Dobutamine
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Questions & Answers
Side Effects & Adverse Reactions
1. Increase in Heart Rate or Blood Pressure
Dobutamine may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Dobutamine may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Approximately 10% of patients in clinical studies have had rate increases of 30 beats/minute or more, and about 7.5% have had a 50 mm Hg or greater increase in systolic pressure. Usually, reduction of dosage promptly reverses these effects. Because dobutamine facilitates atrioventricular conduction, patients with atrial fibrillation are at risk of developing rapid ventricular response. Patients with preexisting hypertension appear to face an increased risk of developing an exaggerated pressor response.
2. Ectopic Activity
Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.
3. Hypersensitivity
Reactions suggestive of hypersensitivity associated with administration of dobutamine injection, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.
4. Dobutamine injection contains sodium metabisulfite, a sulfite that may cause allergic-type reactions, including anaphylactic symptoms and life-threatening or less severe asthmatic episodes, in certain susceptible people. The overall prevalence of sulfit sensitivity in the general population is unknown and probably low. Sulfite sensitivity is seen more frequently in asthmatic than in nonasthmatic people.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
Dobutamine injection is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of adults with cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures.
In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be use prior to institution of therapy with dobutamine hydrochloride.
History
There is currently no drug history available for this drug.
Other Information
Dobutamine Injection, USP is 1,2-benzenediol, 4-[2-[[3-(4-hydro-xphenyl)-1-methylpropyl]amino]ethyl]-hydrochloride, (±). It is a synthetic catecholamine.
The clinical formulation is supplied in a sterile form for intravenous use only. Each mL contains: Dobutamine hydrochloride, equivalent to 12.5 mg (41.5 umol) dobutamine; 0.24 mg sodium metabisulfite (added during manufacture), and water for injection, pH adjusted between 2.5 to 5.5 with hydrochloric acid and/or sodium hydroxide. Dobutamine is oxygen sensitive.
Sources
Dobutamine Manufacturers
-
General Injectables And Vaccines, Inc.
![Dobutamine (Dobutamine Hydrochloride Injection) Injection, Solution [General Injectables And Vaccines, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dobutamine | General Injectables And Vaccines, Inc.
Note- Do not add dobutamine injection 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 must be further diluted in an IV container: Dilute 20 mL of dobutamine in at least 50 mL of diluent and dilute 40 mL of dobutamine in at least 100 mL of diluent. Use one of the following intravenous solutions as a diluent: Dextrose Injection 5%, Dextrose 5% and Sodium Chloride 0.45% Injection, Dextrose 5% and Sodium Chloride 0.9% Injection, Dextrose Injection 10%, 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, Sodium Chloride Injection 0.9%, or Sodium Lactate Injection. Intravenous solutions should be used within 24 hours.
Recommended Dosage- The rate of infustion needed to increase cardiac output usually ranged from 2.5 to 15 mcg/kg/min (see table). On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect.
The rate of administration and the duration oof 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.
-
Physicians Total Care, Inc.
Dobutamine | Physicians Total Care, Inc.
Note— Do not add dobutamine injection 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 must be further diluted in an IV container. Dilute 20 mL of dobutamine in at least 50 mL of diluent and dilute 40 mL of dobutamine in at least 100 mL of diluent. Use one of the following intravenous solutions as a diluent: Dextrose Injection 5%, Dextrose 5% and Sodium Chloride 0.45% Injection, Dextrose 5% and Sodium Chloride 0.9% Injection, Dextrose Injection 10%, 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, Sodium Chloride Injection 0.9%, or Sodium Lactate Injection. 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). On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect.
Dobutamine Injection
Rates of Infusion for Concentrations of 250, 500, and 1,000 mcg/mL
Drug Delivery Rate
(mcg/kg/min)
250 mcg/mL*
(mL/kg/min)
Infusion Delivery Rate
500 mcg/mL†
(mL/kg/min)
1,000 mcg/mL‡
(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 Injection concentrations of 500 mcg/mL, 1000 mcg/mL, and 2000 mcg/mL are given in Table 2.
Table 2
Dobutamine Injection Infustion Rate (mL/h) for 500 mcg/mL concentration
Drug Delivery Rate Patient Body Weight (kg) mcg/kg/min)
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
Dobutamine Injection Infustion Rate (mL/h) for 1,000 mcg/mL concentration
Drug Delivery Rate Patient Body Weight (kg) mcg/kg/min)
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
Dobutamine Injection Infustion Rate (mL/h) for 2,000 mcg/mL concentration
Drug Delivery Rate Patient Body Weight (kg) mcg/kg/min)
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.
-
Hospira, Inc.
Dobutamine | Hospira, Inc.
Note — Do not add dobutamine injection 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 must be further diluted in an IV container. Dilute 20 mL of dobutamine in at least 50 mL of diluent and dilute 40 mL of dobutamine in at least 100 mL of diluent. Use one of the following intravenous solutions as a diluent: Dextrose Injection 5%, Dextrose 5% and Sodium Chloride 0.45% Injection, Dextrose 5% and Sodium Chloride 0.9% Injection, Dextrose Injection 10%, 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, Sodium Chloride Injection 0.9%, or Sodium Lactate Injection. 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). On rare occasions, infusion rates up to 40 mcg/kg/min have been required to obtain the desired effect.
Dobutamine Injection Rates of Infusion for Concentrations of 250, 500, and 1,000 mcg/mLDrug 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) 2.50.01
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 diluentRates of infusion in mL/h for Dobutamine Injection concentrations of 500 mcg/mL, 1000 mcg/mL, and 2000 mcg/mL are given in Table 2.
Table 2Dobutamine Injection Infusion Rate (mL/h) for 500 mcg/mL concentration
Drug Delivery Rate
(mcg/kg/min)
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
Dobutamine Injection Infusion Rate (mL/h) for 1,000 mcg/mL concentration
Drug Delivery Rate
(mcg/kg/min)
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
7.513.5
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
Dobutamine Injection Infusion Rate(mL/h) for 2,000 mcg/mL concentration
Drug Delivery Rate
(mcg/kg/min)
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.
![Dobutamine (Dobutamine Hydrochloride) Injection, Solution [Physicians Total Care, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=a0882db1-2532-4b80-b753-68f013fe79e7&name=5717-0.jpg)
![Dobutamine (Dobutamine Hydrochloride) Injection, Solution [Hospira, Inc.]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=cb842dc2-fb15-48f9-e4b1-ea4280db0199&name=dobutamine-injection-usp-3-figure-2-jRL-0816.jpg)
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