CORLOPAM Principal Display Panel (fenoldopam mesylate injection, USP) | Pfizer Medical Information - US

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PRINCIPAL DISPLAY PANEL - 1 mL Vial Label

1 mL Single-dose Fliptop Vial
NDC 0409-3373-01

CORLOPAM®
Fenoldopam Mesylate Injection, USP

10 mg/mL

Rx only

Dilute before administering.
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

PRINCIPAL DISPLAY PANEL - 1 mL Vial Label

PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton

NDC 0409-3373-01
1 mL Single-dose Fliptop Vial

CORLOPAM®
Fenoldopam Mesylate
Injection, USP

10 mg/mL

Solution for
Intravenous Infusion

Rx only

Hospira

PRINCIPAL DISPLAY PANEL - 1 mL Vial Carton

PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

2 mL Single-dose Fliptop Vial
NDC 0409-3373-02

CORLOPAM®
Fenoldopam Mesylate Injection, USP

20 mg/2 mL
(10 mg/mL)

Rx only

Dilute before administering.
Distributed by Hospira, Inc., Lake Forest, IL 60045 USA

Hospira

PRINCIPAL DISPLAY PANEL - 2 mL Vial Label

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton

NDC 0409-3373-02
2 mL Single-dose Fliptop Vial

CORLOPAM®
Fenoldopam Mesylate
Injection, USP

20 mg/2 mL
(10 mg/mL)

Solution for
Intravenous
Infusion

Rx only

Hospira

PRINCIPAL DISPLAY PANEL - 2 mL Vial Carton

If you provide additional keywords, you may be able to browse through our database of Scientific Response Documents.

Our scientific content is evidence-based, scientifically balanced and non-promotional. It undergoes rigorous internal medical review and is updated regularly to reflect new information.

CORLOPAM Quick Finder

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HIGHLIGHTS OF PRESCRIBING INFORMATION

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1 INDICATIONS AND USAGE

1.1 Adult Patients

Fenoldopam is indicated for in-hospital, short-term (up to 48 hours) management of severe hypertension when rapid, but...

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2 DOSAGE AND ADMINISTRATION

2.1 Recommended Dosage

Adult Patients

Initiate dosing at 0.01 to 0.3 mcg/kg/min as a continuous...

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3 DOSAGE FORMS AND STRENGTHS

10 mg/mL solution in single-dose vial

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4 CONTRAINDICATIONS

None.

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5 WARNINGS AND PRECAUTIONS

5.1 Tachycardia

Fenoldopam causes a dose-related tachycardia, particularly with infusion rates above 0.1 mcg/kg/min in adults and >0.8...

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6 ADVERSE REACTIONS

6.1 Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the...

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7 DRUG INTERACTIONS

7.1 Beta-Blockers

Avoid concomitant use of fenoldopam with beta-blockers. If the drugs are used together, blood pressure should be monitored...

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8 USE IN SPECIFIC POPULATIONS

8.1 Pregnancy

Risk Summary

There are...

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10 OVERDOSAGE

The most likely reaction in a fenoldopam overdose would be excessive hypotension which should be treated with drug discontinuation and appropriate supportive measures.

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11 DESCRIPTION

CORLOPAM (Fenoldopam Mesylate Injection, USP) is a dopamine D1-like receptor agonist. The product is formulated as a solution to be diluted for intravenous infusion. Chemically it is...

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12 CLINICAL PHARMACOLOGY

12.1 Mechanism of Action

Fenoldopam is a rapid-acting vasodilator. It is an agonist for D1...

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13 NONCLINICAL TOXICOLOGY

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

In a 24-month study, mice treated orally with fenoldopam at 12.5, 25, or 50 mg/...

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16 HOW SUPPLIED/STORAGE AND HANDLING

...

Unit of Sale

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17 PATIENT COUNSELING INFORMATION

•: Advise patients with underlying hypertension that they require continued follow up for their medical condition, and, if applicable, encourage patients to continue taking their oral...

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This product's labeling may have been updated. For the most recent prescribing information, please visit www.pfizer.com.

Distributed by

Hospira, Inc., Lake Forest,...

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Pfizer Safety

To report an adverse event related to a Pfizer product and you are not part of a clinical trial* for this product, click the link below to submit your information: Pfizer Safety Reporting Site

*If you are involved in a clinical trial for either product, adverse events should be reported to your coordinating study site.

If you cannot use the above website to report an adverse event related to a Pfizer product, please call Pfizer Medical Information at (800) 438-1985.

FDA Medwatch

You may also contact the U.S. Food and Drug Administration (FDA) directly to report adverse events or product quality concerns either online at www.fda.gov/medwatchor by calling
(800)-332-1088.