Jane S. Ricciuti, RPh, MS


June 03, 2004

In This Article

Antihypertensive Agents

(fenoldopam mesylate) Injection

Manufacturer: Abbott

Drug Approval Classification: Supplemental New Drug Application (Approval Date: 04/01/2004)

New Indication: This supplemental NDA provides for the use of Corlopam (fenoldopam) as indicated for in-hospital, short-term (up to 4 hours) reduction in blood pressure.

Dosing: Fenoldopam should be administered intravenously to pediatric patients via a continuous infusion pump. Monitoring of blood pressure should be continuous. The usual starting dose in the clinical trials was 0.2 mcg/kg/min, and an effect on mean arterial pressure (MAP) was evident within 5 minutes. At a constant infusion rate, the effect was maximal after 20-25 minutes. Increased dosages of up to 0.3-0.5 mcg/kg/min every 20-30 minutes were generally well tolerated. Tachycardia without further decrease in MAP occurred at dosages greater than 0.8 mcg/kg/min. Upon discontinuation of the fenoldopam infusion after an average of 4 hours of therapy, blood pressure and heart rate returned to near baseline within 30 minutes.

Clinical Summary: A single randomized, multicenter, double-blind, placebo-controlled, dose-ranging study was conducted in pediatric patients who were randomized to 1 of 5 treatment groups: 0.05, 0.2, 0.8, or 3.2 mcg/kg/min fenoldopam or placebo administered as a blinded continuous intravenous (IV) infusion for 30 minutes. Seventy-seven pediatric patients (≤ 12 years of age) were treated for at least 2 hours. The lowest dose at which decreases in MAP were seen during blinded administration was 0.2 mcg/kg/min. The dose at which the maximum effect was seen was 0.8 mcg/kg/min.

Pharmacokinetics: In children between the ages of 1 month and 12 years, steady-state fenoldopam plasma concentrations were proportional to dose (0.05 mcg/kg/min to 3.2 mcg/kg/min). The elimination half-life and clearance were 3-5 minutes and 3 L/h/kg, respectively.

Corlopam (Fenoldopam mesylate) Injection Labeling

Corlopam (Fenoldopam mesylate) Injection