País: Canadà
Idioma: anglès
Font: Health Canada
DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE)
STERIMAX INC
C01CA07
DOBUTAMINE
12.5MG
SOLUTION
DOBUTAMINE (DOBUTAMINE HYDROCHLORIDE) 12.5MG
INTRAVENOUS
10X20ML
Prescription
SELECTIVE BETA 1-ADRENERGIC AGONISTS
Active ingredient group (AIG) number: 0112000001; AHFS:
APPROVED
2015-07-09
1 PRODUCT MONOGRAPH PR DOBUTAMINE INJECTION USP DOBUTAMINE (AS DOBUTAMINE HYDROCHLORIDE) 12.5 MG/ML STERILE SOLUTION FOR INJECTION SYMPATHOMIMETIC SteriMax Inc. Date of Preparation: 2770 Portland Drive July 6, 2015 Oakville, ON Canada L6H 6R4 Control No.: 180258 2 PRODUCT MONOGRAPH PR DOBUTAMINE INJECTION USP DOBUTAMINE (AS DOBUTAMINE HYDROCHLORIDE) 12.5 MG/ML STERILE SOLUTION FOR INJECTION THERAPEUTIC CLASSIFICATION SYMPATHOMIMETIC ACTION AND CLINICAL PHARMACOLOGY Dobutamine is a direct-acting inotropic agent whose primary activity results from stimulation of the β -receptors of the heart while producing less marked chronotropic, hypertensive, arrhythmogenic or vasodilatory effects. Dobutamine, unlike dopamine, does not cause the release of endogenous norepinephrine. No specific effect on the renal vasculature has been observed. Dobutamine produces less increase in heart rate and less decrease in peripheral vascular resistance for a given inotropic effect than does isoproterenol as demonstrated in both animal and human studies. The onset of action is within 1 to 2 minutes, although the peak effect of a particular infusion may not be reached for 10 minutes. The plasma half-life in humans is 2 minutes. INDICATIONS AND CLINICAL USE Dobutamine Injection USP is indicated in the treatment of adults with cardiac decompensation due to depressed contractility resulting from organic heart disease or following cardiac surgical procedures in which parenteral therapy is necessary for inotropic support. Most clinical experience with dobutamine is short-term -- up to several hours in duration. In the 3 limited number of patients who were studied for 24, 48 and 72 hours, a persistent increase in cardiac output occurred in some, whereas the output of others returned toward baseline values. CONTRAINDICATIONS Dobutamine Injection USP is contraindicated in patients with pheochromocytoma, idiopathic hypertrophic subaortic stenosis, and in those patients with hypersensitivity to dobutamine. WARNINGS Dobutamine Injection USP may caus Llegiu el document complet