Sub-Acute Toxicity Study of Fixed Dose Combination of Sulbactomax (Ceftriaxone-Sulbactam) in Swiss Albino Mice and Wistar Rat

摘要

The present study investigated safety/toxicity profile of Sulbactomax (Ceftriaxone-Sulbactam for injection), a fixed dose combination, in Mus musculus mice and SD rats at three dose levels, 10,50 and 150 mg kg~-1 ranging from asymptomatic to high dose. Sulbactomax was introduced in order to enhance the antimicrobial efficacy and to combat resistance towards beta-lactamase producing bacteria. The combination has been reported to be highly effective as well as synergistic for many resistant strains and carry the potential for its usage in empirical therapy for various bacterial infections. To establish the safety profile of combination, 28 days repeated dose sub-acute toxicity study was conducted on mice and rat (male and female). Various hematological parameters were studied in addition to physiological and biochemical parameters in order to study toxicity profile of Sulbactomax. There were no signs of toxicity observed at any of the dose levels used in this study. Animals from control and different treated groups exhibited normal body weight gain throughout the dosing period of 28 days. No mortality was observed in any of the treatment groups during the course of whole study.