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Pharmacokinetics of Ofloxacin in Preterm Newborns
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| Author:
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BINOY VADAKKE NELLISSERY, MD, ASHWIN PRABHU, MD, ANEESH.T.P, PHD, RENJU RADHAKRISHNAN, MPHARM, JAYASREE CHANDRAMATI, MD, SASIDHARAN PONTHENKANDATH, MD, FAAP
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| Abstract:
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Background: Ofloxacin is an inexpensive fluoroquinolone frequently used in treatment of late onset sepsis in neonates. The pharmacokinetics of this drug has not been studied in preterm infants.
Objective: This study was carried out to determine the pharmacokinetics of Ofloxacin in very low birthweight preterm infants.
Setting: Tertiary care NICU in India
Methods: Serum levels of ofloxacin were analyzed by HPLC method after administration of one dose of ofloxacin (7.5mg/kg intravenously) at 0, 30 min, 1 hr, 4 hr, 8 hr, 12hr after the dose was given. Ofloxacin was prescribed for suspected late onset sepsis. There were 9 preterm newborns mean: GA:29±2.9 wks; BW-1049±284 gms; postnatal age:18±12 days.
Results: The Cmax was 72±32 µg/ml at 1 hour; the elimination rate constant (Ke) was 0.13±0.1; half-life (t½) was 10.8±13h. The VD was 0.15L. There was a strong correlation of t½ to postnatal age r=0.84 p=0.01 (<28 days of postnatal age the t½ was 6.3±3 hours).indicating that during the first four weeks, the drug clearance is faster in preterm newborns.
Conclusion: This is the first study of the pharmacokinetics of ofloxacin. The data indicate that ofloxacin elimination is slower in preterm neonates and this might be related to the developmental and temporal changes in renal function and CYP enzyme expression in preterm infants.
Impact on practice:
The current practice of administering ofloxacin every 12 hours should be reassessed. Data from this pilot study suggests that administration ofloxacin in preterm infants should be at 18-to-24-hour intervals instead of 12 hour intervals.
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| Keyword:
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Ofloxacin; pharmacokinetics; Preterm Neonates
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| EOI:
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| DOI:
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https://doi.org/10.31838/ijpr/2021.13.03.223
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