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Anwendungsgebiete

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 (1) for the induction of anesthesia prior to the administration of other general anesthetic agents (1) as a supplement to other anesthetic agents (1).

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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)]. In patients for whom a significant elevation of blood pressure would be a serious hazard (4). Known hypersensitivity to ketamine or to any excipient (4).

Warnhinweise und Vorsichtsmaßnahmen

5.1Hemodynamic 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)].

5.2Emergence 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. 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.

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

5.1Hemodynamic Instability

5.2Emergence Reactions

Schwangerschaft und Stillzeit

8.1Pregnancy 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. The clinical significance of these nonclinical findings is not known, and the benefits of appropriate anesthesia in pregnant women who require procedures should be balanced with the potential risks suggested by the nonclinical data. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown.

All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Pregnant rats were treated intramuscularly with 20 mg/kg ketamine (0.3 times the human dose of 10 mg/kg IM based on body surface area) on either Gestation Days 6 to 10 or Gestation Days 11 to 15.

Ketamine treatment produced an increased incidence of hypoplastic skull, phalanges, and sternebrae in the pups. Pregnant rabbits were treated intramuscularly with 20 mg/kg ketamine (0.6 times the human dose of 10 mg/kg IM based on body surface area) on either Gestation Days 6 to 10 or Gestation Days 11 to 15. An increase in resorptions and skeletal hypoplasia of the fetuses were noted. Additional pregnant rabbits were treated intramuscularly with a single dose 60 mg/kg (1.9 times the human dose of 10 mg/kg IM based on body surface area) on Gestation Day 6 only.

Skeletal hypoplasia was reported in the fetuses. In a study where pregnant rats were treated intramuscularly with 20 mg/kg ketamine (0.3 times the human dose of 10 mg/kg IM based on body surface area) from Gestation Day 18 to 21. There was a slight increase in incidence of delayed parturition by one day in treated dams of this group. No adverse effects on the litters or pups were noted; however, learning and memory assessments were not completed.

Three (3) pregnant beagle dogs were treated intramuscularly with 25 mg/kg ketamine (1.3 times the human dose of 10 mg/kg IM based on body surface area) twice weekly for the three weeks of the first, second, and third trimesters of pregnancy, respectively, without the development of adverse effects in the pups. In a published study in primates, administration of an anesthetic dose of ketamine for 24 hours on Gestation Day 122 increased neuronal apoptosis in the developing brain of the fetus.

In other published studies, administration of either isoflurane or propofol for 5 hours on Gestation Day 120 resulted in increased neuronal and oligodendrocyte apoptosis in the developing brain of the offspring. With respect to brain development, this time period corresponds to the third trimester of gestation in the human. The clinical significance of these findings is not clear; however, studies in juvenile animals suggest neuroapoptosis correlates with long-term cognitive deficits [see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.4 ), and Nonclinical Toxicology ( 13.2 )] .

Nebenwirkungen

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 with or without evidence of biliary obstruction has been reported with recurrent use (e.g., misuse/abuse or medically supervised unapproved indications). 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-infective, cystitis interstitial, cystitis ulcerative, cystitis erosive and cystitis hemorrhagic) as well as hydronephrosis and reduced bladder capacity. Respiratory disorders: Respiratory depression and apnea following rapid intravenous administration of high doses of KETALAR; laryngospasm, and airway obstruction.

Skin and subcutaneous tissue disorders: Transient erythema and/or morbilliform rash The most common adverse reactions are emergence reactions and elevated blood pressure and pulse (6). To report SUSPECTED ADVERSE REACTIONS, contact Par Pharmaceutical at 1-800-828-9393 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

Packung	Code	Status
KETAMINE HYDROCHLORIDE EQ 10MG BASE/ML	NDA016812-001	Prescription
KETAMINE HYDROCHLORIDE EQ 50MG BASE/ML	NDA016812-002	Prescription
KETAMINE HYDROCHLORIDE EQ 100MG BASE/ML	NDA016812-003	Prescription

Ketalar

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

5.1Hemodynamic Instability

5.2Emergence Reactions

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Ketalar

Anwendungsgebiete

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Warnhinweise und Vorsichtsmaßnahmen

5.1Hemodynamic Instability

5.2Emergence Reactions

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5.3Respiratory Depression

5.4Risks of Ketalar Alone for Procedures of the Pharynx, Larynx, or Bronchial Tree

5.5Pediatric Neurotoxicity

5.6Drug-Induced Liver Injury

5.7Increase in Cerebrospinal Fluid Pressure

Wechselwirkungen

7.1Theophylline or Aminophylline

7.2Sympathomimetics and Vasopressin Sympathomimetics

7.3Benzodiazepines, Opioid Analgesics, Or Other CNS Depressants

Schwangerschaft und Stillzeit

8.1Pregnancy Risk Summary

Nebenwirkungen

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