dopamine hydrochloride injection, USP VIAL Highlights

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HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DOPAMINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOPAMINE HYDROCHLORIDE INJECTION.
DOPAMINE HYDROCHLORIDE injection, for intravenous use
Initial U.S. Approval: 1974

INDICATIONS AND USAGE

Dopamine HCl Injection is a catecholamine indicated to improve hemodynamic status in patients in shock. (1)

DOSAGE AND ADMINISTRATION

Correct hypovolemia, acidosis, and hypoxia prior to use. (2.1)

Administer in a large vein with an infusion pump preferably in an intensive care setting. (2.1)

Recommended starting dosage in adults and pediatric patients is 2 to 5 mcg/kg/minute as a continuous intravenous infusion. Titrate in 5 to 10 mcg/kg/minute increments based on hemodynamic response and tolerability, up to not more than 50 mcg/kg/minute. (2.2)

See the Full Prescribing Information for important preparation instructions and drug incompatibilities. (2.1,2.3)

DOSAGE FORMS AND STRENGTHS

The following strengths of Dopamine HCL, USP, are supplied in single-dose vials: (3)

•
200 mg/5 mL (40 mg/mL)
•
400 mg/10 mL (40 mg/mL)

CONTRAINDICATIONS

Dopamine is contraindicated in patients with pheochromocytoma. (4)

WARNINGS AND PRECAUTIONS

•
Tissue ischemia: Severe peripheral and visceral vasoconstriction can occur. Address hypovolemia prior to use, monitor extremities, and infuse into large vein. (5.1)
•
Cardiac arrhythmias: Monitor closely. (5.2)
•
Hypotension after abrupt discontinuation: Gradually reduce infusion rate while expanding blood volume with intravenous fluids. (5.3)
•
Severe hypersensitivity reactions due to sodium metabisulfite excipient: May cause anaphylaxis including life‑threatening or less severe asthmatic episodes in susceptible individuals. (5.4)

ADVERSE REACTIONS

The most common adverse reaction is localized vasoconstriction due to extravasation. (6)

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

•
Halogenated anesthetics: Can sensitize the myocardium to the effects of dopamine and can produce ventricular arrhythmias and hypertension. (7)
•
MAO inhibitors: Risk of severe hypertension. Reduce recommended Dopamine HCl Injection dosage. (7)
•
Tricyclic antidepressants: Risk of hypertension. Monitor blood pressure. (7)
•
Vasopressors: Risk of severe hypertension. Monitor blood pressure. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use DOPAMINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for DOPAMINE HYDROCHLORIDE INJECTION.
DOPAMINE HYDROCHLORIDE injection, for intravenous use
Initial U.S. Approval: 1974

INDICATIONS AND USAGE

Dopamine HCl Injection is a catecholamine indicated to improve hemodynamic status in patients in shock. (1)

DOSAGE AND ADMINISTRATION

Correct hypovolemia, acidosis, and hypoxia prior to use. (2.1)

Administer in a large vein with an infusion pump preferably in an intensive care setting. (2.1)

Recommended starting dosage in adults and pediatric patients is 2 to 5 mcg/kg/minute as a continuous intravenous infusion. Titrate in 5 to 10 mcg/kg/minute increments based on hemodynamic response and tolerability, up to not more than 50 mcg/kg/minute. (2.2)

See the Full Prescribing Information for important preparation instructions and drug incompatibilities. (2.1,2.3)

DOSAGE FORMS AND STRENGTHS

The following strengths of Dopamine HCL, USP, are supplied in single-dose vials: (3)

•
200 mg/5 mL (40 mg/mL)
•
400 mg/10 mL (40 mg/mL)

CONTRAINDICATIONS

Dopamine is contraindicated in patients with pheochromocytoma. (4)

WARNINGS AND PRECAUTIONS

•
Tissue ischemia: Severe peripheral and visceral vasoconstriction can occur. Address hypovolemia prior to use, monitor extremities, and infuse into large vein. (5.1)
•
Cardiac arrhythmias: Monitor closely. (5.2)
•
Hypotension after abrupt discontinuation: Gradually reduce infusion rate while expanding blood volume with intravenous fluids. (5.3)
•
Severe hypersensitivity reactions due to sodium metabisulfite excipient: May cause anaphylaxis including life‑threatening or less severe asthmatic episodes in susceptible individuals. (5.4)

ADVERSE REACTIONS

The most common adverse reaction is localized vasoconstriction due to extravasation. (6)

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

•
Halogenated anesthetics: Can sensitize the myocardium to the effects of dopamine and can produce ventricular arrhythmias and hypertension. (7)
•
MAO inhibitors: Risk of severe hypertension. Reduce recommended Dopamine HCl Injection dosage. (7)
•
Tricyclic antidepressants: Risk of hypertension. Monitor blood pressure. (7)
•
Vasopressors: Risk of severe hypertension. Monitor blood pressure. (7)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 9/2023
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