Statements in which the resource exists as a subject.
PredicateObject
rdf:type
rdfs:label
Ketalar (Injection)
dailymed-instance:dosage
Note: Barbiturates and Ketalar, being chemically incompatible because of precipitate formation, should not be injected from the same syringe. If the Ketalar dose is augmented with diazepam, the two drugs must be given separately. Do not mix Ketalar and diazepam in syringe or infusion flask. For additional information on the use of diazepam, refer to the WARNINGS and DOSAGE AND ADMINISTRATION Sections of the diazepam insert.<br/>Preoperative Preparations::<br/>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 Ketalar is rapid; an intravenous dose of 2 mg/kg (1 mg/lb) 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 (4 to 6 mg/lb) usually produce surgical anesthesia within 3 to 4 minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes.<br/>Dosage:: As with other general anesthetic agents, the individual response to Ketalar 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.<br/>Induction:: Intravenous Route: The initial dose of Ketalar administered intravenously may range from 1 mg/kg to 4.5 mg/kg (0.5 to 2 mg/lb). The average amount required to produce five to ten minutes of surgical anesthesia has been 2 mg/kg (1 mg/lb). 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 Ketalar 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 Ketalar 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 Ketalar administered intramuscularly may range from 6.5 to 13 mg/kg (3 to 6 mg/lb). A dose of 10 mg/kg (5 mg/lb) will usually produce 12 to 25 minutes of surgical anesthesia.<br/>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 Ketalar administered, the longer will be the time to complete recovery. Adult patients induced with Ketalar augmented with intravenous diazepam may be maintained on Ketalar 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 inductionand 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 (50 mg per mL Steri-Vial) or 5 mL (100 mg per mL Steri-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 Ketalar. If fluid restriction is required, Ketalar can be added to a 250 mL infusion as described above to provide a Ketalar concentration of 2 mg/mL. Ketalar Steri-Vials 10 mg/mL are not recommended for dilution.<br/>Supplementary Agents:: Ketalar 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 Ketalar supplemented with diazepam can be used to produce balanced anesthesia by combination with other agents such as nitrous oxide and oxygen.
dailymed-instance:descripti...
Ketalar is a nonbarbiturate anesthetic chemically designated dl 2-(0-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride. 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.
dailymed-instance:clinicalP...
Ketalar is a rapid-acting general anesthetic producing an anesthetic state characterized by profound analgesia, normal pharyngeal-laryngeal reflexes, normal or slightly enhanced skeletal muscle tone, cardiovascular and respiratory stimulation, and occasionally a transient and minimal respiratory depression. A patent airway is maintained partly by virtue of unimpaired pharyngeal and laryngeal reflexes. The biotransformation of Ketalar includes N-dealkylation (metabolite I), hydroxylation of the cyclohexone ring (metabolites III and IV), conjugation with glucuronic acid and dehydration of the hydroxylated metabolites to form the cyclohexene derivative (metabolite II). Following intravenous administration, the ketamine concentration has an initial slope (alpha phase) lasting about 45 minutes with 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 Ketalar 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 . Ketamine has a wide margin of safety; several instances of unintentional administration of overdoses of Ketalar (up to ten times that usually required) have been followed by prolonged but complete recovery. Ketalar 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 Ketalar 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: 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.
dailymed-instance:activeIng...
dailymed-instance:contraind...
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.
dailymed-instance:supply
Store at 20�����25��C (68�����77��F). (See USP controlled room temperature.) Protect from light. Rx only.
dailymed-instance:activeMoi...
dailymed-instance:inactiveI...
dailymed-instance:precautio...
General: 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). The intravenous dose should be administered over a period of 60 seconds. More rapid administration may result in respiratory depression or apnea and enhanced pressor response. 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.<br/>Information for Patients: As appropriate, especially in cases where early discharge is possible, the duration of Ketalar and other drugs employed during the conduct of anesthesia should be considered. The patients should be cautioned that driving an automobile, operating hazardous machinery or engaging in hazardous activities should not be undertaken for 24 hours or more (depending upon the dosage of Ketalar and consideration of other drugs employed) after anesthesia.<br/>Drug Interactions: Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Ketalar. Ketalar is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.<br/>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).<br/>Geriatric Use: 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.<br/>Pediatric Use: Safety and effectiveness in pediatric patients below the age of 16 have not been established.
dailymed-instance:overdosag...
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.
dailymed-instance:genericMe...
ketamine hydrochloride
dailymed-instance:fullName
Ketalar (Injection)
dailymed-instance:adverseRe...
Cardiovascular: Blood pressure and pulse rate are frequently elevated following administration of Ketalar 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 Ketalar. Laryngospasms and other forms of airway obstruction have occurred during Ketalar anesthesia. Eye: Diplopia and nystagmus have been noted following Ketalar administration. It also may cause a slight elevation in intraocular pressure measurement. 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.
dailymed-instance:warning
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.
dailymed-instance:indicatio...
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.
dailymed-instance:represent...
dailymed-instance:routeOfAd...
dailymed-instance:name
Ketalar