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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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