Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/1390
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Ketalar (Injection)
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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.
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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.
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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.
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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.
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dailymed-instance:supply |
Store at 20�����25��C
(68�����77��F). (See USP controlled room temperature.) Protect
from light. Rx only.
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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.
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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.
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dailymed-instance:genericMe... |
ketamine hydrochloride
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dailymed-instance:fullName |
Ketalar (Injection)
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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.
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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.
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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.
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dailymed-instance:name |
Ketalar
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