Post Marketing Observational Study of Fixed Dose Combination of Rifaximin and Metronidazole in the Management of Acute Diarrhea In Children
- Author:
Arif A Faruqui
;
Shaguphta T Shaikh
- Collective Name: Arif A. Faruqui and Shaguphta T. Shaikh.
- Publication Type:Journal Article
- Keywords:
acute diarrhea;
mixed gastrointestinal infection;
rifaximin;
metronidazole;
fixed dose
- From:
Pacific Journal of Medical Sciences
2025;26(2):34-40
- CountryPapua New Guinea
- Language:English
-
Abstract:
Acute diarrhea is a frequent illness in children, especially in developing nations, posing risks of
dehydration, malnutrition, and even death. Recently, there's been rising interest in Rifaximin and
Metronidazole Fixed Dose Combination (FDC) as a treatment option for pediatric acute diarrhea. The
aim of this study was to evaluate the efficiency and tolerability of rifaximin and metronidazole fixed-dose combination in the management of acute diarrhea in children. This was a multicenter, open-label, non- comparative, and non-randomized trial that enrolled 80 patients (age <18 years) experiencing acute diarrhea caused by various factors. This observational study was conducted post-approval of drugs by state Food and Drug Administration (FDA), therefore informed consent and ethics approval were not mandatory. Patients received suspension containing 100mg rifaximin and 200mg metronidazole per 5ml, twice daily for 5 days based on body weight. The primary endpoint assessed was change in frequency of loose/watery stools, fever, nausea, vomiting, abdominal pain, and gas/flatus from baseline to day 5.
