MILRINONE LACTATE IN DEXTROSE- milrinone lactate injection, solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Milrinone Lactate (UNII: 9K8XR81MO8) (MILRINONE - UNII:JU9YAX04C7)

Available from:

Sagent Pharmaceuticals

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Milrinone 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 pro ducts.

Product summary:

Milrinone Lactate in 5% Dextrose Injection, is supplied in single port infusion bags as follows: Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat. Protect from freezing. It is recommended that the product be stored at 20° to 25°C (68° to 77°F). [See USP Controlled Room Temperature]; however, brief exposure up to 40°C (104°F) does not adversely affect the pro duct. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, DEHP-free, PVC-free. The container and container closure are not made with natural rubber latex. SAGENT® Mfd. for SAGENT Pharmaceuticals Schaumburg, IL 60195 (USA) Made in India ©2020 Sagent Pharmaceuticals, Inc. July 2020 SAGENT Pharmaceuticals ®

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILRINONE LACTATE IN DEXTROSE- MILRINONE LACTATE INJECTION, SOLUTION
SAGENT PHARMACEUTICALS
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MILRINONE LACTATE IN 5% DEXTROSE INJECTION
(FOR INTRAVENOUS USE)
SAGENT
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 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 freely soluble in dimethyl sulfoxide, very slightly
soluble in methanol,
practically insoluble in water and in chloroform. As the lactate salt,
it is stable and colorless to pale
yellow in 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 milrinone lactate
equivalent to 200 mcg milrinone. 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 container is manufactured
from a specially designed
multilayer plastic. 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,