
- Manufacturer: Sentiss Pharma
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