Milrinone Lactate

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Side Effects & Adverse Reactions

Whether given orally or by continuous or intermittent intravenous infusion, milrinone has not been shown to be safe or effective in the longer (greater than 48 hours) treatment of patients with heart failure. In a multicenter trial of 1088 patients with Class III and IV heart failure, long-term oral treatment with milrinone was associated with no improvement in symptoms and an increased risk of hospitalization and death. In this study, patients with Class IV symptoms appeared to be at particular risk of life-threatening cardiovascular reactions. There is no evidence that milrinone given by long-term continuous or intermittent infusion does not carry a similar risk.

The use of milrinone both intravenously and orally has been associated with increased frequency of ventricular arrhythmias, including nonsustained ventricular tachycardia. Long-term oral use has been associated with an increased risk of sudden death. Hence, patients receiving milrinone should be observed closely with the use of continuous electrocardiographic monitoring to allow the prompt detection and management of ventricular arrhythmias.

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Uses

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.

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Other Information

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:

CH3CHOHCOOH

Milrinone is an off-white to tan crystalline compound with a molecular weight of 211.22 and a molecular formula of C 12H9N3O. 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.

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Milrinone Lactate Manufacturers

Baxter Healthcare Corporation

Milrinone Lactate | Baxter Healthcare Corporation

Milrinone Lactate Injection 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 The table below shows the loading dose in milliliters (mL) of milrinone (1 mg/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 Maintenance Dose 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
Milrinone Lactate Injection 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
1 mg/mL
(mL) 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 (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
When administering milrinone lactate by continuous infusion, it is advisable to use a calibrated electronic infusion device.

WARNING: Do not use in series connections with flexible plastic containers.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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

No Recall
West-ward Pharmaceutical Corp

Milrinone Lactate | West-ward Pharmaceutical Corp

Milrinone Lactate in 5% Dextrose Injection should not be used for administering a loading dose. The information regarding loading doses for milrinone is for informational purposes only. 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 (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 Maintenance Dose 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 Standard 0.50 mcg/kg/min 0.77 mg/kg continuous Maximum 0.75 mcg/kg/min 1.13 mg/kg intravenous infusion
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.

Note: Milrinone Lactate in 5% Dextrose Injection supplied in 100 mL and 200 mL Flexible Containers (200 mcg/mL in 5% Dextrose Injection) need not be diluted prior to use.
Milrinone Infusion Rate (mL/hr) Using 200 mcg/mL Concentration Maintenance Dose Patient Body Weight (kg) (mcg/kg/min) 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
When administering milrinone by continuous infusion, it is advisable to use a calibrated electronic infusion device.

The Flexible Container has a concentration of milrinone equivalent to 200 mcg/mL in 5% Dextrose Injection and is more convenient to use than dilutions prepared from the vials. To use the Flexible Container, tear the overwrap at the notch and remove the Pre-Mix solution container. Squeeze the container firmly to check for leaks. Discard the container if leaks are found since the sterility of the product could be affected. Do not add supplementary medication.

To prepare the container for administration of milrinone intravenously, use aseptic techniques.
1)The flow control clamp of the administration set is closed. 2)The cover of the outlet port at the bottom of the container is removed. 3)Noting the full directions on the administration set carton, the piercing pin of the set is inserted into the port with a twisting motion until it is firmly seated. 4)The container is suspended on the hanger. 5)The drip chamber is squeezed and released to establish the fill level. 6)The flow control clamp is opened to expel air from the set, and then closed. 7)The set is attached to the venipuncture device, primed, and if not indwelling, the venipuncture is performed. 8)The rate of administration is controlled with the flow control clamp. WARNING- DO NOT USE IN SERIES CONNECTIONS. Caution: 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.
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
(mL/min/1.73m2) Infusion Rate
(mcg/kg/min) 5 0.20 10 0.23 20 0.28 30 0.33 40 0.38 50 0.43

No Recall
West-ward Pharmaceutical Corp

Milrinone Lactate | West-ward Pharmaceutical Corp

Milrinone Lactate in 5% Dextrose Injection should not be used for administering a loading dose. The information regarding loading dose for milrinone is for 1 mg/mL vial only. 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).   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 Maintenance Dose 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
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
1 mg/mL
(mL)   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.

Note: Milrinone Lactate in 5% Dextrose Injection supplied in 100 mL and 200 mL Flexible Containers (200 mcg/mL in 5% Dextrose Injection) need not be diluted prior to use.
  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
When administering milrinone lactate by continuous infusion, it is advisable to use a calibrated electronic infusion device.

The Flexible Container has a concentration of milrinone equivalent to 200 mcg/mL in 5% Dextrose Injection and is more convenient to use than dilutions prepared from the vials. To use the Flexible Container, tear the overwrap at the notch and remove the Pre-Mix solution container. Squeeze the container firmly to check for leaks. Discard the container if leaks are found since the sterility of the product could be affected. Do not add supplementary medication.

To prepare the container for administration of milrinone intravenously, use aseptic techniques.
1. The flow control clamp of the administration set is closed.
2. The cover of the outlet port at the bottom of the container is removed.
3. Noting the full directions on the administration set carton, the piercing pin of the set is inserted into the port with a twisting motion until it is firmly sealed.
4. The container is suspended on the hanger.
5. The drop chamber is squeezed and released to establish the fill level.
6. The flow control clamp is opened to expel air from the set and then closed.
7. The set is attached to the venipuncture device, primed, and if not indwelling, the venipuncture is performed.
8. The rate of administration is controlled with the flow control clamp. WARNING - DO NOT USE IN SERIES CONNECTIONS. Caution: 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.

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 lactate. 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

No Recall
West-ward Pharmaceutical Corp.

Milrinone Lactate | West-ward Pharmaceutical Corp.

Milrinone Lactate Injection 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 The table below shows the loading dose in milliliters (mL) of milrinone (1 mg/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 Maintenance Dose 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
Milrinone Lactate Injection 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
1 mg/mL
(mL) 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 (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
When administering milrinone lactate by continuous infusion, it is advisable to use a calibrated electronic infusion device.

WARNING: Do not use in series connections with flexible plastic containers.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
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

No Recall
Hospira, Inc.

Milrinone Lactate | Hospira, Inc.

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

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

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 Infusion Rate Total Daily Dose
(24 Hours)
Minimum

Standard

Maximum

0.375 mcg/kg/min

0.50 mcg/kg/min

0.75 mcg/kg/min

0.59 mg/kg

0.77 mg/kg

1.13 mg/kg

Administer as a

continuous

intravenous infusion.

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
1 mg/mL
(mL) 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.

Note: Milrinone supplied in 100 mL and 200 mL Flexible Containers (200 mcg/mL in 5% Dextrose Injection) need not be diluted prior to use.
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

10.1

11.3

12.4

13.5

0.400

3.6

4.8

6

7.2

8.4

9.6

10.8

12

13.2

14.4

0.500

4.5

6

7.5

9

10.5

12

13.5

15

16.5

18

0.600

5.4

7.2

9

10.8

12.6

14.4

16.2

18

19.8

21.6

0.700

6.3

8.4

10.5

12.6

14.7

16.8

18.9

21

23.1

25.2

0.750

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.

The Flexible Container has a concentration of milrinone equivalent to 200 mcg/mL in 5% Dextrose Injection and is more convenient to use than dilutions prepared from the vials.

No Recall
App Pharmaceuticals, Llc

Milrinone Lactate | Fresenius Kabi Usa, Llc

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

The table below shows the loading dose in milliliters (mL) of milrinone (1 mg/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

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

Infusion Rate
Total Daily Dose
(24 Hours)
Minimum
Standard
Maximum
0.375 mcg/kg/min
0.50 mcg/kg/min
0.75 mcg/kg/min
0.59 mg/kg
0.77 mg/kg
1.13 mg/kg

Administer as a continuous intravenous infusion.

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

1 mg/mL

(mL)

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: SeeDosage 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

0.375

3.4

4.5

5.6

6.8

7.9

0.400

3.6

4.8

6

7.2

8.4

0.500

4.5

6

7.5

9

10.5

0.600

5.4

7.2

9

10.8

12.6

0.700

6.3

8.4

10.5

12.6

14.7

0.750

   6.8

9

    11.3

    13.5

    15.8

Maintenance

Dose

(mcg/kg/min)

Patient Body Weight (kg)

80

90

100

110

120

0.375

9

10.1

11.3

12.4

13.5

0.400

9.6

10.8

12

13.2

14.4

0.500

12

13.5

15

16.5

18

0.600

14.4

16.2

18

19.8

21.6

0.700

    16.8

    18.9

21

     23.1

    25.2

0.750

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

(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

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

No Recall
Bedford Laboratories

Milrinone Lactate | Bedford Laboratories

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

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 Maintenance Dose 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

Milrinone drawn from vials should be diluted prior to maintenance dose administration. The diluents that may be used are 0.45% Sodium Chloride Injection, 0.9% Sodium Chloride Injection, or 5% Dextrose Injection. 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

1 mg/mL

(mL)

Diluent

(mL)

Total Volume

(mL)

200

10

40

50

300

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) 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

When administering milrinone lactate by continuous infusion, it is advisable to use a calibrated electronic infusion device.
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

Intravenous drug products should be inspected visually and should not be used if particulate matter or discoloration is present.

No Recall
Hospira, Inc.

Milrinone Lactate | Hospira, Inc.

Milrinone lactate injection 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

The table below shows the loading dose in milliliters (mL) of Milrinone lactate injection (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

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

Infusion Rate

Total Daily
Dose

(24 hours)

Minimum

0.375 mcg/kg/min

0.59 mg/kg

Administer as a continuous intravenous infusion.

Standard

0.5 mcg/kg/min

0.77 mg/kg

Maximum

0.75 mcg/kg/min

1.13 mg/kg

Milrinone lactate injection 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

1 mg/mL

(mL)

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) 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

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.
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
Creatinine Clearance

(mL/min/1.73 m2)

Infusion Rate

(mcg/kg/min)

5

0.2

10

0.23

20

0.28

30

0.33

40

0.38

50

0.43

Intravenous drug products should be inspected visually and should not be used if particulate matter or discoloration is present.

No Recall