Properties
What is it?
International Nonproprietary Name - bismuthate tripotassium dicitrate Clinical-pharmacological group: Gastroenterology, Hepatology → Anti-ulcer agents Composition Each tablet contains: Active substance: Bismuth tripotassium dicitrate – 304.6 mg, calculated as bismuth oxide B2O3 – 120 mg. Indications Peptic ulcer and duodenal ulcer in the exacerbation phase, including Helicobacter pylori-associated. Chronic gastritis and gastroduodenitis in the exacerbation phase, including Helicobacter pylori-associated. Irritable bowel syndrome, predominantly with diarrhea. Functional dyspepsia not associated with gastrointestinal diseases. Dosage and Administration For adults and children over 12 years of age, 1 tablet of 120 mg is prescribed 4 times a day, 30 minutes before meals and at bedtime, or 2 tablets of 120 mg twice a day. For children aged 4-12 years, the drug is prescribed at a dose of 8 mg/kg/day. Depending on the child's body weight, 1-3 tablets per day are prescribed (correspondingly 1-3 doses per day). In this case, the daily dose should be as close as possible to the calculated dose (8 mg/kg/day). Tablets are prescribed 30 minutes before meals with a small amount of water. The duration of treatment is 4-8 weeks. Bismuth-containing preparations should not be taken for the next 8 weeks. For Helicobacter pylori eradication, it is recommended to take De-Nol along with other antibacterial agents with anti-Helicobacter pylori activity. Side Effects Gastrointestinal system: nausea, vomiting, increased bowel motility, constipation may occur. These manifestations are not dangerous to health and are temporary. Allergic reactions: skin rash, itching. With prolonged use in high doses – encephalopathy associated with bismuth accumulation in the central nervous system. Contraindications Severe renal impairment, pregnancy, lactation, individual intolerance to the drug. Special Instructions The drug should not be taken for longer than 8 weeks. It is also not recommended to exceed the established daily doses in adolescents and children. During treatment with De-Nol, other bismuth-containing preparations should not be taken. Upon completion of the course, when treated with recommended doses, the concentration of active ingredients in blood plasma does not exceed 3-58 mcg/l, and intoxication is observed only above a concentration of 100 mcg/l. When taking De-Nol, darkening of the stool may occur due to the formation of bismuth sulfite. Sometimes, slight darkening of the tongue is also noted.