MILRINONE LACTATE injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

West-ward Pharmaceutical Corp.

INN (International Name):

MILRINONE LACTATE

Composition:

MILRINONE 1 mg 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 1 mg (base)/mL is supplied in the following: 10 mL (10 mg/10 mL) Single Dose (preservative-free) vial packaged in 10s (NDC 0641-6065-10) 20 mL (20 mg/20 mL) Single Dose (preservative-free) vial packaged in 10s (NDC 0641-6067-10) Store at 20 °-25 °C (68 °-77 °F), excursions permitted to 15 °-30 °C (59 °-86 °F) [See USP Controlled Room Temperature]. To report SUSPECTED ADVERSE REACTIONS, contact West-Ward Pharmaceutical Corp. at 1-877-845-0689, or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. For Product Inquiry call 1-877-845-0689. Manufactured by: WEST-WARD PHARMACEUTICALS Eatontown, NJ 07724 USA Revised June 2011 462-011-02

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

MILRINONE LACTATE- MILRINONE LACTATE INJECTION
WEST-WARD PHARMACEUTICAL CORP.
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MILRINONE LACTATE INJECTION
FOR INTRAVENOUS USE
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:
CH CHOHCOOH
Milrinone is an off-white to tan crystalline compound with a molecular
weight of 211.22 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 Injection is available as a sterile aqueous solution
of the lactate salt of milrinone for
intravenous use.
Each mL of the 10 mL and 20 mL single dose vials contains milrinone
lactate equivalent to 1 mg
milrinone and 47 mg Dextrose, Anhydrous, USP in Water for Injection,
USP. The pH is adjusted
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.
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 vasorelaxant concentrations, is a
selective inhibitor of peak III
cAMP phosphodiesterase isozyme in cardiac and vascular muscle. This
inhibitory action is consistent
with cAMP mediated increases in intracellular ionized calcium and
contractile force in cardiac muscle,
as well as with cAMP dependent contractile protein phosphorylation and
relaxation in vascular muscle.
Additional experimental evidence also indicates that milrinone is not
a beta-adrener