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SEVOFLURANE is a brand name for Sevoflurane. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Sevoflurane is indicated for induction and maintenance of general anaesthesia in adult and paediatric patients for inpatient and outpatient surgery.
Verbatim from this product's MHRA label. Tap a section to expand.
Premedication should be selected according to the need of the individual patient, and at the discretion of the anaesthetist.
Surgical Anaesthesia:
Sevoflurane should be delivered via a vaporiser specifically calibrated for use with sevoflurane so that the concentration delivered can be accurately controlled. MAC (minimum alveolar concentration) values for sevoflurane decrease with age and with the addition of nitrous oxide.
The table below indicates average MAC values for different age groups. 7% * Neonates are full term gestational age. MAC in premature infants has not been determined. ** In 1 – <3 year old paediatric patients, 60% N2O/40% O2 was used.
Induction:
Dosage should be individualised and titrated to the desired effect according to the patient's age and clinical status. A short acting barbiturate or other intravenous induction agent may be administered followed by inhalation of sevoflurane.
Induction with sevoflurane may be achieved in oxygen or in combination with oxygen-nitrous oxide mixtures. In adults inspired concentrations of up to 5% sevoflurane usually produce surgical anaesthesia in less than 2 minutes. In children, inspired concentrations of up to 7% sevoflurane usually produce surgical anaesthesia in less than 2 minutes.
Alternatively, for induction of anaesthesia in unpremedicated patients, inspired concentrations of up to 8% sevoflurane may be used. 5 - 3% sevoflurane with or without the concomitant use of nitrous oxide.
Emergence:
Emergence times are generally short following sevoflurane anaesthesia. Therefore, patients may require early post-operative pain relief.
Older people:
MAC decreases with increasing age. The average concentration of sevoflurane to achieve MAC in an 80 year old is approximately 50% of that required in a 20 year old.
Paediatric population:
Refer to Table 1 for MAC values for paediatric patients according to age.
Summary of the safety profile As with all potent inhaled anaesthetics, sevoflurane may cause dose-dependent cardio-respiratory depression. Most adverse reactions are mild to moderate in severity and are transient in duration. Nausea, vomiting and delirium are commonly observed in the post-operative period, at a similar incidence to those found with other inhalation anaesthetics.
These effects are common sequelae of surgery and general anaesthesia which may be due to the inhalational anaesthetic, other agents administered intra-operatively or post-operatively and to the patient's response to the surgical procedure.
The most commonly reported adverse reactions were as follows:
In adult patients: hypotension, nausea and vomiting; In elderly patients: bradycardia, hypotension and nausea; and In paediatric patients: agitation, cough, vomiting and nausea. Tabulated summary of adverse reactions All adverse reactions at least possibly relating to sevoflurane from clinical trials and post-marketing experience are presented in the following table by MedDRA System Organ Class, Preferred Term and frequency.
The following frequency categories are used:
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), including isolated reports. Post-marketing adverse reactions are reported voluntarily from a population with an unknown rate of exposure.
Therefore it is not possible to estimate the true incidence of adverse events and the frequency is “unknown”. The type, severity and frequency of adverse reactions in sevoflurane patients in clinical trials were comparable to adverse reactions in reference-drug patients.
8 – Description of selected adverse reactions. 4. 8 – Paediatric population. 4 There have been very rare post-marketing reports of cardiac arrest in the setting of sevoflurane use. 5 Occasional cases of transient changes in hepatic function tests were reported with sevoflurane and reference agents.
Sevoflurane may cause respiratory depression, which may be augmented by narcotic premedication or other agents causing respiratory depression. Respiration should be supervised and if necessary, assisted. Sevoflurane should be administered only by persons trained in the administration of general anaesthesia.
Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment and circulatory resuscitation must be immediately available. The concentration of sevoflurane being delivered from a vaporiser must be known exactly.
As volatile anaesthetics differ in their physical properties, only vaporisers specifically calibrated for sevoflurane must be used. The administration of general anaesthesia must be individualised based on the patient’s response. Hypotension and respiratory depression increase as anaesthesia is deepened.
Malignant Hyperthermia In susceptible individuals, potent inhalation anaesthetic agents may trigger a skeletal muscle hypermetabolic state leading to high oxygen demand and the clinical syndrome known as malignant hyperthermia. The clinical syndrome is signalled by hypercapnia, and may include muscle rigidity, tachycardia, tachypnoea, cyanosis, arrhythmias, and/or unstable blood pressure.
Some of these nonspecific signs may also appear during light anaesthesia, acute hypoxia, hypercapnia and hypovolaemia. In clinical trials, one case of malignant hyperthermia was reported. In addition, there have been postmarketing reports of malignant hyperthermia.
Some of these reports have been fatal. g. sevoflurane), administration of intravenous dantrolene sodium (consult prescribing information for intravenous dantrolene sodium for additional information on patient management), and application of supportive therapy.
Such therapy includes vigorous efforts to restore body temperature to normal, respiratory and circulatory support as indicated, and management of electrolyte-fluid- acid-base abnormalities. Renal failure may appear later, and urine flow should be monitored and sustained if possible.
g. history of liver function disorder, fever or leucocytosis of unknown cause after anaesthesia with one of these agents). Sevoflurane is also contraindicated in patients with known or suspected genetic susceptibility to malignant hyperthermia.
Sevoflurane is contraindicated in patients in whom general anaesthesia is contraindicated.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
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6 Transient increases in serum inorganic fluoride levels may occur during and after sevoflurane anaesthesia. See Description of selected adverse reactions below. Description of selected adverse reactions Transient increases in serum inorganic fluoride levels may occur during and after sevoflurane anaesthesia.
Concentrations of inorganic fluoride generally peak within two hours of the end of sevoflurane anaesthesia and return within 48 hours to pre- operative levels. In clinical trials, elevated fluoride concentrations were not associated with impairment of renal function.
Rare reports of post-operative hepatitis exist. In addition, there have been rare post- marketing reports of hepatic failure and hepatic necrosis associated with the use of potent volatile anaesthetic agents, including sevoflurane. 4).
Rare reports of hypersensitivity (including contact dermatitis, rash, dyspnoea, wheezing, chest discomfort, swelling face, or anaphylactic reaction) have been received, particularly in association with long-term occupational exposure to inhaled anaesthetic agents, including sevoflurane.
4). Paediatric population The use of sevoflurane has been associated with seizures. Many of these have occurred in children and young adults starting from 2 months of age, most of whom had no predisposing risk factors. 4). Reporting of suspected adverse reactions Reporting suspected adverse reactions after authorisation of the medicinal […]
Perioperative Hyperkalemia Use of inhaled anaesthetic agents has been associated with rare increases in serum potassium levels that have resulted in cardiac arrhythmias and death in paediatric patients during the postoperative period.
Patients with latent as well as overt neuromuscular disease, particularly Duchenne muscular dystrophy, appear to be most vulnerable. Concomitant use of succinylcholine has been associated with most, but not all, of these cases. These patients also experienced significant elevations in serum creatine kinase levels and, in some cases, changes in urine consistent with myoglobinuria.
Despite the similarity in presentation to malignant hyperthermia, none of these patients exhibited signs or symptoms of muscle rigidity or hypermetabolic state. Early and aggressive intervention to treat the hyperkalaemia and resistant arrhythmias is recommended, as is subsequent evaluation for latent neuromuscular disease.
Isolated reports of QT prolongation, very rarely associated with torsade de pointes (in exceptional cases, fatal), have been received. Caution should be exercised when administering sevoflurane to susceptible patients. Isolated cases of ventricular arrhythmia were reported in paediatric patients with Pompe’s disease.
Caution should be exercised in administering general anaesthesia, including sevoflurane, to patients with mitochondrial disorders. Hepatic Very rare cases of mild, moderate and severe post-operative hepatic dysfunction or hepatitis with or without jaundice have been reported from postmarketing experiences.
8). Patients with repeated exposures to halogenated hydrocarbons, including sevoflurane, within a relatively short interval may have an increased risk of hepatic injury. General During the maintenance of anaesthesia, increasing the concentration of sevoflurane produces dose-dependent decreases in blood pressure.
Excessive decrease in blood pressure may be related to depth of anaesthesia and in such instances may be corrected by decreasing the inspired concentration of sevoflurane. , due to concomitant medications. As with all anaesthetics, maintenance of haemodynamic stability is important to avoid myocardial ischaemia in patients with coronary artery disease.
6). The recovery from general anaesthesia should be assessed carefully before patients are discharged from the recovery room. Rapid emergence from anaesthesia is generally seen with sevoflurane so early relief of postoperative pain may be required.
Although recovery of consciousness following sevoflurane administration generally occurs within minutes, the impact on intellectual function for two or three days following anaesthesia has not been studied. 7). Rapid emergence in children may be associated with agitation and lack of co-operation (in about 25% of cases).
g Baralyme). An unusually delayed rise or unexpected decline of inspired sevoflurane concentration compared to the vaporiser setting may be associated […]