Abstract
The pharmacokinetics of indomethacin (I) was assessed in infants who received prophylactic (I) for patent ductus arteriosus (PDA). The first dose (0.2 mg/kg), given within 12 hours after birth, was followed by two q 12 hourly doses (0.1 mg/kg). The mean birth weight (BW) of these infants was 923 ± 134.0 gm (range: 730-1070gm) with a mean gestational age of 28.1 ± 2 wks (range:31-25 wks). None of the infants subsequently developed a significant PDA. Plasma (I) levels were measured by high performance liquid chromatography at 1, 13, 36, 72, 96, 168 and 216 hours after the administration of the first dose.
The mean plasma t 1/2 of (I) in these infants (71.3±39.1 hrs) was significantly prolonged when compared with previously reported values. Furthermore the mean plasma t 1/2 of (I) was significantly longer in the <1000 gm infants (p<0.05). While the minimum efficacious dose for prophylactic (I) has not been established, all but one infant had a level > .250μg 7 days following (I). These data strongly suggest that previously recommended dosages of (I) for very low birth weight infants in the first 48 hrs. may result in very elevated and prolonged levels.
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Smith, M., Setzer, E., Garg, D. et al. PHARMACOKINETICS OF PROPHYLACTIC INDOMETHACIN IN VERY LOW-BIRTHWEIGHT PREMATURE INFANTS. Pediatr Res 18 (Suppl 4), 161 (1984). https://doi.org/10.1203/00006450-198404001-00407
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DOI: https://doi.org/10.1203/00006450-198404001-00407