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 to 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:
mL of Concentrate (mg of drug)
Added to
Final Concentration
4 mL (40 mg)
1000 mL
40 mcg/mL
2 mL (20 mg)
500 mL
40 mcg/mL
1 mL (10 mg)
250 mL
40 mcg/mL
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.
Body Weight
(kg)
Infusion Rate
0.025
mcg/kg/min
0.05
mcg/kg/min
0.1
mcg/kg/min
0.2
mcg/kg/min
0.3
mcg/kg/min
40
50
60
Infusion Rates (mL/hour) of 40 mcg/mL solution
1.5
1.9
2.3
3
3.8
4.5
6
7.5
9
12
15
18
18
22.5
27
70
2.6
5.3
10.5
21
31.5
80
90
100
110
120
130
140
150
3
3.4
3.8
4.1
4.5
4.9
5.3
5.6
6
6.8
7.5
8.3
9
9.8
10.5
11.3
12
13.5
15
16.5
18
19.5
21
22.5
24
27
30
33
36
39
42
45
36
40.5
45
49.5
54
58.5
63
67.5
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.
Body Weight
(kg)
Infusion Rate
0.5
mcg/kg/min
0.8
mcg/kg/min
1
mcg/kg/min
1.2
mcg/kg/min
1.4
mcg/kg/min
1.6
mcg/kg/min
40
50
60
Infusion Rates (mL/hour) of 40 mcg/mL solution
30
37.5
45
48
60
72
60
75
90
72
90
108
84
105
126
96
120
144
70
52.5
84
105
126
147
168
80
90
100
110
120
130
140
150
60
67.5
75
82.5
90
97.5
105
112.5
96
108
120
132
144
156
168
180
120
135
150
165
180
195
210
225
144
162
180
198
216
234
252
270
168
189
210
231
252
273
294
315
192
216
240
264
288
312
336
360
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:
mL of Concentrate (mg of drug)
Added to
Final Concentration
3 mL (30 mg)
500 mL
60 mcg/mL
1.5 mL (15 mg)
250 mL
60 mcg/mL
0.6 mL (6 mg)
100 mL
60 mcg/mL
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.
Body Weight
(kg)
Infusion Rate
0.2
mcg/kg/min
0.5
mcg/kg/min
0.8
mcg/kg/min
1
mcg/kg/min
1.2
mcg/kg/min
5
Infusion Rates (mL/hour) of 60 mcg/mL solution
1
2.5
4
5
6
10
2
5
8
10
12
20
4
10
16
20
24
30
6
15
24
30
36
40
8
20
32
40
48
50
10
25
40
50
60
60
12
30
48
60
72
70
14
35
56
70
84
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.
