| Product Description: | DOBUTamine Injection, USP, 250 mg per 20 mL, 20 mL Single-dose Fliptop Vial, Rx only, Manufactured for Hospira Inc., Lake Forest, IL 60045 USA. NDC 0409-2344-02 |
|---|---|
| Status: | Ongoing |
| City: | Lake Forest |
| State: | IL |
| Country: | US |
| Voluntary/Mandated: | Voluntary: Firm Initiated |
| Initial Firm Notification: | Letter |
| Distribution Pattern: | Nationwide and Puerto Rico. |
| Classification: | Class I |
| Product Quantity: | 123,900 vials |
| Reason For Recall: | Presence of Particulate Matter: Discolored solution due to a chip in the glass at the neck of the vial, also glass particulate was found within the solution. |
| Recall Initiation Date: | 20140110 |
| Report Date: | 20140827 |
Dobutamine Hydrochloride
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Questions & Answers
Side Effects & Adverse Reactions
-
Increase in Heart Rate or Blood Pressure
Dobutamine hydrochloride may cause a marked increase in heart rate or blood pressure, especially systolic pressure. Approximately 10% of adult 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. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine. Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressure response.
-
Ectopic Activity
Dobutamine may precipitate or exacerbate ventricular ectopic activity, but it rarely has caused ventricular tachycardia.
-
Hypersensitivity
Reactions suggestive of hypersensitivity associated with administration of Dobutamine in 5% Dextrose Injection, USP, including skin rash, fever, eosinophilia, and bronchospasm, have been reported occasionally.
Additive medications should not be delivered via this solution.
-
Dobutamine in 5% Dextrose Injection, USP contains sodium bisulfite, 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 sulfite 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 in 5% Dextrose Injection, USP is indicated when parenteral therapy is necessary for inotropic support in the short-term treatment of cardiac decompensation due to depressed contractility resulting either from organic heart disease or from cardiac surgical procedures. Experience with intravenous dobutamine in controlled trials does not extend beyond 48 hours of repeated boluses and/or continuous infusions.
Whether given orally, continuously intravenously, or intermittently intravenously, neither dobutamine nor any other cyclic-AMP-dependent inotrope has been shown in controlled trials to be safe or effective in the long-term treatment of congestive heart failure. In controlled trials of chronic oral therapy with various such agents, symptoms were not consistently alleviated, and the cyclic-AMP-dependent inotropes were consistently associated with increased risks of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.
History
There is currently no drug history available for this drug.
Other Information
Dobutamine in 5% Dextrose Injection, USP is a sterile, nonpyrogenic, prediluted solution of dobutamine hydrochloride and dextrose in water for injection. It is administered by intravenous infusion.
Each 100 mL contains dobutamine hydrochloride equivalent to 50 mg, 100 mg, 200 mg, or 400 mg of dobutamine; dextrose, hydrous 5 g in water for injection, with sodium metabisulfite 25 mg and edetate disodium, dihydrate 10 mg added as stabilizers; osmolar concentration, respectively, 260, 263, 270, or 284 mOsmol/liter (calc.). The pH is 3.0 (2.5 to 5.5). May contain hydrochloric acid and/or sodium hydroxide for pH adjustment. Dobutamine in 5% Dextrose Injection, USP is oxygen sensitive.
Dobutamine Hydrochloride, USP is chemically designated (±)-4-[2-[[3-(p-hydroxyphenyl)-1-methylpropyl]amino]ethyl]-pyrocatechol hydrochloride. It is a synthetic catecholamine.
Dextrose, USP is chemically designated D-glucose monohydrate (C6H12O6• H2O), a hexose sugar freely soluble in water. It has the following structural formula:
Water for Injection, USP is chemically designated H2O.
The flexible plastic container is fabricated from a specially formulated CR3 plastic material. Water can permeate from inside the container into the overwrap but not in amounts sufficient to affect the solution significantly. Solutions in contact with the plastic container may leach out certain chemical components from the plastic in very small amounts; however, biological testing was supportive of the safety of the plastic container materials. Exposure to temperatures above 25°C/77°F during transport and storage will lead to minor losses in moisture content. Higher temperatures lead to greater losses. It is unlikely that these minor losses will lead to clinically significant changes within the expiration period.
Sources
Dobutamine Hydrochloride Manufacturers
-
Physicians Total Care, Inc.
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Dobutamine Hydrochloride | Physicians Total Care, Inc.
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.
-
General Injectables & Vaccines, Inc
Dobutamine Hydrochloride | General Injectables & Vaccines, Inc
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.
-
Hospira, Inc.
Dobutamine Hydrochloride | Hospira, Inc.
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/mLDrug Delivery
RateInfusion 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 diluentRates 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 2Drug 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.
![Dobutamine Hydrochloride Injection, Powder, Lyophilized, For Solution [General Injectables & Vaccines, Inc]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=d79db1b1-e04b-46f4-ba7c-ed5bde835463&name=Label1.jpg)
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