ketamine hydrochloride injection, USP Highlights

Ketamine Hydrochloride Injection is a general anesthetic indicated:

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as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation (1)

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for the induction of anesthesia prior to the administration of other general anesthetic agents (1)

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as a supplement to other anesthetic agents. (1)

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See Full Prescribing Information for important dosage and administration instructions. (2)

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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)

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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)

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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)

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

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In patients for whom a significant elevation of blood pressure would be a serious hazard. (4)

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Known hypersensitivity to ketamine or to any excipient. (4)

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Hemodynamic Instability: Monitor vital signs and cardiac function during Ketamine Hydrochloride Injection administration. (5.1)

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Emergence Reactions: Postoperative confusional states may occur during the recovery period. Reduce by minimizing verbal, tactile, and visual stimulation of the patient. (5.2)

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Risk of Respiratory Depression: May occur with overdosage or too rapid a rate of administration. Maintain adequate oxygenation and ventilation. (5.3)

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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)

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Pediatric Neurotoxicity: Long-term cognitive deficits may occur when used for longer than 3 hours in children ≤3 years. (5.5)

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.

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Theophylline or Aminophylline: Do not co-administer with Ketamine Hydrochloride Injection as concomitant use may lower the seizure threshold. (7.1)

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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)

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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)

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