KETAMINE G.L. PHARMA

Posology Note All doses are given in terms of ketamine base. 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 glycopyrrolate) 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. v. injection, the patient should be in a supported position during administration. v. dose of 2 mg/kg of bodyweight usually produces surgical anaesthesia within 30 seconds after injection and the anaesthetic effect usually lasts 5-10 minutes.

m. dose of 10 mg/kg of bodyweight usually produces surgical anaesthesia within 3-4 minutes following injection and the anaesthetic effect usually lasts 12-25 minutes. Return to consciousness is gradual. A. L. L. Pharma 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. A solution containing 1 mg/mL of ketamine 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).

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. v. 5 mg/kg body weight (in terms of ketamine base). 0 mg/kg.

v. administration be accomplished slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response. v. 6). L. 5- 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.

The following adverse events have been reported. The frequencies are defined as follows: very common (≥ 1/10), common (≥ 1/100 to < 1/10), uncommon (≥ 1/1,000 to < 1/100), rare (≥ 1/10,000 to < 1/1,000), very rare (< 1/10,000) and not known (cannot be estimated from available data).

System organ class Frequency Adverse event Immune system disorders Rare Anaphylactic reactions1 Metabolism and nutrition disorders Uncommon Anorexia Common Hallucinations Abnormal dreams, nightmare Confusion Agitation Abnormal behaviour Uncommon Anxiety Psychiatric disorders Rare Delirium1 Flashback1 Dysphoria1 System organ class Frequency Adverse event Insomnia Disorientation1 Nervous system disorders Common Nystagmus Hypertonia Tonic clonic movements Common DiplopiaEye disorders Not known Intraocular pressure increased Common Blood pressure increased Heart rate increased Cardiac disorders Uncommon Arrhythmia Bradycardia Vascular disorders Uncommon Hypotension Common Respiratory rate increased Uncommon Laryngospasm Respiratory depression Respiratory, thoracic and mediastinal disorders Rare Obstructive airway disorder1 Apnoea1 Common Nausea Vomiting Gastrointestinal disorders Rare Salivary hypersecretion1 Hepatobiliary disorders Not known Liver function test abnormal Drug induced liver injury2 Skin and subcutaneous tissue disorders Common Rash morbilliform Erythema Renal and urinary disorders Rare Cystitis1 Haemorrhagic cystitis1 General disorders and administration site conditions Uncommon Injection site pain Injection site rash 1 AE frequency estimated from post-marketing safety database 2 Extended period use (> 3 days) or drug abuse Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal product is important.

It allows continued monitoring of the benefit/risk balance of the medicinal product. uk/yellowcard

Ketamine should be used only in hospitals or under the supervision of an experienced medically qualified anaesthetist 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. As the pharyngeal and laryngeal reflexes generally 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, 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, ketamine should be used with special caution in patients with preanaesthetic elevated CSF pressure.

3. 6. 1. L. Pharma in vials must not be used (because of the content of the excipient benzethonium chloride): o in the paediatric population o in larger volumes than 15 ml in single doses (in all patient populations)