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:

Baxter Healthcare Corporation

INN (International Name):

MILRINONE LACTATE

Composition:

MILRINONE 0.2 mg in 1 mL

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 arrythmias, 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.

Product summary:

Baxter’s Milrinone Lactate in 5% Dextrose Injection is supplied in INTRAVIA Plastic Container as follows: 2J0900 NDC 0338-6010-48 100 mL (200 mcg/mL) 2J0901 NDC 0338-6011-37 200 mL (200 mcg/mL) 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.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILRINONE LACTATE IN DEXTROSE- MILRINONE LACTATE INJECTION, SOLUTION
BAXTER HEALTHCARE CORPORATION
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MILRINONE LACTATE IN 5% DEXTROSE INJECTION
IN INTRAVIA PLASTIC CONTAINER
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 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 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 - 4.0). The flexible container is
manufactured from a specially designed multilayer plastic (PL 2408).
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 va