DOBUTAMINE HYDROCHLORIDE injection, solution

Country: Ամերիկայի Միացյալ Նահանգներ

language: անգլերեն

source: NLM (National Library of Medicine)

active_ingredient:

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

MAH:

Physicians Total Care, Inc.

INN:

DOBUTAMINE HYDROCHLORIDE

composition:

DOBUTAMINE HYDROCHLORIDE 400 mg in 100 mL

administration_route:

INTRAVENOUS

prescription_type:

PRESCRIPTION DRUG

therapeutic_indication:

Dobutamine in 5% Dextrose Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of 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% Dextros

leaflet_short:

DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 and 500 mL LifeCare® flexible containers as follows: List No. 2347 − 500 mg DOBUTamine in 5% Dextrose Injection, USP 250 mL NDC 54868-5777-0 Store at 20 to 25ºC (68 to 77ºF). [See USP Controlled Room Temperature.] Protect from freezing. June, 2006

authorization_status:

New Drug Application

SPC

DOBUTAMINE HYDROCHLORIDE - DOBUTAMINE HYDROCHLORIDE INJECTION,
SOLUTION
PHYSICIANS TOTAL CARE, INC.
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FLEXIBLE PLASTIC CONTAINER
R 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 50 mg, 100
mg, 200 mg, or 400 mg of
dobutamine; dextrose, hydrous 5 g in water for injection, with sodium
metabisulfite 25 mg and edetate
disodium, dihydrate 10 mg added as stabilizers; osmolar concentration,
respectively, 260, 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 (C H O
• H O), a hexose sugar
freely soluble in water. It has the following structural formula:
Water for Injection, USP is chemically designated H O.
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 within
the expiration period.
CLINICAL PHARMACOLOGY
Dobutamine is a direct-acting inotropic agent whose primary activ