Dobutamine Hydrochloride In Dextrose
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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 reverses these effects.
Because dobutamine facilitates atrioventricular conduction, patients with atrial fibrillation are at risk of developing rapid ventricular response. Patients with pre-existing hypertension appear to face an increased risk of developing an exaggerated pressure response. In patients who have atrial fibrillation with rapid ventricular response, a digitalis preparation should be used prior to institution of therapy with dobutamine.
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.
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.
Solutions containing dextrose should not be administered through the same administration set as blood, as this may result in pseudoagglutination or hemolysis.
The intravenous administration of solutions may cause fluid overloading resulting in dilution of serum electrolyte concentrations, overhydration, congested states or pulmonary edema. The risk of dilutional states is inversely proportional to the electrolyte concentrations of the injections. The risk of solute overload causing congested states with peripheral and pulmonary edema is directly proportional to the electrolyte concentration of the injections.
Excess administration of potassium-free solutions may result in significant hypokalemia.
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 patients with 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 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, 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 In Dextrose Manufacturers
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Hospira, Inc.
![Dobutamine Hydrochloride In Dextrose (Dobutamine Hydrochloride) Injection, Solution [Hospira, Inc.]](/wp-content/themes/bootstrap/assets/img/loading2.gif)
Dobutamine Hydrochloride In Dextrose | Hospira, Inc.
Recommended Dosage
Dobutamine in 5% Dextrose Injection, USP is administered intravenously through a suitable intravenous catheter or needle. A calibrated electronic infusion device is recommended for controlling the rate of flow in mL/hour or drops/minute.
Infusion of dobutamine should be started at a low rate (0.5-1.0 µg/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 2-20 µg/kg/min but sometimes slightly outside of this range. On rare occasions, infusion rates up to 40 µg/kg/min have been required to obtain the desired effect.
Rates of infusion in mL/hour for dobutamine hydrochloride concentrations of 500, 1,000, 2,000 and 4,000 mg/L are in Table 2.
This container system may be inappropriate for the dosage requirements of pediatric patients under 30 kg. Other dosage forms may be more appropriate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Dobutamine in 5% Dextrose Injection, USP solutions may exhibit a pink color that, if present, will increase with time. This color change is due to slight oxidation of the drug, but there is no significant loss of potency.
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.
Do not add supplementary medications to Dobutamine in 5% Dextrose Injection, USP. Do not administer Dobutamine in 5% Dextrose Injection, USP simultaneously with solutions containing sodium bicarbonate or strong alkaline solutions.
Table 2. Infusion Rate (mL/hr) of Dobutamine Hydrochloride in 5% Dextrose Injection500 mcg/mL Patient’s Weight (kg)
Drug Delivery Rate (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
11
12
13
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
30
45
60
75
90
105
120
135
150
165
15
9
18
36
54
72
90
108
126
144
162
180
198
17.5
11
21
42
63
84
105
126
147
168
189
210
231
20
12
24
48
72
96
120
144
168
192
216
240
264
1000 mcg/mL Patient’s Weight (kg)
Drug Delivery Rate (mcg/kg/min)
5
10
20
30
40
50
60
70
80
90
100
110
0.5
0.15
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
0.75
1.5
3
4.5
6
7.5
9
11
12
14
15
17
5
1.5
3
6
9
12
15
18
21
24
27
30
33
7.5
2.3
4.5
9
14
18
23
27
32
36
41
45
50
10
3
6
12
18
24
30
36
42
48
54
60
66
12.5
3.8
7.5
15
23
30
38
45
53
60
68
75
83
15
4.5
9
18
27
36
45
54
63
72
81
90
99
17.5
5.3
11
21
32
42
53
63
74
84
95
105
116
20
6
12
24
36
48
60
72
84
96
108
120
132
2000 mcg/mL Patient’s Weight (kg)
Drug Delivery Rate (mcg/kg/min)
5
10
20
30
40
50
60
70
80
90
100
110
0.5
0.08
0.15
0.3
0.45
0.6
0.75
0.9
1.1
1.2
1.4
1.5
1.7
1
0.15
0.3
0.6
0.9
1.2
1.5
1.8
2.1
2.4
2.7
3
3.3
2.5
0.38
0.75
1.5
2.3
3
3.8
4.5
5.3
6
6.8
7.5
8.3
5
0.75
1.5
3
4.5
6
7.5
9
11
12
14
15
17
7.5
1.1
2.3
4.5
6.8
9
11
14
16
18
20
23
25
10
1.5
3
6
9
12
15
18
21
24
27
30
33
12.5
1.9
3.8
7.5
11
15
19
23
26
30
34
38
41
15
2.3
4.5
9
14
18
23
27
32
36
41
45
50
17.5
2.6
5.3
11
16
21
26
32
37
42
47
53
58
20
3
6
12
18
24
30
36
42
48
54
60
66
4000 mcg/mL Patient’s Weight (kg)
Drug Delivery Rate (mcg/kg/min)
5
10
20
30
40
50
60
70
80
90
100
110
0.5
0.04
0.08
0.15
0.23
0.3
0.38
0.45
0.53
0.6
0.68
0.75
0.83
1
0.08
0.15
0.3
0.45
0.6
0.75
0.9
1.1
1.2
1.4
1.5
1.7
2.5
0.19
0.38
0.75
1.1
1.5
1.9
2.3
2.6
3
3.4
3.8
4.1
5
0.38
0.75
1.5
2.3
3
3.8
4.5
5.3
6
6.8
7.5
8.3
7.5
0.56
1.1
2.3
3.4
4.5
5.6
6.8
7.9
9
10
11
12
10
0.75
1.5
3
4.5
6
7.5
9
11
12
14
15
17
12.5
0.94
1.9
3.8
5.6
7.5
9.4
11
13
15
17
19
21
15
1.1
2.3
4.5
6.8
9
11
14
16
18
20
23
25
17.5
1.3
2.6
5.3
7.9
11
13
16
18
21
24
26
29
20
1.5
3
6
9
12
15
18
21
24
27
30
33
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.
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Baxter Healthcare Corporation
Dobutamine Hydrochloride In Dextrose | Baxter Healthcare Corporation
Recommended DosageDobutamine Hydrochloride in 5% Dextrose Injection is administered intravenously through a suitable intravenous catheter or needle. A calibrated electronic infusion device is recommended for controlling the rate of flow in mL/hour or drops/minute.
Infusion of dobutamine should be started at a low rate (0.5-1.0 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 2-20 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 in mL/hour for dobutamine hydrochloride concentrations of 1,000, 2,000 and 4,000 mcg/mL are in Table 2.
This container system may be inappropriate for the dosage requirements of pediatric patients under 30 kg. Other dosage forms may be more appropriate.
Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
Dobutamine Hydrochloride in 5% Dextrose Injection solutions may exhibit a pink color that, if present, will increase with time. This color change is due to slight oxidation of the drug, but there is no significant loss of potency.
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.
Do not add supplementary medications to Dobutamine Hydrochloride in 5% Dextrose Injection. Do not administer Dobutamine Hydrochloride in 5% Dextrose Injection simultaneously with solutions containing sodium bicarbonate or strong alkaline solutions.
![Dobutamine Hydrochloride In Dextrose (Dobutamine Hydrochloride) Injection [Baxter Healthcare Corporation]](http://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=6b17b98b-e06d-42ed-925f-69aa2699dead&name=e2e34f01-681a-4cde-9ed4-103552946845-03.jpg)
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