Država: Sjedinjene Američke Države
Jezik: engleski
Izvor: NLM (National Library of Medicine)
MILRINONE LACTATE (UNII: 9K8XR81MO8) (MILRINONE - UNII:JU9YAX04C7)
Armas 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 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, is a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Supplied in single-dose vials as follows: Storage 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. Protect from freezing. Discard unused portion. Distributed by: Armas Pharmaceuticals, Inc., Freehold, NJ 07728 (USA) Manufactured by: Caplin Steriles Limited, Gummidipoondi - 601 201, India. Made in India September, 2022 Code: TN/Drugs/TN00003457 22200454
Abbreviated New Drug Application
MILRINONE LACTATE - MILRINONE LACTATE INJECTION, SOLUTION ARMAS PHARMACEUTICALS INC. ---------- MILRINONE LACTATE INJECTION, USP RX ONLY DESCRIPTION Milrinone Lactate Injection is a member of a 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 an off-white to tan crystalline compound with a molecular weight of 211.2 and a molecular formula of C H N O. It is slightly soluble in methanol, and very slightly soluble in chloroform and in water. As the lactate salt, it is stable and colorless to pale yellow in solution. Milrinone Lactate 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, 20 and 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/mL and 1.29 mg/mL. These vials require preparation of dilutions prior to administration to patients intravenously. CLINICAL PHARMACOLOGY 12 9 3 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 vascular muscle. Additional experimental evidence also indicates that milrinone Pročitajte cijeli dokument