Ketamine Hydrochloride (3 brand names, 2 dosage forms, 2 routes)
Available dosage forms: INJECTABLE, SOLUTION.
Routes of administration: INJECTION, INTRAMUSCULAR, INTRAVENOUS.
Brand Names
- KETALAR
- KETAMINE HCL
- KETAMINE HYDROCHLORIDE
Indications and Usage
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.
Dosage and Administration
Important Dosage and Administration InformationKetamine Hydrochloride Injection should be administered by or under the direction of physicians experienced in the administration of general anesthetics, maintenance of a patent airway, and oxygenation and ventilation. Continuously monitor vital signs in patients receiving Ketamine Hydrochloride Injection. Emergency airway equipment must be immediately available. Do not administer the 100 mg/mL concentration of Ketamine Hydrochloride Injection intravenously without proper dilution [see DOSAGE AND ADMINISTRATION (2.3)]. Must be used immediately after dilution. While some degree of airway protection may be afforded due to active laryngeal-pharyngeal reflexes, vomiting and aspiration may occur with ketamine. Ketamine Hydrochloride Injection is not recommended for use in patients who have not followed nil per os guidelines. Due to the potential for salivation during Ketamine Hydrochloride Injection administration, administer an antisialagogue prior to induction of anesthesia. In individuals with a history of chronic ketamine use for off-label indications, there have been case reports of genitourinary pain that may be related to the ketamine treatment, not the underlying condition [see ADVERSE REACTIONS (6)]. Consider cessation of ketamine if genitourinary pain continues in the setting of other genitourinary symptoms. 2.2 Recommended Dosage and AdministrationThe Ketamine Hydrochloride Injection dosage must be individualized and titrated to the desired clinical effect. If a longer duration of effect is desired, additional increments can be administered intravenously or intramuscularly to maintain anesthesia. However, a higher total dose will result in a longer time to complete recovery. Induction of Anesthesia Intravenous Route: The initial dose of Ketamine Hydrochloride Injection administered intravenously may range from 1 mg/kg to 4.5 mg/kg. The average amount required to produce 5 to 10 minutes of surgical anesthesia w
Contraindications
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)].
Warnings and Precautions
Hemodynamic InstabilityTransient increases in blood pressure, heart rate, and cardiac index are frequently observed following administration of Ketamine Hydrochloride Injection. Decreases in blood pressure and heart rate, arrhythmias, and cardiac decompensation have also been observed. Monitor vital signs and cardiac function during Ketamine Hydrochloride Injection administration. Ketamine Hydrochloride Injection is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see CONTRAINDICATIONS (4)]. 5.2 Emergence ReactionsEmergence delirium (postoperative confusional states or agitation) has occurred in approximately 12% of patients during the recovery period, and the duration is generally a few hours. The neuropsychological manifestations vary in severity between pleasant dream-like states, vivid imagery, hallucinations, and emergence delirium. In some cases, these states have been accompanied by confusion, excitement, and irrational behavior, which have been recalled as unpleasant experiences. No residual psychological effects are known to have resulted from use of Ketamine Hydrochloride Injection during induction and maintenance of anesthesia. Intramuscular administration results in a lower incidence of emergence reactions. The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by using lower recommended dosages of Ketamine Hydrochloride Injection in conjunction with an intravenous benzodiazepine during induction and maintenance of anesthesia [see DOSAGE AND ADMINISTRATION (2.3)]. Also, these reactions may be reduced if verbal, tactile, and visual stimulation of the patient is minimized during the recovery period. This does not preclude the monitoring of vital signs. 5.3 Respiratory DepressionRespiratory depression may occur with overdosage or a rapid rate of administration of Ketamine Hydrochloride Injection. Maintain
Adverse Reactions
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 Injection 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. Gastrointestinal disorders: Anorexia, nausea, vomiting, hepatobiliary dysfunction. Administration site disorders: Local pain and exanthema at the injection site. Immune system disorders: Anaphylaxis. Neurologic disorders: Emergence reactions (post-operative delirium), [see WARNINGS AND PRECAUTIONS (5.2)]. During administration, enhanced muscle tone and spasms (resembling a partial motor or generalized motor seizure). Psychiatric disorders: Adverse psychiatric events have occurred and/or persisted days to weeks after ketamine exposure. Renal and urinary disorders: In individuals with history of chronic ketamine use or abuse, lower urinary tract and bladder symptoms including dysuria, increased urinary frequency, urgency, urge incontinence, and hematuria have been reported [see DOSAGE AND ADMINISTRATION (2.1)]. In addition, diagnostic studies performed to assess the cause of these symptoms have reported cystitis (including cystitis non-in
Drug Interactions
Theophylline or AminophyllineConcomitant administration of Ketamine Hydrochloride Injection and theophylline or aminophylline may lower the seizure threshold. Consider using an alternative to Ketamine Hydrochloride Injection in patients receiving theophylline or aminophylline. 7.2 Sympathomimetics and VasopressinSympathomimetics and vasopressin may enhance the sympathomimetic effects of ketamine. Closely monitor vital signs when Ketamine Hydrochloride Injection and sympathomimetics or vasopressin are co-administered and consider dose adjustment individualized to the patient’s clinical situation. 7.3 Benzodiazepines, Opioid Analgesics, Or Other CNS DepressantsConcomitant use of ketamine with opioid analgesics, benzodiazepines, or other central nervous system (CNS) depressants, including alcohol, may result in profound sedation, respiratory depression, coma, and death [see WARNINGS AND PRECAUTIONS (5.8)]. Opioid analgesics administered concomitantly with Ketamine Hydrochloride Injection may prolong time to complete recovery from anesthesia.
Overdosage
Changes in heart rate and blood pressure, respiratory depression, and apnea may occur with overdosage or by a rapid rate of administration of Ketamine Hydrochloride Injection. Monitor patients for clinically relevant changes in heart rate and blood pressure. Assisted ventilation, including mechanical ventilation, may be required. In cases of unintentional overdose of Ketamine Hydrochloride Injection (up to ten times that usually required), patients had a prolonged but complete recovery.