Ketamine hydrochloride is available in concentrations equivalent to 10, 50, or 100 mg/mL of ketamine in 20-, 10-, or 5-mL multidose vials, respectively.3116; 3117 The injections also contain no more than 0.1 mg/mL of the preservative benzethonium chloride.3116; 3117
The 10-mg/mL concentration should not be diluted.3116 However, the 100-mg/mL injection is a concentrate and must be diluted prior to intravenous use.3116; 3117 Doses should be diluted with an equal volume of sterile water for injection, dextrose 5%, or sodium chloride 0.9%.3116; 3117
pH
Tonicity
The 10-mg/mL concentration is made isotonic with sodium chloride.3116
Osmolality
The osmolalities of ketamine hydrochloride products were determined to be 300 mOsm/kg for the 10-mg/mL concentration and 387 mOsm/kg for the 50-mg/mL concentration.1233
Trade Name(s)
Ketalar
Ketamine hydrochloride may be administered intramuscularly or by slow intravenous injection over 60 seconds.3116; 3117 The 100-mg/mL preparation should not be administered without proper dilution.3116; 3117 For intravenous infusion, a 1- or 2-mg/mL solution may be prepared by adding 500 mg of ketamine to 500 or 250 mL, respectively, of dextrose 5% or sodium chloride 0.9%.3116; 3117
Diazepam and barbiturates must be administered separately from ketamine hydrochloride and must not be mixed in the same container.3116; 3117
Intact vials of ketamine hydrochloride should be stored at controlled room temperature and protected from light.3116; 3117 Ketamine hydrochloride injection varies from colorless to very slightly yellow.3117 The drug may darken upon prolonged exposure to light; however, this darkening does not affect potency.3117 The product should be visually inspected for particulate matter and discoloration prior to administration and should not be used if a precipitate appears.3117
Ketamine hydrochloride (Sandoz) prepared at a ketamine concentration of 10 mg/mL diluted in sterile water for injection was packaged in 5-mL glass vials and stored at room temperature with exposure to light for 182 days.3118 The solution remained clear and without discoloration and less than 4% drug loss occurred.3118
Syringes
Ketamine hydrochloride (Abbott) prepared at a ketamine concentration of 10 mg/mL diluted in sterile water for injection was packaged in 1-mL polypropylene tuberculin syringes (Becton Dickinson) and was stored at 25°C.2431 The drug solution remained clear and no loss occurred in 30 days.2431
Ketamine hydrochloride (JHP Pharmaceuticals) undiluted at a ketamine concentration of 10 mg/mL was packaged as 5 mL in 10-mL polypropylene syringes (Becton Dickinson) and stored at ambient room temperature protected from light.3887 The solutions remained clear and colorless with no loss of drug in 100 days.3887
Ketamine hydrochloride (Fagron) prepared at a ketamine concentration of 1 mg/mL diluted in sodium chloride 0.9% was packaged in polypropylene syringes with tip caps and stored at 4, 25, and 40°C for 12 months.2779 No visible changes occurred, and drug concentrations remained above 95% at all temperatures.2779
Ketamine hydrochloride (Pfizer) undiluted at a ketamine concentration of 50 mg/mL was packaged as 1 mL in 3-mL polypropylene syringes (Terumo).3194 The syringes were stored at 25°C protected from light for 180 days.3194 Solutions were physically stable with no substantial changes in pH or optical density throughout the study.3194 Little loss of the drug occurred in 180 days.3194
Ketamine hydrochloride (Pfizer) undiluted at a ketamine concentration of 50 mg/mL was packaged as 1 mL in 3-mL syringes (Becton Dickinson).3584 The syringes were stored at room temperature for 50 days.3584 Solutions were physically stable with no substantial changes in pH or spectrophotometric measurements throughout the study.3584 Less than 10% loss of the drug occurred in 50 days.3584
Ketamine hydrochloride (Combiphar) was prepared at a ketamine concentration of 192 mcg/mL in dextrose 5% and packaged as 50 mL in 50-mL syringes.3607; 3608 The syringes were stored for 7 days at a temperature of 25 to 28°C and relative humidity of 70 to 80%.3607 While visual observations revealed physical compatibility throughout the study period, substantial pH changes were noted after 72 hours.3607 Ketamine concentrations were not measured using a stability indicating assay.3607; 3608
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 Ketamine3635; 3636
| Patient Population | Concentration Standards | Dosing Units |
|---|---|---|
| Adults | 2 mg/mL 10 mg/mL | mg/kg/hour or mcg/kg/minute, based on indication |
| Pediatric patients (50 kg) | 2 mg/mL 10 mg/mL | mg/kg/hour |
Table 2: Standardize 4 Safety PCA Standard Concentrations for Ketamine3990
| Patient Population | Concentration Standards | Dosing Units |
|---|---|---|
| Adults | 5 mg/mL 10 mg/mL | mg/kg/hour |
| Pediatric patients (50 kg) | 2 mg/mL 10 mg/mL | mg/kg/hour |
For a list of references cited in the text of this monograph, search the monograph titled References.