DRUG REGISTRATION GUIDANCE DOCUMENT (DRGD) - BPFK

Drug Registration Guidance Document (DRGD)NO.SPECIFIC LABELLING REQUIREMENTS (SUBSTANCE SPECIFIC)83. LOPERAMIDE83.1 The following boxed warning shall be included on the labels of productscontaining Loperamide:NOT RECOMMENDED FOR CHILDREN UNDER 6 YEARS OF AGE83.2 The following statement shall be included in the package inserts ofproducts containing Loperamide:WARNINGNot recommended for children under 6 years of age. Its use has beenassociated with fatal episodes of paralytic ileus in infants and youngchildren.PRECAUTIONAppropriate fluid and electrolyte therapy should be given to protectagainst dehydration in all cases of diarrhoea. Oral rehydration therapywhich is the use of appropriate fluids including oral rehydration saltsremains the most effective treatment for dehydration due to diarrhoea.The intake of as much of these fluids as possible is therefore imperative.Drug-induced inhibition of peristalsis may result in fluid retention in theintestine, which may aggravate and mask dehydration and depletion ofelectrolytes. If severe dehydration or electrolyte imbalance is presentLoperamide should be withheld until appropriate corrective therapy hasbeen initiated.National Pharmaceutical Control Bureau (NPCB)First Edition, January 2013 Page | 393