DOBUTAMINE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Slate Run Pharmaceuticals

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 patients 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 hydrochloride is contraindic

Product summary:

Dobutamine Injection, USP is supplied in 20 mL single-dose glass vials containing 250 mg dobutamine, respectively, as the hydrochloride as follows: Unit of Sale Concentration NDC 70436-203-80 Carton containing 1 Vial 250 mg/20 mL (12.5 mg/mL) NDC 70436-203-82 Carton containing 10 Vials 250 mg/20 mL (12.5 mg/mL) Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Discard unused portion. Manufactured by: Hainan Poly Pharm. Co., Ltd., Guilinyang Economic Development Zone, Haikou, Hainan, 571127, China Distributed by: Slate Run Pharmaceuticals, LLC., Columbus, Ohio 43215 10000396/01 Revised: 02/2023

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

DOBUTAMINE- DOBUTAMINE INJECTION
SLATE RUN PHARMACEUTICALS
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DOBUTAMINE INJECTION
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 5.0).
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 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.
18
23
3
Systemic vascular resistance is usually decreased with administration
of dobutamine.
Occasionally, minimum vasoconstriction has been observed.
Most clinical experience with dobutamine is short-term − n