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Ketamine hydrochloride is a nonbarbiturate anesthetic chemically designated dl 2-(0-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride. It is formulated as a slightly acid (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 10, 50 or 100 mg ketamine base per milliliter and contains not more than 0.1 mg/mL Phemerol® (benzethonium chloride) added as a preservative. The 10 mg/mL solution has been made isotonic with sodium chloride.
Dilution:
To prepare a dilute solution containing 1 mg of ketamine per mL, aseptically transfer 10 mL from a 50 mg per mL vial or 5 mL from a 100 mg per mL vial to 500 mL of 5% Dextrose Injection, USP or Sodium Chloride (0.9%) Injection, USP (Normal Saline) and mix well. The resultant solution will contain 1 mg of ketamine per mL.
The fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of ketamine hydrochloride injection. If fluid restriction is required, ketamine hydrochloride injection can be added to a 250 mL infusion as described above to provide a ketamine hydrochloride concentration of 2 mg/mL.
Ketamine hydrochloride injection 10 mg/mL vials are not recommended for dilution.
Information for Patients
As appropriate, especially in cases where early discharge is possible, the duration of ketamine hydrochloride and other drugs employed during the conduct of anesthesia should be considered. The patients should be cautioned that driving an automobile, operating hazardous machinery or engaging in hazardous activities should not be undertaken for 24 hours or more (depending upon the dosage of ketamine hydrochloride and consideration of other drugs employed) after anesthesia.
WARNINGS
ardiac function should be continually monitored during the procedure in patients found to have hypertension or cardiac decompensation.
Postoperative confusional states may occur during the recovery period. (See Special Note.)
Respiratory depression may occur with overdosage or too rapid a rate of administration of ketamine hydrochloride, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.
KETAMINE HYDROCHLORIDE