April 29, 2016
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Corlopam

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Corlopam

Indications
Dosage
How Supplied

INDICATIONS

Adult Patients

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.

Pediatric Patients

Fenoldopam is indicated for in-hospital, short-term (up to 4 hours) reduction in blood pressure [ CLINICAL PHARMACOLOGY].

DOSAGE AND ADMINISTRATION

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]; 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 MAP but did worsen tachycardia.

Preparation And Administration

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)

HOW SUPPLIED

Dosage Forms And Strengths

10 mg/mL solution in single-dose vial 10 mg/mL solution in single-dose ampule

Storage And Handling

Container Concentration (mg/mL) Fill Quantity (per carton) NDC#
Single-dose vials 10 1 mL 1 0409-3373-01
Single-dose vials 10 2 mL 1 0409-3373-02
Single-dose ampule 10 1 mL 1 0409-2304-01
Single-dose ampule 10 2 mL 1 0409-2304-02

Store at 2 to 30°C (35.6 to 86°F).

Hospira, Inc., Lake Forest, IL 60045 USA. Revised: Dec 2015

This monograph has been modified to include the generic and brand name in many instances.

Last reviewed on RxList: 12/26/2015

Indications
Dosage
How Supplied

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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