Abstract
Fungal infections, occurring frequently in VLBW infants, are usually treated by the toxic amphotericin B and flucytosine. Ketoconazole (keto), an oral antifungal agent with broad spectrum activity and low toxicity, might be a good alternative. Data on the gastro-intestinal absorption of keto in preterm infants with a gestational age below 32 weeks are not available. Desired therapeutic levels are between 100-10000 ng/mL and area under the curve (AUC) > 2400 ng/h/ml. We studied the gastro-intestinal absorption of keto in relation to gastric pH in 8 preterm infants (gestational age: 26-32 wks) in the first week of life. All infants were on total parenteral nutrition and received a single oral dose of 10 mg/kg of keto as a suspension. Blood samples were taken before and 1, 2, 4, 8, 12, 24 hrs after the keto administration. Plasma keto concentrations were analyzed by HPLC-assay. Gastric pH was measured at t = 0. AUC (ng/h/ml), peak concentration (Cmax in ng/ml) and gastric pH were:
Conclusions. 1. Preterm infants can absorb ketoconazole from the gastrointestinal tract leading to therapeutic levels. 2. However, a gastric pH above 2.5 is associated with insufficient absorption. 3. Continuous oral feeding will cause insufficient keto absorption due to an increase in gastric pH.
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Van Den Anker, J., Van Ussel-Dijk, A., Woestenborghs, R. et al. 9 THE EFFECT OF GASTRIC PH ON THE ABSORPTION OF KETOCONAZOLE BY VERY-LOW-BIRTH-WEIGHT INFANTS. Pediatr Res 36, 4 (1994). https://doi.org/10.1203/00006450-199407000-00009
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DOI: https://doi.org/10.1203/00006450-199407000-00009