Ketamine-Hameln 50 mg/ml Injection

/ Pharma Medis

As with other general anaesthetic 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.
General Anaesthesia Induction
Intravenous Route:
Adults: The initial dose of Ketamine administered intravenously may range from 1 mg/kg to 4.5 mg/kg. The average amount required to produce 5 to 10 minutes of surgical anaesthesia has been 2.0 mg/kg.
Alternatively, in adult patients an induction dose of 1.0 mg to 2.0 mg/kg intravenous ketamine at a rate of 0.5 mg/kg/min may be used for induction of anaesthesia. 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.
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:
Adults: The initial dose of ketamine administered intramuscularly may range from 6.5 mg/kg to 13 mg/kg. A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anaesthesia.
Dosage in Hepatic Insufficiency: Dose reductions should be considered in patients with cirrhosis or other types of liver impairment.
Maintenance of General Anaesthesia
The maintenance dose should be adjusted according to the patient’s anaesthetic needs and whether an additional anaesthetic agent is employed.
Increments of one-half to the full induction dose may be repeated as needed for
maintenance of anaesthesia. However, it should be noted that 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. 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 0.1 mg/minute 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.

As the sole anaesthetic agent for diagnostic and surgical procedures. When used by intravenous or intramuscular injection, Ketamine-hameln is best suited for short procedures.
With additional doses, or by intravenous infusion, Ketamine-hameln can be used for longer procedures. If skeletal muscle relaxation is desired, a muscle relaxant should be used and respiration should be supported.
For the induction of anaesthesia prior to the administration of other general anaesthetic agents.
To supplement other anaesthetic agents.
Specific areas of application or types of procedures: When the intramuscular route of administration is preferred.
Debridement, painful dressings, and skin grafting in burned patients, as well as other superficial surgical procedures.
Neurodiagnostic procedures such as pneumoencephalograms, ventriculograms,
myelograms, and lumbar punctures.
Diagnostic and operative procedures of the eye, ear, nose, and mouth, including dental extractions.
Note: Eye movements may persist during ophthalmological procedures.
Anaesthesia in poor-risk patients with depression of vital functions or where depression of vital functions must be avoided, if at all possible.
Orthopaedic procedures such as closed reductions, manipulations, femoral pinning, amputations, and biopsies.
Sigmoidoscopy and minor surgery of the anus and rectum, circumcision and pilonidal sinus.
Cardiac catheterization procedures.
Caesarian section; as an induction agent in the absence of elevated blood pressure.
Anaesthesia in the asthmatic patient, either to minimise the risks of an attack of
bronchospasm developing, or in the presence of bronchospasm where anaesthesia cannot be delayed.

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 or its components.

Ketamine should be used by or under the direction of physicians experienced in
administering general anaesthetics and in maintenance of an airway and in the control of respiration.
Resuscitative equipment should be ready for use.
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 are usually active, ketamine 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 ketamine is used alone. Muscle relaxants, with proper attention to respiration, may be required in both of these instances.
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.
Postoperative confusional states may occur during the recovery period.
See prescribing information for full details.

Common: Hallucination, Abnormal dreams, Nightmare, Confusion, Agitation, Abnormal behaviour, Nystagmus, Hypertonia, Tonic clonic movements, Diplopia, Blood pressure increased, Heart rate increased, Respiratory rate increased, Nausea, Vomiting, Erythema, Rash morbilliform.
See prescribing information for full details.

Prolonged recovery time may occur if barbiturates and/or opiate agonists are used concurrently with Ketamine.
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.
The use of ketamine with other central nervous system (CNS) depressants (e.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 antagonize the hypnotic effect of thiopental.
Patients taking thyroid hormones have an increased risk of developing hypertension and tachycardia when given ketamine.
Concomitant use of antihypertensive agents and ketamine increase the risk of developing hypotension.
When ketamine and theophylline are given concurrently, a clinically significant reduction in the seizures threshold observed. Unpredictable extensor-type seizures have been reported with concurrent administration of these agents.

Pregnancy: With the exception of administration during surgery for abdominal delivery or vaginal delivery, no controlled clinical studies in pregnancy have been conducted. Ketamine readily crosses the placenta. The safe use in pregnancy has not been established, and such use is not recommended.
Lactation: The safe use of ketamine during lactation has not been established, and such use is not recommended.

Respiratory depression may occur with overdosage or too rapid rate of administration of ketamine, in which case supportive ventilation should be employed. Mechanical support of respiration is preferred to administration of analeptics.