MILRINONE LACTATE IN DEXTROSE 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 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 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 is contraindicated in patients who are hypersensitive to it.

Product summary:

Milrinone Lactate Injection 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 Injection in 5% Dextrose 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: WEST-WARD PHARMACEUTICAL CORP. Eatontown, NJ 07724 USA Revised: 04/2011 PIN238-WES/2

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILRINONE LACTATE IN DEXTROSE- MILRINONE LACTATE IN DEXTROSE
INJECTION, SOLUTION
WEST-WARD PHARMACEUTICALS CORP
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MILRINONE LACTATE INJECTION
RX ONLY
DESCRIPTION
Milrinone lactate injection 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:
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 solution.
CLINICAL PHARMACOLOGY