Monograph: |
Adverse Effects and Precautions
Ranitidine bismuth citrate would be expected to combine the adverse effects of both bismuth compounds and ranitidine. Blackening of the tongue and faeces is common, and gastrointestinal disturbances, headache, mild anaemia, and altered liver enzyme values have been reported. Rarely, hypersensitivity reactions (including anaphylaxis), have occurred.
Ranitidine bismuth citrate should not be given to patients with moderate to severe renal impairment. It is not suitable for long-term or maintenance therapy because of the risk of bismuth accumulation. As with other antisecretory drugs, the possibility of malignancy should be considered when giving ranitidine bismuth citrate to patients with gastric ulcers since the drug may mask symptoms and delay diagnosis.
interactions:
Ranitidine Bismuth Citrate has the following interaction information:
Ranitidine bismuth citrate reduces absorption of tetracyclines
Ranitidine antagonises effects of tolazoline
Atazanavir: histamine H2-antagonists possibly reduce plasma concentration of atazanavir
Cefpodoxime: histamine H2-antagonists reduce absorption of cefpodoxime Itraconazole: histamine H2-antagonists reduce absorption of itraconazole Ketoconazole: histamine H2-antagonists reduce absorption of ketoconazole
Pharmacokinetics
After oral doses, ranitidine bismuth citrate dissociates into its ranitidine and bismuth components in the stomach. For the pharmacokinetics of ranitidine, see ranitidine record, and for those of bismuth, see bismuth record.
Uses and Administration
Ranitidine bismuth citrate is a complex of ranitidine with bismuth and citrate, which releases ranitidine and bismuth in the gastrointestinal tract and therefore possesses both the actions of the bismuth compounds and of ranitidine. It is used in the management of peptic ulcer disease, and may be given with antibacterials for the eradication of Helicobacter pylori infection and the prevention of relapse of peptic ulcer disease.
Doses are 400 mg twice daily by mouth; treatment is usually given for 4 to 8 weeks for duodenal ulceration and for 8 weeks for benign gastric ulceration. Ranitidine bismuth citrate should not be used for maintenance therapy, and a maximum of 16 weeks of treatment (two 8-week courses or four 4-week courses) may be given in a 12-month period. For duodenal ulceration where H. pylori infection is present, ranitidine bismuth citrate may be given as part of a 7-day triple therapy regimen, typically combined with any two of clarithromycin 500 mg twice daily, amoxicillin 1 g twice daily, or metronidazole 400 mg twice daily. Alternatively, a 14-day dual therapy regimen of ranitidine bismuth citrate combined with clarithromycin 500 mg two or three times daily may be given. In both regimens ranitidine bismuth citrate alone may be continued to a total of 28 days.
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