DOBUTAMINE injection, solution

Šalis: Jungtinės Valstijos

kalba: anglų

Šaltinis: NLM (National Library of Medicine)

Veiklioji medžiaga:

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

Prieinama:

Hikma Pharmaceuticals USA Inc.

Vartojimo būdas:

INTRAVENOUS

Recepto tipas:

PRESCRIPTION DRUG

Terapinės indikacijos:

Dobutamine 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. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions. Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risk of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk. Dobutamine is contraindicated in patients with idiopath

Produkto santrauka:

Dobutamine Injection USP, 20 mL single dose vial contains dobutamine hydrochloride, equivalent to 250 mg dobutamine per 20 mL; ten vials per carton. NDC 0143-9141-10 . Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 September 2022                                                                                                             PIN612-WES/1

Autorizacija statusas:

Abbreviated New Drug Application

Prekės savybės

DOBUTAMINE- DOBUTAMINE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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DOBUTAMINE INJECTION USP
RX ONLY
DESCRIPTION
Dobutamine Injection USP is (±)-4-[2-[[3-(_p_-Hydroxyphenyl)-1-
methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a
synthetic catecholamine.
Molecular Formula: C
H
NO •HCl
Molecular Weight: 337.84
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;
sodium metabisulfite 0.26 mg, and water for injection, q.s.
Hydrochloric acid and/or
sodium hydroxide may have been added during manufacture to adjust the
pH (2.5 to
5.5).
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
18
23
3
duratio