Țară: Statele Unite ale Americii
Limbă: engleză
Sursă: NLM (National Library of Medicine)
DOBUTAMINE HYDROCHLORIDE (UNII: 0WR771DJXV) (DOBUTAMINE - UNII:3S12J47372)
Hospira, Inc.
DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE 200 mg in 100 mL
INTRAVENOUS
PRESCRIPTION DRUG
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
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
New Drug Application
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- Citiți documentul complet