MILRINONE LACTATE injection

Pays: États-Unis

Langue: anglais

Source: NLM (National Library of Medicine)

Ingrédients actifs:

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

Disponible depuis:

Gland Pharma Limited

Mode d'administration:

INTRAVENOUS

Type d'ordonnance:

PRESCRIPTION DRUG

indications thérapeutiques:

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.

Descriptif du produit:

Milrinone lactate injection, 1 mg/mL is a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone and is supplied as follows: Storage 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. Manufactured by: Gland Pharma Limited Hyderabad 500 043, India Revised: 07/2017

Statut de autorisation:

Abbreviated New Drug Application

Résumé des caractéristiques du produit

MILRINONE LACTATE - MILRINONE LACTATE INJECTION
GLAND PHARMA LIMITED
---------- 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:
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 syringes: Single-dose syringes of 5 mL contain in
each mL milrinone lactate
equivalent to 1 mg milrinone USP 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 USP or sodium
hydroxide NF. The total
concentration of lactic acid USP can vary between 0.95 mg/mL and 1.29
mg/mL. These syringes 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
i