CORLOPAM Dosage and Administration

(fenoldopam mesylate injection, USP)

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Adult Patients

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.

Pediatric Patients

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.

2.2 Preparation and Administration

Dilute contents of vials with 0.9% Sodium Chloride Injection or 5% Dextrose in Water before infusion. Each 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)

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Dosage and Administration

2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Adult Patients

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.

Pediatric Patients

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.

2.2 Preparation and Administration

Dilute contents of vials with 0.9% Sodium Chloride Injection or 5% Dextrose in Water before infusion. Each 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)

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