"The U.S. Food and Drug Administration today notified Ranbaxy Laboratories, Ltd., that it is prohibited from manufacturing and distributing active pharmaceutical ingredients (APIs) from its facility in Toansa, India, for FDA-regulated drug product"...
Cardiac function should be continually monitored during the procedure in patients found to have hypertension or cardiac decompensation.
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.
Ketalar should be used by or under the direction of physicians experienced in administering general anesthetics and in maintenance of an airway and in the control of respiration.
Because pharyngeal and laryngeal reflexes are usually active, Ketalar should not be used alone in surgery or diagnostic procedures of the pharynx, larynx, or bronchial tree. Mechanical stimulation of the pharynx should be avoided, whenever possible, if Ketalar is used alone. Muscle relaxants, with proper attention to respiration, may be required in both of these instances.
Resuscitative equipment should be ready for use.
The incidence of emergence reactions may be reduced if verbal and tactile stimulation of the patient is minimized during the recovery period. This does not preclude the monitoring of vital signs (see Special Note).
In surgical procedures involving visceral pain pathways, Ketalar should be supplemented with an agent which obtunds visceral pain.
Use with caution in the chronic alcoholic and the acutely alcohol-intoxicated patient.
An increase in cerebrospinal fluid pressure has been reported following administration of ketamine hydrochloride. Use with extreme caution in patients with preanesthetic elevated cerebrospinal fluid pressure.
Usage in Pregnancy
Since the safe use in pregnancy, including obstetrics (either vaginal or abdominal delivery), has not been established, such use is not recommended (see Animal Pharmacology And Toxicology, Reproduction).
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.
Safety and effectiveness in pediatric patients below the age of 16 have not been established.
Last reviewed on RxList: 3/16/2012
This monograph has been modified to include the generic and brand name in many instances.
Additional Ketalar Information
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