PRIMACOR milrinone lactate injection solution

Negara: Amerika Serikat

Bahasa: Inggris

Sumber: NLM (National Library of Medicine)

Beli Sekarang

Unduh Karakteristik produk (SPC)
14-01-2018

Bahan aktif:

milrinone lactate (UNII: 9K8XR81MO8) (milrinone - UNII:JU9YAX04C7)

Tersedia dari:

sanofi-aventis U.S. LLC

INN (Nama Internasional):

milrinone lactate

Komposisi:

200 ug in 1 mL

Jenis Resep:

PRESCRIPTION DRUG

Karakteristik produk

                                PRIMACOR- MILRINONE LACTATE INJECTION, SOLUTION
SANOFI-AVENTIS U.S. LLC
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PRIMACOR
MILRINONE LACTATE INJECTION IN 5% DEXTROSE INJECTION
200 MCG/ML IN 5% DEXTROSE INJECTION
DESCRIPTION
PRIMACOR, brand of milrinone lactate injection, is a member of a class
of bipyridine
inotropic/vasodilator agents with phosphodiesterase inhibitor
activity, distinct from digitalis glycosides
or catecholamines. PRIMACOR (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 an off-white to tan crystalline compound with a molecular
weight of 211.2 and an empirical
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. PRIMACOR is available
as sterile aqueous solutions of the lactate salt of milrinone for
infusion intravenously.
Pre-Mix Flexible Containers:The Flexible Containers provide two
ready-to-use dilutions of milrinone
in volumes of 100 mL and 200 mL of 5% Dextrose Injection. Each mL
contains milrinone lactate
equivalent to 200 mcg milrinone. The nominal concentration of lactic
acid is 0.282 mg/mL. Each mL
also contains 49.4 mg dextrose, anhydrous, USP. The pH is adjusted to
between 3.2 and 4.0 with lactic
acid or sodium hydroxide. The flexible plastic container is comprised
of polyvinyl chloride with a foil
overwrap. Water can permeate the plastic into the overwrap, but the
amount is insufficient to
significantly affect the pre-mix solution.
CLINICAL PHARMACOLOGY
PRIMACOR is a positive inotrope and vasodilator, with little
chronotropic activity different in
structure and mode of action from either the digitalis glycosides or
catecholamines.
PRIMACOR, 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 intracellula
                                
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