milrinone lactate in dextrose- Milrinone Lactate and Dextrose monohydrate injection

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Milrinone lactate (UNII: 9K8XR81MO8) (Milrinone - UNII:JU9YAX04C7), Dextrose monohydrate (UNII: LX22YL083G) (Dextrose - UNII:IY9XDZ35W2)

Available from:

B. Braun Medical Inc.

INN (International Name):

Milrinone Lactate and Dextrose monohydrate

Pharmaceutical form:

INJECTION

Composition:

200 ug in 1 mL

Administration route:

INTRAVENOUS

Prescription type:

PRESCRIPTION DRUG

Therapeutic indications:

Milrinone Lactate in 5% Dextrose 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 in 5% Dextrose Injection is contraindicated in patients who are hypersensitive to milrinone. Solutions containing dextrose may be contraindicated in patients with hypersensitivity to corn products.

Product summary:

Milrinone Lactate 20 mg (base)/100 mL (200 mcg (0.2 mg)[base]/mL) in 5% Dextrose Injection is supplied sterile and nonpyrogenic in 100 mL fill PAB® plastic containers packaged 4 per carton, 6 cartons per case (24 per case). 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. Store the individual container in the storage carton until ready to use.

Summary of Product characteristics

MILRINONE LACTATE IN DEXTROSE- MILRINONE LACTATE AND DEXTROSE
MONOHYDRATE INJECTION
B. BRAUN MEDICAL INC.
----------
SINGLE DOSE
PAB PLASTIC CONTAINER
FOR INTRAVENOUS INFUSION ONLY.
DESCRIPTION
Milrinone Lactate in 5% Dextrose Injection is a sterile, aqueous
solution of milrinone in 5% dextrose. It
is administered by the intravenous route. It is premixed and requires
no further dilution.
Milrinone 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.
Milrinone is an off-white to tan crystalline compound with 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.
The molecular structures of milrinone lactate and dextrose (hydrous)
are as follows:
The PAB Container is Latex-free, PVC-free, and DEHP-free.
The PAB plastic container system provides a ready-to-use dilution of
milrinone in a volume of 100 mL
of 5% Dextrose Injection. Each mL contains milrinone lactate
equivalent to 200 mcg milrinone. The
nominal concentration of Lactic Acid USP is 0.282 mg/mL. Each mL also
contains 49.4 mg Dextrose,
Anhydrous, USP in Water for Injection, USP. The pH is adjusted to
between 3.2 and 4.0 with lactic acid
and/or sodium hydroxide.
The solution contains no preservative and is intended only for use as
a single-dose injection. When
smaller doses are required the unused portion should be discarded.
The PAB plastic container system is a copolymer of ethylene and
propylene formulated and developed
for parenteral drugs. The copolymer contains no plasticizers and
exhibits virtually no leachability. The
safety of the plastic container has been confirmed by biological
evaluation procedures.
The material passes Class Vl testing as specified in the U.S.
Pharmacopeia for Bio