DOPAMINE HYDROCHLORIDE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOPAMINE HYDROCHLORIDE (UNII: 7L3E358N9L) (DOPAMINE - UNII:VTD58H1Z2X)

Available from:

Hospira, Inc.

INN (International Name):

DOPAMINE HYDROCHLORIDE

Composition:

DOPAMINE HYDROCHLORIDE 40 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dopamine HCl Injection is indicated to improve hemodynamic status in patients in distributive shock or shock due to reduced cardiac output. Dopamine is contraindicated in patients with pheochromocytoma. Risk Summary There are no human data with dopamine use in pregnant women. There are risks to the mother and fetus from hypotension associated with shock, which can be fatal if left untreated (see Clinical Considerations ). In animal reproduction studies, adverse developmental outcomes were observed with intravenous dopamine HCl administration in pregnant rats during organogenesis at doses, on a mcg/m2 basis, of one‑third the human starting dose of 2 mcg/kg/minute (90 mcg/m2 /minute). The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies carry some risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2‑4% and 15‑20%,

Product summary:

Dopamine Hydrochloride Injection, USP is a clear, practically colorless solution supplied as follows: NDC 0409-5820-01 25 Fliptop Single-dose Vials in a Tray 200 mg/5 mL (40 mg/mL) NDC 0409-9104-20 25 Fliptop Single-dose Vials in a Tray 400 mg/10 mL (40 mg/mL) Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.]

Authorization status:

New Drug Application

Summary of Product characteristics

DOPAMINE HYDROCHLORIDE- DOPAMINE HYDROCHLORIDE INJECTION, SOLUTION,
CONCENTRATE
HOSPIRA, INC.
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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)
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CONTRAINDICATIONS
Dopamine is contraindicated in patients with pheochromocytoma. (4)
WARNINGS AND PRECAUTIONS
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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
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SEE 17 FOR PATIENT COUNSELING INFORMATION.
REVISED: 9/2023
200 mg/5 mL (40 mg/mL)
400 mg/10 mL (40 mg/mL)
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 intra