dobutamine injection, USP 250 mg/20 ml VIAL Dosage and Administration

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DOSAGE AND ADMINISTRATION

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 intravenous 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‡

(mcg/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.

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Dosage and Administration

DOSAGE AND ADMINISTRATION

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 intravenous 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‡

(mcg/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.

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