Data from FDA - Curated by EPG Health - Last updated 01 June 2018

Indication(s)

INDICATIONS AND USAGE 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 used prior to institution of therapy with dobutamine hydrochloride.

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Advisory information

contraindications
CONTRAINDICATIONS Dobutamine hydrochloride is contraindicated in patients with idiopathic hypertrophic subaortic stenosis and in patients who have shown previous manifestations of hypersensitivity to dobutamine injection.
Special warnings and precautions
PRECAUTIONS General 1. During the administration of dobutamine injection, as with any adrenergic agent, ECG and blood pressure should be continuously monitored. In addition, pulmonary wedge pressure and cardiac output should be monitored whenever possible to aid in the safe and effective infusion of dobutamine hydrochloride. 2. Hypovolemia should be corrected with suitable volume expanders before treatment with dobutamine is instituted. 3. No improvement may be observed in the presence of marked mechanical obstruction, such as severe valvular aortic stenosis. Usage Following Acute Myocardial Infarction — Clinical experience with dobutamine injection following myocardial infarction has been insufficient to establish the safety of the drug for this use. There is concern that any agent that increases contractile force and heart rate may increase the size of an infarction by intensifying ischemia, but it is not known whether dobutamine does so. Laboratory Tests — Dobutamine, like other ß2- agonists, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels. Accordingly, consideration should be given to monitoring serum potassium. Drug Interactions — Animal studies indicate that dobutamine may be ineffective if the patient has recently received a ß-blocking drug. In such a case, the peripheral vascular resistance may increase. Preliminary studies indicate that the concomitant use of dobutamine and nitroprusside results in a higher cardiac output and, usually, a lower pulmonary wedge pressure than when either drug is used alone. There was no evidence of drug interactions in clinical studies in which dobutamine was administered concurrently with other drugs, including digitalis preparations, furosemide, spironolactone, lidocaine, nitroglycerin, isosorbide dinitrate, morphine, atropine, heparin, protamine, potassium chloride, folic acid, and acetaminophen. Carcinogenesis, Mutagenesis, Impairment of Fertility — Studies to evaluate the carcinogenic or mutagenic potential of dobutamine hydrochloride, or its potential to affect fertility, have not been conducted. Pregnancy-Teratogenic Effects — Reproduction studies performed in rats at doses up to the normal human dose (10 mcg/kg/min for 24 h, total daily dose of 14.4 mg/kg) and in rabbits at doses up to 2 times the normal human dose have revealed no evidence of harm to the fetus due to dobutamine. There are, however, no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if clearly needed. Labor and Delivery — The effect of dobutamine injection on labor and delivery is unknown. Nursing Mothers — It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when dobutamine hydrochloride is administered to a nursing woman. If a mother requires dobutamine treatment, breast-feeding should be discontinued for the duration of the treatment. Pediatric Use — The safety and effectiveness of dobutamine injection for use in pediatric patients have not been studied.
Adverse reactions
ADVERSE REACTIONS Increased Heart Rate, Blood Pressure, and Ventricular Ectopic Activity — A 10- to 20-mm increase in systolic blood pressure and an increase in heart rate of 5 to 15 beats/minute have been noted in most patients (see WARNINGS regarding exaggerated chronotropic and pressor effects). Approximately 5% of patients have had increased premature ventricular beats during infusions. These effects are dose related. Hypotension — Precipitous decreases in blood pressure have occasionally been described in association with dobutamine therapy. Decreasing the dose or discontinuing the infusion typically results in rapid return of blood pressure to baseline values. In rare cases, however, intervention may be required and reversibility may not be immediate. Reactions at Sites of Intravenous Infusion — Phlebitis has occasionally been reported. Local inflammatory changes have been described following inadvertent infiltration. Isolated cases of cutaneous necrosis (destruction of skin tissue) have been reported. Miscellaneous Uncommon Effects — The following adverse effects have been reported in 1% to 3% of patients: nausea, headache, anginal pain, nonspecific chest pain, palpitations, and shortness of breath. Isolated cases of thrombocytopenia have been reported. Administration of dobutamine, like other catecholamines, can produce a mild reduction in serum potassium concentration, rarely to hypokalemic levels (see PRECAUTIONS). Longer-Term Safety — Infusions of up to 72 hours have revealed no adverse effects other than those seen with shorter infusions.

Usage information

Dosing and administration
DOSAGE AND ADMINISTRATION 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 intravenous 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 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 Injection concentrations of 500 mcg/mL, 1000 mcg/mL, and 2000 mcg/mL are given in Table 2. Table 2 Dobutamine 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 7.5 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 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.

More information

Category Value
Authorisation number ANDA074292
Agency product number 0WR771DJXV
Orphan designation No
Product NDC 0409-2025
Date Last Revised 02-05-2018
Type HUMAN PRESCRIPTION DRUG
RXCUI 1812170
Marketing authorisation holder Hospira, Inc.