Ketalar®

ketalar1

Ketalar®

(ketamine hydrochloride injection, USP)

Product Summary

Therapeutic Class: General Anesthetics
This product is manufactured and distributed by JHP Pharmaceuticals, LLC

Therapeutic Class: General Anesthetics
This product is manufactured and distributed by JHP Pharmaceuticals, LLC

Product Profile:

  • Latex Free
  • Bar Coded
  • Rapid-acting general anesthetic
  • Controlled drug schedule III

Special Note
Emergence reactions have occurred in approximately 12 percent of patients.

The psychological 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 a few patients recall as an unpleasant experience. The duration ordinarily is no more than a few hours; in a few cases, however, recurrences have taken place up to 24 hours postoperatively. No residual psychological effects are known to have resulted from use of Ketalar® .

The incidence of these emergence phenomena is least in the elderly (over 65 years of age) patient. Also, they are less frequent when the drug is given intramuscularly and the incidence is reduced as experience with the drug is gained.

The incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by using lower recommended dosages of Ketalar®  in conjunction with intravenous diazepam during induction and maintenance of anesthesia. (see dosage and administration section.). Also, these reactions may be reduced if verbal, tactile, and visual stimulation of the patient is minimized during the recovery period. This does not preclude the monitoring of vital signs.

In order to terminate a severe emergence reaction, the use of a small hypnotic dose of a short-acting or ultra short-acting barbiturate may be required.

When Ketalar®  is used on an outpatient basis, the patient should not be released until recovery from anesthesia is complete and then should be accompanied by a responsible adult.

Description

Ketalar®  is a nonbarbiturate anesthetic. 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.

Indications and Usage

Ketalar®  is indicated as the sole anesthetic agent for diagnostic and surgical procedures that do not require skeletal muscle relaxation. Ketalar®  is best suited for short procedures but it can be used, with additional doses, for longer procedures.
Ketalar®
 is indicated for the induction of anesthesia prior to the administration of other general anesthetic agents.
Ketalar®  is indicated to supplement low-potency agents, such as nitrous oxide. Specific areas of application are described in the CLINICAL PHARMACOLOGY Section of Prescribing Information.

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 Events
Cardiovascular: Elevated blood pressure and pulse rate. Hypotension, bradycardia, arrhythmia

Respiration: Stimulated respiration, severe depression of respiration or apnea following rapid IV administration of high doses. Laryngospasms and other forms of airway obstruction.

Eye: Diplopia, nystagmus, sight elevation in intraocular pressure measurement

Psychological: (See Special Note)

Neurological: Enhanced skeletal muscle tone may be manifested by tonic and clonic movements sometimes resembling seizures

Gastrointestinal: Anorexia, nausea, vomiting

General: Anaphylaxis. Local pain and exanthema at injection site. Transient erythema, morbilliform rash

Drug Abuse and Dependence

Ketamine has been reported being used as a drug of abuse. Reports suggest that ketamine produces a variety of symptoms including, but not limited to anxiety, dysphoria, disorientation, insomnia, flashbacks, hallucinations, and psychotic episodes. Ketamine dependence and tolerance are possible following prolonged administration. A withdrawal syndrome with psychotic features has been described following discontinuation of long-term ketamine use. Therefore, ketamine should be prescribed and administered with caution.


Please see the full prescribing information link above for additional information.