Ketamine

KETALAR (ketamine hydrochloride) injection is indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. for the induction of anesthesia prior to the administration of other general anesthetic agents. as a supplement to other anesthetic agents. KETALAR is a general anesthetic indicated: as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation for the induction of anesthesia prior to the administration of other general anesthetic agents as a supplement to other anesthetic agents.

KETALAR, a racemic mixture of ketamine, is a non-selective, non-competitive antagonist of the N-methyl-D-aspartate (NMDA) receptor, an ionotropic glutamate receptor. The major circulating metabolite of ketamine (norketamine) demonstrated activity at the same receptor with less affinity. Norketamine is about 1/3 as active as ketamine in reducing halothane requirements (MAC) of the rat.

See Full Prescribing Information for important dosage and administration instructions. 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. -- Intramuscular route: Initially, 6.5 to 13 mg/kg. Maintenance of anesthesia: Increments of one-half to the full induction dose may be repeated as needed. Adjust the dose according to the patient's anesthetic needs and whether an additional anesthetic agent is employed. Supplement to other anesthetic agents: The regimen of a reduced dose of KETALAR supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents.

KETALAR is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard. KETALAR is contraindicated in patients with known hypersensitivity to ketamine or to any excipient. In patients for whom a significant elevation of blood pressure would be a serious hazard. Known hypersensitivity to ketamine or to any excipient.

Hemodynamic Instability: Monitor vital signs and cardiac function during KETALAR administration. Emergence Reactions: Postoperative confusional states may occur during the recovery period. Reduce by minimizing verbal, tactile, and visual stimulation of the patient. Risk of Respiratory Depression: May occur with overdosage or too rapid a rate of administration. Maintain adequate oxygenation and ventilation. Risks of KETALAR alone for Procedures of the Pharynx, Larynx, or Bronchial Tree: Pharyngeal and laryngeal reflexes are not suppressed with KETALAR 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. Pediatric Neurotoxicity: Long-term cognitive deficits may occur when used for longer than 3 hours in children ≤3 years

The following clinically significant adverse reactions are described elsewhere in the labeling: Hemodynamic Instability Emergence Reactions Respiratory Depression Pediatric Neurotoxicity Drug-Induced Liver Injury The following adverse reactions associated with the use of KETALAR were identified in clinical studies or postmarketing reports. Because some of these reactions were reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Cardiovascular disorders: Elevated blood pressure, heart rate, and cardiac index, decreases in blood pressure and heart rate, arrhythmias, cardiac decompensation (in patients with suspected catecholamine depletion). Eye disorders: Diplopia, nystagmus, elevation in intraocular pressure.

Theophylline or Aminophylline: Do not co-administer with KETALAR as concomitant use may lower the seizure threshold. Sympathomimetics and Vasopressin: Closely monitor vital signs when co-administered with KETALAR. Consider dose adjustment individualized to the patient’s clinical situation. 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.

KETALAR injection should be stored at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (59°F to 86°F). Protect from light.