Corlopam
Loading...Corlopam Recall
Get an alert when a recall is issued.
Questions & Answers
Side Effects & Adverse Reactions
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms and life-threatening or less severe asthmatic episodes in certain susceptible people. The overall prevalence of sulfite sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
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).
History
There is currently no drug history available for this drug.
Other Information
Corlopam (Fenoldopam Mesylate Injection, USP) is a dopamine D1-like receptor agonist. The product is formulated as a solution to be diluted for intravenous infusion. Chemically it is 6-chloro-2,3,4,5-tetrahydro-1-(4-hydroxyphenyl)-[1H]-3-benzazepine-7,8-diol methanesulfonate with the following structure:
fenoldopam mesylate
Fenoldopam mesylate is a white to off-white powder with a molecular weight of 401.87 and a molecular formula of C16H16ClNO3•CH3SO3H. It is sparingly soluble in water, ethanol and methanol, and is soluble in propylene glycol.
Each 1 mL contains, in sterile aqueous solution, citric acid 3.44 mg; fenoldopam mesylate equivalent to fenoldopam 10 mg; propylene glycol 518 mg; sodium citrate dihydrate 0.61 mg; sodium metabisulfite 1 mg.
Sources
Corlopam Manufacturers
-
Hospira, Inc.
![Corlopam (Fenoldopam Mesylate) Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Corlopam | Hospira, Inc.
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 5FENOLDOPAM 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.
Infusion Rate
Body Weight
(kg)
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
Infusion Rates (mL/hour) of 40 mcg/mL solution
40
1.5
3
6
12
18
50
1.9
3.8
7.5
15
22.5
60
2.3
4.5
9
18
27
70
2.6
5.3
10.5
21
31.5
80
3
6
12
24
36
90
3.4
6.8
13.5
27
40.5
100
3.8
7.5
15
30
45
110
4.1
8.3
16.5
33
49.5
120
4.5
9
18
36
54
130
4.9
9.8
19.5
39
58.5
140
5.3
10.5
21
42
63
150
5.6
11.3
22.5
45
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.
Infusion Rate
Body Weight
(kg)
0.5
mcg/kg/min0.8
mcg/kg/min1
mcg/kg/min
1.2
mcg/kg/min
1.4
mcg/kg/min1.6
mcg/kg/min
Infusion Rates (mL/hour) of 40 mcg/mL solution
40
30
48
60
72
84
96
50
37.5
60
75
90
105
120
60
45
72
90
108
126
144
70
52.5
84
105
126
147
168
80
60
96
120
144
168
192
90
67.5
108
135
162
189
216
100
75
120
150
180
210
240
110
82.5
132
165
198
231
264
120
90
144
180
216
252
288
130
97.5
156
195
234
273
312
140
105
168
210
252
294
336
150
112.5
180
225
270
315
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 CONCENTRATIONNOTE: 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
Infusion Rates (mL/hour) of 60 mcg/mL solution
5
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.
-
Hospira, Inc.
Corlopam | Hospira, Inc.
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
5.310.5
2131.5
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
14470
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.
![Corlopam (Fenoldopam Mesylate) Injection, Solution [Hospira, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=df4cd207-c3b8-4008-5290-02f296c2b4a6&name=corlopam-2-figure-2-jRL-3624.jpg)
Login To Your Free Account