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ketamine hydrochloride injection, USP Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use KETAMINE HYDROCHLORIDE INJECTION safely and effectively. See full prescribing information for KETAMINE HYDROCHLORIDE INJECTION.

KETAMINE HYDROCHLORIDE injection, for intravenous or intramuscular use, CIII
Initial U.S. Approval: 1970

RECENT MAJOR CHANGES

Warnings and Precautions, Drug Induced Liver Injury (5.6)8/2020

INDICATIONS AND USAGE

Ketamine Hydrochloride Injection is a general anesthetic indicated:

  • as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation (1)
  • for the induction of anesthesia prior to the administration of other general anesthetic agents (1)
  • as a supplement to other anesthetic agents. (1)

DOSAGE AND ADMINISTRATION

  • See Full Prescribing Information for important dosage and administration instructions. (2)
  • Induction of Anesthesia:

    --Intravenous Route: Initially, 1 to 4.5 mg/kg administered slowly (over a period of 60 seconds). Alternatively, administer a dose of 1 to 2 mg/kg at a rate of 0.5 mg/kg/min. (2.2)

    --Intramuscular Route: Initially, 6.5 to 13 mg/kg. (2.2)

  • Maintenance of Anesthesia: Increments of one-half to the full induction dose may be repeated as needed (2.2). Adjust the dose according to the patient's anesthetic needs and whether an additional anesthetic agent is employed. (2.2)
  • Supplement to Other Anesthetic Agents: The regimen of a reduced dose of Ketamine Hydrochloride Injection supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents. (2.2)

DOSAGE FORMS AND STRENGTHS

Injection: 500 mg/10 mL (50 mg/mL) and 500 mg/5 mL (100 mg/mL) multiple-dose vials. (3)

CONTRAINDICATIONS

  • In patients for whom a significant elevation of blood pressure would be a serious hazard. (4)
  • Known hypersensitivity to ketamine or to any excipient. (4)

WARNINGS AND PRECAUTIONS

  • Hemodynamic Instability: Monitor vital signs and cardiac function during Ketamine Hydrochloride Injection administration. (5.1)
  • Emergence Reactions: Postoperative confusional states may occur during the recovery period. Reduce by minimizing verbal, tactile, and visual stimulation of the patient. (5.2)
  • Respiratory Depression: May occur with overdosage or too rapid a rate of administration. Maintain adequate oxygenation and ventilation. (5.3)
  • Risks of Ketamine Hydrochloride Injection Alone for Procedures of the Pharynx, Larynx, or Bronchial Tree: Pharyngeal and laryngeal reflexes are not suppressed with Ketamine Hydrochloride Injection when it is used alone. Avoid use as a sole anesthetic agent in surgery or diagnostic procedures of the pharynx, larynx, or bronchial tree. Muscle relaxants may be required. (5.4)
  • Pediatric Neurotoxicity: Long-term cognitive deficits may occur when used for longer than 3 hours in children ≤3 years. (5.5)

ADVERSE REACTIONS

The most common adverse reactions are emergence reactions and elevated blood pressure and pulse. (6)


To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

  • Theophylline or Aminophylline: Do not co-administer with Ketamine Hydrochloride Injection as concomitant use may lower the seizure threshold. (7.1)
  • Sympathomimetics and Vasopressin: Closely monitor vital signs when co-administered with Ketamine Hydrochloride Injection. Consider dose adjustment individualized to the patient's clinical situation. (7.2)
  • Benzodiazepines, Opioid Analgesics, or Other CNS Depressants: Concomitant use may result in profound sedation, respiratory depression, coma, or death. Concomitant use of opioid analgesics may prolong recovery time. (7.3)

USE IN SPECIFIC POPULATIONS

  • Pregnancy: Animal data show that Ketamine Hydrochloride Injection may cause harm to the fetus; avoid use during pregnancy, labor, and delivery. (8.1)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 3/2021

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