Background Amoxicillin-clavulanate (AMC) is among the most frequently used antibiotic for paediatric infections globally. AMC child-appropriate formulations are largely limited to dry powder suspensions, which have to be stored refrigerated once reconstituted due to stability limitations of clavulanate.

Methods Oral Amoxicillin (AMX) and AMC formulations were identified from IQVIA-MIDAS wholesale data, and 2015 antibiotic consumption in courses/1000 child-years was estimated in Bangladesh, India, Indonesia, Pakistan, Philippines and Vietnam with an assumed average treatment of 7 days. Costs per course in US-$ standardised to 2015 were estimated from the same dataset. Nationally representative data on access to a refrigerator was extracted from the Demographic & Health Surveys Program. Degradation under different temperature conditions of two different AMC suspensions commercially available in Switzerland was tested. Average degradation (three bottles of each product) was measured during 8 days with ambient temperatures of 8°C versus 28°C.

Results In India and Pakistan more AMC than AMX courses were sold. In all countries AMC was at least twice and up to 10 times as expensive as AMX. Access to refrigeration was below 45%, even in countries with a high number of sold AMC courses (compared with AMX). In the evaluated co-formulated products, clavulanate showed a maximum degradation of 34% at 8°C, and 73% at 28°C after 8 days. AMX was largely stable at 8°C but 13% degraded at 28°C after 8 days.

Conclusions Oral amoxicillin-clavulanate suspensions are widely used in six Asian countries classified as middle-income countries by the World Bank. In reconstituted liquid AMC formulations, neither component is satisfactorily stable at room temperature. Storage conditions for stability are likely inadequate for AMC in many households in the six Asian countries of interest.

Disclosure(s) Nothing to disclose