Ketasol is used as an anesthetic agent during surgical procedures.
KETASOL DESCRIPTION
Ketasol contains Ketamine HCl equivalent to Ketasol base per mL. It also contains benzethonium chloride and water for injection. Additionally, the 10-mg/mL vial also contains sodium chloride.
KETASOL DOSAGE
Note: All doses are given in terms of Ketasol base.
Adults, Elderly (>65 years) and Children: For surgery in elderly patients, Ketasol has been shown to be suitable either alone or supplemented with other anaesthetic agents.
Preoperative Preparations: Ketasol has been safely used alone when the stomach was not empty. However, since the need for supplemental agents and muscle relaxants cannot be predicted, when preparing for elective surgery, it is advisable that nothing be given by mouth for at least 6 hrs prior to anaesthesia.
Premedication with an anticholinergic agent (eg, atropine, hyoscine or glycopyrolate) or another drying agent should be given at an appropriate interval prior to induction to reduce Ketasol-induced hypersalivation.
Midazolam, diazepam, lorazepam or flunitrazepam used as a premedicant or as an adjunct to Ketasol, have been effective in reducing the incidence of emergence reactions.
Onset and Duration: As with other general anaesthetic agents, the individual response to Ketasol is somewhat varied depending on the dose, route of administration, age of patient and concomitant use of other agents, so that dosage recommendation cannot be absolutely fixed. The dose should be titrated against the patient's requirements.
Because of rapid induction following IV injection, the patient should be in a supported position during administration. An IV dose of 2 mg/kg of body weight usually produces surgical anaesthesia within 30 sec after injection and the anaesthetic effect usually lasts 5-10 min. An IM dose of 10 mg/kg of body weight usually produces surgical anaesthesia within 3-4 min following injection and the anaesthetic effect usually lasts 12-25 min. Return to consciousness is gradual.
Ketasol as the Sole Anaesthetic Agent: IV Infusion: The use of Ketasol by continuous infusion enables the dose to be titrated more closely, thereby reducing the amount of Ketasol administered compared with intermittent administration. This results in a shorter recovery time and better stability of vital signs.
A solution containing Ketasol 1 mg/mL in 5% dextrose or 0.9% sodium chloride is suitable for administration by infusion.
General Anaesthesia Induction: An infusion corresponding to 0.5-2 mg/kg as total induction dose.
Maintenance of Anaesthesia: Anaesthesia may be maintained using a microdrip infusion of 10-45 mcg/kg/min (approximately 1-3 mg/min).
The rate of infusion will depend on the patient's reaction and response to anaesthesia. The dosage required may be reduced when a long-acting neuromuscular-blocking agent is used.
Intermittent Injection: Induction: IV Route: The initial dose of Ketasol administered IV may range from 1-4.5 mg/kg (in terms of Ketasol base). The average amount required to produce 5-10 min of surgical anaesthesia has been 2 mg/kg. It is recommended that IV administration be accomplished slowly (over a period of 60 sec). More rapid administration may result in respiratory depression and enhanced pressor response.
Note: The Ketasol 100 mg/mL concentration should not be injected IV without proper dilution. It is recommended that the drug be diluted with an equal volume of either sterile water for injection, normal saline or 5% dextrose in water.
IM Route: The initial dose of Ketasol administered IM may range from 6.5-13 mg/kg (in terms of Ketasol base). A low initial IM dose of 4 mg/kg has been used in diagnostic manoeuvers and procedures not involving intensely painful stimuli. A dose of 10 mg/kg will usually produce 12-25 min of surgical anaesthesia.
Maintenance of General Anaesthesia: Lightening of anaesthesia may be indicated by nystagmus, movements in response to stimulation and vocalization. Anaesthesia is maintained by the administration of additional doses of Ketasol by either the IV or IM route.
Each additional dose is from ½ to the full induction dose recommended previously for the route selected for maintenance, regardless of the route used for induction.
The larger the total amount of Ketasol administered, the longer will be the time to complete recovery.
Purposeless and tonic-clonic movements of extremities may occur during the course of anaesthesia. These movements do not imply a light plane and are not indicative of the need for additional doses of the anaesthetic.
Ketasol as Induction Agent Prior to the Use of Other General Anaesthetics: Induction is accomplished by a full IV or IM dose of Ketasol as defined previously. If Ketasol has been administered IV and the principal anaesthetic is slow-acting, a 2nd dose of Ketasol may be required 5-8 min following the initial dose. If Ketasol has been administered IM and the principal anaesthetic is rapid-acting, administration of the principal anaesthetic may be delayed up to 15 min following the injection of Ketasol.
Ketasol as Supplement to Anaesthetic Agents: Ketasol is clinically compatible with the commonly used general and local anaesthetic agents when an adequate respiratory exchange is maintained. The dose of Ketasol for use in conjunction with other anaesthetic agents is usually in the same range as the dosage stated previously; however, the use of another anaesthetic agent may allow a reduction in the dose of Ketasol.
Management of Patients in Recovery: Following the procedure, the patient should be observed but left undisturbed. This does not preclude the monitoring of vital signs. If during the recovery, the patient shows any indication of emergence delirium, consideration may be given to the use of diazepam (5-10 mg IV in an adult). A hypnotic dose of a thiobarbiturate (50-100 mg IV) may be used to terminate severe emergence reactions. If any 1 of these agents is employed, the patient may experience a longer recovery period.
Hepatic Insufficiency: Dose reductions should be considered in patients with cirrhosis or other types of liver impairment.
Administration: For IV infusion, IV or IM injection.
KETASOL INTERACTIONS
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Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with Ketasol.
Ketasol is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.
Ketasol may potentiate the neuromuscular-blocking effects of atracurium and tubocurarine including respiratory depression with apnoea.
The use of halogenated anaesthetics concomitantly with Ketasol can lengthen the elimination half-life of Ketasol and delay recovery from anaesthesia. Concurrent use of Ketasol (especially in high doses or when rapidly administered) with halogenated anaesthetics can increase the risk of developing bradycardia, hypotension or decreased cardiac output.
The use of Ketasol with other CNS depressants (eg, ethanol, phenothiazines, sedating H1-blockers or skeletal muscle relaxants) can potentiate CNS depression and/or increase risk of developing respiratory depression. Reduced doses of Ketasol may be required with concurrent administration of other anxiolytics, sedatives and hypnotics.
Ketasol has been reported to antagonise the hypnotic effect of thiopental.
Patients taking thyroid hormones have an increased risk of developing hypertension and tachycardia when given Ketasol.
Concomitant use of antihypertensive agents and Ketasol increases the risk of developing hypotension.
When Ketasol and theophylline are given concurrently, a clinically significant reduction in the seizure threshold is observed. Unpredictable extensor-type seizures have been reported with concurrent administration of these agents.
Incompatibilities: Ketasol is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid.
KETASOL SIDE EFFECTS
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Cardiovascular
Blood pressure and pulse rate are frequently elevated following administration of Ketasol 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 Ketasol. Laryngospasms and other forms of airway obstruction have occurred during Ketasol anesthesia.
Eye
Diplopia and nystagmus have been noted following Ketasol administration. It also may cause a slight elevation in intraocular pressure measurement.
Psychological
Neurological
In some patients, enhanced skeletal muscle tone may be manifested by tonic and clonic movements sometimes resembling seizures.
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.
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/.
Drug Abuse And Dependence
Ketasol has been reported being used as a drug of abuse. Reports suggest that Ketasol produces a variety of symptoms including, but not limited to anxiety, dysphoria, disorientation, insomnia, flashbacks, hallucinations, and psychotic episodes. Ketasol dependence and tolerance are possible following prolonged administration. A withdrawal syndrome with psychotic features has been described following discontinuation of long-term Ketasol use. Therefore, Ketasol should be prescribed and administered with caution.
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