MILRINONE LACTATE IN DEXTROSE- milrinone lactate injection, solution

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

Gland Pharma Limited

Pot uporabe:

INTRAVENOUS

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

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 products.

Povzetek izdelek:

Milrinone Lactate in 5% Dextrose Injection, is supplied in single port infusion bags as follows: Storage Conditions 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 product. Discard unused portion. Sterile, Nonpyrogenic, Preservative-free, DEHP-free, PVC-free. The container and container closure are not made with natural rubber latex.   Manufactured by: Gland Pharma Limited D.P. Pally, Dundigal post, Hyderabad-500 043, India. Revised: July 2020

Status dovoljenje:

Abbreviated New Drug Application

Lastnosti izdelka

MILRINONE LACTATE IN DEXTROSE - MILRINONE LACTATE INJECTION, SOLUTION
GLAND PHARMA LIMITED
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MILRINONE LACTATE IN 5% DEXTROSE INJECTION
(FOR INTRAVENOUS USE)
RX ONLY
DESCRIPTION
Milrinone lactate is a member of a new class of bipyridine is
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, at r