DOBUTAMINE IN DEXTROSE injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Hospira, Inc.

INN (International Name):

DOBUTAMINE HYDROCHLORIDE

Composition:

DOBUTAMINE 200 mg in 100 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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% Dext

Product summary:

DOBUTamine in 5% Dextrose Injection, USP is supplied in 250 LifeCare™ single-dose flexible containers as follows: Do not freeze. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature.] Distributed by Hospira, Inc., Lake Forest, IL 60045 USA                                                                                       LAB-1181-3.0 Revised: 3/2021

Authorization status:

New Drug Application

Summary of Product characteristics

DOBUTAMINE IN DEXTROSE- DOBUTAMINE IN DEXTROSE INJECTION, SOLUTION
HOSPIRA, INC.
----------
DOBUTAMINE
IN 5% DEXTROSE INJECTION, USP
FLEXIBLE PLASTIC CONTAINER
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 (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
6
12
6
2
2
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-