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Milrinone in Dextrose (Milrinone Lactate) - Indications and Dosage

 
 



INDICATIONS AND USAGE

Milrinone 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 arrythmias, 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.

DOSAGE AND ADMINISTRATION

Milrinone should be administered with a loading dose followed by a continuous infusion (maintenance dose) according to the following guidelines:

Loading Dose

50 mcg/kg: Administer slowly over 10 minutes

Note: Milrinone (200 mcg/mL) in INTRAVIA Plastic Container is for intravenous infusion only.

Dosage recommendations using a 1 mg/mL concentration of milrinone are included for informational purposes only.

The table below shows the loading dose in milliliters (mL) of milrinone (1mg/mL) by patient body weight (kg).

Loading 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 2.0 2.5 3.0 3.5 4.0 4.5 5.0 5.5 6.0

The loading dose may be given undiluted, but diluting to a rounded total volume of 10 or 20 mL (see appropriate package insert for diluents) may simplify the visualization of the injection rate.

Maintenance Dose

  Infusion Rate Total Daily Dose
(24 Hours)
 
Minimum 0.375 mcg/kg/min 0.59 mg/kg Administer as a continuous intravenous infusion
Standard 0.50 mcg/kg/min 0.77 mg/kg
Maximum 0.75 mcg/kg/min 1.13 mg/kg

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 (mcg/kg/min) 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 9.0 10.1 11.3 12.4 13.5
0.400 3.6 4.8 6.0 7.2 8.4 9.6 10.8 12.0 13.2 14.4
0.500 4.5 6.0 7.5 9.0 10.5 12.0 13.5 15.0 16.5 18.0
0.600 5.4 7.2 9.0 10.8 12.6 14.4 16.2 18.0 19.8 21.6
0.700 6.3 8.4 10.5 12.6 14.7 16.8 18.9 21.0 23.1 25.2
0.750 6.8 9.0 11.3 13.5 15.8 18.0 20.3 22.5 24.8 27.0

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
(mL/min/1.73 m2)
Infusion Rate
(mcg/kg/min)
5 0.20
10 0.23
20 0.28
30 0.33
40 0.38
50 0.43

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Milrinone Lactate in 5% Dextrose Injection is a clear, colorless to pale yellow solution.

DIRECTIONS FOR USE

When administering Milrinone Lactate in 5% Dextrose Injection by continuous infusion, it is advisable to use a calibrated electronic infusion device.

To open

Tear overwrap down side at slit and remove solution container. Some opacity of the plastic due to moisture absorption during the sterilization process may be observed. This is normal and does not affect the solution quality or safety. The opacity will diminish gradually. After removing overwrap, check for minute leaks by squeezing inner bag firmly. If leaks are found, discard solution as sterility may be impaired.

Preparation for Administration

Visually inspect the container. If the administration port protector is damaged, detached, or not present, discard container as solution path sterility may be impaired.

(Use aseptic technique)

  1. Suspend container from eyelet support.
  2. Remove protector from administration port at bottom of container.
  3. Attach administration set. Refer to complete directions accompanying set.

Caution: Do not administer simultaneously with blood. Do not use plastic containers in series connections. Such use could result in air embolism due to residual air being drawn from the primary container before administration of the fluid from the secondary container is complete.

HOW SUPPLIED

Baxter’s Milrinone Lactate in 5% Dextrose Injection is supplied in INTRAVIA Plastic Container as follows:

2J0900 NDC 0338-6010-48 100 mL (200 mcg/mL)
2J0901 NDC 0338-6011-37 200 mL (200 mcg/mL)

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.

Baxter Healthcare Corporation
Deerfield, IL 60015 USA

Printed in USA

BAXTER and INTRAVIA are trademarks of
Baxter International Inc.

07-19-73-096

Rev. April 2014

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