Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
DOBUTAMINE HYDROCHLORIDE (UNII: 0WR771DJXV) (DOBUTAMINE - UNII:3S12J47372)
Baxter Healthcare Corporation
DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE 100 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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
New Drug Application
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 Lees het volledige document