Comparison of racecadotril and loperamide in children with acute diarrhoea

Abstract

Methods A multicentre, parallel‐group, double‐blind, double‐placebo study was carried out to compare the efficacy, tolerability, and safety of racecadotril and loperamide in children aged 2 to 10 years who were suffering from acute diarrhoea. Patients received racecadotril (1.5 mg/kg) or loperamide (0.03 mg/kg) three times daily plus matching placebo until recovery. Fifty‐two children received racecadotril and 50 loperamide. Results Patients on racecadotril passed a mean (± S.E.M.) of 2.7 ± 0.4 stools before recovery compared with 2.1 ± 0.4 stools for loperamide. The duration of diarrhoea was similar with both treatments. The incidence of adverse events was lower with racecadotril than with loperamide (11.5% vs. 22%), and significantly more patients on loperamide suffered from constipation (58% vs. 36.5%; P = 0.03). Moreover, significantly more children receiving loperamide required concomitant medication during the study (38%v 19.2%; P = 0.047). Measurement of abdominal circumference at the final consultation, 6 days after entry to the study, revealed no significant differences between treatments. Conclusions Racecadotril and loperamide were equally effective in treating acute diarrhoea in these children, and racecadotril had a superior tolerability and safety profile.

Importance of P-glycoprotein for Drug–Drug Interactions

“…In a study with healthy volunteers, the simultaneous administration of loperamide with the P-glycoprotein inhibitor quinidine led to respiratory depression due to a central opioid effect of loperamide (Sadeque et al 2000). In children whose blood-brain barrier function is not fully developed, loperamide can cause serious central side effects like constipation and respiratory depression (Turck et al 1999). Additional studies tried to clarify the influence of polymorphisms in the ABCB1 gene on the central side effects of loperamide (Pauli-Magnus et al 2003;Skarke et al 2003).…”

Drug prescribing pattern in acute gastroenteritis in an in-patient setting in a private hospital

“…Racecadotril has a superior tolerability and safety compared to loperamide hence its use is preferred. 6,7 At times patients having typhoid infection may present as gastroenteritis which needs modifications in the choice of an antibiotic thus emphasizing the importance of relevant investigations. Rising trends of antibiotic resistance requires that patients not responding to first line of antibiotics be subject to culture sensitivity testing to select appropriate antibiotic.…”

Therapie der Reisediarrhö

“…Mit Placebo verglichen, reduzierte sich die Diarrhö-dauer von 52 auf 28 h [14]. Mit Loperamid verglichen waren beide Substanzen gleich effektiv, jedoch kam es unter Racecadotril weniger oft (38% vs. 58%) zu Obstipation [2,20]. In Deutschland ist es bislang nur für Kinder (10 und 30 mg Granulat), im Ausland auch für Erwachsene bei unkomplizierter Diarrhö zugelassen.…”