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Dobutamine

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Dobutamine

INDICATIONS

Dobutamine 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. 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 risk of hospitalization and death. Patients with NYHA Class IV symptoms appeared to be at particular risk.

DOSAGE AND ADMINISTRATION

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 1.0 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. 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
(mcg/kg/ min)
Patient Body Weight (kg)
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 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 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
(mcg/kg/ min)
Patient Body Weight (kg)
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
(mcg/kg/ min)
Patient Body Weight (kg)
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 1.5 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.

HOW SUPPLIED

Dobutamine Injection USP, 20 mL single dose vial contains dobutamine hydrochloride, equivalent to 250 mg dobutamine per 20 mL; ten vials per carton. NDC 55390-560-90.

Store at controlled room temperature, 15° to 30°C (59° to 86°F) [see USP].

Manufactured by: Ben Venue Laboratories, Inc., Bedford, Ohio 44146. Manufactured for: Bedford Laboratories™, Bedford, OH 44146. June 2005.

Last reviewed on RxList: 11/22/2010
This monograph has been modified to include the generic and brand name in many instances.

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