Toxicological Studies
Title: Sub-acute toxicity study of Cefepime+Amikacin combination on swiss albino mice.
Total number of animals: Swiss albino mice (n=48)
No significant change in hematological parameters (hemoglobin, total leuckocyte count, total RBC count, platelets and retics) was observed in treated mice of either sex as compared to respective control groups. Similarly no significant change in plasma glucose levels, alkaline phospahatase (ALP) and Alanine amino transferase (ALT)activity, albumin, creatinine, calcium and phosphorus levels were observed. Histological examination of liver, kidney, correlated well with biochemical observation as no alterations were observed in morphology.
Conclusion: Potentox is safe upto six times of maximum (human dose) dose.
Title: Subacute intravenous toxicity study of Cefepime+Amikacin on SD rats.
Total number of animals: SD rats (n=48)
No significant changes in hematological parameters (hemoglobin, total leuckocyte count, total RBC count, platelets and retics) were observed in treated female rats as compared to respective control groups. Lowering of Hb and RBC was observed in male rats but was not dose related. No significant change in retics and platelet counts was observed in male rats. Similarly no significant changes in plasma glucose levels, alkaline phospahatase (ALP) and alanine amino transferase (ALT) activity, albumin, creatinine, calcium and phosphorus levels were observed as compared to respective control group animals. Histological examiniation of liver, kidney, correlated well with biochemical observation as no alterations were observed in morphology.