Země: Spojené státy
Jazyk: angličtina
Zdroj: NLM (National Library of Medicine)
MILRINONE LACTATE (UNII: 9K8XR81MO8) (MILRINONE - UNII:JU9YAX04C7)
Hospira, 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 is contraindicated in patients who are hypersensitive to it.
Milrinone Lactate Injection is supplied as 10 mL, 20 mL and 50 mL single-dose vials containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Discard unused portion after initial use. Store between 20°C to 25°C (68°F 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. Manufactured by: Gland Pharma Limited, Hyderabad 500043, India Manufactured for: Hospira Inc. Lake Forest, IL 60045, USA LAB-1255-2.0 Revised: 02/2021
Abbreviated New Drug Application
MILRINONE LACTATE- MILRINONE LACTATE INJECTION, SOLUTION HOSPIRA, INC. ---------- MILRINONE LACTATE INJECTION RX ONLY DESCRIPTION Milrinone Lactate Injection, 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 structural formula: 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 injection is available as a sterile aqueous solution 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 in Water for Injection. The pH is adjusted to between 3.2 and 4.0 with lactic acid and/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 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 12 9 3 phosphorylation and relaxation in vascular muscle. Additional experimental evidence also indicates that milrinone i Přečtěte si celý dokument