Sulfamethoxazole-trimethoprim (also known as co-trimoxazole) is a fixed-dose combination (FDC) of two antibiotics used to treat a number of bacterial infections. Several member states have reported recurring difficulties in procuring this FDC antibiotic, with paediatric forms especially affected.

In line with the approved procedure on technical recommendations on medicine shortage mitigation strategies, the European Drug Shortages Formulary Working Party (EDSForm WP) has compiled existing knowledge on extemporaneous or stock oral formulations of sulfamethoxazole-trimethoprim that have been or are being used to alleviate the lack of age-appropriate licensed products.

The information provided in the resulting technical recommendation is intended to help healthcare professionals in their risk-assessment and decision-making processes on how to provide the best treatment to the patient when faced with the temporary unavailability of paediatric forms of sulfamethoxazole-trimethoprim.

This technical recommendation addresses general considerations on unlicensed pharmaceutical preparations containing sulfamethoxazole-trimethoprim. It includes nine oral suspensions, one of which, shared directly with the EDSForm WP, could be suitable for large-batch preparations and is backed by relevant stability data.

The EDQM and the EDSForm WP remind users that, wherever possible, it remains preferable to use a licensed medicine rather than an unlicensed pharmaceutical preparation and that it is the responsibility of the healthcare professionals involved to carry out a risk-benefit analysis before considering the preparation of an unlicensed pharmaceutical preparation.