Land: Kanada
Språk: engelska
Källa: Health Canada
MILRINONE (MILRINONE LACTATE)
STERIMAX INC
C01CE02
MILRINONE
1MG
SOLUTION
MILRINONE (MILRINONE LACTATE) 1MG
INTRAVENOUS
10ML/20ML
Prescription
CARDIOTONIC AGENTS
Active ingredient group (AIG) number: 0131285001; AHFS:
APPROVED
2015-10-30
PRODUCT MONOGRAPH PR MILRINONE LACTATE INJECTION (MILRINONE LACTATE INJECTION) 1 MG/ML MILRINONE (AS MILRINONE LACTATE) INOTROPE - VASODILATOR Sterimax Inc. Date of Preparation 2770 Portland Drive October 21, 2015 Oakville, ON L6H 6R4 Control # 182944 Milrinone Lactate Injection Page 2 of 16 PRODUCT MONOGRAPH PR MILRINONE LACTATE INJECTION (MILRINONE LACTATE INJECTION) 1 MG/ML MILRINONE (AS MILRINONE LACTATE) THERAPEUTIC CLASSIFICATION Inotrope/Vasodilator ACTIONS AND CLINICAL PHARMACOLOGY 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 milrinone lactate 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. Studies in normal subjects have shown that milrinone lactate 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 concentrations of 100-300 ng/mL. PHARMACOKINETICS Followi Läs hela dokumentet