Ketamine

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]

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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

There is limited information regarding Ketamine Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Ketamine in women who are pregnant.
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

There is no FDA guidance on the use of Ketamine in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Ketamine in geriatric settings.

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

There is limited information regarding Ketamine overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

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

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

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Package and Label Display Panel

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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.