Šalis: Kanada
kalba: anglų
Šaltinis: Health Canada
MILRINONE (MILRINONE LACTATE)
APOTEX INC
C01CE02
MILRINONE
1.0MG
SOLUTION
MILRINONE (MILRINONE LACTATE) 1.0MG
INTRAVENOUS
10/20ML
Prescription
CARDIOTONIC AGENTS
Active ingredient group (AIG) number: 0131285001; AHFS:
CANCELLED POST MARKET
2013-08-02
PRODUCT MONOGRAPH APO-MILRINONE INJECTABLE MILRINONE LACTATE INJECTION 10 ML AND 20 ML (1 MG MILRINONE/ML) INOTROPE / VASODILATOR APOTEX INC. DATE OF PREPARATION: 150 SIGNET DRIVE April 30, 2004 WESTON, ONTARIO M9L 1T9 Submission Control No.: 083487 - 1 - PRODUCT MONOGRAPH APO-MILRINONE Injectable Milrinone Lactate Injection 10 mL and 20 mL (1 mg milrinone/mL) 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 to 300 ng/mL. - 2 - PHARMACOKINETICS Following intravenous loading injections of 12 Perskaitykite visą dokumentą