Ketamine

Preoperative Preparations 1. Ketamine hydrochloride injection has been safely used alone when the stomach was not empty. However, since the need to use supplementary anesthetic or muscle relaxant agents cannot always be predicted, it is preferable not to give anything by mouth for at least six hours before elective surgery.

Ketamine Hydrochloride Injection, USP is recommended for use in patients whose stomach is not empty when in the judgment of the physician the benefits of the drug outweigh the possible hazards. 2. Atropine, scopolamine, or other drying agents should be given at an appropriate interval prior to induction.

3. Certain drugs such as droperidol or diazepam intramuscularly have been used in an attempt to reduce the incidence of emergence reactions: sufficient data have not yet been accumulated to constitute thorough documentation. The incidence of emergence reactions is reduced as experience with the drug is gained.

Dosage As with other general anesthetic agents, the individual response to ketamine hydrochloride injection 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 to the patient’s requirements. As with all parenteral drug products, intravenous admixtures should be inspected visually for clarity, particulate matter, precipitation, and leakage prior to administration whenever solution and container permit.

Solutions showing haziness, particulate matter, precipitate, or leakage should not be used. Discard unused portion. Do not use if precipitate appears. 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 ketamine hydrochloride injection is rapid; an intravenous dose of 2 mg/kg 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, from experience primarily in children, in a range of 9 to 13 mg/kg usually produce surgical anesthesia within three to four minutes following injection, with the anesthetic effect usually lasting 12 to 25 minutes.

5 mg/kg. The average amount required to produce five to ten minutes of surgical anesthesia has been 2 mg/kg.

Rate of Administration:

It is recommended that Ketamine Hydrochloride Injection, USP be administered slowly (over a period of 60 seconds). More rapid administration may result in respiratory depression and enhanced pressor response. 5 - 13 mg/kg. A dose of 10 mg/kg will usually produce 12 to 25 minutes of surgical anesthesia.

Maintenance of Anesthesia:

Increments of 1/2 to the full induction dose, either intravenous or intramuscular may be repeated as needed for maintenance of anesthesia. Nystagmus, movements in response to stimulation, and vocalization may indicate lightening of anesthesia.

Use of Ketamine Hydrochloride Injection, USP Prior to the Administration of Other General Anesthetic Agents Ketamine Hydrochloride Injection, USP is clinically compatible with the commonly used general and local anesthetic agents when an adequate respiratory exchange is maintained.

When Ketamine Hydrochloride Injection, USP is used as an induction agent, prior to the administration of other general anesthetic agents: 1. The full induction dose of Ketamine Hydrochloride Injection, USP should be given intravenous over 60 seconds.

2. At the completion of the induction dose of Ketamine Hydrochloride Injection, USP, the anesthetist should proceed immediately with the chosen general anesthetic procedure. A second dose of Ketamine Hydrochloride Injection, USP (half the original induction dose) may be required at five to eight minutes following the initial induction dose when using an agent such as methoxyflurane where some considerable time is required for full surgical anesthesia to be established with the gaseous anesthetic.

Otherwise, lightening in the depth of anesthesia may occur and the patient may enter the stage of excitement, associated with vocalization and purposeful movements. Recovery Following the procedure, the patient should be observed but left undisturbed.

This does not preclude the monitoring of vital signs. 2 g/mol Structural Formula: Physicochemical properties: White or almost white crystalline powder, odorless or slight characteristic odor. 1 (1 g in 10 mL water). 7% of the salt. Ketamine hydrochloride injection, dl 2-(o-chlorophenyl)-2-(methylamino) cyclohexanone hydrochloride, is a white crystalline compound, soluble in water to 20% clear and colorless solution.

5. 7% of the salt. 5) solution for intravenous or intramuscular injection in concentrations containing the equivalent of either 10 to 50 […]

Ketamine is indicated in children, adolescents and adults. Ketamine is recommended - as an anaesthetic agent in diagnostic and surgical procedures. ) injection, ketamine is best suited for short procedures. With additional doses, or by intravenous infusion, ketamine 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 catheterisation procedures - Caesarean 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

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.

A dose of 10 mg/kg will usually produce 12-25 minutes of surgical anaesthesia. 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. L. Pharma 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. L. Pharma 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. L. L. Pharma may be required 5-8 minutes following the initial dose.

L. L. Pharma. C. L. L. Pharma is clinically compatible with the commonly used general and local anaesthetic agents when an adequate respiratory exchange is maintained. L. Pharma 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 ketamine.

D. 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 […]

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 Insomnia Disorientation1 System organ class Frequency Adverse event 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

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)