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:

Hikma Pharmaceuticals USA Inc.

INN (International Name):

MILRINONE LACTATE

Composition:

MILRINONE LACTATE 10 mg in 10 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Milrinone Lactate Injection, USP and Milrinone Lactate in 5% Dextrose Injection are 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 Lactate Injection, USP and Milrinone Lactate in 5% Dextrose Injection are contraindicated in patients who are hypersensitive to it.

Product summary:

Milrinone Lactate Injection, USP is supplied as 10 mL single dose vials in a box of 10, NDC 0143-9710-10, or box of 25, NDC 0143-9710-25; as 20 mL single dose vials in a box of 10, NDC 0143-9709-10; as a 50 mL single dose vial in a box of 1, NDC 0143-9708-01, or box of 10, NDC 0143-9708-10, containing a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Milrinone Lactate in 5% Dextrose Injection in Flexible Containers are supplied as 100 mL (200 mcg/mL) in 5% Dextrose Injection single units, NDC 0143-9719-10; as 200 mL (200 mcg/mL) in 5% Dextrose Injection single units, NDC 0143-9718-10. Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature]. Avoid freezing. Exposure of pharmaceutical products to heat should be minimized. Avoid excessive heat.  Brief exposure of Flexible Containers up to 40ºC (104ºF) does not adversely affect the product.    Manufactured by: HIKMA FARMACÊUTICA (PORTUGAL), S.A. Estrada do Rio da Mó, 8, 8A e 8B – Fervença – 2705-906 Terrugem SNT, PORTUGAL   Distributed by: Hikma Pharmaceuticals USA Inc. Berkeley Heights, NJ 07922 Revised: 10/2020 PIN238-WES/3

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILRINONE LACTATE- MILRINONE LACTATE INJECTION, SOLUTION
HIKMA PHARMACEUTICALS USA INC.
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MILRINONE LACTATE INJECTION, USP
MILRINONE LACTATE IN 5% DEXTROSE INJECTION
RX ONLY
DESCRIPTION
Milrinone Lactate is a member of a 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:
CH CHOHCOOH
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 Lactate is available as sterile aqueous
solutions of the lactate
salt of milrinone for injection or infusion intravenously.
Sterile, single dose vials: Single dose vials of 10, 20 and 50 mL
contain in each mL
milrinone lactate equivalent to 1 mg milrinone and 47 mg Dextrose,
Anhydrous, USP, in
Water for Injection, USP. The pH is adjusted to between 3.2 and 4.0
with lactic acid or
sodium hydroxide. The total concentration of lactic acid can vary
between 0.95 mg/mL
and 1.29 mg/mL. These vials require preparation of dilutions prior to
administration to
patients intravenously.
Pre-Mix Flexible Containers: 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 (0.2 mg) 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 comprised of polypropylene with a foil
overwrap. Water can
permeate the plastic into the overwrap, but the amount is insufficient
to significantly
affect the pre-mix solu