Loading…
KETALAR is a brand name for Ketamine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Ketamine is indicated in children and in adults. Ketamine is recommended: 1. As an anaesthetic agent for diagnostic and surgical procedures. When used by intravenous or intramuscular injection, ketamine is best suited for short procedures. With additional doses, or by intravenous infusion, ketamine can be used for…
Verbatim from this product's MHRA label. Tap a section to expand.
For intravenous infusion, intravenous injection or intramuscular injection.
NOTE:
All doses are given in terms of ketamine base. 4).
Posology Adults, elderly (over 65 years) and children:
For surgery in elderly patients, ketamine has been shown to be suitable either alone or supplemented with other anaesthetic agents. Preoperative preparations Ketamine 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 six hours prior to anaesthesia.
g. atropine, hyoscine or glycopyrolate) or another drying agent should be given at an appropriate interval prior to induction to reduce ketamine-induced hypersalivation. Midazolam, diazepam, lorazepam, or flunitrazepam used as a premedicant or as an adjunct to ketamine, have been effective in reducing the incidence of emergence reactions.
Onset and duration As with other general anaesthetic agents, the individual response to ketamine 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 intravenous injection, the patient should be in a supported position during administration. An intravenous dose of 2 mg/kg of bodyweight usually produces surgical anaesthesia within 30 seconds after injection and the anaesthetic effect usually lasts 5 to 10 minutes.
An intramuscular dose of 10 mg/kg of bodyweight usually produces surgical anaesthesia within 3 to 4 minutes following injection and the anaesthetic effect usually lasts 12 to 25 minutes. Return to consciousness is gradual. Method of administration A.
Ketamine as the sole anaesthetic agent Intravenous Infusion The use of ketamine by continuous infusion enables the dose to be titrated more closely, thereby reducing the amount of drug administered compared with intermittent administration.
This results in a shorter recovery time and better stability of vital signs. 9% is suitable for administration by infusion. 5 – 2 mg/kg as total induction dose. Maintenance of anaesthesia Anaesthesia may be maintained using a microdrip infusion of 10 - 45 microgram/kg/min (approximately 1 – 3 mg/min).
8. Drug Abuse and Dependence Ketamine has been reported as being a drug of abuse. 8). Other adverse effects have also been reported: see “Long Term Use”. If used on a daily basis for a few weeks, dependence and tolerance may develop, particularly in individuals with a history of drug abuse and dependence.
Therefore, the use of ketamine should be closely supervised and it should be prescribed and administered with caution. 5 Interaction with other medicinal products and other forms of interaction Prolonged recovery time may occur if barbiturates and/or narcotics are used concurrently with ketamine.
Ketamine is chemically incompatible with barbiturates and diazepam because of precipitate formation. Therefore, these should not be mixed in the same syringe or infusion fluid. Diazepam is known to increase the half-life of ketamine and prolongs its pharmacodynamic effects.
Dose adjustments may therefore be needed. Ketamine may potentiate the neuromuscular blocking effects of atracurium and tubocurarine including respiratory depression with apnoea. The use of halogenated anaesthetics concomitantly with ketamine can lengthen the elimination half-life of ketamine and delay recovery from anaesthesia.
Concurrent use of ketamine (especially in high doses or when rapidly administered) with halogenated anaesthetics can increase the risk of developing bradycardia, hypotension or decreased cardiac output. g. ethanol, phenothiazines, sedating H1 – blockers or skeletal muscle relaxants) can potentiate CNS depression and/or increase risk of developing respiratory depression.
Reduced doses of ketamine may be required with concurrent administration of other anxiolytics, sedatives and hypnotics. Ketamine 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 ketamine.
To be used only in hospitals by or under the supervision of experienced medically qualified anaesthetists except under emergency conditions. As with any general anaesthetic agent, resuscitative equipment should be available and ready for use.
Respiratory depression may occur with overdosage of ketamine, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to the administration of analeptics. The intravenous dose should be administered over a period of 60 seconds.
More rapid administration may result in transient respiratory depression or apnoea and enhanced pressor response. Because pharyngeal and laryngeal reflexes usually remain active, mechanical stimulation of the pharynx should be avoided unless muscle relaxants, with proper attention to respiration, are used.
Although aspiration of contrast medium has been reported during ketamine anaesthesia under experimental conditions (Taylor, P A and Towey, R M, Brit. Med. J. 1971, 2: 688), in clinical practice aspiration is seldom a problem. In surgical procedures involving visceral pain pathways, ketamine should be supplemented with an agent which obtunds visceral pain.
When ketamine is used on an outpatient basis, the patient should not be released until recovery from anaesthesia is complete and then should be accompanied by a responsible adult.
Ketamine should be used with caution in patients with the following conditions:
Use with caution in the chronic alcoholic and the acutely alcohol-intoxicated patient. Ketamine is metabolised in the liver and hepatic clearance is required for termination of clinical effects. A prolonged duration of action may occur in patients with cirrhosis or other types of liver impairment.
Dose reductions should be considered in these patients. Abnormal liver function tests associated with ketamine use have been reported, particularly with extended use (>3 days) or drug abuse. Since an increase in cerebrospinal fluid (CSF) pressure has been reported during ketamine anaesthesia, this medicine should be used with special caution in patients with preanaesthetic elevated cerebrospinal fluid pressure.
1. 8). Ketamine should not be used in patients with eclampsia or pre-eclampsia, severe coronary or myocardial disease, cerebrovascular accident or cerebral trauma.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Ketamine in United Kingdom.
Know a brand we are missing in United Kingdom? Suggest a brand →
Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
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. 5 mg/kg (in terms of ketamine base). 0 mg/kg. It is recommended that intravenous administration be accomplished slowly (over a period of 60 seconds).
More rapid administration may result in respiratory depression and enhanced pressor response. 6 Fertility, pregnancy and lactation). 5 mg/kg to 13 mg/kg (in terms of ketamine base). A low initial intramuscular dose of 4 mg/kg has been used in diagnostic manoeuvres and procedures not involving intensely painful stimuli.
A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anaesthesia. 4). Dosage in Obstetrics Data are lacking for intramuscular injection and maintenance infusion of ketamine in the parturient population, and recommendations cannot be made.
2. 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 ketamine by either the intravenous or intramuscular route.
Each additional dose is from ½ to the full induction dose recommended above for the route selected for maintenance, regardless of the route used for induction. The larger the total amount of ketamine 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. B. Ketamine as induction agent prior to the use of other general anaesthetics Induction is accomplished by a full intravenous or intramuscular dose of ketamine as defined above.
If ketamine has been administered intravenously and the principal anaesthetic is slow-acting, a second dose of ketamine may be required 5 to 8 minutes following the initial dose. If ketamine has been administered intramuscularly and the principal anaesthetic is rapid-acting, administration of the principal anaesthetic may be delayed up to 15 minutes following the injection of ketamine.
C. Ketamine as supplement to anaesthetic agents Ketamine is clinically compatible with the commonly used general and local anaesthetic agents when an adequate respiratory exchange is maintained. The dose of ketamine for use in conjunction with other anaesthetic agents is usually in the same range as the dosage stated above; however, the use of another anaesthetic agent may allow a reduction in the dose of […]
Concomitant use of antihypertensive agents and ketamine increases the risk of developing hypotension. Sympathomimetics (directly or indirectly acting) and vasopressin may enhance the sympathomimetic effects of ketamine. Concomitant use with ergometrine may lead to an increase in blood pressure.
When ketamine and theophylline or aminophylline are given concurrently, a clinically significant reduction in the seizure threshold may be observed. Unpredictable extensor-type seizures have been reported with concurrent administration of these agents.
Drugs that inhibit CYP3A4 enzyme activity generally decrease hepatic clearance, resulting in increased plasma concentration of CYP3A4 substrate medications, such as ketamine. Coadministration of ketamine with drugs that inhibit CYP3A4 enzyme may require a decrease in ketamine dosage to achieve the desired clinical outcome.
Drugs that induce CYP3A4 enzyme activity generally increase hepatic clearance, resulting in decreased plasma concentration of CYP3A4 substrate medications, such as ketamine. Coadministration of ketamine with drugs that induce CYP3A4 enzyme may require an increase in ketamine dosage to achieve the desired clinical outcome.
6 Fertility, pregnancy and lactation Pregnancy Ketamine crosses the placenta. This should be borne in mind during operative obstetric procedures in pregnancy. No controlled clinical studies in pregnancy have been conducted. The use in pregnancy has not been established, and such use is not recommended, with the exception of administration during surgery for abdominal delivery or vaginal delivery.
5 mg/kg during delivery have experienced respiratory depression and low Apgar scores requiring newborn resuscitation. Marked increases in maternal blood pressure and uterine tone have been observed at intravenous doses greater than 2 mg/kg.
Data are lacking for intramuscular injection and maintenance infusion of ketamine in the parturient population, and recommendations cannot be made. 2. Lactation The safe use of ketamine during lactation has not been established, and such use is not recommended.
3). 7 Effects on ability to drive and use machines Patients should be cautioned that driving a car, operating hazardous machinery or engaging in hazardous activities should not be undertaken for 24 hours or more after anaesthesia. This medicine can impair cognitive function and can affect a patient’s ability to drive safely.
This class of medicine is in the list of drugs included in regulations under 5a of the Road Traffic Act 1988. When prescribing this medicine, patients should be told: • The medicine is likely to affect your ability to drive. • Do not drive until you know how the medicine affects you.
• It is an offence to drive while under the influence of this medicine. However, you would not be committing an offence (called ‘statutory defence’) if: o The medicine has been prescribed to treat a medical or dental problem and o You have taken it according to the instructions given by the prescriber and in the information provided with the medicine and It was not affecting your ability to drive safely.
8 Undesirable effects The following Adverse Events have been reported: MedDRA System Organ Class Frequency† Undesirable Effects Immune system disorders Rare Anaphylactic reaction* Metabolism and nutrition disorders Uncommon Anorexia Common Hallucination, Abnormal dreams, Nightmare, Confusion, Agitation, Abnormal behaviour Uncommon Anxiety Psychiatric disorders Rare Delirium*, Disorientation*, Flashback*, Dysphoria*, Insomnia Nervous system disorders Common Nystagmus, Hypertonia, Tonic clonic movements Common DiplopiaEye […]
g. glaucoma) because the pressure may increase significantly after a single dose of ketamine. g. schizophrenia and acute psychosis). Use in caution in patients with acute intermittent porphyria. Use in caution in patients with seizures.
Use in caution in patients with hyperthyroidism or patients receiving thyroid replacement (increased risk of hypertension and tachycardia). Use in caution in patients with pulmonary or upper respiratory infection (ketamine sensitises the gag reflex, potentially causing laryngospasm).
Use in caution in patients with intracranial mass lesions, a presence of head injury, or hydrocephalus. Emergence Reaction The psychological manifestations vary in severity between pleasant dream-like states, vivid imagery, hallucinations, nightmares and emergence delirium (often consisting of dissociative or floating sensations).
8). Emergence delirium phenomena may occur during the recovery period. The incidence of these reactions may be reduced if verbal and tactile stimulation of the patient is minimised during the recovery period. This does not preclude the monitoring of vital signs.
g. congestive heart failure, myocardial ischemia and myocardial infarction). In addition, ketamine should be used with caution in patients with mild-to-moderate hypertension and tachyarrhythmias. Cardiac function should be continually monitored during the procedure in patients found to have hypertension or cardiac decompensation.
Elevation of blood pressure begins shortly after the injection of ketamine, reaches a maximum within a few minutes and usually returns to preanaesthetic values within 15 minutes after injection. The median peak rise of blood pressure in clinical studies has ranged from 20 to 25 percent of preanaesthetic values.
Depending on the condition of the patient, this elevation of blood pressure may be considered a beneficial effect, or in others, an adverse reaction. 2). Cases of cystitis, including haemorrhagic cystitis, acute kidney injury, hydronephrosis, and ureteral disorders have been reported in patients being given ketamine on a long term basis, especially in the setting of ketamine abuse.
These adverse reactions develop in patients receiving long term ketamine treatment after a time ranging from 1 month to several years. Hepatotoxicity such as mixed liver injury, cholestatic liver injury and biliary dilation has also been reported in patients with extended use (> 3 days).
8. Drug Abuse and Dependence Ketamine has been reported as being a drug of abuse. 8). Other adverse effects have also been reported: see “Long Term Use”. If used on a daily basis for a few weeks, dependence and tolerance may develop, particularly in individuals with a history of drug abuse and dependence.
Therefore, the use of ketamine should be closely supervised and it should be prescribed and administered with caution.