Dobutamine hydrochloride is available as a concentrate for injection in 20-mL single-dose vials.3672 Each mL of the concentrate for injection contains 12.5 mg of dobutamine (as the hydrochloride), sodium metabisulfite 0.2 mg, and hydrochloric acid and/or sodium hydroxide to adjust the pH.3672 Dobutamine hydrochloride concentrate for injection must be diluted in an intravenous container to at least 50 mL in a compatible infusion solution prior to use.3672
Dobutamine hydrochloride also is available in plastic bags as premixed solutions in dobutamine concentrations of 1000, 2000, and 4000 mcg/mL in dextrose 5%.3673; 3674 Each bag also contains sodium metabisulfite and edetate disodium dihydrate3673 or sodium bisulfite.3674 Hydrochloric acid and/or sodium hydroxide also may be present to adjust the pH.3673; 3674
pH
Dobutamine hydrochloride concentrate for injection has a pH of 3.3 with a range from 2.5 to 5.5.3672 The premixed infusion solution in dextrose 5% (Hospira) has a pH of 3 with a range from 2.5 to 5.5.3673 The premixed infusion solution in dextrose 5% (Baxter) has a pH of 3.5 with a range from 2.5 to 5.5.3674
Osmolality
The osmolality of dobutamine hydrochloride injection (Lilly) was determined to be 273 mOsm/kg by freezing-point depression and vapor pressure.1071 At a dobutamine concentration of 5 mg/mL (manufacturer and diluent unspecified), the osmolality was determined to be 361 mOsm/kg by freezing-point depression.1233
Osmolarity
The calculated osmolarity of premixed dobutamine hydrochloride in dextrose 5% (Hospira) is 263, 270, and 284 mOsm/L for the 1000-, 2000-, and 4000-mcg/mL concentrations, respectively.3673 The calculated osmolarity of premixed dobutamine hydrochloride in dextrose 5% (Baxter) is 259, 266, and 280 mOsm/L for the 1000-, 2000-, and 4000-mcg/mL concentrations, respectively.3674
Dobutamine hydrochloride concentrate for injection is administered by intravenous infusion after dilution in a compatible diluent.3672 Dobutamine concentrations of up to 5000 mcg/mL have been administered.3672
Dobutamine hydrochloride premixed solutions in dextrose 5% also are administered by intravenous infusion.3673; 3674
The dosage and rate of infusion should be individualized according to the patient’s response and fluid requirements.3672; 3673; 3674 A calibrated electronic infusion device is recommended to control the flow rate.3673; 3674
Intact vials of dobutamine hydrochloride concentrate for injection should be stored at controlled room temperature.3672 Intact bags of the premixed solution of dobutamine hydrochloride should be stored at controlled room temperature in their overwrap until use; some manufacturers also state that bags should be protected from freezing and that excessive heat should be avoided.3673; 3674 Solutions prepared from diluting the concentrate for injection in a compatible diluent should be used within 24 hours.3672
Dobutamine hydrochloride concentrate for injection is a clear, practically colorless solution.3672 Solutions of dobutamine hydrochloride may have a pink discoloration.3673; 3674 This discoloration, which will increase with time, results from a slight oxidation of the drug; however, there is no significant loss of drug.3673; 3674
Dobutamine hydrochloride should not be mixed or administered simultaneously with sodium bicarbonate or any other strongly alkaline solution.3672; 3673; 3674
Syringes
Dobutamine hydrochloride (Lilly) concentrate for injection was diluted in dextrose 5% to a dobutamine concentration of 5 mg/mL and stored as 50 mL in 60-mL plastic syringes (Becton Dickinson) for 24 hours at 25°C.1579 No change in appearance or drug loss occurred.1579
Dobutamine hydrochloride (Lilly) was diluted in dextrose 5% to a dobutamine concentration of 5 mg/mL, packaged in 50-mL polypropylene syringes (Becton Dickinson), and stored at 4 and 24°C in the dark and exposed to room light for 48 hours. Dobutamine losses were less than 10% throughout the study.1961
To assess the stability of dobutamine 500 mg in 50-mL syringes, dobutamine hydrochloride (Phoenix) concentrate for injection was mixed with dextrose 5% for final dobutamine and dextrose concentrations of 10 mg/mL and 1%, respectively, and packaged as 3 mL in 50-mL syringes (Becton Dickinson).3511 Syringes were stored at 4 and 40°C protected from light and at room temperature, both protected from and exposed to light.3511 Calculated times to 5% loss from initial concentrations were approximately 111, 74, 56, and 45 days for samples stored at 4°C protected from light, room temperature protected from light, room temperature exposed to light, and 40°C protected from light, respectively.3511 However, syringes stored at room temperature protected from light, 40°C protected from light, and room temperature exposed to light demonstrated discoloration at 42, 35, and 28 days, respectively; syringes stored at 4°C protected from light did not demonstrate any such discoloration.3511 While all samples demonstrated less than 10% loss from initial concentrations in 42 days, the authors concluded that syringes stored at 4°C protected from light and room temperature protected from light have a shelf life of 42 and 35 days, respectively.3511
Sorption
Dobutamine hydrochloride (Lilly) diluted in dextrose 5% to a dobutamine concentration of 5 mg/mL and delivered by syringe pump over 12 hours at 24°C through polyvinyl chloride (PVC) and polyethylene tubing did not result in substantial dobutamine losses.1961
Filtration
Dobutamine hydrochloride (Lilly) diluted in dextrose 5% and sodium chloride 0.9% to a dobutamine concentration of 0.5 mg/mL was filtered through a 0.22-µm cellulose ester membrane filter (Ivex-HP, Millipore) over 6 hours. No significant drug loss due to binding to the filter was noted.1034
Central Venous Catheter
Dobutamine hydrochloride (Astra) diluted in dextrose 5% to a dobutamine concentration of 4 mg/mL was found to be compatible with the ARROWg+ard Blue Plus (Arrow International) chlorhexidine-bearing triple-lumen central catheter. Essentially complete delivery of the drug was found with little or no drug loss occurring. Furthermore, chlorhexidine delivered from the catheter remained at trace amounts with no substantial increase due to the delivery of the drug through the catheter.2335
Standardize 4 Safety
One or more standardized concentrations for this drug have been established through Standardize 4 Safety (S4S), a national patient safety initiative to reduce medication errors, especially during transitions of care. (See Standardize 4 Safety in Users Guide.) Recommendations developed to date through this initiative are available at www.ashp.org/pharmacy-practice/standardize-4-safety-initiative.
Table 1. Standardize 4 Safety Continuous IV Infusion Standard Concentrations for Dobutamine3635; 3636
| Patient Population | Concentration Standards | Dosing Units |
|---|---|---|
| Adults | 2000 mcg/mL 4000 mcg/mL | mcg/kg/minute |
| Pediatric patients (50 kg) | 1000 mcg/mL 2000 mcg/mL 4000 mcg/mL | mcg/kg/minute |
Drugs in Syringe Compatibility
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Peritoneal Dialysis Solutions
Dobutamine hydrochloride (Lilly) diluted in Dianeal PD-1 (Baxter) with dextrose 1.5 and 4.25% to dobutamine concentrations of 2.5, 5, and 7.5 mcg/mL retained at least 90% when stored for 24 hours at 4, 26, and 37°C.1417; 1702
For a list of references cited in the text of this monograph, search the monograph titled References.