MILRINONE LACTATE- milrinone lactate in 5% dextrose injection, solution

Ország: Egyesült Államok

Nyelv: angol

Forrás: NLM (National Library of Medicine)

Aktív összetevők:

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

Beszerezhető a:

Eugia US LLC

Az alkalmazás módja:

INTRAVENOUS

Recept típusa:

PRESCRIPTION DRUG

Terápiás javallatok:

Milrinone Lactate in 5% Dextrose 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 is contraindicated in patients who are hypersensitive to it. Solutions containing dextrose may be contraindicated in patients with known allergy to corn or corn products.

Termék összefoglaló:

Milrinone Lactate in 5% Dextrose Injection is a clear, colorless to pale yellow solution and is supplied in Flexible Plastic Containers as follows: 20 mg per 100 mL (200 mcg (0.2 mg)/mL) 100 mL Single-Dose Flexible Containers packaged in a Carton of 10                                                              NDC 55150-287-10 40 mg per 200 mL (200 mcg (0.2 mg)/mL) 200 mL Single-Dose Flexible Containers packaged in a Carton of 10                                                              NDC 55150-288-10 Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at room temperature, 25°C (77°F); however, brief exposure up to 40°C (104°F) does not adversely affect the product. Discard unused portion. The container closure is not made with natural rubber latex. Distributed by: Eugia US LLC 279 Princeton-Hightstown Rd. E. Windsor, NJ 08520 Manufactured by: Eugia Pharma Specialities Limited Hyderabad - 500032 India Revised: February 2023

Engedélyezési státusz:

Abbreviated New Drug Application

Termékjellemzők

MILRINONE LACTATE - MILRINONE LACTATE IN 5% DEXTROSE INJECTION,
SOLUTION
EUGIA US LLC
----------
MILRINONE LACTATE
IN 5% DEXTROSE INJECTION
RX ONLY
DESCRIPTION
Milrinone lactate 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, USP is a white to tan crystalline powder 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
clear, colorless to pale
yellow solution. Milrinone is available as sterile aqueous solutions
of the lactate salt of
milrinone for infusion intravenously. 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 285 mcg milrinone lactate equivalent to 200 mcg milrinone
USP. The
nominal concentration of lactic acid is 0.282 mg/mL. Each mL also
contains 54.3 mg
Dextrose Hydrous, USP. The pH is adjusted with lactic acid and/or
sodium hydroxide pH
3.5 (3.2 to 4.0). The flexible plastic container is made up of
multilayer polypropylene with
a foil overwrap. Solutions in contact with the plastic container leach
out certain chemical
components from the plastic in very small amounts; however, biological
testing was
supportive of the safety of the plastic container materials. The
flexible container has a
foil overwrap. Water can permeate the plastic into the overwrap, but
the amount is
insufficient to significantly affect the premixed solution.
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 concentrati