MILRINONE LACTATE injection, solution

Country: Bandaríkin

Tungumál: enska

Heimild: NLM (National Library of Medicine)

Virkt innihaldsefni:

Milrinone Lactate (UNII: 9K8XR81MO8) (Milrinone - UNII:JU9YAX04C7)

Fáanlegur frá:

Meitheal Pharmaceuticals Inc.

Stjórnsýsluleið:

INTRAVENOUS

Gerð lyfseðils:

PRESCRIPTION DRUG

Ábendingar:

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.

Vörulýsing:

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

Leyfisstaða:

Abbreviated New Drug Application

Vara einkenni

MILRINONE LACTATE- MILRINONE LACTATE INJECTION, SOLUTION
MEITHEAL PHARMACEUTICALS INC.
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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