Χώρα: Ηνωμένες Πολιτείες
Γλώσσα: Αγγλικά
Πηγή: NLM (National Library of Medicine)
Milrinone Lactate (UNII: 9K8XR81MO8) (Milrinone - UNII:JU9YAX04C7)
Meitheal Pharmaceuticals Inc.
INTRAVENOUS
PRESCRIPTION DRUG
Milrinone Lactate Injection is indicated for the short-term intravenous treatment of patients with acute decompensated heart failure. Patients receiving Milrinone Lactate Injection should be observed closely with appropriate electrocardiographic equipment. The facility for immediate treatment of potential cardiac events, which may include life threatening ventricular arrhythmias, must be available. The majority of experience with intravenous milrinone has been in patients receiving digoxin and diuretics. There is no experience in controlled trials with infusions of milrinone for periods exceeding 48 hours. Milrinone lactate injection is contraindicated in patients who are hypersensitive to it.
Milrinone Lactate Injection, USP, containing a clear, sterile, colorless to pale yellow solution is supplied as follows: Store at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature.] Avoid freezing. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Preservative-free. The container closure is not made with natural rubber latex. meitheal® Mfd. for Meitheal Pharmaceuticals Chicago, IL 60631 (USA) ©2019 Meitheal Pharmaceuticals Inc. May 2019 810033
Abbreviated New Drug Application
MILRINONE LACTATE- MILRINONE LACTATE INJECTION, SOLUTION MEITHEAL PHARMACEUTICALS INC. ---------- MILRINONE LACTATE INJECTION, USP meitheal Rx only DESCRIPTION Milrinone Lactate Injection, USP is a member of a new class of bipyridine inotropic/vasodilator agents with phosphodiesterase inhibitor activity, distinct from digitalis glycosides or catecholamines. Milrinone lactate is designated chemically as 1,6- dihydro-2-methyl-6-oxo-[3,4′-bipyridine]-5-carbonitrile lactate and has the following structure: Milrinone is a white to tan crystalline compound with a molecular weight of 211.2 and an empirical formula of C H N O. It is very slightly soluble in methanol, and very practically insoluble in water, ethanol and chloroform. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone Lactate Injection is available as sterile aqueous solutions of the lactate salt of milrinone for injection or infusion intravenously. Sterile, single-dose vials: Single-dose vials of 10 mg per 10 mL, 20 mg per 20 mL or 50 mg per 50 mL contain in each mL milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous, USP, in Water for Injection, USP. The pH is adjusted to between 3.2 and 4.0 with lactic acid or sodium hydroxide. The total concentration of lactic acid can vary between 0.95 mg per mL and 1.29 mg per mL. These vials require preparation of dilutions prior to administration to patients intravenously. CLINICAL PHARMACOLOGY Milrinone 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 Διαβάστε το πλήρες έγγραφο