AHFS Class:

24:20 beta-Adrenergic Blocking Agents

Generic Name

• Labetalol Hydrochloride

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

Solution Compatibility

Additive Compatibility

Drugs in Syringe Compatibility

Y-Site Injection Compatibility (1:1 Mixture)

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions September 12, 2024. © Copyright, 2024. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.