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