ABSTRACT
According to Food and Drug Administration (FDA), therapeutically equivalent antibiotics is
expected to have equivalent clinical efficacy and safety when used under the conditions of their
labeling. However, any defect in the quality of an antibiotic may negatively affect its efficacy and
safety and accordingly are considered a substandard drug. Cefuroxime is a semi-synthetic, broadspectrum
cephalosporin antibiotic intended for oral administration. Any quality defect in this product
may cause inefficacy and future bacterial resistance. The aim of this study was to evaluate the
quality and cost price of all commercial Cefuroxime axetil tablet products available on the Palestinian
market (One brand and two generic products). A survey on the price of all commercial tablet
products was conducted. To assess quality, all products were examined visually for their general
appearance. They were tested for weight uniformity, friability, disintegration, and dissolution profile,
and assayed for Cefuroxime content. The original brand was more expensive than the two locally
produced generic products. Based on our testing procedure, all Cefuroxime tablet products
were equivalent to the brand product. Although, the two generic products released more than 85%
of their Cefuroxime content within 15 minutes, while the brand released only 74.5%. These results
demonstrate that generic Cefuroxime tablets produced by local manufacturers are often comparable
in vitro to the brand product and have lower price. Accordingly, we encourage our physician to
prescribe the local product since they may be interchangeable and have same safety and efficacy
profile.
Keywords: Cefuroxime Axetil, Tablet, Analysis, Interchangeability, Price.

العنوان

Palestinian Medical and Pharmaceutical Journal (PMPJ).

الناشر

An-Najah National University

بلد الناشر

فلسطين

نوع المنشور

إلكتروني فقط

المجلد

1

السنة

2016

الصفحات

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