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warnings
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 ketamine hydrochloride, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.
ADVERSE REACTIONS Cardiovascular : Blood pressure and pulse rate are frequently elevated following administration of ketamine hydrochloride 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 ketamine hydrochloride. Laryngospasms and other forms of airway obstruction have occurred during ketamine hydrochloride anesthesia. Eye : Diplopia and nystagmus have been noted following ketamine hydrochloride 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/.