ugh the first several months of life, but may extend out to approximately three years of age in humans. (see precautions/pregnancy). some published studies in children suggest that similar deficits may occur after repeated or prolonged exposures to anesthetic agents early in life and may result in adverse cognitive or behavioral effects. these studies have substantial limitations, and it is not clear if the observed effects are due to the anesthetic/sedation drug administration or other factors such as the surgery or underlying illness. anesthetic and sedation drugs are a necessary part of the care of children needing surgery, other procedures, or tests that cannot be delayed, and no specific medications have been shown to be safer than any other. decisions regarding the timing of any elective procedures requiring anesthesia should take into consideration the benefits of the procedure weighed against the potential risks.

must be considered. ketamine is recommended for use in the patient whose stomach is not empty when, in the judgment of the practitioner, the benefits of the drug outweigh the possible risks. 2. atropine, scopolamine, or another drying agent should be given at an appropriate interval prior to induction. onset and duration because of rapid induction following the initial intravenous injection, the patient should be in a supported position during administration. the onset of action of ketamine is rapid; an intravenous dose of 2 mg/kg of body weight usually produces surgical anesthesia within 30 seconds after injection, with the anesthetic effect usually lasting five to ten minutes. if a longer effect is desired, additional increments can be administered intravenously or intramuscularly to maintain anesthesia without producing significant cumulative effects. intramuscular doses, in a range of 9 to 13 mg/kg usually produce surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes. dosage as with other general anesthetic agents, the individual response to ketamine is somewhat varied depending on the dose, route of administration, and age of patient, so that dosage recommendation cannot be absolutely fixed. the drug should be titrated against the patient's requirements. in individuals with a history of chronic ketamine use for off-label indications, there have been case reports of genitourinary pain that may be related to the ketamine treatment, not the underlying condition (see adverse reactions section). consider cessation of ketamine if genitourinary pain continues in the setting of other genitourinary symptoms. induction intravenous route the initial dose of ketamine administered intravenously may range from 1 mg/kg to 4.5 mg/kg. the average amount required to produce five to ten minutes of surgical anesthesia has been 2 mg/kg. alternatively, in adult patients an induction dose of 1 mg to 2 mg/kg intravenous ketamine at a rate of 0.5 mg/kg/min may be used for induction of anesthesia. in addition, diazepam in 2 mg to 5 mg doses, administered in a separate syringe over 60 seconds, may be used. in most cases, 15 mg of intravenous diazepam or less will suffice. the incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by this induction dosage program. note: the 100 mg/ml concentration of ketamine should not be injected intravenously without proper dilution. it is recommended the drug be diluted with an equal volume of either sterile water for injection, usp, normal saline, or 5% dextrose in water. rate of administration it is recommended that ketamine be administered slowly (over a period of 60 seconds). more rapid administration may result in respiratory depression and enhanced pressor response. intramuscular route the initial dose of ketamine administered intramuscularly may range from 6.5 to 13 mg/kg. a dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anesthesia. maintenance of anesthesia the maintenance dose should be adjusted according to the patient's anesthetic needs and whether an additional anesthetic agent is employed. increments of one-half to the full induction dose may be repeated as needed for maintenance of anesthesia. however, it should be noted that purposeless and tonic-clonic movements of extremities may occur during the course of anesthesia. these movements do not imply a light plane and are not indicative of the need for additional doses of the anesthetic. it should be recognized that the larger the total dose of ketamine administered, the longer will be the time to complete recovery. adult patients induced with ketamine augmented with intravenous diazepam may be maintained on ketamine given by slow microdrip infusion technique at a dose of 0.1 to 0.5 mg/minute, augmented with diazepam 2 to 5 mg administered intravenously as needed. in many cases 20 mg or less of intravenous diazepam total for combined induction and maintenance will suffice. however, slightly more diazepam may be required depending on the nature and duration of the operation, physical status of the patient, and other factors. the incidence of psychological manifestations during emergence, particularly dream-like observations and emergence delirium, may be reduced by this maintenance dosage program. dilution to prepare a dilute solution containing 1 mg of ketamine per ml, aseptically transfer 10 ml from a 50 mg per ml vial or 5 ml from a 100 mg per ml vial to 500 ml of 5% dextrose injection, usp or sodium chloride (0.9%) injection, usp (normal saline) and mix well. the resultant solution will contain 1 mg of ketamine per ml. the fluid requirements of the patient and duration of anesthesia must be considered when selecting the appropriate dilution of ketamine hydrochloride injection. if fluid restriction is required, ketamine hydrochloride injection can be added to a 250 ml infusion as described above to provide a ketamine concentration of 2 mg/ml. supplementary agents ketamine is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained. the regimen of a reduced dose of ketamine supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents such as nitrous oxide and oxygen.

reported cystitis (including cystitis non-infective, cystitis interstitial, cystitis ulcerative, cystitis erosive and cystitis hemorrhagic) as well as hydronephrosis and reduced bladder capacity. 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 hospira, inc. at 1-800-441-4100 or fda at 1-800-fda-1088 or www.fda.gov/medwatch.

th a half-life of 10 to 15 minutes. this first phase corresponds clinically to the anesthetic effect of the drug. the anesthetic action is terminated by a combination of redistribution from the cns to slower equilibrating peripheral tissues and by hepatic biotransformation to metabolite i. this metabolite is about 1/3 as active as ketamine in reducing halothane requirements (mac) of the rat. the later half-life of ketamine (beta phase) is 2.5 hours. the anesthetic state produced by ketamine has been termed "dissociative anesthesia" in that it appears to selectively interrupt association pathways of the brain before producing somatesthetic sensory blockade. it may selectively depress the thalamoneocortical system before significantly obtunding the more ancient cerebral centers and pathways (reticular-activating and limbic systems). elevation of blood pressure begins shortly after injection, reaches a maximum within a few minutes and usually returns to preanesthetic values within 15 minutes after injection. in the majority of cases, the systolic and diastolic blood pressure peaks from 10% to 50% above preanesthetic levels shortly after induction of anesthesia, but the elevation can be higher or longer in individual cases (see contraindications section). ketamine has a wide margin of safety; several instances of unintentional administration of overdoses of ketamine (up to ten times that usually required) have been followed by prolonged but complete recovery. ketamine has been studied in over 12,000 operative and diagnostic procedures, involving over 10,000 patients from 105 separate studies. during the course of these studies ketamine hydrochloride was administered as the sole agent, as induction for other general agents, or to supplement low-potency agents. specific areas of application have included the following: debridement, painful dressings, and skin grafting in burn patients, as well as other superficial surgical procedures. neurodiagnostic procedures such as pneumonencephalograms, ventriculograms, myelograms, and lumbar punctures. see also precaution concerning increased intracranial pressure. diagnostic and operative procedures of the eye, ear, nose, and mouth, including dental extractions. diagnostic and operative procedures of the pharynx, larynx, or bronchial tree. note: muscle relaxants, with proper attention to respiration, may be required (see precautions section). sigmoidoscopy and minor surgery of the anus and rectum, and circumcision. extraperitoneal procedures used in gynecology such as dilatation and curettage. orthopedic procedures such as closed reductions, manipulations, femoral pinning, amputations, and biopsies. as an anesthetic in poor-risk patients with depression of vital functions. in procedures where the intramuscular route of administration is preferred. in cardiac catheterization procedures. in these studies, the anesthesia was rated either "excellent" or "good" by the anesthesiologist and the surgeon at 90% and 93%, respectively; rated "fair" at 6% and 4%, respectively; and rated "poor" at 4% and 3%, respectively. in a second method of evaluation, the anesthesia was rated "adequate" in at least 90%, and "inadequate" in 10% or less of the procedures.

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