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Fenoldopam (Fenoldopam Mesylate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

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 anytime after blood pressure is stable during fenoldopam mesylate infusion.

Pediatric Patients: Information related to the indicated use of fenoldopam injection in pediatric patients is approved for Abbott Laboratories’ fenoldopam drug products. However, due to Abbott’s marketing exclusivity rights, this drug product is not labeled for pediatric use.

DOSAGE AND ADMINISTRATION

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 patients. An initial fenoldopam mesylate injection dose may be chosen from Tables 1 and 2 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 mesylate injection 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 mesylate injection infusion. In clinical trials, fenoldopam mesylate injection 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 mesylate injection infusion can be abruptly discontinued or gradually tapered prior to discontinuation. Oral antihypertensive agents can be added during fenoldopam mesylate injection infusion or following its discontinuation. Patients in controlled clinical trials have received intravenous fenoldopam mesylate injection for as long as 48 hours.

PREPARATION OF INFUSION SOLUTION

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

Dilution:

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

mL of Concentrate (mg of drug)Added toFinal Concentration
4 mL (40 mg)1000 mL40 mcg/mL
2 mL (20 mg)500 mL40 mcg/mL
1 mL (10 mg)250 mL40 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 4 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 4 FENOLDOPAM ADULT INFUSION RATES (mL/hour) DRUG DOSAGE FOR ADULTS > 40 KG, USING 40 MCG/ML CONCENTRATION NOTE: CONCENTRATION IS DIFFERENT FROM PEDIATRIC PATIENTS, SEE BELOW: PEDIATRIC PATIENTS
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
Infusion Rate (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 9.0 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 4 (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, SEE BELOW: PEDIATRIC PATIENTS
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 Infusion Rate (mL/hour) of 40 mcg/mL solution
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: Information related to the dosing and administration of fenoldopam injection in pediatric patients is approved for Abbott Laboratories’ fenoldopam drug products. However, due to Abbott’s marketing exclusivity rights, this drug product is not labeled for pediatric use.

HOW SUPPLIED

Fenoldopam Mesylate Injection USP is supplied in single-dose vials as follows:
NDC 55390-071-01, 10 mg/mL; 1 mL vial, individually boxed.
NDC 55390-072-01, 10 mg/mL; 2 mL vial, individually boxed.

Store at 2° to 30°C (35.6° to 86°F). Discard unused portion.

Manufactured by:                                                                                                  Manufactured for:

Ben Venue Laboratories, Inc.                                                                       Bedford Laboratories™

Bedford, OH 44146                                                                                             Bedford, OH 44146

August 2004                                                                                                                        FDP-P01

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