Medicines

The International Pharmacopoeia (Ph. Int.): Oral Rehydration

Oral Rehydration Salts

Acute diarrhoeal diseases are among the leading causes of mortality in infants and young children in many developing countries. In most cases, death is caused by dehydration. Action to reduce such deaths will help countries achieve the Millenium Development Goal of reducing the under-five mortality rate by two-thirds by the year 2015. Dehydration from diarrhoea can be prevented by giving extra fluids at home, or it can be treated simply, effectively and cheaply in all age groups and in all but the most severe cases by giving patients by mouth an adequate glucose electrolyte solution called Oral Rehydration Salts (ORS) solution.

A revised monograph for Oral Rehydration Salts has been published in the fourth edition of The International Pharmacopoeia. The revised monograph provides the quality specifications for the reduced osmolarity formula ORS now recommended by WHO and UNICEF.

Detailed recommendations concerning the provision and production of oral rehydration salts are provided in a revised joint WHO/UNICEF publication entitled "Oral Rehydration Salts - Production of the New ORS". This publication updates an earlier document (WHO/CDD/SER/85.8) and is available on the website.

Zinc Supplementation

WHO and UNICEF now recommend zinc supplementation in addition to the use of the reduced osmolarity ORS in the management of diarrhoeal diseases. The monographs listed here have been adopted by the Expert Committee on Specifications for Pharmaceutical Preparations.

Detailed recommendations concerning the provision and production of zinc preparations are provided in a publication titled " Production of Zinc Tablets and Zinc Oral solutions available on the Child and Adolescent Health and Development website.

Additional advice on diarrhoea is given under Facts for Life on the UNICEF website

Proposals for inclusion

APIs

  • Zinc acetate
  • Zinc gluconate

Dosage forms

  • Paediatric zinc acetate tablets
  • Paediatric zinc acetate oral solution
  • Paediatric zinc gluconate tablets
  • Paediatric zinc gluconate oral solution
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