Ketamine: Difference between revisions
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NDC 42023-114-10 — Each 10-mL multi-dose vial contains 50 mg/mL. Supplied in cartons of 10. | NDC 42023-114-10 — Each 10-mL multi-dose vial contains 50 mg/mL. Supplied in cartons of 10. | ||
NDC 42023-115-10 — Each 5-mL multi-dose vial contains 100 mg/mL. Supplied in cartons of 10. | NDC 42023-115-10 — Each 5-mL multi-dose vial contains 100 mg/mL. Supplied in cartons of 10. | ||
|storage= Store between 20° to 25°C (68° to 77°F). (See USP controlled room temperature.) | |storage=Store between 20° to 25°C (68° to 77°F). (See USP controlled room temperature.) | ||
Protect from light. | Protect from light. | ||
Rx only. | Rx only. | ||
|fdaPatientInfo=As appropriate, especially in cases where early discharge is possible, the duration of Ketalar and other drugs employed during the conduct of anesthesia should be considered. The patients should be cautioned that driving an automobile, operating hazardous machinery or engaging in hazardous activities should not be undertaken for 24 hours or more (depending upon the dosage of Ketalar and consideration of other drugs employed) after anesthesia. | |||
|alcohol=Alcohol-Ketamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | |alcohol=Alcohol-Ketamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication. | ||
}} | }} | ||
Revision as of 15:51, 19 June 2014
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]
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Overview
Ketamine is a general anesthetic that is FDA approved for the {{{indicationType}}} of general anesthesia; adjunct, procedural sedation. Common adverse reactions include cardiovascular: hypertension, tachycardia, neurologic: emergence from anesthesia, psychiatric sign or symptom (12% to 50% )..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
- General anesthesia; adjunct: induction, 1 to 4.5 mg (base)/kg IV single dose
- General anesthesia; adjunct: induction, 1 to 2 mg/kg IV infusion at 0.5 mg/kg/min; in addition to diazepam 2 to 5 mg IV over 1 min
- General anesthesia; adjunct: induction, 6.5 to 13 mg (base)/kg IM
- General anesthesia; adjunct: maintenance, 0.1 to 0.5 mg (base)/min IV infusion, repeat as needed; augmented with diazepam 2 to 5 mg IV
- General anesthesia; adjunct: maintenance, 0.01 to 0.03 mg/kg/min continuous IV infusion
- General anesthesia; adjunct: maintenance, increments of one-half to the full induction dose may be repeated as needed
- Procedural sedation: 1 to 2 mg/kg IV over 1 to 2 min, may be followed by 0.25 to 0.5 mg/kg IV every 5 to 10 min as needed.
- Rapid sequence intubation, Induction: 2 mg/kg IV.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
- General anesthesia; Adjunct.
- Procedural sedation.
Non–Guideline-Supported Use
- Administration of analgesic - sedation.
- Bronchospasm.
- Rapid sequence intubation, induction
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
- Safety and efficacy have not been established in children younger than 16 years.
- General anesthesia; adjunct: induction, 5 to 10 mg (base)/kg IM; range, 4 to 13 mg/kg.
- General anesthesia; adjunct: induction, 1 to 2 mg/kg IV; range, 0.5 to 4.5 mg/kg.
- General anesthesia; adjunct: maintenance, 0.01 to 0.03 mg/kg/min continuous IV infusion.
- General anesthesia; adjunct: maintenance, increments of one-half to the full induction dose may be repeated as needed.
- Procedural sedation: 0.5 to 2 mg/kg IV over 1 to 2 min, may repeat 0.25 to 1 mg/kg IV (one-half initial dose) every 10 to 15 min as needed.
- Procedural sedation: 2 to 5 mg/kg IM, may repeat 2 to 4 mg/kg after 10 min.
- Rapid sequence intubation, Induction: 1 to 3 mg/kg IV.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information about Off-Label Guideline-Supported Use of Ketamine in pediatric patients.
Non–Guideline-Supported Use
There is limited information about Off-Label Non–Guideline-Supported Use of Ketamine in pediatric patients.
Contraindications
- Ketamine hydrochloride is contraindicated in those in whom a significant elevation of blood pressure would constitute a serious hazard and in those who have shown hypersensitivity to the drug.
Warnings
- Cardiac function should be continually monitored during the procedure in patients found to have hypertension or cardiac decompensation.
- Postoperative confusional states may occur during the recovery period. (See Special Note.)
- Respiratory depression may occur with overdosage or too rapid a rate of administration of Ketalar, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.
Adverse Reactions
Clinical Trials Experience
Cardiovascular: Blood pressure and pulse rate are frequently elevated following administration of Ketalar alone. However, hypotension and bradycardia have been observed. Arrhythmia has also occurred.
Respiration: Although respiration is frequently stimulated, severe depression of respiration or apnea may occur following rapid intravenous administration of high doses of Ketalar. Laryngospasms and other forms of airway obstruction have occurred during Ketalar anesthesia.
Eye: Diplopia and nystagmus have been noted following Ketalar administration. It also may cause a slight elevation in intraocular pressure measurement.
Genitourinary: Severe irritative and inflammatory urinary tract and bladder symptoms including cystitis have been reported in individuals with history of chronic ketamine use or abuse.
Psychological: (See Special Note.)
Neurological: In some patients, enhanced skeletal muscle tone may be manifested by tonic and clonic movements sometimes resembling seizures (see DOSAGE AND ADMINISTRATION Section).
Gastrointestinal: Anorexia, nausea and vomiting have been observed; however, this is not usually severe and allows the great majority of patients to take liquids by mouth shortly after regaining consciousness (see DOSAGE AND ADMINISTRATION Section).
General: Anaphylaxis. Local pain and exanthema at the injection site have infrequently been reported. Transient erythema and/or morbilliform rash have also been reported.
For medical advice about adverse reactions contact your medical professional. To report SUSPECTED ADVERSE REACTIONS, contact JHP at 1-866-923-2547 or MEDWATCH at 1-800-FDA-1088 (1-800-332-1088) or http://www.fda.gov/medwatch/.
Postmarketing Experience
There is limited information regarding Ketamine Postmarketing Experience in the drug label.
Drug Interactions
Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Ketalar.
Ketalar is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
Since the safe use in pregnancy, including obstetrics (either vaginal or abdominal delivery), has not been established, such use is not recommended.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Ketamine in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Ketamine during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Ketamine in women who are nursing.
Pediatric Use
Safety and effectiveness in pediatric patients below the age of 16 have not been established.
Geriatic Use
Clinical studies of ketamine hydrochloride did not include sufficient numbers of subjects aged 65 and over to determine whether they respond differently from younger subjects. Other reported clinical experience has not identified differences in responses between the elderly and younger patients. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
Gender
There is no FDA guidance on the use of Ketamine with respect to specific gender populations.
Race
There is no FDA guidance on the use of Ketamine with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Ketamine in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Ketamine in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Ketamine in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Ketamine in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Ketamine Administration in the drug label.
Monitoring
There is limited information regarding Ketamine Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Ketamine and IV administrations.
Overdosage
Respiratory depression may occur with overdosage or too rapid a rate of administration of Ketalar, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.
Pharmacology
Mechanism of Action
There is limited information regarding Ketamine Mechanism of Action in the drug label.
Structure
Ketalar is a nonbarbiturate anesthetic chemically designated dl 2-(0-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride. It is formulated as a slightly acid (pH 3.5-5.5) sterile solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 10, 50 or 100 mg ketamine base per milliliter and contains not more than 0.1 mg/mL Phemerol® (benzethonium chloride) added as a preservative. The 10 mg/mL solution has been made isotonic with sodium chloride.
Pharmacodynamics
Ketalar is a rapid-acting general anesthetic producing an anesthetic state characterized by profound analgesia, normal pharyngeal-laryngeal reflexes, normal or slightly enhanced skeletal muscle tone, cardiovascular and respiratory stimulation, and occasionally a transient and minimal respiratory depression.
A patent airway is maintained partly by virtue of unimpaired pharyngeal and laryngeal reflexes. (See WARNINGS and PRECAUTIONS Sections.)
The biotransformation of Ketalar includes N-dealkylation (metabolite I), hydroxylation of the cyclohexone ring (metabolites III and IV), conjugation with glucuronic acid and dehydration of the hydroxylated metabolites to form the cyclohexene derivative (metabolite II).
The anesthetic state produced by Ketalar has been termed "dissociative anesthesia" in that it appears to selectively interrupt association pathways of the brain before producing somatesthetic sensory blockade. It may selectively depress the thalamoneocortical system before significantly obtunding the more ancient cerebral centers and pathways (reticular-activating and limbic systems).
Elevation of blood pressure begins shortly after injection, reaches a maximum within a few minutes and usually returns to preanesthetic values within 15 minutes after injection. In the majority of cases, the systolic and diastolic blood pressure peaks from 10% to 50% above preanesthetic levels shortly after induction of anesthesia, but the elevation can be higher or longer in individual cases (see CONTRAINDICATIONS Section).
Ketamine has a wide margin of safety; several instances of unintentional administration of overdoses of Ketalar (up to ten times that usually required) have been followed by prolonged but complete recovery.
Ketalar has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients from 105 separate studies. During the course of these studies Ketalar was administered as the sole agent, as induction for other general agents, or to supplement low-potency agents.
Specific areas of application have included the following:
debridement, painful dressings, and skin grafting in burn patients, as well as other superficial surgical procedures. neurodiagnostic procedures such as pneumonencephalograms, ventriculograms, myelograms, and lumbar punctures. See also Precaution concerning increased intracranial pressure. diagnostic and operative procedures of the eye, ear, nose, and mouth, including dental extractions. diagnostic and operative procedures of the pharynx, larynx, or bronchial tree. NOTE: Muscle relaxants, with proper attention to respiration, may be required (see PRECAUTIONS Section). sigmoidoscopy and minor surgery of the anus and rectum, and circumcision. extraperitoneal procedures used in gynecology such as dilatation and curettage. orthopedic procedures such as closed reductions, manipulations, femoral pinning, amputations, and biopsies. as an anesthetic in poor-risk patients with depression of vital functions. in procedures where the intramuscular route of administration is preferred. in cardiac catheterization procedures.
In these studies, the anesthesia was rated either "excellent" or "good" by the anesthesiologist and the surgeon at 90% and 93%, respectively; rated "fair" at 6% and 4%, respectively; and rated "poor" at 4% and 3%, respectively. In a second method of evaluation, the anesthesia was rated "adequate" in at least 90%, and "inadequate" in 10% or less of the procedures.
Pharmacokinetics
The biotransformation of Ketalar includes N-dealkylation (metabolite I), hydroxylation of the cyclohexone ring (metabolites III and IV), conjugation with glucuronic acid and dehydration of the hydroxylated metabolites to form the cyclohexene derivative (metabolite II).
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. The anesthetic action is terminated by a combination of redistribution from the CNS to slower equilibrating peripheral tissues and by hepatic biotransformation to metabolite I. This metabolite is about 1/3 as active as ketamine in reducing halothane requirements (MAC) of the rat. The later half-life of ketamine (beta phase) is 2.5 hours.
Nonclinical Toxicology
There is limited information regarding Ketamine Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Ketamine Clinical Studies in the drug label.
How Supplied
Ketalar is supplied as the hydrochloride in concentrations equivalent to ketamine base. NDC 42023-113-10 — Each 20-mL multi-dose vial contains 10 mg/mL. Supplied in cartons of 10. NDC 42023-114-10 — Each 10-mL multi-dose vial contains 50 mg/mL. Supplied in cartons of 10. NDC 42023-115-10 — Each 5-mL multi-dose vial contains 100 mg/mL. Supplied in cartons of 10.
Storage
Store between 20° to 25°C (68° to 77°F). (See USP controlled room temperature.)
Protect from light.
Rx only.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
As appropriate, especially in cases where early discharge is possible, the duration of Ketalar and other drugs employed during the conduct of anesthesia should be considered. The patients should be cautioned that driving an automobile, operating hazardous machinery or engaging in hazardous activities should not be undertaken for 24 hours or more (depending upon the dosage of Ketalar and consideration of other drugs employed) after anesthesia.
Precautions with Alcohol
Alcohol-Ketamine interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Ketamine Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Ketamine Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.
- ↑ Hijazi, Y.; Boulieu, R. (July 2002). "Contribution of CYP3A4, CYP2B6, and CYP2C9 isoforms to N-demethylation of ketamine in human liver microsomes". Drug Metabolism and Disposition. 30 (7): 853–8. doi:10.1124/dmd.30.7.853. PMID 12065445.