DOBUTAMINE injection, solution

País: Estados Unidos

Língua: inglês

Origem: NLM (National Library of Medicine)

Ingredientes ativos:

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

Disponível em:

Hospira, Inc.

DCI (Denominação Comum Internacional):

DOBUTAMINE HYDROCHLORIDE

Composição:

DOBUTAMINE 12.5 mg in 1 mL

Via de administração:

INTRAVENOUS

Tipo de prescrição:

PRESCRIPTION DRUG

Indicações terapêuticas:

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 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.

Resumo do produto:

Dobutamine Injection, USP, 12.5 mg/mL is available as: Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.]

Status de autorização:

Abbreviated New Drug Application

Características técnicas

DOBUTAMINE- DOBUTAMINE INJECTION, SOLUTION
HOSPIRA, INC.
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DOBUTAMINE
INJECTION, USP
R only
DESCRIPTION
Dobutamine Injection, USP is 1,2-benzenediol,
4-[2-[[3-(4-hydro-xyphenyl)-1-
methylpropyl]amino]ethyl]-hydrochloride, (±). It is a synthetic
catecholamine.
Molecular Formula: C
H NO ·HCl Molecular Weight: 337.85
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 µmol)
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 ß
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 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 volume 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 clinical experience with dobutamine is short-term-not more than
several hours in duration.