Adult Patients: Fenoldopam is indicated for the in-hospital, short-term (up to 48 hours) management of severe hypertension when rapid, but quickly reversible, emergency reduction of blood pressure is clinically indicated, including malignant hypertension with deteriorating end-organ function. Transition to oral therapy with another agent can begin at any time after blood pressure is stable during fenoldopam infusion.

Pediatric Patients: Fenoldopam is indicated for the in-hospital, short-term (up to 4 hours) reduction in blood pressure (See CLINICAL PHARMACOLOGY/Pediatric Patients).

Adult Patients: The optimal magnitude and rate of blood pressure reduction in acutely hypertensive patients have not been rigorously determined, but, in general, both delay and too rapid decreases appear undesirable in sick adult patients. An initial fenoldopam dose may be chosen from Tables 2 and 3 in the Clinical Pharmacology Section that produces the desired magnitude and rate of blood pressure reduction in a given clinical situation. Doses below 0.1 mcg/kg/min have very modest effects and appear only marginally useful in this population. In general, as the initial dose increases, there is a greater and more rapid blood pressure reduction. However, lower initial doses (0.03 to 0.1 mcg/kg/min) titrated slowly have been associated with less reflex tachycardia than have higher initial doses ( ≥ 0.3 mcg/kg/min). In clinical trials, doses from 0.01-1.6 mcg/kg/min have been studied. Most of the effect of a given infusion rate is attained in 15 minutes.

Fenoldopam should be administered by continuous intravenous infusion. A bolus dose should not be used.Hypotension and rapid decreases of blood pressure should be avoided. The initial dose should be titrated upward or downward, no more frequently than every 15 minutes (and less frequently as goal pressure is approached) to achieve the desired therapeutic effect. The recommended increments for titration are 0.05 to 0.1 mcg/kg/min.

Use of a calibrated, mechanical infusion pump is recommended for proper control of infusion rate during fenoldopam infusion. In clinical trials, fenoldopam treatment was safely performed without the need for intra-arterial blood pressure monitoring; blood pressure and heart rate were monitored at frequent intervals, typically every 15 minutes. Frequent blood pressure monitoring is recommended.

Fenoldopam infusion can be abruptly discontinued or gradually tapered prior to discontinuation. Oral antihypertensive agents can be added during fenoldopam infusion or following its discontinuation. Patients in controlled clinical trials have received intravenous fenoldopam for as long as 48 hours.

PREPARATION OF INFUSION SOLUTION

WARNING: CONTENTS OF AMPULES MUST BE DILUTED BEFORE INFUSION. EACH AMPULE IS FOR SINGLE USE ONLY.

Dilution

Adult Patients: The fenoldopam injection ampule concentrate must be diluted in 0.9% Sodium Chloride Injection, USP, or 5% Dextrose Injection, USP, using the following dilution schedule:

The drug dose rate must be individualized according to body weight and according to the desired rapidity and extent of pharmacodynamic effect. Table 5 provides the calculated infusion volume in mL/hour for a range of drug doses and body weights. The infusion should be administered using a calibrated mechanical infusion pump that can accurately and reliably deliver the desired infusion rate.

Infusion Rates

Table 5
FENOLDOPAM ADULT INFUSION RATES (mL/hour)
DRUG DOSAGE FOR ADULTS > 40 KG, USING 40 MCG/ML CONCENTRATION
NOTE: CONCENTRATION IS DIFFERENT FROM PEDIATRIC PATIENTS, TABLE 6.

Table 5 (continued)
FENOLDOPAM ADULT INFUSION RATES (mL/hour)
DRUG DOSAGE FOR ADULTS > 40 KG, USING 40 MCG/ML CONCENTRATION
NOTE: CONCENTRATION IS DIFFERENT FROM PEDIATRIC PATIENTS, TABLE 6.

The diluted solution is stable under normal ambient light and temperature conditions for at least 24 hours. Diluted solution that is not used within 24 hours of preparation should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or cloudiness is observed, the drug should be discarded.

Pediatric Patients: Fenoldopam should be administered intravenously to pediatric patients by a continuous infusion pump appropriate for the delivery of low infusion rates. Monitoring of blood pressure should be continuous, usually by way of an intra-arterial line. Heart rate should also be continuously monitored. In the clinical trial, the usual starting dose was 0.2 mcg/kg/min with an effect on MAP evident within 5 minutes. At a constant infusion rate the effect was maximal after 20 to 25 minutes. Increased dosages of up to 0.3 to 0.5 mcg/kg/min every 20 to 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.

PREPARATION OF INFUSION SOLUTION

WARNING: CONTENTS OF AMPULES MUST BE DILUTED BEFORE INFUSION. EACH AMPULE IS FOR SINGLE USE ONLY.

Dilution

Pediatric Patients

Table 6 provides the calculated infusion volume in mL/hour for a range of drug doses and body weights. The infusion should be administered using a calibrated mechanical infusion pump that can accurately and reliably deliver the desired infusion rate. As low flow rates (e.g., < 0.5 mL/hr) may not be practical, and due to volume overload, it may be necessary to increase the concentration of fenoldopam in the infused solutions.

Infusion Rates

Table 6: FENOLDOPAM PEDIATRIC INFUSION RATES (mL/hour)
DRUG DOSAGE FOR CHILDREN BETWEEN 5 AND 70 KG, USING 60 MCG/ML CONCENTRATION
NOTE: CONCENTRATION IS DIFFERENT FROM ADULT PATIENTS, TABLE 5.

The diluted solution is stable under normal ambient light and temperature conditions for at least 24 hours. Diluted solution that is not used within 24 hours of preparation should be discarded. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or cloudiness is observed, the drug should be discarded.

Store at 2 to 30°C (35.6 to 86°F).

ABBOTT LABORATORIES, NORTH CHICAGO, IL 60064, USA. FDA Rev date: 4/1/2004

Last reviewed on RxList: 10/24/2008
This monograph has been modified to include the generic and brand name in many instances.