Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
DOBUTAMINE HYDROCHLORIDE (UNII: 0WR771DJXV) (DOBUTAMINE - UNII:3S12J47372)
Physicians Total Care, Inc.
DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE 12.5 mg in 1 mL
INTRAVENOUS
PRESCRIPTION DRUG
Dobutamine injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine hydrochloride. Dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine injection.
Dobutamine Injection, USP, 12.5 mg/mL is available as: 20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), NDC 54868-5717-0 20 mL Single-Dose Vials containing 250 mg dobutamine (as the hydrochloride), boxes of 10, NDC 54868-5717-2 40 mL Single-Dose Vials containing 500 mg dobutamine (as the hydrochloride), boxes of 10, NDC 54868-5717-1 Store at 20 to 25°C (68 to 77°F). [See USP Controlled Room Temperature.] October, 2004. ©Hospira 2004 EN-0623
Abbreviated New Drug Application
DOBUTAMINE - DOBUTAMINE HYDROCHLORIDE INJECTION, SOLUTION PHYSICIANS TOTAL CARE, INC. ---------- R only DESCRIPTION Dobutamine Injection, USP is 1,2-benzenediol, 4-[2-[[3-(4-hydro-xyphenyl)-1- methylpropyl]amino]ethyl]-hydrochloride, (±). It is a synthetic catecholamine. The clinical formulation is supplied in a sterile form for intravenous use only. Each mL contains: Dobutamine hydrochloride, equivalent to 12.5 mg (41.5 µmol) dobutamine; 0.24 mg sodium metabisulfite (added during manufacture), and water for injection. pH adjusted between 2.5 to 5.5 with hydrochloric acid and/or sodium hydroxide. Dobutamine is oxygen sensitive. CLINICAL PHARMACOLOGY Dobutamine is a direct-acting inotropic agent whose primary activity results from stimulation of the β receptors of the heart while producing comparatively mild chronotropic, hypertensive, arrhythmogenic, and vasodilative effects. It does not cause the release of endogenous norepinephrine, as does dopamine. In animal studies, dobutamine produces less increase in heart rate and less decrease in peripheral vascular resistance for a given inotropic effect than does isoproterenol. In patients with depressed cardiac function, both dobutamine and isoproterenol increase the cardiac output to a similar degree. In the case of dobutamine, this increase is usually not accompanied by marked increases in heart rate (although tachycardia is occasionally observed), and the cardiac stroke volume is usually increased. In contrast, isoproterenol increases the cardiac index primarily by increasing the heart rate while stroke volume changes little or declines. Facilitation of atrioventricular conduction has been observed in human electrophysiologic studies and in patients with atrial fibrillation. Systemic vascular resistance is usually decreased with administration of dobutamine. Occasionally, minimum vasoconstriction has been observed. Most clinical experience with dobutamine is short-term-not more than several hours in duration. In the limited number of patients who were studied fo Baca dokumen lengkap