Страна: США
мова: англійська
Джерело: NLM (National Library of Medicine)
MILRINONE LACTATE (UNII: 9K8XR81MO8) (MILRINONE - UNII:JU9YAX04C7)
West-ward Pharmaceutical Corp.
MILRINONE LACTATE
MILRINONE 1 mg in 1 mL
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 1 mg (base)/mL is supplied in the following: 10 mL (10 mg/10 mL) Single Dose (preservative-free) vial packaged in 10s (NDC 0641-6065-10) 20 mL (20 mg/20 mL) Single Dose (preservative-free) vial packaged in 10s (NDC 0641-6067-10) Store at 20 °-25 °C (68 °-77 °F), excursions permitted to 15 °-30 °C (59 °-86 °F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA Revised June 2011 462-011-02
Abbreviated New Drug Application
MILRINONE LACTATE- MILRINONE LACTATE INJECTION WEST-WARD PHARMACEUTICAL CORP. ---------- MILRINONE LACTATE INJECTION FOR INTRAVENOUS USE 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 structure: CH CHOHCOOH Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.22 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 intravenous use. Each mL of the 10 mL and 20 mL single dose vials contains milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose, Anhydrous, USP in Water for Injection, USP. The pH is adjusted 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 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 is not a beta-adrener Прочитайте повний документ