DOBUTAMINE HYDROCHLORIDE IN DEXTROSE- dobutamine hydrochloride injection

מדינה: ארצות הברית

שפה: אנגלית

מקור: NLM (National Library of Medicine)

מרכיב פעיל:

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

זמין מ:

Baxter Healthcare Corporation

INN (שם בינלאומי):

DOBUTAMINE HYDROCHLORIDE

הרכב:

DOBUTAMINE 100 mg in 100 mL

מסלול נתינה (של תרופות):

INTRAVENOUS

סוג מרשם:

PRESCRIPTION DRUG

סממני תרפויטית:

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

leaflet_short:

Dobutamine Hydrochloride in 5% Dextrose Injection in Viaflex Plus plastic containers is available as follows: 2B0791 Dobutamine 250 mg/250 mL NDC 0338-1073-02 2B0792 Dobutamine 500 mg/250 mL NDC 0338-1075-02 2B0793 Dobutamine 1000 mg/250 mL NDC 0338-1077-02 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. The overwrap is a moisture and oxygen barrier. Do not remove unit from overwrap until ready for use. A sulfur dioxide odor may occur upon removal of the product from the overwrap container. The sulfur dioxide odor from Dobutamine Injection does not pose risk to the clinician or patient using the product. 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. 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. 1000 mcg/mL Patient's Weight (kg) Drug Delivery Rate (mcg/kg/min) 5 10 20 30 40 50 60 70 80 90 100 110 0.5 0.15 0.30 0.60 0.90 1.2 1.5 1.8 2.1 2.4 2.7 3.0 3.3 1 0.30 0.60 1.2 1.8 2.4 3.0 3.6 4.2 4.8 5.4 6.0 6.6 2.5 0.75 1.5 3.0 4.5 6.0 7.5 9.0 11 12 14 15 17 5 1.5 3.0 6.0 9.0 12 15 18 21 24 27 30 33 7.5 2.3 4.5 9.0 14 18 23 27 32 36 41 45 50 10 3.0 6.0 12 18 24 30 36 42 48 54 60 66 12.5 3.8 7.5 15 23 30 38 45 53 60 68 75 83 15 4.5 9.0 18 27 36 45 54 63 72 81 90 99 17.5 5.3 11 21 32 42 53 63 74 84 95 105 116 20 6.0 12 24 36 48 60 72 84 96 108 120 132   2000 mcg/mL Patient's Weight (kg) Drug Delivery Rate (mcg/kg/min) 5 10 20 30 40 50 60 70 80 90 100 110 0.5 0.08 0.15 0.30 0.45 0.60 0.75 0.90 1.1 1.2 1.4 1.5 1.7 1 0.15 0.30 0.60 0.90 1.2 1.5 1.8 2.1 2.4 2.7 3.0 3.3 2.5 0.38 0.75 1.5 2.3 3.0 3.8 4.5 5.3 6.0 6.8 7.5 8.3 5 0.75 1.5 3.0 4.5 6.0 7.5 9.0 11 12 14 15 17 7.5 1.1 2.3 4.5 6.8 9.0 11 14 16 18 20 23 25 10 1.5 3.0 6.0 9.0 12 15 18 21 24 27 30 33 12.5 1.9 3.8 7.5 11 15 19 23 26 30 34 38 41 15 2.3 4.5 9.0 14 18 23 27 32 36 41 45 50 17.5 2.6 5.3 11 16 21 26 32 37 42 47 53 58 20 3.0 6.0 12 18 24 30 36 42 48 54 60 66   4000 mcg/mL Patient's Weight (kg) Drug Delivery Rate (mcg/kg/min) 5 10 20 30 40 50 60 70 80 90 100 110 0.5 0.04 0.08 0.15 0.23 0.30 0.38 0.45 0.53 0.60 0.68 0.75 0.83 1 0.08 0.15 0.30 0.45 0.60 0.75 0.90 1.1 1.2 1.4 1.5 1.7 2.5 0.19 0.38 0.75 1.1 1.5 1.9 2.3 2.6 3.0 3.4 3.8 4.1 5 0.38 0.75 1.5 2.3 3.0 3.8 4.5 5.3 6.0 6.8 7.5 8.3 7.5 0.56 1.1 2.3 3.4 4.5 5.6 6.8 7.9 9.0 10 11 12 10 0.75 1.5 3.0 4.5 6.0 7.5 9.0 11 12 14 15 17 12.5 0.94 1.9 3.8 5.6 7.5 9.4 11 13 15 17 19 21 15 1.1 2.3 4.5 6.8 9.0 11 14 16 18 20 23 25 17.5 1.3 2.6 5.3 7.9 11 13 16 18 21 24 26 29 20 1.5 3.0 6.0 9.0 12 15 18 21 24 27 30 33 Baxter, Viaflex and Viaflex Plus are trademarks of Baxter International Inc. or its subsidiaries. Baxter Healthcare Corporation Deerfield, IL 60015 USA Printed in USA 07-19-00-5947 Rev. September 2023

מצב אישור:

New Drug Application

מאפייני מוצר

DOBUTAMINE HYDROCHLORIDE IN DEXTROSE- DOBUTAMINE
HYDROCHLORIDE INJECTION
BAXTER HEALTHCARE CORPORATION
----------
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 o