May 10, 2002

ORAL REHYDRATION SALTS (ORS)
A NEW REDUCED OSMOLARITY FORMULATION

For more than 25 years WHO and UNICEF have recommended a single formulation of glucose-based Oral Rehydration Salts (ORS) to prevent or treat dehydration from diarrhoea irrespective of the cause or age group affected. This product, which provides a solution containing 90 mEq/l of sodium with a total osmolarity of 311 mOsm/l, has proven effective and without apparent adverse effects in worldwide use. It has contributed substantially to the dramatic global reduction in mortality from diarrhoeal disease during the period. For the past 20 years, numerous studies have been undertaken to develop an “improved” ORS. The goal was a product that would be at least as safe and effective as standard ORS for preventing or treating dehydration from all types of diarrhoea but which, in addition, would reduce stool output or have other important clinical benefits. One approach has consisted in reducing the osmolarity of ORS solution to avoid possible adverse effects of hypertonicity on net fluid absorption. This was done by reducing the solution’s glucose and salt (NaCl) concentrations . Studies to evaluate this approach were reviewed at a consultative technical meeting held in New York (USA) in July 2001 ¹, and technical recommendations were made to WHO and UNICEF on the efficacy and safety of reduced osmolarity ORS in children with acute non-cholera diarrhoea, and in adults and children with cholera. These studies showed that the efficacy of ORS solution for treatment of children with acute non-cholera diarrhoea is improved by reducing its sodium concentration to 75 mEq/l, its glucose concentration to 75 mmol/l, and its total osmolarity to 245 mOsm/l. The need for unscheduled supplemental IV therapy in children given this solution was reduced by 33%. In a combined analysis of this study and studies with other reduced osmolarity ORS solutions (osmolarity 210-268 mOsm/l, sodium 50-75 mEq/l) stool output was also reduced by about 20% and the incidence of vomiting by about 30% ¹. The 245 mOsm/l solution also appeared to be as safe and at least as effective as standard ORS for use in children with cholera. The reduced osmolarity ORS containing 75 mEq/l sodium, 75 mmol/l glucose (total osmolarity of 245 mOsm/l) is as effective as standard ORS in adults with cholera. However, it is associated with an increased incidence of transient, asymptomatic hyponatraemia. This reduced osmolarity ORS may be used in place of standard ORS for treating adults with cholera, but careful monitoring is advised to better assess the risk, if any, of symptomatic hyponatraemia.Because of the improved effectiveness of reduced osmolarity ORS solution, especially for children with acute, non-cholera diarrhoea, WHO and UNICEF now recommend that countries use and manufacture the following formulation in place of the previously recommended ORS solution with a total osmolarity of 311 mOsm/l.
¹ Reduced osmolarity oral rehydration salts (ORS) formulation Report from a meeting of experts jointly organised by UNICEF and WHO. WHO/CAH/01.22

Reduced osmolarity ORS	grams /litre		Reduced osmolarity ORS	mmol/ litre
Sodium chloride	2.6		Sodium	75
Glucose, anhydrous	13.5		Chloride	65
Potassium chloride	1.5		Glucose, anhydrous	75
Trisodium citrate dihydrate	2.9		Potassium	20
			Citrate	10
Total Weight	20.5		Total Osmolarity	245

Although this single ORS formulation is recommended, WHO and UNICEF have previously published criteria, which remain unchanged, for acceptable ORS formulations. These criteria are listed below; they specify the desired characteristics of the solution after it has been prepared according to the instructions on the packet: