MILRINONE LACTATE injection, solution

البلد: الولايات المتحدة

اللغة: الإنجليزية

المصدر: NLM (National Library of Medicine)

العنصر النشط:

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

متاح من:

Fresenius Kabi USA, LLC

طريقة التعاطي:

INTRAVENOUS

نوع الوصفة الطبية :

PRESCRIPTION DRUG

الخصائص العلاجية:

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.

ملخص المنتج:

Milrinone Lactate Injection is supplied as follows: This container closure is not made with natural rubber latex. Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature].  Avoid freezing.

الوضع إذن:

Abbreviated New Drug Application

خصائص المنتج

MILRINONE LACTATE - MILRINONE LACTATE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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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
structure:
C
H N O M.W. 211.2
Milrinone is an off-white to tan crystalline compound. 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 sterile
aqueous solutions of the lactate salt of milrinone for injection or
infusion intravenously.
Sterile, 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:
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-adrenergic agonist nor
does it inhibit sodium-potas