A comparative study of the population pharmacokinetics of gentamicin and amikacin in newborn patients

SUMMARY The population kinetics of gentamicin and amikacin were studied comparatively in newborn patients with a similar range of gestation age (37.9 ± 2.9 and 36.7 ± 3.6 weeks), postnatal age (13.8 ± 7.4 and 16.7 ± 7 days) and weight (2.85 ± 0.57 and 2.72 ± 0.75 kg), undergoing routine therapeutic monitoring of their serum levels. Individual kinetic analysis of serum drug levels was done using a single-compartment model. The population model employed assumes the existence of residual variability in the serum concentrations and interindividual variability in the pharmacokinetic parameters. The clearance and the apparent distribution volume were calculated for each patient using a two-stage …

Randomised double-blind clinical trial of intermediate- versus high-dose chloral hydrate for neuroimaging of children.

Orally administered chloral hydrate is the most widely used sedative in children undergoing MRI. We compared intermediate- and high-dose oral chloral hydrate in 97 consecutive children undergoing MRI in a prospective, controlled, double-blind, randomised clinical trial. There were 50 girls and 47 boys, mean weight (+/- SD) 14.7 +/- 6.4 kg, and mean age 38 +/- 31. The children were randomly allocated to receive chloral hydrate syrup either 70 mg/kg (group A, n = 50) or 100 mg/kg (group B, n = 47). These two groups were not significantly different in sex, weight, age, diagnosis or ambulatory medication. The mean initial dose (+/- SEM) was 64 +/- 2 mg/kg for group A and 93 +/- 2 mg/kg for grou…

Expanded gentamicin volume of distribution in critically ill adult patients receiving total parenteral nutrition

Aminoglycoside antibiotics distribute into the extracellular fluid compartment and are eliminated by the kidney via glomerular filtration. Malnutrition and total parenteral nutrition influence the fluid and electrolyte status of the patient, and cause organ changes. The purpose of this clinical study was to characterize the kinetic behaviour of gentamicin in the parenterally fed critically ill adult patient. Eighty-six critically ill adult patients treated with gentamicin for severe Gram-negative infections were enrolled in the study (mean +/- SD): age, 60 +/- 14 years; weight, 69.4 +/- 10.2 kg; height, 163 +/- 10 cm; 22 females and 64 males. Four study groups were defined (2 x 2): total pa…

Selection of optimal prophylactic aminoglycoside dosage in cancer patients: population pharmacokinetic approaches.

We report an alternative dose-finding approach for the selection of optimal prophylactic aminoglycoside dosage in specific (sub)populations of patients. Relative a priori utility of several intervals of gentamicin or tobramycin (AMG) peak and trough serum levels were assigned by a group of pharmacokinetics experts, assuming prophylactic administration for laryngectomy interventions. A group of 27 adult patients, with normal renal function, undergoing elective surgery for laryngeal problems and treated prophylactically with gentamicin (80 mg t.i.d.) or tobramycin (100 mg t.i.d.) was studied. Two blood samples (peak and trough) were drawn at steady-state for AMG assay. Three different methods…

Abstracts of papers and posters safe handling of medicines

Oral chloral hydrate provides effective and safe sedation in paediatric magnetic resonance imaging.

SUMMARY Sedation is routinely required for successful Magnetic Resonance imaging in infants and children. Five hundred and ninety-six paediatric patients (270 female and 326 male, age (mean±SD) 41±30 months and weight 14.8±6.5 kg) entered an open, non-comparative, prospective study to assess oral chloral hydrate sedation in a large and homogeneous paediatric population undergoing Magnetic Resonance imaging. Chloral hydrate syrup 70 mg/ml was administered 20–40 min prior to the procedure. Effective sedation was reached in 94.1% with a total dose (mean±SEM) of 68±1 mg/kg (range 20–170 mg/kg). Statistical analysis of sedation failures vs. successful examinations after the total dose showed sig…