DOBUTAMINE- dobutamine hydrochloride injection injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

General Injectables and Vaccines, Inc.

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Dobutamine injection 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 use 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.

Product summary:

Dobutamine Injection, USP, 12.5 mg/mL is available as: 20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025). 40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10 (List 2025). Store at 20 to 25C (68 to 77F). [See USP Controlled Room Temperature.] Revised: January, 2005. HOSPIRA, INC., Lake Forest, IL 60045 USA

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOBUTAMINE- DOBUTAMINE HYDROCHLORIDE INJECTION INJECTION, SOLUTION
GENERAL INJECTABLES AND VACCINES, INC.
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DOBUTAMINE
DESCRIPTION
Dobutamine Injection, USP is 1,2-benzenediol,
4-[2-[[3-(4-hydro-xphenyl)-1-
methylpropyl]amino]ethyl]-hydrochloride, (±). It is a synthetic
catecholamine.
The clinical formulation is supplied in a sterile form for intravenous
use only. Each mL contains:
Dobutamine hydrochloride, equivalent to 12.5 mg (41.5 umol)
dobutamine; 0.24 mg sodium metabisulfite
(added during manufacture), and water for injection, pH adjusted
between 2.5 to 5.5 with hydrochloric
acid and/or sodium hydroxide. Dobutamine is oxygen sensitive.
CLINICAL PHARMACOLOGY
Dobutamine 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 ccause the release of endogenous
norepinephrine, as does
dopamine. In animal studies, dobutamine 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 and
isoproterenol increase the cardiac
output to a similar degree. In the case of dobutamine, this increase
is usually not accompanied by marked
increases in heart rate (although tachycardia is occasionally
observed), and the cardiac stroke bolume is
usually increased. In contrast, isoproterenol increases the cardiac
index primarily by increasing the
heart rate while stroke volume changes little or declines.
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
of dobutamine. Occasionally,
minimum vasoconstriction has been observed.
Most clincical experience with dobutamine is short-term-not more than
several hours in duration. In the
limited number of pati