Because of the susceptibility of newborns, particularly low-birth-weight premature neonates, to vertically and nosocomially transmitted bacterial infections, pediatricians managing these infants often prescribe antibiotics for presumptive sepsis. Pharmacology of these drugs is unique to the neonate and cannot be extrapolated from data derived from studies in older infants and adults. For these reasons, safety and efficacy of antimicrobial products in the neonatal period must be established for term and premature infants.

Clinical Pharmacology of Antibacterial Agents

CHAPTER 37 – Clinical Pharmacology of Anti-Infective Drugs

Other therapeutic agents used in foals for specific diseases are discussed elsewhere. The marked effect of species, age, and degree of maturity on drug metabolism in the neonate reinforces the danger of interspecies extrapolation of pharmacology, the need for information specific for the foal, and the necessity for monitoring drug levels in the individual. Suggested antimicrobial doses are listed in Tables 3, 4, and 6. Recommended doses of anticonvulsants and sedatives are listed in Table 8 and in the article "Intensive Care of the Neonatal Foal." The following are recommendations for drug therapy in the neonate: Avoid unnecessary administration of drug to the dam at parturition because of possible placental transfer of the drug with subsequent effects on the neonate. If possible, avoid unnecessary drug therapy in foals under 30 days of age. Select a drug that undergoes minimal biotransformation (hepatic metabolism) and is not highly protein bound. Owing to probable immunodeficiency in the neonate, broad-spectrum, bactericidal drugs are preferred for treatment of life-threatening infections. Every attempt should be made to identify the etiologic agent so that drug therapy can be based on cultures and sensitivity test results to maximize the benefit-risk ratio. Parenteral (intramuscular or intravenous) drug administration is preferable to oral. Avoid drugs that are known oxidants, which may produce hemolysis or methemoglobinemia. In general, the same or a slightly higher initial dose should be employed in the neonate, but it should be given less frequently than in the adult if it has a high potential to cause toxicity. When possible, individual monitoring of serum levels of potentially toxic drugs should be employed in premature and newborn foals unless specific drug pharmacokinetics are known for that age group.

Aspects of Pharmacology in the Neonatal Foal

To investigate gentamicin pharmacokinetics in neonates with moderate-to-severe hypoxic-ischemic encephalopathy (HIE) who underwent therapeutic hypothermia (TH). Data were collected retrospectively from infants admitted between January 2007 and February 2011. Gentamicin was given at 2.5 mg/kg/dose q12h intravenously. Infants not eligible for TH underwent therapeutic normothermia (TN). After reviewing the data which showed >85 % of infants undergoing TH had gentamicin trough concentration >2 µg/ml at steady state, the gentamicin level monitoring protocol was modified since March 2011. In the initial retrospective study, 15 TN infants were compared with 19 TH infants. There was significant difference in median gentamicin half-life (7.01 vs. 9.57 h). A higher proportion of infants in the TH group required dosage adjustment (8/15 vs. 17/19). After March 2011, gentamicin level taken 12-h post 1st dose was measured routinely and 18/22 infants had trough gentamicin levels >2 µg/ml. Their dosing intervals were extended to Q18h or beyond. Infants with moderate-to-severe HIE who undergo TH may exhibit changes in the pharmacokinetic properties of gentamicin compared to infants who undergo TN. By measuring gentamicin level at 12-h after the first dose of 2.5 mg/kg/dose, appropriate dosing interval can be determined and the duration of exposure to toxic gentamicin level can be reduced.

Pharmacokinetics of gentamicin in newborns with moderate-to-severe hypoxic-ischemic encephalopathy undergoing therapeutic hypothermia.

Gentamicin is a bactericidal aminoglycoside antibiotic, it inhibits the protein synthesis. Gentamicin is active against the majority of aerobic gram-negative bacilli such as Pseudomonas, Klebsiella and Escherichia coli. The gentamicin doses are 3 mg/kg once-daily for preterm newborns 35 weeks of gestation. The monitoring of gentamicin serum concentration is recommended when infants are treated for 48 hours or more. The gentamicin peak concentration must be at least 8 times the minimum inhibitory concentration (MIC) to be bactericidal and the gentamicin trough concentration must be < 2 µg/ml to avoid ototoxicity and nephrotoxicity.Once-daily dosing of gentamicin (4 mg/kg), is preferred than twice-daily dose of 2.5 mg/kg gentamicin. A gentamicin loading dose (4 mg/kg), followed by once-daily dosing of 2.5 mg/kg yields safe and target range in neonates. An extended dosing interval of 48-hour (5 mg/kg gentamicin), was compared with twice-daily dose of 2.5 mg/kg gentamicin. Infants in the 48-hour interval and in the twice-daily achieved peak gentamicin concentrations of 9.43 µg/ml and 6.0 µg/ml, respectively, (p<0.001), and trough gentamicin concentrations were 1.08 µg/ml and 1.54 µg/ml, respectively, (p<0.001). The infants born small for gestational age have a reduced gentamicin clearance, and a more prolonged gentamicin half-life than infants born appropriate for gestational age. Patent ductus arteriosus, extracorporeal membrane oxygenation, therapeutic hypothermia, and asphyxia reduce the gentamicin clearance.

http://ijp.mums.ac.ir/article_8365_44a262c6a0e188d2e410cf0c8eaf2505.pdf

Clinical Pharmacokinetics of Gentamicin in Neonates

The purpose of this study was to investigate the effects of changes in renal function on gentamicin disposition following perinatal asphyxia. Gentamicin pharmacokinetics, renal function, mean arterial pressure (MAP) and five-minute Apgar scores were determined in 80 preterm infants admitted to two neonatal intensive care units over an 18 month period. A 2.5 mg/kg dose of gentamicin was infused intravascularly over 20 to 30 minutes in a retrograde fashion. The gentamicin half-life and clearance were prolonged in asphyxiated infants. For the asphyxiated infants gentamicin half-life increased and urine output decreased with a significant correlation (r = -0.66, p less than 0.05). Gentamicin clearance and urine output in the asphyxia group correlated with MAP (r = +0.67, p = 0.07). In non-asphyxia infants no such correlation was seen. This study does not distinguish between asphyxia-induced or gentamicin-induced nephrotoxicity following gentamicin therapy. We suggest that gentamicin concentrations be closely monitored in asphyxiated newborns who demonstrate compromised renal function.

Gentamicin disposition in asphyxiated newborns: relationship to mean arterial blood pressure and urine output.

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Gentamicin disposition in asphyxiated newborns: relationship to mean arterial blood pressure and urine output.