Ketamine: Difference between revisions

Jump to navigation Jump to search
No edit summary
No edit summary
Line 54: Line 54:
|drugInteractions=Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Ketalar.
|drugInteractions=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.  
Ketalar is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.
|useInPregnancyFDA=Since the safe use in pregnancy, including obstetrics (either vaginal or abdominal delivery), has not been established, such use is not recommended.
|useInPregnancyFDA=Since the safe use in pregnancy, including obstetrics (either vaginal or abdominal delivery), has not been established, such use is not recommended.
|useInPed=Safety and effectiveness in pediatric patients below the age of 16 have not been established.  
|useInPed=Safety and effectiveness in pediatric patients below the age of 16 have not been established.
|useInGeri=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.  
|useInGeri=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.
|overdose=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.
|overdose=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.
|drugBox={{drugbox2
| Watchedfields = changed
| verifiedrevid = 477168837
| IUPAC_name = (''RS'')-2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone
| image = Ketamine.svg
| width = 150
| image2 = Ketamine3Dan.gif
| width2 = 250
| imagename = 1 : 1 mixture (racemate)
| drug_name = Ketamine
<!--Clinical data-->
| Drugs.com = {{drugs.com|CDI|ketamine}}
| licence_US = Ketamine
| pregnancy_AU = B3
| pregnancy_US = C
| legal_AU = S8
| legal_CA = Schedule I
| legal_UK = CD
| legal_US = Schedule III
| routes_of_administration = [[Intravenous therapy|IV]], [[Intramuscular injection|IM]], [[Insufflation (medicine)|Insufflate]]d, oral, [[topical]]
| dependency_liability= Moderate
<!--Pharmacokinetic data-->
| metabolism = Hepatic, primarily by CYP3A4<ref>{{Cite journal|last1=Hijazi |first1=Y. |last2=Boulieu |first2=R. |title=Contribution of CYP3A4, CYP2B6, and CYP2C9 isoforms to N-demethylation of ketamine in human liver microsomes|journal=Drug Metabolism and Disposition|volume=30|issue=7|pages=853–8|date=July 2002|pmid=12065445|doi=10.1124/dmd.30.7.853}}</ref>
| elimination_half-life = 2.5–3 hours
| excretion = renal (>90%)
<!--Identifiers-->
| CASNo_Ref = {{cascite|correct|CAS}}
| CAS_number_Ref = {{cascite|correct|??}}
| CAS_number = 6740-88-1
| ATC_prefix = N01
| ATC_suffix = AX03
| ChEBI_Ref = {{ebicite|correct|EBI}}
| ChEBI = 6121
| PubChem = 3821
| DrugBank_Ref = {{drugbankcite|correct|drugbank}}
| DrugBank = DB01221
| ChemSpiderID_Ref = {{chemspidercite|correct|chemspider}}
| ChemSpiderID = 3689
| UNII_Ref = {{fdacite|correct|FDA}}
| UNII = 690G0D6V8H
| KEGG_Ref = {{keggcite|correct|kegg}}
| KEGG = D08098
| ChEMBL_Ref = {{ebicite|correct|EBI}}
| ChEMBL = 742
<!--Chemical data-->
| C=13 | H=16 | Cl=1 | N=1 | O=1
| molecular_weight = 237.725 g/mol
| smiles = CNC1(C2=CC=CC=C2Cl)CCCCC1=O
| InChI = 1/C13H16ClNO/c1-15-13(9-5-4-8-12(13)16)10-6-2-3-7-11(10)14/h2-3,6-7,15H,4-5,8-9H2,1H3
| StdInChI_Ref = {{stdinchicite|correct|chemspider}}
| StdInChI = 1S/C13H16ClNO/c1-15-13(9-5-4-8-12(13)16)10-6-2-3-7-11(10)14/h2-3,6-7,15H,4-5,8-9H2,1H3
| StdInChIKey_Ref = {{stdinchicite|correct|chemspider}}
| StdInChIKey = YQEZLKZALYSWHR-UHFFFAOYSA-N
| melting_point = 262
}}
|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 15:32, 19 June 2014

Ketamine
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Chetan Lokhande, M.B.B.S [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

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

Template:Px
Template:Px
1 : 1 mixture (racemate)Ketamine
Systematic (IUPAC) name
(RS)-2-(2-Chlorophenyl)-2-(methylamino)cyclohexanone
Identifiers
CAS number 6740-88-1
ATC code N01AX03
PubChem 3821
DrugBank DB01221
Chemical data
Formula Template:OrganicBox atomTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBox atomTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBoxTemplate:OrganicBox 
Mol. mass 237.725 g/mol
SMILES eMolecules & PubChem
Physical data
Melt. point 262 °C (504 °F)
Pharmacokinetic data
Bioavailability ?
Metabolism Hepatic, primarily by CYP3A4[1]
Half life 2.5–3 hours
Excretion renal (>90%)
Therapeutic considerations
Licence data

US

Pregnancy cat.

B3(AU) C(US)

Legal status

Controlled (S8)(AU) Schedule I(CA) CD(UK) Schedule III(US)

Dependence Liability Moderate
Routes IV, IM, Insufflated, oral, topical

Mechanism of Action

There is limited information regarding Ketamine Mechanism of Action in the drug label.

Structure

There is limited information regarding Ketamine Structure in the drug label.

Pharmacodynamics

There is limited information regarding Ketamine Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Ketamine Pharmacokinetics in the drug label.

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

There is limited information regarding Ketamine How Supplied in the drug label.

Storage

There is limited information regarding Ketamine Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Ketamine |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Ketamine |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Ketamine Patient Counseling Information in the drug label.

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.

  1. 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.