Source: FDA, National Drug Code (US) Revision Year: 2020
Fenoldopam is indicated for 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.
Fenoldopam is indicated for in-hospital, short-term (up to 4 hours) reduction in blood pressure [see Clinical Pharmacology (12.2)].
Initiate dosing at 0.01 to 0.3 mcg/kg/min as a continuous intravenous infusion. Dosing may be increased in increments of 0.05 to 0.1 mcg/kg/minute every 15 minutes or longer, until target blood pressure is reached [see Clinical Pharmacology (12.2)]; the maximal infusion rate reported in clinical studies was 1.6 mcg/kg/minute. Doses lower than 0.1 mcg/kg/min and slow up-titration have been associated with less reflex tachycardia. Maintenance infusions may be continued for up to 48 hours.
Oral antihypertensive agents can be added during fenoldopam infusion or after discontinuation.
Initiate dosing at 0.2 mcg/kg/minute and titrate dose by 0.3 to 0.5 mcg/kg/min every 20-30 minutes to a maximum dose of 0.8 mcg/kg/minute. Higher doses generally produced no further decreases in Mean Arterial Pressure (MAP) but did worsen tachycardia.
Dilute contents of ampules or vials with 0.9% Sodium Chloride Injection or 5% Dextrose in Water before infusion. Each ampule or vial is for single use only. Discard diluted solution if not being administered to a patient after 4 hours at room temperature or 24 hours at refrigerated temperature. Inspect parenteral drug products for particulate matter and discoloration prior to administration, whenever solution and container permit. If particulate matter or cloudiness is observed, discard the drug.
Table 1. Dilution Instructions for Adults:
| 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 |
Table 2. Dilution Instructions for 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 |
Rates of infusion in mL/hour for fenoldopam may be calculated using the following formula:
Infusion Rate (mL/h) = [Dose (mcg/kg/min) x Weight (kg) x 60 min/h] / Concentration (mcg/mL)
Example calculations for infusion rates are as follows:
Example 1: for a 60 kg patient at an initial dose of 0.01 mcg/kg/min using a 40 mcg/mL concentration, the infusion rate would be as follows:
Infusion Rate (mL/h) = [0.01 (mcg/kg/min) x 60 (kg) x 60 (min/h)] = 0.9 (mL/h) / 40 (mcg/mL)
Example 2: for a 10 kg patient at a dose of 0.2 mcg/kg/min using a 60 mcg/mL concentration, the infusion rate would be as follows:
Infusion Rate (mL/h) = [0.2 (mcg/kg/min) x 10 (kg) x 60 (min/h)] = 2.0 (mL/h) / 60 (mcg/mL)
The most likely reaction in a fenoldopam overdose would be excessive hypotension which should be treated with drug discontinuation and appropriate supportive measures.
Store at 2 to 30°C (35.6 to 86°F).
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