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:

Hospira, Inc.

INN (International Name):

MILRINONE LACTATE

Composition:

MILRINONE 200 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

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 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 is contraindicated in patients who are hypersensitive to it. To Open Tear outer wrap at notch and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. Preparation for Administration (Use aseptic technique) - Close flow control clamp of ad

Product summary:

Milrinone Lactate Injection in 5% Dextrose is supplied as follows: Use only if solution is clear, colorless to pale yellow, and container is undamaged. Store at 20°C to 25°C (68°F to 77°F). [See USP Controlled Room Temperature]. Avoid freezing.

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILRINONE LACTATE- MILRINONE LACTATE INJECTION, SOLUTION
HOSPIRA, INC.
----------
MILRINONE
LACTATE INJECTION
IN 5% DEXTROSE INJECTION
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 an empirical 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.
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 49.4 mg Dextrose, Anhydrous, USP. The pH is adjusted to
between 3.2
and 4.0 with lactic acid or sodium hydroxide.
The flexible plastic container is fabricated from a specially
formulated polyvinylchloride.
Water can permeate from inside the container into the overwrap but not
in amounts
sufficient to affect the solution significantly. Solutions in contact
with the plastic
container may 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. Exposure to temperatures above 25°C/77°F during
transport and
storage will lead to minor losses in moisture content. Higher
temperatures lead to
12
9
3
greater losses. It is unlikely that these minor losses will lead to
clinically significant
changes within the expiration period.
CLINIC