Naloxone hydrochloride is available as a preservative-free 0.4-mg/mL injection solution in 1-mL single-dose vials, ampuls, and cartridges and as a preservative-free 1-mg/mL injection solution in 2-mL single-dose prefilled syringes.3697; 3698; 3699 Each mL of these preservative-free injection solutions also contains sodium chloride and may contain hydrochloric acid or sodium hydroxide to adjust the pH.3697; 3698; 3699
Naloxone hydrochloride also is available as preserved 0.4-mg/mL injection solution in 10-mL multiple-dose vials and in 1-mL vials.3698; 3700 Each mL of these preserved injection solutions also contains sodium chloride, methylparaben 1.8 mg, and propylparaben 0.2 mg and may contain hydrochloric acid to adjust the pH.3698; 3700
pH
The pH is adjusted during manufacturing to a usual target pH of 4 with a usual range of 3 to 6.5.3697; 3698; 3699; 3700
Osmolality
The osmolality of naloxone hydrochloride 0.02 mg/mL (no longer commercially available) was determined to be 293 mOsm/kg by freezing-point depression and 289 mOsm/kg by vapor pressure.1071
The osmolality of naloxone hydrochloride 0.4 mg/mL was determined to be 301 mOsm/kg.1233
Osmolarity
The osmolarity of naloxone hydrochloride 0.4 mg/mL was calculated to be 310 mOsm/L.3698
Trade Name(s)
Narcan
Naloxone hydrochloride is administered by subcutaneous, intramuscular, or intravenous injection or by continuous intravenous infusion.3697; 3698; 3699; 3700 Solutions for continuous intravenous infusion may be prepared by adding 2 mg of naloxone hydrochloride to 500 mL of sodium chloride 0.9% or dextrose 5% to yield an infusion solution with a final naloxone hydrochloride concentration of 4 mcg/mL.3697; 3698; 3699; 3700
Intact containers of naloxone hydrochloride should be stored at controlled room temperature and protected from light.3697; 3698; 3699; 3700 Some manufacturers recommend storing the products in the carton until use.3699; 3700 Naloxone hydrochloride should not be mixed with bisulfite, metabilsulfite, or long-chain or high molecular weight anions, or any solution with an alkaline pH.3697; 3698; 3699; 3700
Manufacturers state that infusion solutions prepared as directed for continuous infusion should be used within 24 hours.3697; 3698; 3699; 3700
Naloxone hydrochloride under simulated summer conditions in paramedic vehicles was exposed to 26 to 38°C over 4 weeks. Analysis found no loss of the drug under these conditions.2562
Syringes
Naloxone hydrochloride (Astra) prepared at a concentration of 0.133 mg/mL in sodium chloride 0.9% and packaged in polypropylene syringes (Sherwood) was physically stable and exhibited little or no loss in 24 hours stored at 4 and 23°C.2199
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 Naloxone3635; 3636
| Patient Population | Concentration Standards | Dosing Units |
|---|---|---|
| Adults | 16 mcg/mL 40 mcg/mL | mg/hour (note dosing units differ from concentration units) mcg/kg/hour (pruritus) |
| Pediatric patients (50 kg)a | 16 mcg/mL 40 mcg/mL 400 mcg/mL | mcg/kg/hour |
a The panel recognizes that the 40- and 400-mcg/mL concentrations are 10× different; however, these are the only two concentrations studied for stability.
For a list of references cited in the text of this monograph, search the monograph titled References.