pharmacopeia
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Mechanism of action

Sourced from openFDA

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.

DopamineIonotropic Glutamate Receptor

Indications

Sourced from openFDA
  • 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.

Contraindications

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

Dosage & administration

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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 KETALAR supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents. ( 2.2 ) 2.1 Important Dosage and Administration Information KETALAR 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 KETALAR. Emergency airway equipment must be immediately available. KETALAR is a clear, colorless sterile solution. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit. Discard if product is discolored or contains particulate matter. Do not administer the 100 mg/mL concentration of KETALAR intravenously without proper dilution [see Dosage and Administration ( 2.3 )] .

Warnings & precautions

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Hemodynamic Instability: Monitor vital signs and cardiac function during KETALAR 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 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. ( 5.4 ) Pediatric Neurotoxicity: Long-term cognitive deficits may occur when used for longer than 3 hours in children ≤3 years ( 5.5 ) 5.1 Hemodynamic Instability Transient increases in blood pressure, heart rate, and cardiac index are frequently observed following administration of KETALAR. Decreases in blood pressure and heart rate, arrhythmias, and cardiac decompensation have also been observed. Monitor vital signs and cardiac function during KETALAR administration. KETALAR is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see Contraindications ( 4 )] . 5.2 Emergence Reactions Emergence 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.

Adverse reactions

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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 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. Gastrointestinal disorders : Anorexia, nausea, vomiting; hepatobiliary dysfunction, biliary duct dilatation, biliary duct stricture and/or stenosis with or without evidence of biliary obstruction; secondary sclerosing cholangitis [see Warnings and Precautions ( 5.6 )]. 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 )].

Use in specific populations

Sourced from openFDA

8.1 Pregnancy Risk Summary Available data on the use of ketamine in pregnant women mostly describe its use at the time of cesarean section and have not identified a drug-associated risk of adverse maternal or fetal outcomes. The data are limited by retrospective collection, small sample sizes, and a lack of long-term follow-up. There are no available data on ketamine use during other stages of pregnancy to allow for an evaluation of drug-associated risk of major birth defects or miscarriage. In animal reproduction studies in rats developmental delays (hypoplasia of skeletal tissues) were noted at 0.3 times the human intramuscular dose of 10 mg/kg. In rabbits, developmental delays and increased fetal resorptions were noted at 0.6 times the human dose. Published studies in pregnant primates demonstrate that the administration of anesthetic and sedation drugs that block NMDA receptors and/or potentiate GABA activity during the period of peak brain development increases neuronal apoptosis in the developing brain of the offspring when used for longer than 3 hours. There are no data on pregnancy exposures in primates corresponding to periods prior to the third trimester in humans.

Pharmacokinetics

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Metabolism
Distribution Following 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.

Overdosage

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Changes in heart rate and blood pressure, respiratory depression, and apnea may occur with overdosage or by a rapid rate of administration of KETALAR. 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 KETALAR (up to ten times the usual dose), patients had a prolonged but complete recovery.

Approval history

Sourced from openFDA
  • Feb 19, 1970NDANDA016812Ph Health
  • Mar 22, 1996ANDAANDA074524Hikma
  • Jun 27, 1996ANDAANDA074549Hospira
  • Dec 28, 2001ANDAANDA076092Eugia Pharma
  • Jan 13, 2023ANDAANDA215808Fresenius Kabi Usa
  • Jan 24, 2023ANDAANDA216809Gland
  • Sep 17, 2025ANDAANDA219684Baxter Hlthcare Corp

FAERS reports

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Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
4,595 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Infusion Site Pain68515%
  2. 2Drug Ineffective49611%
  3. 3Off Label Use46910%
  4. 4Nausea45910.0%
  5. 5Infusion Site Erythema4279.3%
  6. 6Headache2996.5%
  7. 7Infusion Site Swelling2906.3%
  8. 8Drug Abuse2876.2%
  9. 9Dyspnoea2776.0%
  10. 10Diarrhoea2746.0%
  11. 11Fatigue2054.5%
  12. 12Vomiting2004.4%
  13. 13Hypotension1954.2%
  14. 14Infusion Site Haemorrhage1924.2%
  15. 15Hyperhidrosis1904.1%

Literature

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Recent PubMed references pinned to Ketamine as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

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The 10 most recently updated of 1,847 ClinicalTrials.gov registrations naming Ketamine as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Ketamine work?
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.
What is Ketamine used for?
According to FDA labeling, Ketamine carries indications including: 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.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Ketamine?
Ketamine is classified as Other general anesthetics, General Anesthetic, Dopamine Agonists, Ionotropic Glutamate Receptor Antagonists, Blood Pressure Alteration, Decreased Cerebral Cortex Organized Electrical Activity, Decreased Midbrain Organized Electrical Activity, Decreased Sensory-Somatic Nervous System Organized Electrical Activity, General Anesthesia, Increased Epinephrine Activity, Increased Norepinephrine Activity.
What are the brand names for Ketamine?
Ketamine is marketed under brand names including Ketalar, Ketaset, Zetamine.
What are the contraindications for Ketamine?
Ketamine labeling lists contraindications including: KETALAR is contraindicated in patients for whom a significant elevation of blood pressure would constitute a serious hazard [see Warnings and Precautions ( 5.1 ) ]. KETALAR is contraindicated in patients with known hypersensitivity to ketamine or to any excipient [see Adverse Reactions ( 6 ) ].. Always consult the full prescribing information and a clinician.
Note. Data for ketamine is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

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