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ESKETAMINE is a brand name for Esketamine. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Induction and maintenance of general anaesthesia, as the only anaesthetic or possibly in combination with hypnotics. - Supplementation of regional or local anaesthesia. - Anaesthesia and pain relief (analgesia) in emergency medicine. - Pain control in artificial respiration (intubation)
Verbatim from this product's MHRA label. Tap a section to expand.
Esketamine should be administered only by specialist of anaesthesiology or emergency medicine. Esketamine is for hospital use only. As aspiration cannot be completely excluded and due to the possibility of respiratory depression, intubation and ventilation equipment must be available.
5 to 1 mg/kg of esketamine is given intravenously or 2 to 4 mg/kg intramuscularly, half the initial dose is re-injected as needed, generally every 10 to 15 minutes. 5 to 3 mg esketamine/kg/h. In case of multiple injuries (polytrauma) and in patients with poor general condition a dose reduction may be necessary.
25 mg esketamine/kg/h is administered as intravenous infusion. 5) mg esketamine/kg/h with simultaneous benzodiazepine administration. When used as a permanent infusion for analgesia in artificial respiration, the duration of the application should not exceed 4 to 6 weeks.
25 mg/kg as a slow intravenous injection. 4). 8). Where possible, the use of esketamine should follow the ordinary guidelines regarding fasting, 4 to 6 hours before anaesthesia. In case of hepatic impairment, a dose reduction may be required.
Paediatric population In paediatric surgery, as well as in emergency medicine, esketamine hydrochloride is generally used as monotherapy; in case of other indications, a combination with hypnotics is recommended. Dosage of esketamine across subgroups of paediatric patients of different ages has not been adequately studied.
Based on the information available, dosage in paediatric patients is not expected to differ substantially from that in adults. Method of administration Esketamine is for intravenous or intramuscular use. It can be injected slowly or administered as an infusion.
For infusion, either the undiluted injection solution can be used or it can be diluted beforehand. 6.
Adverse effects are usually dependent on the dose and speed of injection and are spontaneously reversible. Nervous system (CNS) and psychiatric adverse effects are more common if esketamine is administered as the only anaesthetic. The risk of psychic reaction occurring during recovery from anaesthesia can be greatly reduced by the co- administration of a benzodiazepine.
The adverse reaction terms were categorized utilising the incidence rate as follows: Very common (≥ 1/10) Common (≥ 1/100, < 1/10) Uncommon (≥ 1/1,000, < 1/100) Rare (≥ 1/10,000, < 1/1,000) Very rare (< 1/10,000) Not known (frequency cannot be estimated from the available data) Immune system disorder Rare Anaphylaxis Very rare Hypersensitivity reactions (anaphylactoid reactions).
In patients with shock, there may also be a further reduction in blood pressure. Psychiatric disorders Very common Recovery reactions1. These include vivid dreams, including nightmares, dizziness and motor restlessness2 Not known Hallucinations, dysphoria, anxiety and disorientation Nervous system disorders Uncommon Tonic and clonic movements, which can resemble convulsions (as a result of increased muscle tonus), and nystagmus Eye disorders Common Blurred vision Uncommon Diplopia, increased intraocular pressure Cardiac disorders Very common Increase in blood pressure and heart rate (an increase of about 20 % of the starting level is common) Common Temporary tachycardia Rare Arrhythmia, bradycardia Vascular disorders Rare Hypotension (especially in connection with circulatory shock) Respiratory, thoracic and mediastinal disorders Common Especially in patients with restricted coronary reserve, increase in vascular resistance in pulmonary circulation, and increase in mucus secretion.
Increased oxygen consumption, laryngospasm, and temporary respiratory depression. (The risk of respiratory depression usually depends on the dose and the speed of the injection) Gastrointestinal Disorders Common Nausea and vomiting, increased salivation Hepatobiliary Disorders Not Known Liver function test abnormal Drug-induced liver injury* Skin and subcutaneous tissue disorders Uncommon Morbilliform rash, and exanthema General disorders and administration site conditions Uncommon Pain and erythema at the injection site Injury, poisoning and procedural complications Common Diagnostic and therapeutic interventions in the area of the upper respiratory tract (especially in children) may lead to reflex (hyperreflexia) and laryngeal spasms (laryngospasm).
Esketamine should be used with caution in the following situations: - unstable angina pectoris or myocardial infarction in the last 6 months, - cardiac insufficiency - elevated intracranial pressure, except under appropriate ventilation, and in the case of central nervous system damages or diseases, since elevation of cerebrospinal pressure has been described in connection with ketamine anaesthesia, - in patients who have or have had severe psychiatric disturbances, - increased eye pressure (glaucoma) and perforating eye injuries as well as in connection with eye examinations or eye surgery in which intraocular pressure should not increase, - surgery in the upper respiratory tract, - in patients under chronic or acute influence of alcohol, - in patients who have liver disease, - in patients who have a history of drug abuse or addiction.
Esketamine is metabolized in the liver, and hepatic clearance is required for a termination of the clinical effects. Abnormal liver function tests associated with esketamine use have been reported, particularly with extended use (> 3 days) or drug abuse.
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. In case of high dose and rapid intravenous injection, respiratory depression may occur.
Increased salivation should be prophylactically treated with atropine. 8). In outpatient surgery, adequate patient monitoring must be ensured until discharge. The patient should be accompanied home and should not consume alcohol within the next 24 hours.
Continuous monitoring of cardiac function during surgery is required in patients with hypertension or cardiac decompensation. In surgical procedures that may involve visceral pain, muscle relaxation and supplemental analgesia (controlled ventilation and administration of nitrous oxide / oxygen) are indicated.
1, - in patients to whom elevation of blood pressure or intracranial pressure forms a serious risk, - if hypertension is poorly adjusted or not treated (arterial hypertension - systolic / diastolic blood pressure above 180/100 mmHg at rest), - in eclampsia and preeclampsia, - in patients with hyperthyroidism (or insufficiently treated hyperthyroidism), - in situations which require relaxed uterus myometrium (eg threatening uterus rupture, prolapsed umbilical cord), - as sole anaesthetic agent in patients with manifest ischemic cardiac disorders.
g. aminophylline or theophylline) (the convulsion threshold may become lower). - in combination with ergometrine.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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In the case of interventions on the pharynx, larynx and bronchial tree, a muscle relaxation with adequate ventilation may therefore be necessary. Under inadequate ventilation, there is often an increase in brain pressure, an increase in intraocular pressure, and an increase in muscle tone.
1 When esketamine is administered as the only anaesthetic, up to 30% of patients may experience dose-dependent reactions during the recovery phase. 2 The incidence of these events can be greatly reduced by the co-administration of a benzodiazepine.
* 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.
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In patients with alcohol intoxication, care should be taken when using esketamine. In patients with known history of severe angina pectoris, caution should be taken when using esketamine. When using esketamine in patients in shock, the basic principles of shock therapy (volume replenishment, O2 intake) must be observed.
In the most severe patients in shock, with hardly or not measurable blood pressure, caution should be taken when using esketamine. In diagnostic and therapeutic procedures of the upper respiratory tract, hyperreflexia and laryngospasm are possible, especially in children.
In the case of interventions on the pharynx, larynx and bronchial tree, a muscle relaxation with adequate ventilation may therefore be necessary. Long-Term Use In patients who received racemic ketamine as long-term therapy (1 month to several years), cases of cystitis, including haemorrhagic cystitis, have been reported.
Similar effects may also occur following esketamine abuse. Furthermore, hepatotoxicity has been reported in patients after extended use (> 3 days). Drug Abuse and Dependence Racemic ketamine has been reported being used as a drug abuse.
Reports suggest that abuse of ketamine produces a variety of symptoms including, among others, flashbacks, hallucinations, dysphoria, anxiety, insomnia or disorientation. Cases of cystitis, including haemorrhagic cystitis, and cases of hepatotoxicity have also been reported after use of ketamine racemic.
Similar effects therefore cannot be ruled out following esketamine use. Esketamine dependence may be developed by individuals with history of drug abuse. Therefore, esketamine should be prescribed and administered with caution only under the supervision of a doctor.
This medicinal product contains less than 1 mmol sodium (23 mg) per ml, that is to say essentially ‘sodium-free’.