CORLOPAM Highlights

(fenoldopam mesylate injection, USP)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CORLOPAM safely and effectively. See full prescribing information for CORLOPAM.

CORLOPAM (fenoldopam mesylate) injection, for intravenous use
Initial U.S. Approval: 1997

INDICATIONS AND USAGE

Fenoldopam injection is a dopaminergic agonist indicated:

•
In adult patients for short term management of severe hypertension when rapid and reversible reduction of blood pressure is clinically indicated, including for malignant hypertension with deteriorating end-organ function (1.1).
•
In pediatric patients for short-term reduction in blood pressure (1.2).

DOSAGE AND ADMINISTRATION

•
Adults: Initiate dosing at 0.01 to 0.3 mcg/kg/min by continuous infusion. Dosing can be increased in increments of 0.05 to 0.1 mcg/kg/minute every 15 minutes or longer until target blood pressure is reached (2.1).
•
Dilute prior to administration (2.1, 2.2).
•
Pediatrics: Initiate dosing at 0.2 mcg/kg/minute by continuous infusion 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 (2.1, 2.2).

DOSAGE FORMS AND STRENGTHS

•
10 mg/mL solution in single-dose vial (3).

CONTRAINDICATIONS

None (4).

WARNINGS AND PRECAUTIONS

•
Fenoldopam causes a dose-related tachycardia, particularly with infusion rates above 0.1 mcg/kg/min (5.1).
•
Hypokalemia: Monitor potassium levels (5.2).
•
Increased intraocular pressure in patients with glaucoma or intraocular hypertension (5.3).
•
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms in susceptible patients (5.4).

ADVERSE REACTIONS

The most common events (occurring in more than 5% of patients) reported associated with use are headache, cutaneous dilation (flushing), nausea, and hypotension (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Beta-blockers: Avoid concomitant use (7.1).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2021

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use CORLOPAM safely and effectively. See full prescribing information for CORLOPAM.

CORLOPAM (fenoldopam mesylate) injection, for intravenous use
Initial U.S. Approval: 1997

INDICATIONS AND USAGE

Fenoldopam injection is a dopaminergic agonist indicated:

•
In adult patients for short term management of severe hypertension when rapid and reversible reduction of blood pressure is clinically indicated, including for malignant hypertension with deteriorating end-organ function (1.1).
•
In pediatric patients for short-term reduction in blood pressure (1.2).

DOSAGE AND ADMINISTRATION

•
Adults: Initiate dosing at 0.01 to 0.3 mcg/kg/min by continuous infusion. Dosing can be increased in increments of 0.05 to 0.1 mcg/kg/minute every 15 minutes or longer until target blood pressure is reached (2.1).
•
Dilute prior to administration (2.1, 2.2).
•
Pediatrics: Initiate dosing at 0.2 mcg/kg/minute by continuous infusion 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 (2.1, 2.2).

DOSAGE FORMS AND STRENGTHS

•
10 mg/mL solution in single-dose vial (3).

CONTRAINDICATIONS

None (4).

WARNINGS AND PRECAUTIONS

•
Fenoldopam causes a dose-related tachycardia, particularly with infusion rates above 0.1 mcg/kg/min (5.1).
•
Hypokalemia: Monitor potassium levels (5.2).
•
Increased intraocular pressure in patients with glaucoma or intraocular hypertension (5.3).
•
Contains sodium metabisulfite, a sulfite that may cause allergic-type reactions including anaphylactic symptoms in susceptible patients (5.4).

ADVERSE REACTIONS

The most common events (occurring in more than 5% of patients) reported associated with use are headache, cutaneous dilation (flushing), nausea, and hypotension (6.1).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Beta-blockers: Avoid concomitant use (7.1).

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2021
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