ADEQUACY OF THE CURRENT RECOMMENDED DOSAGE OF CIPROFLOXACIN IN PRETERM AND TERM NEONATES WITH SEPSIS

Objectives: To determine the percentage of neonates with sepsis, on treatment with standard recommended dose of intravenous  ciprofloxacin, who had the serum ciprofloxacin Peak concentration: Minimum inhibitory concentration (Cmax:MIC), within the acceptable range. Design: Observational study design Intervention : In the Neonatology ICU, ciprofloxacin was initiated at a dose of 10mg/kg, twice daily in 95 neonates diagnosed with sepsis. On day 3 of ciprofloxacin, blood specimens were collected to measure the trough and peak concentrations  of ciprofloxacin and was measured by high performance liquid chromatography. The MIC was measured if the blood culture was positive. When the blood culture was negative,the reference values for the MIC from ‘The Clinical and Laboratory Standard Institute Guidelines’ were adopted. Main outcomes : Minimum inhibitory concentration and serum concentrations of ciprofloxacin Results: Blood culture was positive in 14 babies. The mean (±SD) trough concentration of ciprofloxacin in term, preterm and very preterm neonates was 3.21(±1.99), 2.54 (±1.26)  and  4.01(±1.80) μg/mL respectively. The mean (±SD) peak concentration of serum ciprofloxacinin term, preterm and very preterm neonates was, 12.55 (±4.945) 8.68(±3.61) and 12.07(±3.63) μg/mL, respectively.  The percentage of neonates who achieved the acceptable Cmax /MIC ratio was predicted to be 74.07% if the strain was sensitive, 7.41% if intermediate and zero for resistant strains. Conclusion: The current recommended dose of intravenous ciprofloxacin in neonates in India may be adequate for treating sepsis due to susceptible organisms. For the treatment of sepsis caused by organisms with intermediate susceptibility, higher dosing regimens may be needed.