DOBUTAMINE injection, solution, concentrate

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

DOBUTAMINE HYDROCHLORIDE (UNII: 0WR771DJXV) (DOBUTAMINE - UNII:3S12J47372)

Available from:

Hospira, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dobutamine Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride. Dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to Dobutamine Injection, USP solution.

Product summary:

Dobutamine Injection, USP is supplied in 20 mL single-dose glass vials containing 250 mg dobutamine, as the hydrochloride as follows: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045, USA Novaplus is a registered trademark of Vizient, Inc. LAB-1054-3.0 Revised: 11/2020

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOBUTAMINE- DOBUTAMINE INJECTION, SOLUTION, CONCENTRATE
HOSPIRA, INC.
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DOBUTAMINE
INJECTION, USP
FLIPTOP VIAL
R only
MUST BE DILUTED PRIOR TO
ADMINISTRATION
DESCRIPTION
Dobutamine Injection, USP is a clear, practically colorless, sterile,
nonpyrogenic solution
of dobutamine hydrochloride for intravenous use only. Each milliliter
contains 12.5 mg
(41.5 μmol) dobutamine, as the hydrochloride and sodium
metabisulfite, 0.2 mg added
as antioxidant. May contain hydrochloric acid and/or sodium hydroxide
for pH
adjustment. pH is 3.3 (2.5 to 5.5).
Dobutamine Hydrochloride, USP is chemically designated
(±)-4-[2-[[3-(ρ-
hydroxyphenyl)-1-methylpropyl] amino]ethyl]-pyrocatechol
hydrochloride.
It is a synthetic catecholamine.
Molecular Weight: 337.85
Molecular Formula: C
H
NO •HCl
CLINICAL PHARMACOLOGY
Dobutamine hydrochloride is a direct-acting inotropic agent whose
primary activity
results from stimulation of the β receptors of the heart while
producing comparatively
mild chronotropic, hypertensive, arrhythmogenic, and vasodilative
effects. It does not
cause the release of endogenous norepinephrine, as does dopamine. In
animal studies,
dobutamine hydrochloride produces less increase in heart rate and less
decrease in
peripheral vascular resistance for a given inotropic effect than does
isoproterenol.
In patients with depressed cardiac function, both dobutamine
hydrochloride and
isoproterenol increase the cardiac output to a similar degree. In the
case of dobutamine
hydrochloride, this increase is usually not accompanied by marked
increases in heart
rate (although tachycardia is occasionally observed), and the cardiac
stroke volume is
usually increased. In contrast, isoproterenol increases the cardiac
index primarily by
increasing the heart rate while stroke volume changes little or
declines.
x
18
23
3
Facilitation of atrioventricular conduction has been observed in human
electrophysiologic
studies and in patients with atrial fibrillation.
Systemic vascular resistance is usually decreased with administration
o