Source:http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/3267
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Sevoflurane (Liquid)
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The concentration of sevoflurane being delivered from a vaporizer during anesthesia should be known. This may be accomplished by using a vaporizer calibrated specifically for sevoflurane. The administration of general anesthesia must be individualized based on the patient's response.<br/>Replacement of Desiccated COAbsorbents: When a clinician suspects that the COabsorbent may be desiccated, it should be replaced. The exothermic reaction that occurs with sevoflurane and COabsorbents is increased when the COabsorbent becomes desiccated, such as after an extended period of dry gas flow through the COabsorbent canisters .<br/>Pre-anesthetic Medication: No specific premedication is either indicated or contraindicated with sevoflurane. The decision as to whether or not to premedicate and the choice of premedication is left to the discretion of the anesthesiologist.<br/>Induction: Sevoflurane has a nonpungent odor and does not cause respiratory irritability; it is suitable for mask induction in pediatrics and adults.<br/>Maintenance: Surgical levels of anesthesia can usually be achieved with concentrations of 0.5 to 3% sevoflurane with or without the concomitant use of nitrous oxide. Sevoflurane can be administered with any type of anesthesia circuit.
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Sevoflurane is an inhalational anesthetic agent for use in induction and maintenance of general anesthesia. Minimum alveolar concentration (MAC) of sevoflurane in oxygen for a 40 year old adult is 2.1%. The MAC of sevoflurane decreases with age .<br/>PHARMACOKINETICS:<br/>Uptake and Distribution:<br/>Pharmacokinetics of Fluoride Ion: Fluoride ion concentrations are influenced by the duration of anesthesia, the concentration of sevoflurane administered, and the composition of the anesthetic gas mixture. In studies where anesthesia was maintained purely with sevoflurane for periods ranging from 1 to 6 hours, peak fluoride concentrations ranged between 12��M and 90��M. As shown in Figure 6, peak concentrations occur within 2 hours of the end of anesthesia and are less than 25��M (475 ng/mL) for the majority of the population after 10 hours. The half-life is in the range of 15 to 23 hours. It has been reported that following administration of methoxyflurane, serum inorganic fluoride concentration>50��M were correlated with the development of vasopressin-resistant, polyuric, renal failure. In clinical trials with sevoflurane, there were no reports of toxicity associated with elevated fluoride ion levels.<br/>PHARMACODYNAMICS: Changes in the depth of sevoflurane anesthesia rapidly follow changes in inspired concentration. In the sevoflurane clinical program, the following recovery variables were evaluated: 1. Time to events measured from the end of the study drug: 2. Recovery of cognitive function and motor coordination was evaluated based on: 3. Other recovery times were: Some of these variables are summarized as follows:<br/>Cardiovascular Effects: Sevoflurane was studied in 14 healthy volunteers (18 to 35 years old) comparing sevoflurane-O(Sevo/O) to sevoflurane-NO/O(Sevo/NO/O) during 7 hours of anesthesia. During controlled ventilation, hemodynamic parameters measured are shown in Figures 7-10: Sevoflurane is a dose-related cardiac depressant. Sevoflurane does not produce increases in heart rate at doses less than 2 MAC. A study investigating the epinephrine induced arrhythmogenic effect of sevoflurane versus isoflurane in adult patients undergoing transsphenoidal hypophysectomy demonstrated that the threshold dose of epinephrine (i.e., the dose at which the first sign of arrhythmia was observed) producing multiple ventricular arrhythmias was 5 mcg/kg with both sevoflurane and isoflurane. Consequently, the interaction of sevoflurane with epinephrine appears to be equal to that seen with isoflurane.<br/>Adult Anesthesia: The efficacy of sevoflurane in comparison to isoflurane, enflurane, and Propofol was investigated in 3 outpatient and 25 inpatient studies involving 3591 adult patients. Sevoflurane was found to be comparable to isoflurane, enflurane, and propofol for the maintenance of anesthesia in adult patients. Patients administered sevoflurane showed shorter times (statistically significant) to some recovery events (Extubation, response to command, and orientation) than patients who received isoflurane or propofol.<br/>Pediatric Anesthesia: The concentration of sevoflurane required for maintenance of general anesthesia is age-dependent . Sevoflurane or halothane was used to anesthetize 1620 pediatric patients aged 1 day to 18 years, and ASA physical status I or II (948 sevoflurane, 672 halothane). In one study involving 90 infants and children, there were no clinically significant decreases in heart rate compared to awake values at 1 MAC. Systolic blood pressure decreased 15 to 20% in comparison to awake values following administration of 1 MAC sevoflurane; however, clinically significant hypotension requiring immediate intervention did not occur. Overall incidences of bradycardia [more than 20 beats/min lower than normal (80 beats/min)] in comparative studies were 3% for sevoflurane and7% for halothane. Patients who received sevoflurane had slightly faster emergence times (12 vs. 19 minutes), and a higher incidence of post-anesthesia agitation (14% vs. 10%). Sevoflurane (n=91) was compared to halothane (n=89) in a single-center study for elective repair or palliation of congenital heart disease. The patients ranged in age from 9 days to 11.8 years with an ASA physical status of II, III, and IV (18%, 68%, and 13% respectively). No significant differences were demonstrated between treatment groups with respect to the primary outcome measures: cardiovascular decompensation and severe arterial desaturation. Adverse event data was limited to the study outcome variables collected during surgery and before institution of cardiopulmonary bypass.<br/>Cardiovascular Surgery:<br/>Cesarean Section: Sevoflurane (n=29) was compared to isoflurane (n=27) in ASA Class I or II patients for the maintenance of anesthesia during cesarean section. Newborn evaluations and recovery events were recorded. With both anesthetics, Apgar scores averaged 8 and 9 at 1 and 5 minutes, respectively. Use of sevoflurane as part of general anesthesia for elective cesarean section produced no untoward effects in mother or neonate. Sevoflurane and isoflurane demonstrated equivalent recovery characteristics. There was no difference between sevoflurane and isoflurane with regard to the effect on the newborn, as assessed by Apgar score and Neurological and Adaptive Capacity Score (average=29.5). The safety of sevoflurane in labor and vaginal delivery has not been evaluated.<br/>Neurosurgery: Three studies compared sevoflurane to isoflurane for maintenance of anesthesia during neurosurgical procedures. In a study of 20 patients, there was no difference between sevoflurane and isoflurane with regard to recovery from anesthesia In 2 studies, a total of 22 patients with intracranial pressure (ICP) monitors received either sevoflurane or isoflurane. There was no difference between sevoflurane and isoflurane with regard to ICP response to inhalation of 0.5, 1.0, and 1.5 MAC inspired concentrations of volatile agent during NO-O-fentanyl anesthesia. During progressive hyperventilation from PaCO= 40 to PaCO= 30, ICP response to hypocarbia was preserved with sevoflurane at both 0.5 and 1.0 MAC concentrations. In patients at risk for elevations of ICP, sevoflurane should be administered cautiously in conjunction with ICP-reducing maneuvers such as hyperventilation.<br/>Hepatic Impairment: A multicenter study (2 sites) compared the safety of sevoflurane and isoflurane in 16 patients with mild-to-moderate hepatic impairment utilizing the lidocaine MEGX assay for assessment of hepatocellular function. All patients received intravenous propofol (1 to 3 mg/kg) or thiopental (2 to 7 mg/kg) for induction and succinylcholine, vecuronium, or atracurium for intubation. Sevoflurane or isoflurane was administered in either 100% Oor up to 70% NO/O. Neither drug adversely affected hepatic function. No serum inorganic fluoride level exceeded 45��M/L, but sevoflurane patients had prolonged terminal disposition of fluoride, as evidenced by longer inorganic fluoride half-life than patients with normal hepatic function (23 hours vs. 10 to 48 hours).<br/>Renal Impairment: Sevoflurane was evaluated in renally impaired patients with baseline serum creatinine>1.5 mg/dL. Fourteen patients who received sevoflurane were compared with 12 patients who received isoflurane. In another study, 21 patients who received sevoflurane were compared with 20 patients who received enflurane. Creatinine levels increased in 7% of patients who received sevoflurane, 8% of patients who received isoflurane, and 10% of patients who received enflurane. Because of the small number of patients with renal insufficiency (baseline serum creatinine greater than 1.5 mg/dL) studied, the safety of sevoflurane administration in this group has not yet been fully established. Therefore, sevoflurane should be used with caution in patients with renal insufficiency .
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Sevoflurane, Volatile Liquid for Inhalation, is packaged in amber colored bottles containing 250mL sevoflurane, NDC # 12164-005-25.<br/>SAFETY AND HANDLING:<br/>Occupational Caution: There is no specific work exposure limit established for sevoflurane. However, the National Institute for Occupational Safety and Health has recommended an 8 hour time-weighted average limit of 2 ppm for halogenated anesthetic agents in general (0.5 ppm when coupled with exposure to NO).<br/>STORAGE: Store at 20��to 25��C (68��to 77��F). Excursions permitted to 15��to 30��C (59��to 86��F). See USP controlled room temperature.
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In the event of overdosage, or what may appear to be overdosage, the following action should be taken: discontinue administration of sevoflurane, maintain a patent airway, initiate assisted or controlled ventilation with oxygen, and maintain adequate cardiovascular function.
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Sevoflurane
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Sevoflurane (Liquid)
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Adverse events are derived from controlled clinical trials conducted in the United States, Canada, and Europe. The reference drugs were isoflurane, enflurane, and propofol in adults and halothane in pediatric patients. The studies were conducted using a variety of premedications, other anesthetics, and surgical procedures of varying length. Most adverse events reported were mild and transient, and may reflect the surgical procedures, patient characteristics (including disease) and/or medications administered. Of the 5182 patients enrolled in the clinical trials, 2906 were exposed to sevoflurane, including 118 adults and 507 pediatric patients who underwent mask induction. Each patient was counted once for each type of adverse event. Adverse events reported in patients in clinical trials and considered to be possibly or probably related to sevoflurane are presented within each body system in order of decreasing frequency in the following listings. One case of malignant hyperthermia was reported in pre-registration clinical trials.<br/>Adverse Events During the Induction Period (from Onset of Anesthesia by Mask Induction to Surgical Incision) Incidence>1%: Adult Patients (N=118) Pediatric Patients (N=507)<br/>Adverse Events During Maintenance and Emergence Periods, Incidence>1% (N=2906):<br/>Adverse Events, All Patients in Clinical Trials (N=2906), All Anesthetic Periods, Incidence<1% (Reported in 3 or More Patients): See WARNINGS for information regarding malignant hyperthermia.<br/>Adverse Events During Post-Marketing Experience: Post-marketing reports indicate that sevoflurane use has been associated with seizures. The majority of cases were in children and young adults, most of whom had no medical history of seizures. Several cases reported no concomitant medications, and at least one case was confirmed by EEG. Although many cases were single seizures that resolved spontaneously or after treatment, cases of multiple seizures have also been reported. Seizures have occurred during, or soon after sevoflurane induction, during emergence, and during post-operative recovery up to a day following anesthesia. Rare cases of malignant hyperthermia and allergic reactions, such as rash, urticaria, pruritis, bronchospasm, anaphylactic or anaphylactoid reactions have been reported. Very rare cases of mild, moderate and severe post-operative hepatic dysfunction or hepatitis with or without jaundice have been reported. Histological evidence was not provided for any of the reported hepatitis cases. In most of these cases, patients had underlying hepatic conditions or were under treatment with drugs known to cause hepatic dysfunction. Most of the reported events were transient and resolved spontaneously . In addition, there have been rare post-marketing reports of hepatic failure and hepatic necrosis associated with the use of potent volatile anesthetic agents, including sevoflurane. However, the actual incidence and relationship of sevoflurane to these events cannot be established with certainty.<br/>Laboratory Findings: Transient elevations in glucose, liver function tests, and white blood cell count may occur as with use of other anesthetic agents.
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Sevoflurane is indicated for induction and maintenance of general anesthesia in adult and pediatric patients for inpatient and outpatient surgery. Sevoflurane should be administered only persons trained in the administration of general anesthesia. Facilities for maintenance of a patent airway, artificial ventilation, oxygen enrichment, and circulatory resuscitation must be immediately available. Since level of anesthesia may be altered rapidly, only vaporizers producing concentrations of sevoflurane should be used.
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Sevoflurane
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