DOPAMINE HYDROCHLORIDE IN DEXTROSE injection, solution

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 0.8 mg in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dopamine Hydrochloride in Dextrose 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 dosages, on a mcg/m2 basis, of one-third the human starting dosage 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 pregna

Product summary:

Dopamine Hydrochloride in 5% Dextrose Injection, USP, is supplied in 250 and 500 mL LifeCare flexible single-dose plastic containers (the solutions are clear to slightly yellow in appearance) as follows. Each 100 mL contains 5 grams of hydrous dextrose in Water for Injection. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Protect from freezing. Discard unused portion.

Authorization status:

New Drug Application

Summary of Product characteristics

DOPAMINE HYDROCHLORIDE IN DEXTROSE- DOPAMINE HYDROCHLORIDE IN
DEXTROSE INJECTION, SOLUTION
HOSPIRA, INC.
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HIGHLIGHTS OF PRESCRIBING INFORMATION
THESE HIGHLIGHTS DO NOT INCLUDE ALL THE INFORMATION NEEDED TO USE
DOPAMINE
HYDROCHLORIDE IN DEXTROSE INJECTION SAFELY AND EFFECTIVELY. SEE FULL
PRESCRIBING
INFORMATION FOR DOPAMINE HYDROCHLORIDE IN DEXTROSE INJECTION.
DOPAMINE HYDROCHLORIDE IN DEXTROSE INJECTION, FOR INTRAVENOUS USE
INITIAL U.S. APPROVAL: 1974
INDICATIONS AND USAGE
Dopamine HCl in Dextrose 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.
(2.3)
DOSAGE FORMS AND STRENGTHS
Following strengths of Dopamine Hydrochloride in 5% Dextrose
Injection, USP, are supplied in LifeCare
flexible single-dose plastic containers (each 100 mL contains 5 grams
of hydrous dextrose in Water for
Injection): (3)
800 mcg/mL (250 and 500 mL)
1600 mcg/mL (250 and 500 mL)
3200 mcg/mL (250 mL)
CONTRAINDICATIONS
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 as