CAS No.:124858-35-1

TOXICITY DATA with REFERENCE：

 

SAFETY PROFILE：

 

Standards and Recommendations：Following a single topical application of 10gm nadifloxacin 1% cream to normal human back skin, the highest plasma concentration was determined to be 107ng./ml with an elimination half-life of 19.4 hours. Approximately 0.09% of the administered dose was excreted in the urine over 48 hours post- dosing. The plasma concentration reached a steady state on Day 5 of repeated administration study when nadifloxacin 1% cream was applied at 5 gm twice daily to normal healthy individuals for a period of 7 days. The plasma concentration reached a peak of 4.1 ng/ml at 8 hours post-final dosing with an elimination half-Life of 23.2 hours. The urinary excretion rate reached 0.16% on Day 7.