MILRINONE LACTATE injection, solution

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

Wirkstoff:

MILRINONE LACTATE (UNII: 9K8XR81MO8) (MILRINONE - UNII:JU9YAX04C7)

Verfügbar ab:

Hikma Pharmaceuticals USA Inc.

Verabreichungsweg:

INTRAVENOUS

Verschreibungstyp:

PRESCRIPTION DRUG

Anwendungsgebiete:

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.

Produktbesonderheiten:

Milrinone Lactate Injection is supplied as 20 mL single dose vials in a box of 10, NDC 0143-9326-10, containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. 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.  Brief exposure of Flexible Containers up to 40ºC (104ºF) does not adversely affect the product.  PREMIER ProRx® PREMIERProRx® is a registered trademark of Premier Healthcare Alliance, L.P., used under license. Manufactured by:                                                      HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, nº 8, 8A e 8B - Fervença, 2705 – 906 Terrugem SNT PORTUGAL Distributed by: WEST-WARD A HIKMA COMPANY Eatontown NJ 07724 USA June 2018 PIN498-PRX/1

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

MILRINONE LACTATE- MILRINONE LACTATE INJECTION, SOLUTION
WEST-WARD PHARMACEUTICALS CORP
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MILRINONE LACTATE INJECTION
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:
CH CHOHCOOH
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 20 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
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