DOBUTAMINE injection, solution

Land: USA

Språk: engelska

Källa: NLM (National Library of Medicine)

Aktiva substanser:

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

Tillgänglig från:

HF Acquisition Co LLC, DBA HealthFirst

Administreringssätt:

INTRAVENOUS

Receptbelagda typ:

PRESCRIPTION DRUG

Terapeutiska indikationer:

Dobutamine in 5% Dextrose 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 risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk. Dobutamine in 5% Dextrose Injection, USP is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine or any of its components.

Produktsammanfattning:

DOBUTAMINE IN 5% DEXTROSE INJECTION, USP is supplied in the following dosage forms. NDC 51662-1330-1 DOBUTAMINE IN 5% DEXTROSE INJECTION, USP 500mg 250mL BAG HF Acquisition Co LLC, DBA HealthFirst Mukilteo, WA 98275 Also supplied in the following manufacture supplied dosage forms DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 and 500 mL LifeCare™ flexible containers as follows: Do not freeze. Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA LAB-1181-1.0 Revised: 04/2018

Bemyndigande status:

New Drug Application

Produktens egenskaper

DOBUTAMINE- DOBUTAMINE INJECTION, SOLUTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
----------
DOBUTAMINE IN 5% DEXTROSE INJECTION, USP 500MG 250ML BAG
SPL UNCLASSIFIED
DOBUTamine
in 5% Dextrose Injection, USP
Flexible Plastic Container
Hospira
Rx only
DESCRIPTION
Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic,
prediluted solution
of dobutamine hydrochloride and dextrose in water for injection. It is
administered by
intravenous infusion.
Each 100 mL contains dobutamine hydrochloride equivalent to 100 mg,
200 mg, or 400
mg of dobutamine; dextrose (derived from corn), hydrous 5 g in water
for injection, with
sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added
as stabilizers;
osmolar concentration, respectively, 263, 270, or 284 mOsmol/liter
(calc.). The pH is 3.0
(2.5 to 5.5). May contain hydrochloric acid and/or sodium hydroxide
for pH adjustment.
Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive.
Dobutamine Hydrochloride, USP is chemically designated
(±)-4-[2-[[3-(p-
hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride.
It is a
synthetic catecholamine.
Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6
• H2O), a
hexose sugar freely soluble in water. It has the following structural
formula:
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially
formulated CR3 plastic
material. Water can permeate from inside the container into the
overwrap but not in
amounts sufficient to affect the solution significantly. Solutions in
contact with the plastic
container may leach out certain chemical components from the plastic
in very small
amounts; however, biological testing was supportive of the safety of
the plastic
container materials. Exposure to temperatures above 25°C/77°F during
transport and
storage will lead to minor losses in moisture content. Higher
temperatures lead to
greater losses. It is unlikely that these minor losses will lead to
clinically significant
changes w