Phenylephrine hydrochloride is available as a 10-mg/mL concentrate for injection in 1-mL single-dose vials and 5- and 10-mL pharmacy bulk vials.3051; 3052 Each mL of solution contains phenylephrine hydrochloride 10 mg with sodium citrate dihydrate 4 mg, citric acid monohydrate 1 mg, sodium chloride 3.5 mg, and sodium metabisulfite 2 mg in water for injection.3051; 3052 The pH may have been adjusted with sodium hydroxide and/or hydrochloric acid during manufacturing.3051; 3052
Pharmacy bulk vials should only be used in the preparation of solutions for continuous infusion.3051; 3052
The concentrate for injection must be diluted prior to intravenous administration.3051; 3052 For intravenous bolus administration, 1 mL of the concentrate (10 mg) should be diluted in 99 mL of sodium chloride 0.9% or dextrose 5% to yield a final concentration of 100 mcg/mL.3051; 3052 The appropriate dose should be withdrawn from the diluted solution for bolus administration.3051; 3052 For continuous intravenous infusion, 1 mL of the concentrate (10 mg) should be diluted in 500 mL of sodium chloride 0.9% or dextrose 5% to yield a final concentration of 20 mcg/mL.3051; 3052
Phenylephrine hydrochloride (Biorphen, Eton) also is available as a 0.1-mg/mL ready-to-use solution in 5-mL single-dose (preservative-free) ampuls.3718 Each mL of solution contains phenylephrine hydrochloride 0.1 mg with sodium chloride 9 mg in water for injection.3718 The pH is adjusted with hydrochloric acid if necessary.3718 No further dilution of the ready-to-use solution is necessary.3718
Equivalency
Phenylephrine hydrochloride 0.1 mg is equivalent to 0.08 mg of phenylephrine base.3718
pH
Phenylephrine hydrochloride concentrate for injection has a pH ranging from 3 to 6.5 (Hikma) or 3.5 to 5.5 (Vazculep, Exela).3051; 3052
Phenylephrine hydrochloride 0.1 mg/mL solution (Biorphen, Eton) has a pH ranging from 3 to 5.3718
Trade Name(s)
Vazculep, Biorphen
Phenylephrine hydrochloride concentrate for injection is administered by intravenous bolus injection or by continuous intravenous infusion following dilution in dextrose 5% or sodium chloride 0.9%.3051; 3052
Phenylephrine hydrochloride (Biorphen, Eton) 0.1-mg/mL ready-to-use solution is administered by intravenous bolus injection only.3718
Phenylephrine hydrochloride concentrate for injection is a clear, colorless solution.3051; 3052 Intact vials should be stored at controlled room temperature and protected from light by storing in the original carton until time of use.3051; 3052
The diluted solution should be visually inspected for particulate matter and discoloration prior to use; the solution should not be used if particulate matter is present or discoloration or cloudiness occur..3051; 3052
Diluted solutions of phenylephrine hydrochloride may be stored for up to 4 hours at room temperature or 24 hours at 2 to 8°C.3051; 3052 Any unused portion of the solution should be discarded.3051; 3052
Once the closure of the pharmacy bulk vial has been penetrated with a suitable sterile transfer set or dispensing set that allows the measured dispensing of the vial contents, the vial should not be re-entered, and dispensing from the vial should be completed within 4 hours.3051; 3052 Any unused portion should be discarded.3051; 3052
Phenylephrine hydrochloride (Biorphen, Eton) 0.1-mg/mL solution is a clear, colorless solution.3718 Intact ampuls should be stored at controlled room temperature.3718 The solution should be visually inspected for particulate matter and discoloration prior to use; the solution should not be used if particulate matter is present or discoloration or cloudiness occur.3718 Any unused portion should be discarded.3718
Phenylephrine hydrochloride was stable for 84 days at 60°C in a 250-mg/100-mL concentration in sterile water for injection.132
Syringes
Phenylephrine hydrochloride (Gensia Sicor) 0.1 mg/mL packaged in polypropylene plastic syringes fitted with tip seals and stored at 23 to 25°C in fluorescent light and at 3 to 5°C and at -20°C in the dark for 30 days exhibited no precipitation, cloudiness, or color change and virtually no loss of drug.2737
Central Venous Catheter
Phenylephrine hydrochloride (Ohmeda) 1 mg/mL in dextrose 5% 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 Phenylephrine3635; 3636
| Patient Population | Concentration Standards | Dosing Units |
|---|---|---|
| Adults | 80 mcg/mL 400 mcg/mL | mcg/kg/minute |
| Pediatric patients (50 kg) | 80 mcg/mL 400 mcg/mL | mcg/kg/minute |
Drugs in Syringe Compatibility
Y-Site Injection Compatibility (1:1 Mixture)
Additional Compatibility Information
Infusion Solutions
In a simulated Y-site administration study, turbidity increased within 1 hour when phenylephrine hydrochloride (West-Ward) 40 mcg/mL in dextrose 5% was mixed with Normosol R at 21°C protected from light.3719
For a list of references cited in the text of this monograph, search the monograph titled References.