DOBUTAMINE HYDROCHLORIDE IN DEXTROSE- dobutamine hydrochloride injection

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

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

Commercializzato da:

A-S Medication Solutions

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Dobutamine Hydrochloride in 5% Dextrose Injection 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 Hy

Dettagli prodotto:

Product: 50090-4562 NDC: 50090-4562-0 250 mL in a BAG

Stato dell'autorizzazione:

New Drug Application

Scheda tecnica

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE- DOBUTAMINE
HYDROCHLORIDE INJECTION
A-S MEDICATION SOLUTIONS
----------
DOBUTAMINE HYDROCHLORIDE IN 5% DEXTROSE INJECTION
IN PLASTIC CONTAINER
VIAFLEX PLUS CONTAINER
DESCRIPTION
Dobutamine Hydrochloride in 5% Dextrose Injection is a sterile,
nonpyrogenic solution of
Dobutamine Hydrochloride, USP and Dextrose, USP in Water for
Injection, USP.
Dobutamine hydrochloride is chemically designated as
(±)-4-[2-[[3-(p-hydroxyphenyl)-1-
methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a
synthetic catecholamine.
Dextrose Hydrous, USP is chemically designated as D-Glucopyranose
monohydrate.
Structural formulas are shown below:
DOBUTAMINE HYDROCHLORIDE, USP
(D-GLUCOPYRANOSE MONOHYDRATE) DEXTROSE HYDROUS, USP
Dobutamine Hydrochloride in 5% Dextrose Injection is intended for
intravenous use
only. It contains no antimicrobial agents. The pH is adjusted with
sodium hydroxide
and/or hydrochloric acid. Sodium bisulfite is added as a stabilizer.
The solution is
intended for single use only. When smaller doses are required, the
unused portion
should be discarded. Composition, osmolarity, pH and caloric content
are given in Table
1.
TABLE 1. COMPOSITION DOBUTAMINE HYDROCHLORIDE IN 5% DEXTROSE
INJECTION.
Dobutamine
(mg/Container)
Dobutamine
(mcg/mL)
Dextrose
Hydrous, USP
(g/L)
Osmolarity
(mOsmol/L)
(calc)
pH
kcal/L
250 mg/250 mL
1000
50
259
3.5
(2.5 to 5.5)
170
*
†
*
†
500 mg/250 mL
2000
50
266
3.5
(2.5 to 5.5)
170
1000 mg/250 mL
4000
50
280
3.5
(2.5 to 5.5)
170
This VIAFLEX PLUS plastic container is fabricated from a specially
formulated polyvinyl
chloride (PL 2207 Plastic). VIAFLEX containers, including VIAFLEX PLUS
containers, are
made of flexible plastic and are for parenteral use. VIAFLEX PLUS on
the container
indicates the presence of a drug additive in a drug vehicle. The
amount of water that can
permeate from inside the container into the overwrap is insufficient
to affect the solution
significantly. Solutions in contact with the plastic container can
leach out certain of its