24:20 beta-Adrenergic Blocking Agents
Generic Name
Labetalol hydrochloride is available in 20- and 40-mL multiple-dose vials and 4-mL single-dose vials and cartridges.3692; 3693; 3694; 3695 Each mL of solution contains labetalol hydrochloride 5 mg, dextrose anhydrous 45 mg, edetate disodium 0.1 mg, methylparaben 0.8 mg, propylparaben 0.1 mg, and citric acid (monohydrate or anhydrous) and/or sodium hydroxide as necessary to adjust pH.3692; 3693; 3694; 3695
Labetalol hydrochloride also is available as a premixed, ready-to-use solution at a concentration of 1 mg/mL in sodium chloride in bags containing 100, 200, and 300 mL and in dextrose in bags containing 200 mL.3691 Each mL of the premixed solution in sodium chloride contains labetalol hydrochloride 1 mg, sodium chloride 7.2 mg, dextrose anhydrous 9 mg, edetate disodium 0.02 mg, and citric acid monohydrate and sodium hydroxide as necessary to adjust the pH.3691 Each mL of the premixed solution in dextrose contains labetalol hydrochloride 1 mg, dextrose anhydrous 45 mg, edetate disodium 0.02 mg, and citric acid monohydrate and sodium hydroxide as necessary to adjust the pH.3691
pH
Labetalol hydrochloride injection has a pH ranging from 3 to 43694 or 4.5.3692; 3693; 3695 The premixed infusion solutions in sodium chloride and dextrose have a pH ranging from 3.5 to 4.5.3691
Tonicity
Both the injection solution and the premixed solutions are isotonic.3691; 3692; 3693; 3694; 3695
Labetalol hydrochloride is administered by slow direct intravenous injection over 2 minutes or by slow continuous intravenous infusion at an initial rate of 2 mg/min with subsequent adjustments based on blood pressure response.3691; 3692; 3693; 3694; 3695 For continuous infusion, diluted solutions with labetalol hydrochloride concentrations of 1 mg/mL or 2 mg/3 mL can be prepared by adding 200 mg (40 mL) to 160 or 250 mL, respectively, of compatible infusion solution;3692; 3693; 3694; 3695 alternatively, the premixed ready-to-use solution may be administered by continuous infusion with no further dilution required.3691 To facilitate the infusion of labetalol hydrochloride at an accurate rate of administration, a controlled-infusion device, such as a pump, may be used.3692; 3693; 3694; 3695
Both the injection solution and the premixed solutions are clear and colorless to lightly yellow.3691; 3692; 3693; 3694; 3695 Intact containers of labetalol hydrochloride should be stored at controlled room temperature and protected from light and freezing.3691; 3692; 3693; 3694; 3695 Some manufacturers state that the drug should be stored in its original carton until time of use.3692; 3693 Intact bags of the premixed solutions of labetalol hydrochloride should be stored in their overwrap until use.3691
pH Effects
Labetalol hydrochloride has optimal stability at pH 3 to 4; addition to an alkaline drug or solution has resulted in precipitate formation.757; 1715; 2062 Manufacturers state that labetalol hydrochloride should not be administered in the same infusion line with other alkaline drug products (e.g., furosemide, sodium bicarbonate).3692; 3693; 3694; 3695
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 Labetalol3635; 3636
| Patient Population | Concentration Standards | Dosing Units |
|---|---|---|
| Adults | 1 mg/mL 5 mg/mL | mg/minute |
| Pediatric patients (50 kg) | 1 mg/mL 5 mg/mL | mg/kg/hour |
For a list of references cited in the text of this monograph, search the monograph titled References.