DOBUTAMINE- dobutamine hydrochloride injection, solution

Valsts: Amerikas Savienotās Valstis

Valoda: angļu

Klimata pārmaiņas: NLM (National Library of Medicine)

Aktīvā sastāvdaļa:

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

Pieejams no:

Physicians Total Care, Inc.

SNN (starptautisko nepatentēto nosaukumu):

DOBUTAMINE HYDROCHLORIDE

Kompozīcija:

DOBUTAMINE HYDROCHLORIDE 12.5 mg in 1 mL

Ievadīšanas:

INTRAVENOUS

Receptes veids:

PRESCRIPTION DRUG

Ārstēšanas norādes:

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.

Produktu pārskats:

Dobutamine Injection, USP, 12.5 mg/mL is available as: 20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride),   NDC 54868-5717-0 20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10,   NDC 54868-5717-2 40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10,   NDC 54868-5717-1 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] October, 2004. ©Hospira 2004   EN-0623

Autorizācija statuss:

Abbreviated New Drug Application

Produkta apraksts

DOBUTAMINE - DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION
PHYSICIANS TOTAL CARE, INC.
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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.
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 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 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. In the
limited number of patients who were studied fo