Milrinone Lactate
Milrinone Lactate Injection, USP Rx Only
fde1e354-4f15-4ade-9ae3-db2ba67e0431
HUMAN PRESCRIPTION DRUG LABEL
Apr 5, 2023
Armas Pharmaceuticals Inc.
DUNS: 098405973
Products 3
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Milrinone Lactate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (5)
Drug Labeling Information
DOSAGE & ADMINISTRATION SECTION
DOSAGE AND ADMINISTRATION
A loading dose of Milrinone Lactate Injection (1 mg [base]/mL) should be administered followed by a continuous infusion (maintenance dose) according to the following guidelines:
Loading Dose
50 mcg/kg: Administer slowly over 10 minutes.
The table below shows the loading dose in milliliters (mL) of milrinone (1 mg/mL) by patient body weight (kg).
|
Loa****ding Dose (mL) Using 1 mg/mL Concentration | ||||||||||
|
Patient Body Weight (kg) | ||||||||||
|
kg |
30 |
40 |
50 |
60 |
70 |
80 |
90 |
100 |
110 |
120 |
|
mL |
1.5 |
2 |
2.5 |
3 |
3.5 |
4 |
4.5 |
5 |
5.5 |
6 |
The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see Maintenance Dose for diluents) may simplify the visualization of the injection rate.
Maintenance Dose
|
Maintenance Dose | ||
|
Infusion Rate |
Total Daily Dose |
Administer as a continuous intravenous infusion |
|
Minimum |
0.375 mcg/kg/min |
0.59 mg/kg |
|
Standard |
0.5 mcg/kg/min |
0.77 mg/kg |
|
Maximum |
0.75 mcg/kg/min |
1.13 mg/kg |
Milrinone drawn from vials should be diluted prior to maintenance dose administration. The diluents that may be used are 0.45% Sodium Chloride Injection, USP; 0.9% Sodium Chloride Injection, USP; or 5% Dextrose Injection, USP. The table below shows the volume of diluent in milliliters (mL) that must be used to achieve 200 mcg/mL concentration for infusion, and the resultant total volumes.
|
Desired Infusion Concentration mcg/mL |
Milrinone |
Diluent (mL) |
Total Volume (mL) |
|
200 |
10 |
40 |
50 |
|
200 |
20 |
80 |
100 |
The infusion rate should be adjusted according to hemodynamic and clinical response. Patients should be closely monitored. In controlled clinical studies, most patients showed an improvement in hemodynamic status as evidenced by increases in cardiac output and reductions in pulmonary capillary wedge pressure.
Note: See “Dosage Adjustment in Renally Impaired Patients**.**” Dosage may be titrated to the maximum hemodynamic effect and should not exceed 1.13 mg/kg/day. Duration of therapy should depend upon patient responsiveness.
The maintenance dose in mL/hr by patient body weight (kg) may be determined by reference to the following table.
|
Milrinone Infusion Rate (mL/hr) Using 200 mcg/mL Concentration | ||||||||||
|
Maintenance Dose |
Patient Body Weight (kg) | |||||||||
|
30 |
40 |
50 |
60 |
70 |
80 |
90 |
100 |
110 |
120 | |
|
0.375 |
3.4 |
4.5 |
5.6 |
6.8 |
7.9 |
9 |
10.1 |
11.3 |
12.4 |
13.5 |
|
0.4 |
3.6 |
4.8 |
6 |
7.2 |
8.4 |
9.6 |
10.8 |
12 |
13.2 |
14.4 |
|
0.5 |
4.5 |
6 |
7.5 |
9 |
10.5 |
12 |
13.5 |
15 |
16.5 |
18 |
|
0.6 |
5.4 |
7.2 |
9 |
10.8 |
12.6 |
14.4 |
16.2 |
18 |
19.8 |
21.6 |
|
0.7 |
6.3 |
8.4 |
10.5 |
12.6 |
14.7 |
16.8 |
18.9 |
21 |
23.1 |
25.2 |
|
0.75 |
6.8 |
9 |
11.3 |
13.5 |
15.8 |
18 |
20.3 |
22.5 |
24.8 |
27 |
When administering milrinone lactate by continuous infusion, it is advisable
to use a calibrated electronic infusion device.
Intravenous drug products should be inspected visually and should not be used
if particulate matter or discoloration is present.
Dosage Adjustment in Renally Impaired Patients
Data obtained from patients with severe renal impairment (creatinine clearance
= 0 to 30 mL/min) but without congestive heart failure have demonstrated that
the presence of renal impairment significantly increases the terminal
elimination half-life of milrinone. Reductions in infusion rate may be
necessary in patients with renal impairment. For patients with clinical
evidence of renal impairment, the recommended infusion rate can be obtained
from the following table:
|
Creatinine Clearance |
** Infusion Rate** |
|
5 |
0.2 |
|
10 |
0.23 |
|
20 |
0.28 |
|
30 |
0.33 |
|
40 |
0.38 |
|
50 |
0.43 |
HOW SUPPLIED SECTION
HOW SUPPLIED
Milrinone Lactate Injection USP, is a sterile, clear, colorless to pale yellow solution. Each mL contains milrinone lactate equivalent to 1 mg milrinone. Supplied in single-dose vials as follows:
|
NDC No. |
Strength |
How Supplied |
|
NDC 72485-501-10 |
10 mg/10 mL |
10 mL Single-dose vials, in packages of 10. |
|
NDC 72485-502-10 |
20 mg/20 mL |
20 mL Single dose vials, in packages of 10. |
|
NDC 72485-503-01 |
50 mg/50 mL |
50 mL Single dose vial, packaged individually. |
Storage
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. Protect from freezing.
Discard unused portion.
Distributed by:
Armas Pharmaceuticals, Inc.,
Freehold, NJ 07728 (USA)
Manufactured by:
Caplin Steriles Limited,
Gummidipoondi - 601 201, India.
Made in India September, 2022
Code: TN/Drugs/TN00003457 22200454