KETAMINE HYDROCHLORIDE

DistributionFollowing intravenous administration, the ketamine concentration has an initial slope (alpha phase) lasting about 45 minutes with a half-life of 10 to 15 minutes. This first phase corresponds clinically to the anesthetic effect of the drug.

Elimination

MetabolismKetamine is metabolized via N-dealkylation to the active metabolite norketamine primarily by CYP2B6 and CYP3A4 and to a lesser extent by other CYP enzymes. Norketamine undergoes hydroxylation of the cyclohexone ring to form...

Ketamine Hydrochloride Injection has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients in 105 separate studies. During the course of these studies, Ketamine Hydrochloride Injection was administered as the sole general anesthetic, as an induction agent prior to administration of other general anesthetics, or to supplement other anesthetic agents. Ketamine Hydrochloride Injection has been evaluated during the following procedures: 1. debridement, dressing changes, and skin grafting in burn patients, as well as other superficial surgical procedures. 2...

The following clinically significant adverse reactions are described elsewhere in the labeling:

• Hemodynamic Instability [see Warnings and Precautions (5.1) ]
• Emergence Reactions [see Warnings and Precautions (5.2) ]
• Respiratory Depression [see Warnings and Precautions (5.3) ]
• Pediatric Neurotoxicity [see Warnings and Precautions (5.5) ]
• Drug-Induced Liver Injury [see Warnings and Precautions (5.6) ] The following adverse reactions associated with the use of Ketamine Hydrochloride Injec...

• Ketamine Hydrochloride Injection is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see Warnings and Precautions (5.1) ] .
• Ketamine Hydrochloride Injection is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see Adverse Reactions (6) ] .
• In patients for whom a significant elevation of bl...

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

7 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...