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Pharmaco kinetics and Pharmaco dynamics of Bumetanide in Critically Ill Pediatric Patients

Departments of Pediatrics and Pharmacology, University of Missouri-Kansas City, Kansas City, Missouri; Section of Pediatric Critical Care Medicine, Department of Anesthesia, Kansas City, Missouri; Section of Pediatric Clinical Pharmacology and Experimental Therapeutics, Kansas City, Missouri; Department of Pediatrics, Arkansas Children's Hospital, Little Rock, Arkansas

Thomas G. Wells, MD

The Children's Mercy Hospital, Kansas City, Missouri; Section of Pediatric Clinical Pharmacology, Little Rock, Arkansas; Division of Pediatric Nephrology, Little Rock, Arkansas; Department of Pediatrics, Arkansas Children's Hospital, Little Rock, Arkansas

Lynda Letzig, BA

The Children's Mercy Hospital, Kansas City, Missouri; Section of Pediatric Clinical Pharmacology, Little Rock, Arkansas; Department of Pediatrics, Arkansas Children's Hospital, Little Rock, Arkansas

Gregory L. Kearns, PharmD

Departments of Pediatrics and Pharmacology, University of Missouri-Kansas City, Kansas City, Missouri; Section of Pediatric Clinical Pharmacology and Experimental Therapeutics, Kansas City, Missouri; Department of Pediatrics, Arkansas Children's Hospital, Little Rock, Arkansas

This prospective, open-label, clinical trial was conducted to describe the pharmacology of bumetanide in pediatric patients with edema. Nine infants, children, and young adults with edema who were selected for diuretic therapy were studied. After a brief baseline period, each patient received parenteral bumetanide 0.2 mg/kg divided into two equal doses and administered every 12 hours. Urine excretion rate, fractional and total excretion of Na', Cl-, and K+, creatinine clearance, and plasma and urine cocentrations of bumetanide were measured at multiple itervals after drug administration. Bumetanide caused sinificant increases in the excretion rate of urine and each measured electrolyte. Unexpectedly, creatinine clearance increased dramatically after each dose. Adverse effects, including hypokalemia and hypochloremic metabolic akalosis, were evident by the end of the treatment period. The plasma pharmacokinetics of bumetanide revealed mean + standard deviation values for total clearance and apparent volume of distribution of 3.9+ 2.4 mL/min/kg and 0.74 + 0.54 L/kg, respectively. Patients excreted an average of 340% of each dose unchanged in the urine over 12 hours. Plasma concentrations of bumetanide accurately predicted several renal effects using a link model with similar pharmacodynamic parameters in each case. Paenteral bumetanide 0.1 mg/kg administered every 12 hours produced significant beneficial and adverse effects in these critically ill pediatric patients with edema. Pharmcokinetic parameters are similar to those previously rported for infants. Plasma concentrations of bumetanide can predict effect-compartment pharmacodynamics.

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