Dobutamine Hydrochloride

Do NOT add sodium bicarbonate or other alkalinizing substance, since dobutamine is inactivated in alkaline solution. Dobutamine in 5% Dextrose Injection, USP is administered only intravenously via a suitable catheter or needle infusion. The less concentrated 0.5 mg/mL solution may be preferred when fluid expansion is not a problem. The more concentrated 1 mg/mL, 2 mg/mL, or 4 mg/mL solutions may be preferred in patients with fluid retention or when a slower rate of infusion is desired.

Recommended Dosage: Infusion of dobutamine should be started at a low rate (0.5 to 1.0 mcg/kg/min) and titrated at intervals of a few minutes, guided by the patient’s response, including systemic blood pressure, urine flow, frequency of ectopic activity, heart rate, and (whenever possible) measurements of cardiac output, central venous pressure, and/or pulmonary capillary wedge pressure. In reported trials, the optimal infusion rates have varied from patient to patient, usually 2 to 20 mcg/kg/min but sometimes slightly outside of this range. On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect. For the infusion rates necessary to achieve various delivery rates (mcg/kg/min) for patients of different weights, refer to the Dobutamine Infusion Rate (mL/hr) charts below.

Rate of Administration: When administering dobutamine (or any potent medication) by continuous intravenous infusion, it is advisable to use a precision volume control I.V. set.

Each patient must be individually titrated to the desired hemodynamic response to dobutamine. The rate of administration and the duration of therapy should be adjusted according to the patient's response as determined by heart rate, presence of ectopic activity, blood pressure, urine flow, and, whenever possible, measurement of central venous or pulmonary wedge pressure and cardiac output.

As with all potent intravenously administered drugs, care should be taken to control the rate of infusion so as to avoid inadvertent administration of a bolus of the drug.

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

Dobutamine Infusion Rate (mL/hr) Chart Using 500 mcg/mL Concentration

Patient Body Weight (kg)

Infusion rate (mcg/kg/min)

5

10

20

30

40

50

60

70

80

90

100

110

120

2.5

1.5

3

6

9

12

15

18

21

24

27

30

33

36

5

3

6

12

18

24

30

36

42

48

54

60

66

72

7.5

4.5

9

18

27

36

45

54

63

72

81

90

99

108

10

6

12

24

36

48

60

72

84

96

108

120

132

144

12.5

7.5

15

30

45

60

75

90

105

120

135

150

165

180

15

9

18

36

54

72

90

108

126

144

162

180

198

216

17.5

10.5

21

42

63

84

105

126

147

168

189

210

231

252

Dobutamine Infusion Rate (mL/hr) Chart Using 1000 mcg/mL Concentration

Patient Body Weight (kg)

Infusion rate (mcg/kg/min)

5

10

20

30

40

50

60

70

80

90

100

110

120

2.5

0.75

1.5

3

4.5

6

7.5

9

10.5

12

13.5

15

16.5

18

5

1.5

3

6

9

12

15

18

21

24

27

30

33

36

7.5

2.25

4.5

9

13.5

18

22.5

27

31.5

36

40.5

45

49.5

54

10

3

6

12

18

24

30

36

42

48

54

60

66

72

12.5

3.75

7.5

15

22.5

30

37.5

45

52.5

60

67.5

75

82.5

90

15

4.5

9

18

27

36

45

54

63

72

81

90

99

108

17.5

5.25

10.5

21

31.5

42

52.5

63

73.5

84

94.5

105

115.5

126

Dobutamine Infusion Rate (mL/hr) Chart Using 2000 mcg/mL Concentration

Patient Body Weight (kg)

Infusion rate (mcg/kg/min)

30

40

50

60

70

80

90

100

110

120

2.5

2.25

3

3.75

4.5

5.25

6

6.75

7.5

8.25

9

5

4.5

6

7.5

9

10.5

12

13.5

15

16.5

18

7.5

6.75

9

11.25

13.5

15.75

18

20.25

22.5

24.75

27

10

9

12

15

18

21

24

27

30

33

36

12.5

11.25

15

18.75

22.5

26.25

30

33.75

37.5

41.25

45

15

13.5

18

22.5

27

31.5

36

40.5

45

49.5

54

17.5

15.75

21

26.25

31.5

36.75

42

47.25

52.5

57.75

63

Dobutamine Infusion Rate (mL/hr) Chart Using 4000 mcg/mL Concentration

Patient Body Weight (kg)

Infusion rate (mcg/kg/min)

30

40

50

60

70

80

90

100

110

120

2.5

1.125

1.5

1.875

2.25

2.625

3

3.375

3.75

4.125

4.5

5

2.25

3

3.75

4.5

5.25

6

6.75

7.5

8.25

9

7.5

3.375

4.5

5.625

6.75

7.875

9

10.125

11.25

12.375

13.5

10

4.5

6

7.5

9

10.5

12

13.5

15

16.5

18

12.5

5.625

7.5

9.375

11.25

13.125

15

16.875

18.75

20.625

22.5

15

6.75

9

11.25

13.5

15.75

18

20.25

22.5

24.75

27

17.5

7.875

10.5

13.125

15.75

18.375

21

23.625

26.25

28.875

31.5

INSTRUCTIONS FOR USE

To Open

Tear outer wrap at notch 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.

Preparation for Administration

(Use aseptic technique)

Close flow control clamp of administration set.

Remove cover from outlet port at bottom of container.

Insert piercing pin of administration set into port with a twisting motion until the set is firmly seated. NOTE: See full directions on administration set carton.

Suspend container from hanger.

Squeeze and release drip chamber to establish proper fluid level in chamber.

Open flow control clamp and clear air from set. Close clamp.

Attach set to venipuncture device. If device is not indwelling, prime and make venipuncture.

Regulate rate of administration with flow control clamp.

WARNING: Do not use flexible container in series connections.

Note
Do not add dobutamine to 5% Sodium Bicarbonate Injection or to any other strongly alkaline solution. Because of potential physical
incompatibilities, it is recommended that dobutamine not be mixed with other drugs in the same solution. Dobutamine should not be
used in conjunction with other agents or diluents containing both sodium bisulfite and ethanol.

Preparation and Stability
At the time of administration, dobutamine must be further diluted in an IV container to at least a 50 mL solution using one of the
following intravenous solutions as a diluent: 5% Dextrose Injection, 5% Dextrose and 0.45% Sodium Chloride Injection, 5% Dextrose
and 0.9% Sodium Chloride Injection, 10% Dextrose Injection, Isolyte® M with 5% Dextrose Injection, Lactated Ringer’s Injection,
5% Dextrose in Lactated Ringer’s Injection, Normosol®-M in D5-W, 20% Osmitrol® in Water for Injection, 0.9% Sodium Chloride
Injection, or Sodium Lactate Injection. Intravenous solutions should be used within 24 hours.

Recommended Dosage
Infusion of dobutamine should be started at a low rate (0.5 to 1 mcg/kg/min) and titrated at intervals of a few minutes, guided by the
patient’s response, including systemic blood pressure, urine flow, frequency of ectopic activity, heart rate and (whenever possible)
measurements of cardiac output, central venous pressure, and/or pulmonary capillary wedge pressure. In reported trials, the optimal
infusion rates have varied from patient to patient, usually 2 to 20 mcg/kg/min but sometimes slightly outside of this range. On rare
occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect. Rates of infusion (mL/h) for dobutamine
concentrations of 500 mcg/mL, 1000 mcg/mL, and 2000 mcg/mL necessary to attain various delivery rates of dobutamine (mcg/kg/
min) for patients of different weights are given in Table 1.

Table 1 Dobutamine Injection USP Infusion Rate (mL/h) for 500 mcg/mL concentration

Drug Delivery RAte
Patient Body Weight (kg)











(mcg/kg/min)
5
10
20
30
40
50
60
70
80
90
100
110
0.5
0.3
0.6
1.2
1.8
2.4
3
3.6
4.2
4.8
5.4
6
6.6
1
0.6
1.2
2.4
3.6
4.8
6
7.2
8.4
9.6
10.8
12
13.2
2.5
1.5
3
6
9
12
15
18
21
24
27
30
33
5
3
6
12
18
24
30
36
42
48
54
60
66
7.5
4.5
9
18
27
36
45
54
63
72
81
90
99
10
6
12
24
36
48
60
72
84
96
108
120
132
12.5
7.5
15
300
45
60
75
90
105
120
135
150
165
15
9
18
36
54
72
90
108
126
144
162
180
198
17.5
10.5
21
42
63
84
105
126
147
168
189
210
231
20
12
24
48
72
96
120
144
168
192
216
240
264
Dobutamine Injection USP Infusion Rate (mL/h) for 1000 mcg/mL concentration
Drug Delivery Rate
Patient Body Weight (kg)











(mcg/kg/min)
5
10
20
30
40
50
60
70
80
90
100
110
0.5
0.1
0.3
0.6
0.9
1.2
1.5
1.8
2.1
2.4
2.7
3
3.3
1
0.3
0.6
1.2
1.8
2.4
3
3.6
4.2
4.8
5.4
6
6.6
2.5
0.7
1.5
3
4.5
6
7.5
9
10.5
12
13.5
15
16.5
5
1.5
3
6
9
12
15
18
21
24
27
30
33
7.5
2.2
4.5
9
13.5
18
22.5
27
31.5
36
40.5
45
49.5
10
3
6
12
18
24
30
36
42
48
54
60
66
12.5
3.7
7.5
15
22.5
30
37.5
45
52.5
60
67.5
75
82.5
15
4.5
9
18
27
36
45
54
63
72
81
90
99
17.5
5.2
10.5
21
31.5
42
52.5
63
73.5
84
94.5
105
115.5
20
6
12
24
36
48
60
72
84
96
108
120
132
Dobutamine Injection USP Infusion Rate (mL/h) for 2000 mcg/mL concentration
Drug Delivery Rate
Patient Body Weight (kg)











(mcg/kg/min)
5
10
20
30
40
50
60
70
80
90
100
110
0.5
0.07
0.1
0.3
0.4
0.6
0.7
0.9
1
1.2
1.3
1.5
1.6
1
0.1
0.3
0.6
0.9
1.2
1.5
1.8
2.1
2.4
2.7
3
3.3
2.5
0.4
0.7
1.5
2
3
4
4.5
5
6
7
7.5
8
5
0.7
1.5
3
4.5
6
7.5
9
10.5
12
13.5
15
16.5
7.5
1.1
2.2
4.5
7
9
11
13.5
16
18
20
22.5
25
10
1.4
3
6
9
12
15
18
21
24
27
30
33
12.5
1.9
3.7
7
11
15
19
22.5
26
30
34
37.5
41
15
2.2
4.5
9
13.5
18
22.5
27
31.5
36
40.5
45
49.5
17.5
2.6
5.2
10.5
15.7
21
26.2
31.5
36.7
42
47.2
52.5
57.7
20
3
6
12
18
24
30
36
42
48
54
60
66
Concentrations of up to 5,000 mcg/mL have been administered to humans (250 mg/50 mL). The final volume administered should be determined by the fluid requirements of the patient.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.

Note − Do not add Dobutamine Injection, USP to 5% Sodium Bicarbonate Injection or to any other strongly alkaline solution. Because of potential physical incompatibilities, it is recommended that dobutamine hydrochloride not be mixed with other drugs in the same solution. Dobutamine hydrochloride should not be used in conjunction with other agents or diluents containing both sodium bisulfite and ethanol.

Preparation and Stability − At the time of administration, Dobutamine Injection, USP must be further diluted in an I.V. container to at least a 50 mL solution using one of the following intravenous solutions as a diluent: 5% Dextrose Injection, USP; 5% Dextrose and 0.45% Sodium Chloride Injection, USP; 5% Dextrose and 0.9% Sodium Chloride Injection, USP; 10% Dextrose Injection, USP; Isolyte® M with 5% Dextrose Injection; Lactated Ringer's Injection; 5% Dextrose in Lactated Ringer's Injection; Normosol®-M in D5-W; 20% Osmitrol® in Water for Injection; 0.9% Sodium Chloride Injection, USP; or Sodium Lactate Injection, USP. Intravenous solutions should be used within 24 hours.

Recommended Dosage − The rate of infusion needed to increase cardiac output usually ranged from 2.5 to 15 mcg/kg/min (see Table 1). On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect.

Table 1 Dobutamine Infusion Rate (mL/kg/min) for Concentrations of 250, 500, and 1,000 mcg/mL

Drug Delivery
Rate

Infusion Delivery Rate

250 mcg/mL*

500 mcg/mL†

1,000 mcg/mL‡

(mL/kg/min) (mL/kg/min) (mL/kg/min) (mL/kg/min)

2.5

0.01

0.005

0.0025

5

0.02

0.01

0.005

7.5

0.03

0.015

0.0075

10

0.04

0.02

0.01

12.5

0.05

0.025

0.0125

15

0.06

0.03

0.015

* 250 mcg/mL of diluent
† 500 mcg/mL or 250 mg/500 mL of diluent
‡ 1,000 mcg/mL or 250 mg/250 mL of diluent

Rates of infusion in mL/h for Dobutamine concentrations of 500 mcg/mL, 1,000 mcg/mL, and 2,000 mcg/mL are given in Table 2.

Table 2

Drug Delivery
Rate
(mcg/kg/min)

Dobutamine Infusion Rate (mL/h) for 500 mcg/mL concentration

Patient Body Weight (kg)

 

30

40

50

60

70

80

90

100

110

2.5

9

12

15

18

21

24

27

30

33

5

18

24

30

36

42

48

54

60

66

7.5

27

36

45

54

63

72

81

90

99

10

36

48

60

72

84

96

108

120

132

12.5

45

60

75

90

105

120

135

150

165

15

54

72

90

108

126

144

162

180

198

 

Drug Delivery
Rate
(mcg/kg/min)

Dobutamine Infusion Rate (mL/h) for 1,000 mcg/mL concentration

Patient Body Weight (kg)

 

30

40

50

60

70

80

90

100

110

2.5

4.5

6

7.5

9

10.5

12

13.5

15

16.5

5

9

12

15

18

21

24

27

30

33

7.5

13.5

18

22.5

27

31.5

36

40.5

45

49.5

10

18

24

30

36

42

48

54

60

66

12.5

22.5

30

37.5

45

52.5

60

67.5

75

82.5

15

27

36

45

54

63

72

81

90

99

 

Drug Delivery
Rate
(mcg/kg/min)

Dobutamine Infusion Rate (mL/h) for 2000 mcg/mL concentration

Patient Body Weight (kg)

 

30

40

50

60

70

80

90

100

110

2.5

2

3

4

4.5

5

6

7

7.5

8

5

4.5

6

7.5

9

10.5

12

13.5

15

16.5

7.5

7

9

11

13.5

16

18

20

22.5

25

10

9

12

15

18

21

24

27

30

33

12.5

11

15

19

22.5

26

30

34

37.5

41

15

13.5

18

22.5

27

31.5

36

40.5

45

49.5

The rate of administration and the duration of therapy should be adjusted according to the patient's response as determined by heart rate, presence of ectopic activity, blood pressure, urine flow, and, whenever possible, measurement of central venous or pulmonary wedge pressure and cardiac output.

Concentrations of up to 5,000 mcg/mL have been administered to humans (250 mg/50 mL). The final volume administered should be determined by the fluid requirements of the patient.

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