Land: Kanada
Sprache: Englisch
Quelle: Health Canada
MILRINONE (MILRINONE LACTATE)
SANOFI-SYNTHELABO CANADA INC
C01CE02
MILRINONE
1MG
SOLUTION
MILRINONE (MILRINONE LACTATE) 1MG
INTRAVENOUS
10ML & 20ML
Prescription
CARDIOTONIC AGENTS
Active ingredient group (AIG) number: 0131285001; AHFS:
CANCELLED POST MARKET
2005-08-01
PRODUCT MONOGRAPH PR PRIMACOR * INJECTION (milrinone lactate injection) 10 mL and 20 mL vials (1 mg milrinone/mL) 100 mL Flexible Container (200 : g/mL) INOTROPE/VASODILATOR Date of Preparation: * Trade Mark of Sanofi-Synthelabo, Inc. Dec 11, 1996 Sanofi-Synthelabo Canada Inc. Date of revision: Markham, Ontario January 16, 2004 Control #: 087235 -2- PRODUCT MONOGRAPH PR PRIMACOR * INJECTION (milrinone lactate injection) 10 mL and 20 mL vials (1 mg milrinone/mL) PHARMACOLOGICAL CLASSIFICATION inotrope/vasodilator ACTION AND CLINICAL PHARMACOLOGY PRIMACOR (milrinone lactate) Injection is a positive inotrope and vasodilator, with little chronotropic activity, different in structure and mode of action from either the digitalis glycosides or catecholamines. Milrinone, at relevant inotropic and vasorelaxant concentrations, is a selective inhibitor of peak III cAMP phosphodiesterase isozyme in cardiac and vascular muscle. This inhibitory action is consistent with cAMP mediated increases in intracellular ionized calcium and contractile force in cardiac muscle, as well as with cAMP dependent contractile protein phosphorylation and relaxation in vascular muscle. Additional experimental evidence also indicates that it is not a beta-adrenergic agonist, nor does it inhibit sodium-potassium adenosine triphosphatase activity as do the digitalis glycosides. Clinical studies in patients with congestive heart failure have shown that PRIMACOR Injection produces dose and plasma level-related increase in left ventricular dP/dt, increase in forearm blood flow indicating a direct arterial vasodilator activity of the drug, and improves diastolic function as evidenced by improvement in left ventricular diastolic relaxation. -3- Studies in normal subjects have shown that PRIMACOR Injection produces increases in the slope of the left ventricular pressure-dimension relationship, indicating a direct inotropic effect of the drug. Both the inotropic and vasodilatory effects have been observed over the therapeutic range of milrinone plasma conc Lesen Sie das vollständige Dokument