Racecadotril : A New Antidiarrheal!

Discussion Forum:
Racecadotril- any experience?
Does any member have any experience of using the drug racecadrotil? What is this antidiarrheal or antidysenteric? Any age limitation? Any serious side effect?  Any major contraindication? I shall appreciate very much if any member shares his experience. Does anyone know of any study (independent) report?
-Dr Amit K Sanyal
It is an anti-secretory drug, thus useful in secretory diarrhoea.
-Dr. Puneet Kumar, New Delhi
We should wait till some good reports/reviews are available.
- Dr.H.K.Takvani
Search for “Racecatotril” or “Acetorphan” (another name of Racecadotril) in “pubmed.com” - Plenty of references are available!
-Dr. Devaraj Raichur, Hubli
Racecadotrl is not a new salt altogether; available in world market for last 3-4 years, though it is launched here only this year. There is plenty of literature available on its efficacy and role in pediatric and adult diarrhea.
Its place in the management of Ac diarrhea is still not certain, being compared for efficacy and safety with Loperamide, though mechanism of action differs considerably. It was found to be almost equally effective as loperamide but scores high on safety front. Hence, its use can be considered in all situations including ac diarrhea in children where one tended to use loperamide in the past. But ORS still remains the GOLD Standard treatment modality for Ac diarrhea, Racecadotril and pre/probiotics are at best can be deemed as adjuvants.
I have used the drug in more than 50 patients of Ac diarrhea over last few weeks but found not more effective than placebo at least on clinical grounds. Probably, it will have some more virtues in cases of IBS/toddler’s diarrhea than Ac diarrhea of infective origin. Non-availability of the drug in pediatric formulation form is another hinderance to its widespread use.
-Dr Vipin M. Vashishtha, Bijnor
Racecadotril is now available in sachet form of 10 mg marketed by one Genx Pharma [by name AD ee 10] and shotrtly Lyka Hetero is also coming out with 10 mg and 30 mg sachets [Enuff]. The suggested dose is 1.5 mg / kg. The manufactrurer for both these products is a Hyderabad based Hetero Drugs Ltd.
-Dr Vittal
One more formulation with 15 mg per sachet (for a 10 kg child dose : 1 sachet tid) from Fourrts (India) Labs. by name Racetril. This one is made by Chennai based Paris Dakner Microspherules P Ltd
-Dr Vittal
(From www.iapindia.org/cfforum)

Review of Literature
Racecadotril versus loperamide.
Racecadotril is an enkephalinase inhibitor, presented as a purely antisecretory agent with advantages over the opiate-receptor agonist loperamide in the treatment of diarrhea. A critical review of the literature and the models used was performed. Although pretreatment with high doses of racecadotril reduced cholera toxin-induced secretion and although clinical efficacy was demonstrated in young infants—a population characterized by 10-fold higher plasma enkephalin concentrations compared with adults, the analysis calls into question the peripheral antisecretory selectivity and relative clinical efficacy. Conversely, loperamide can be proposed as an antisecretory agent at therapeutic concentrations. Its efficacy is well established in acute and chronic diarrhea. Current experimental and clinical comparative studies of both drugs have problems with regard to the selection of the doses, the validity of models, and/or the trial design. The conclusion is that more research is needed before reliable conclusions can be drawn on the place of racecadotril in diarrhea treatment.
(Dig Dis Sci. 2003 Feb;48(2):239-50.)

Efficacy and tolerability of racecadotril in acute diarrhea in children.
Oral rehydration therapy is the only treatment recommended by the World Health Organization in acute diarrhea in children. Antisecretory drugs available could not be used because of their side effects, except for racecadotril, which is efficient in acute diarrhea in adults.
CONCLUSIONS: This study demonstrates the efficacy (up to 50% reduction in stool output) and tolerability of racecadotril as adjuvant therapy to oral rehydration solution in the treatment of severe diarrhea in infants and children.
(Gastroenterology. 2001 Mar;120(4):799-805.)

Racecadotril in the treatment of acute watery diarrhea in children.
Racecadotril (acetorphan), is an effective and safe treatment for acute diarrhea in adults and children. Whether treatment with racecadotril and oral rehydration therapy is more effective than treatment with oral rehydration alone in hospitalized children with acute watery diarrhea is not known.
METHODS: The researchers treated 135 boys 3 to 35 months of age who had watery diarrhea of five days’ duration or less with racecadotril (1.5 mg per kilogram of body weight orally every eight hours) or placebo, in addition to oral rehydration solution. The primary end point was the 48-hour stool output (measured in grams); the total stool output, duration of diarrhea, and total intake of oral rehydration solution were also measured. RESULTS: The mean (+/-SE) 48-hour stool output was 92+/-12 g per kilogram in the racecadotril group and 170+/-15 g per kilogram in the placebo group (P<0.001), a 46 percent reduction with racecadotril. The results were similar among the 73 boys with rotavirus infections. The total stool output was 157+/-27 g per kilogram in the racecadotril group and 331+/-39 g per kilogram in the placebo group (P<0.001). The median duration of diarrhea was significantly less (P<0.001) in the racecadotril group (28 hours regardless of rotavirus status) than in the placebo group (72 and 52 hours, respectively, for rotavirus-positive and rotavirus-negative patients). The intake of oral rehydration solution was significantly lower in the racecadotril group than in the placebo group (P<0.001). Racecadotril was well tolerated; only seven patients taking racecadotril had adverse effects, which were all mild and transient. CONCLUSIONS: In young boys with acute watery diarrhea, racecadotril is an effective and safe treatment. (N Engl J Med. 2000 Aug 17;343(7):463-7.)