DOBUTAMINE HYDROCHLORIDE injection

국가: 미국

언어: 영어

출처: NLM (National Library of Medicine)

유효 성분:

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

제공처:

HF Acquisition Co LLC, DBA HealthFirst

관리 경로:

INTRAVENOUS

처방전 유형:

PRESCRIPTION DRUG

치료 징후:

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 Hydrochloride in 5% Dextrose Injection is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

제품 요약:

Dobutamine Hydrochloride in 5% Dextrose Injection in VIAFLEX PLUS plastic containers is available as follows: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended the product be stored at room temperature (25°C); brief exposure up to 40°C does not adversely affect the product. Directions for use of VIAFLEX PLUS Plastic Container Do not remove unit from overwrap until ready for use. To open Tear overwrap down side at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired. Preparation for Administration Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired. Caution: Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is completed. 1. Suspend container from eyelet support. 2. Remove plastic protector from administration port at bottom of container. 3. Attach administration set. Refer to complete directions accompanying set. Baxter, Viaflex and Viaflex Plus are trademarks of Baxter International Inc. Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA 07-19-00-0594 Rev. March 2019

승인 상태:

New Drug Application

제품 특성 요약

DOBUTAMINE HYDROCHLORIDE- DOBUTAMINE HYDROCHLORIDE INJECTION
HF ACQUISITION CO LLC, DBA HEALTHFIRST
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DOBUTAMINE HYDROCHLORIDE IN 5% DEXTROSE INJECTION, 250MG PER
250ML (1,000 MCG/ML)
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.
*
Approximately 5 mEq/L sodium bisulfite is added as a stabilizer.
†
Normal physiologic osmolarity range is approximately 280 to 310
mOsmol/L.
Administration of substantially hypertonic solutions (≥ 600
mOsmol/L) may cause vein
damage.
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
chemical components in very small amounts within the expiration
period, e.g., di-2-
ethylhexyl phthalate (DE