{ "http://www4.wiwiss.fu-berlin.de/dailymed/resource/drugs/976" : { "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/indication" : [ { "value" : "SUPRANE\n(desflurane, USP) is indicated as an inhalation agent for induction\nand/or maintenance of anesthesia for inpatient and outpatient surgery in\nadults . SUPRANE\n(desflurane, USP) is not recommended for induction of anesthesia in\npediatric patients because of a high incidence of moderate to severe\nupper airway adverse events . After induction of anesthesia with agents other\nthan SUPRANE, and tracheal intubation, SUPRANE is indicated for\nmaintenance of anesthesia in infants and children.", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/genericMedicine" : [ { "value" : "desflurane", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/supply" : [ { "value" : "SUPRANE\n(desflurane, USP), NDC 10019-641-24, is packaged in amber-colored\nbottles containing 240 mL desflurane.
Safety and Handling:
Occupational Caution: There is no specific work exposure limit established\nfor SUPRANE (desflurane, USP). However, the National\nInstitute for Occupational Safety and Health\nAdministration (NIOSH) recommends that no worker should\nbe exposed at ceiling concentrations greater than 2 ppm of any halogenated anesthetic agent over a sampling\nperiod not to exceed one hour. The\npredicted effects of acute overexposure by inhalation of\nSUPRANE (desflurane, USP) include headache, dizziness or\n(in extreme cases) unconsciousness. There are no documented adverse effects of chronic\nexposure to halogenated anesthetic vapors (Waste Anesthetic Gases or WAGs) in\nthe workplace. Although results of some epidemiological\nstudies suggest a link between exposure to halogenated\nanesthetics and increased health problems (particularly\nspontaneous abortion), the relationship is not\nconclusive. Since exposure to WAGs is one possible\nfactor in the findings for these studies, operating room\npersonnel, and pregnant women in particular, should\nminimize exposure. Precautions include adequate general\nventilation in the operating room, the use of a\nwell-designed and well-maintained scavenging system,\nwork practices to minimize leaks and spills while the\nanesthetic agent is in use, and routine equipment\nmaintenance to minimize leaks.
Storage: Store at room\ntemperature, 15��-30��C\n(59��-86��F). SUPRANE\n(desflurane, USP) has been demonstrated to be stable for\nthe period defined by the expiration dating on the\nlabel. The bottle cap should be replaced after each use\nof SUPRANE. Baxter and SUPRANE are trademarks of Baxter\nInternational Inc. Manufactured for Baxter Healthcare\nCorporation Deerfield, IL 60015 USA For\nProduct Inquiry 1 800 ANA DRUG\n(1-800-262-3784) MLT-00070/8.0", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/possibleDiseaseTarget" : [ { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/372", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/2312", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/374", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/479", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/540", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/1090", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/2331", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/2531", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/2666", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/3974", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/diseasome/resource/diseases/3975", "type" : "uri" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/fullName" : [ { "value" : "SUPRANE (Liquid)", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/clinicalPharmacology" : [ { "value" : "SUPRANE\n(desflurane, USP) is a volatile liquid inhalation anesthetic minimally\nbiotransformed in the liver in humans. Less than 0.02% of the SUPRANE\nabsorbed can be recovered as urinary metabolites (compared to 0.2% for\nisoflurane). Minimum alveolar\nconcentration (MAC) of desflurane in oxygen for a 25 year-old adult is\n7.3%. The MAC of SUPRANE (desflurane, USP) decreases with increasing age\nand with addition of depressants such as opioids or benzodiazepines\n(seeDOSAGE AND\nADMINISTRATION for details).
Pharmacokinetics: Due to the\nvolatile nature of desflurane in plasma samples, the\nwashin-washout profile of desflurane was used as a surrogate of\nplasma pharmacokinetics. Eight healthy male volunteers first\nbreathed 70% NO/30% Ofor 30 minutes and\nthen a mixture of SUPRANE (desflurane, USP) 2.0%, isoflurane\n0.4%, and halothane 0.2% for another 30 minutes. During this\ntime, inspired and end-tidal concentrations (Fand\nF) were measured. The\nF/F(washin) value at 30 minutes for\ndesflurane was 0.91, compared to 1.00 for NO, 0.74\nfor isoflurane, and 0.58 for halothane (See Figure 1). The\nwashin rates for halothane and isoflurane were similar to\nliterature values. The washin was faster for desflurane than for\nisoflurane and halothane at all time points. The\nF/F(washout) value at 5 minutes was\n0.12 for desflurane, 0.22 for isoflurane, and 0.25 for halothane\n(See Figure 2). The washout for SUPRANE was more rapid than that\nfor isoflurane and halothane at all elimination time points. By\n5 days, the F/Ffor desflurane is 1/20th of that for halothane or isoflurane.
Pharmacodynamics: Changes in\nthe clinical effects of SUPRANE (desflurane, USP) rapidly follow\nchanges in the inspired concentration. The duration of\nanesthesia and selected recovery measures for SUPRANE are given\nin the following tables: In 178\nfemale outpatients undergoing laparoscopy, premedicated with\nfentanyl (1.5-2.0��g/kg), anesthesia was initiated with propofol\n2.5 mg/kg, desflurane/NO 60% in Oor\ndesflurane/Oalone. Anesthesia was maintained\nwith either propofol 1.5-9.0 mg/kg/hr, desflurane 2.6-8.4% in\nNO 60% in O, or desflurane 3.1-8.9%\nin O. In 88\nunpremedicated outpatients, anesthesia was initiated with\nthiopental 3-9 mg/kg or desflurane in O. Anesthesia\nwas maintained with isoflurane 0.7-1.4% in NO 60%,\ndesflurane 1.8-7.7% in NO 60%, or desflurane\n4.4-11.9% in O. Recovery\nfrom anesthesia was assessed at 30, 60, and 90 minutes following\n0.5 MAC desflurane (3%) or isoflurane (0.6%) in NO\n60% using subjective and objective tests. At 30 minutes after\nanesthesia, only 43% of the isoflurane group were able to\nperform the psychometric tests compared to 76% in the desflurane\ngroup (p<0.05). SUPRANE (desflurane, USP) was studied in twelve volunteers receiving no\nother drugs. Hemodynamic effects during controlled ventilation\n(PaCO38mm Hg) were: When the\nsame volunteers breathed spontaneously during desflurane\nanesthesia, systemic vascular resistance and mean arterial blood\npressure decreased; cardiac index, heart rate, stroke volume,\nand central venous pressure (CVP) increased compared to values\nwhen the volunteers were conscious. Cardiac index, stroke\nvolume, and CVP were greater during spontaneous ventilation than\nduring controlled ventilation. During\nspontaneous ventilation in the same volunteers, increasing the\nconcentration of SUPRANE (desflurane, USP) from 3% to 12%\ndecreased tidal volume and increased arterial carbon dioxide\ntension and respiratory rate. The combination of NO\n60% with a given concentration of desflurane gave results\nsimilar to those with desflurane alone. Respiratory depression\nproduced by desflurane is similar to that produced by other\npotent inhalation agents. The use of\ndesflurane concentrations higher than 1.5 MAC may produce apnea.
CLINICAL TRIALS: SUPRANE\n(desflurane, USP) was evaluated in 1,843 patients including\nambulatory (N=1,061), cardiovascular (N=277), geriatric (N=103),\nneurosurgical (N=40), and pediatric (N=235) patients. Clinical\nexperience with these patients and with 1,087 control patients\nin these studies not receiving desflurane are described below.\nAlthough desflurane can be used in adults for the inhalation\ninduction of anesthesia via mask, it produces a high incidence\nof respiratory irritation (coughing, breathholding, apnea,\nincreased secretions, laryngospasm). For incidence, seeADVERSE\nREACTIONS. Oxyhemoglobin saturation below 90% occurred in 6% of patients (from pooled data, N = 370\nadults).
Ambulatory\nSurgery: SUPRANE (desflurane, USP) plus NO was\ncompared to isoflurane plus NO in\nmulticenter studies (21 sites) of 792 ASA physical\nstatus I, II, or III patients aged 18-76 years (median\n32).
Cardiovascular Surgery: Desflurane was compared to isoflurane, sufentanil or\nfentanyl for the anesthetic management of coronary\nartery bypass graft (CABG), abdominal aortic aneurysm,\nperipheral vascular and carotid endarterectomy surgery in 7 studies at 15 centers involving a total of 558\npatients. In all patients except the desflurane vs\nsufentanil study, the volatile anesthetics were\nsupplemented with intravenous opioids, usually fentanyl.\nBlood pressure and heart rate were controlled by changes\nin concentration of the volatile anesthetics or opioids\nand cardiovascular drugs if necessary. Oxygen (100%) was\nthe carrier gas in 253 of 277 desflurane cases (24 of\n277 received NO/O). No\ndifferences were found in cardiovascular outcome (death,\nmyocardial infarction, ventricular tachycardia or\nfibrillation, heart failure) among desflurane and the\nother anesthetics.
Geriatric\nSurgery: SUPRANE (desflurane, USP) plus NO was\ncompared to isoflurane plus NO in a\nmulticenter study (6 sites) of 203 ASA physical status\nII or III elderly patients, aged 57-91 years (median\n71).
Neurosurgery: SUPRANE (desflurane, USP) was studied in 38 patients\naged 26-76 years (median 48 years), ASA physical status\nII or III undergoing neurosurgical procedures for\nintracranial lesions.
Pediatric\nSurgery: SUPRANE (desflurane, USP) is not recommended for\ninduction of anesthesia in pediatric patients because of\nthe high incidence of moderate to severe upper airway\nadverse reactions, including laryngospasm, coughing,\nbreathholding, and secretions, seen in studies of\ninduction of anesthesia in pediatric patients.\n. SUPRANE is not approved for maintenance of anesthesia\nin non-intubated pediatric patients due to an increased\nincidence of respiratory adverse reactions, including\ncoughing, laryngospasm and secretions, seen in one study of maintenance of anesthesia in non-intubated pediatric\npatients. (seeWARNINGS andPRECAUTIONS���Pediatric\nUse).
INDIVIDUALIZATION\nOF DOSE: (Also\nseeDOSAGE AND\nADMINISTRATION)
Preanesthetic Medication: Issues such as whether or not to premedicate and the\nchoice of premedicant(s) must be individualized. In\nclinical trials, patients scheduled to be anesthetized\nwith desflurane frequently received IV pre-anesthetic\nmedication, such as opioid and/or\nbenzodiazepine.", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/warning" : [ { "value" : "Perioperative\nHyperkalemia: Use of\ninhaled anesthetic agents has been associated with rare\nincreases in serum potassium levels that have resulted in\ncardiac arrhythmias and death in pediatric patients during the\npostoperative period. Patients with latent as well as overt\nneuromuscular disease, particularly Duchenne muscular dystrophy,\nappear to be most vulnerable. Concomitant use of succinylcholine\nhas been associated with most, but not all, of these cases.\nThese patients also experienced significant elevations in serum\ncreatinine kinase levels and, in some cases, changes in urine\nconsistent with myoglobinuria. Despite the similarity in\npresentation to malignant hyperthermia, none of these patients\nexhibited signs or symptoms of muscle rigidity or hypermetabolic\nstate. Early and aggressive intervention to treat the\nhyperkalemia and resistant arrhythmias is recommended, as is\nsubsequent evaluation for latent neuromuscular\ndisease.
Malignant\nHyperthermia: In\nsusceptible individuals, potent inhalation anesthetic agents may\ntrigger a skeletal muscle hypermetabolic state leading to high\noxygen demand and the clinical syndrome known as malignant\nhyperthermia. In genetically susceptible pigs, desflurane\ninduced malignant hyperthermia. The clinical syndrome is\nsignalled by hypercapnia, and may include muscle rigidity,\ntachycardia, tachypnea, cyanosis, arrhythmias, and/or unstable\nblood pressure. Some of these nonspecific signs may also appear\nduring light anesthesia: acute hypoxia, hypercapnia, and\nhypovolemia. Treatment\nof malignant hyperthermia includes discontinuation of triggering\nagents, administration of intravenous dantrolene sodium, and\napplication of supportive therapy. (Consult prescribing\ninformation for dantrolene sodium intravenous for additional\ninformation on patient management.) Renal failure may appear\nlater, and urine flow should be monitored and sustained if\npossible.
Respiratory Adverse\nReactions in Pediatric Patients: SUPRANE\n(desflurane, USP) is not recommended for induction of general\nanesthesia via mask in children due to a high incidence of\nmoderate to severe respiratory adverse reactions seen in\nclinical studies . SUPRANE is\nnot approved for maintenance of anesthesia in non-intubated\nchildren due to an increased incidence of respiratory adverse\nreactions, including coughing, laryngospasm and secretions .
Administration of\nSuprane: SUPRANE\n(desflurane, USP) should be administered only by persons trained\nin the administration of general anesthesia, using a vaporizer\nspecifically designed and designated for use with desflurane.\nFacilities for maintenance of a patent airway, artificial\nventilation, oxygen enrichment, and circulatory resuscitation\nmust be immediately available. Hypotension and respiratory\ndepression increase as anesthesia is deepened.", "type" : "literal" } ], "http://www.w3.org/2000/01/rdf-schema#label" : [ { "value" : "SUPRANE (Liquid)", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/activeIngredient" : [ { "value" : "http://www4.wiwiss.fu-berlin.de/dailymed/resource/ingredient/desflurane", "type" : "uri" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/dosage" : [ { "value" : "Deliver SUPRANE\n(desflurane, USP) from a vaporizer specifically designed and designated\nfor use with desflurane. The administration\nof general anesthesia must be individualized based on the patient's\nresponse (seeINDIVIDUALIZATION\nOF DOSE). The following two tables provide mean relative\npotency based upon age and drug interaction studies in predominately ASA\nphysical status I or II patients. N = number of\ncrossover pairs (using up-and-down method of quantal response) Opioids or\nbenzodiazepines decrease the amounts of SUPRANE (desflurane, USP)\nrequired to produce anesthesia. The following table is based on studies\nof drug interaction (MAC reduction). SUPRANE\n(desflurane, USP) decreases the doses of neuromuscular blocking agents\nrequired (seePRECAUTIONS, Drug\nInteractions). During the\nmaintenance of anesthesia with inflow rates of 2 L/min or more, the\nalveolar concentration of desflurane will usually be within 10% of the\ninspired concentration. (F/F, see Figure 1\ninPharmacokinetics section.)", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/genericDrug" : [ { "value" : "http://www4.wiwiss.fu-berlin.de/drugbank/resource/drugs/DB01189", "type" : "uri" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/name" : [ { "value" : "SUPRANE", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/routeOfAdministration" : [ { "value" : "http://www4.wiwiss.fu-berlin.de/dailymed/resource/routeOfAdministration/Respiratory_%28inhalation%29", "type" : "uri" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/activeMoiety" : [ { "value" : "http://www4.wiwiss.fu-berlin.de/dailymed/resource/ingredient/desflurane", "type" : "uri" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/representedOrganization" : [ { "value" : "http://www4.wiwiss.fu-berlin.de/dailymed/resource/organization/Baxter_Healthcare_Corporation", "type" : "uri" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/adverseReaction" : [ { "value" : "Adverse event\ninformation is derived from controlled clinical trials, the majority of\nwhich were conducted in the United States. The studies were conducted\nusing a variety of premedications, other anesthetics, and surgical procedures of varying length. Most adverse events reported were mild and\ntransient, and may reflect the surgical procedures, patient\ncharacteristics (including disease) and/or medications administered. Of the 2,143\npatients exposed to SUPRANE (desflurane, USP) in clinical trials, 370\nadults and 152 children were induced with desflurane alone and 987\npatients were maintained principally with desflurane. The frequencies\ngiven reflect the percent of patients with the event. Each patient was\ncounted once for each type of adverse event. They are presented in\nalphabetical order according to body system.
Frequency of Events\nOccurring in Greater Than 1% of Clinical Trial Patients (in Reports\nDeemed���Probably Causally Related���):
Induction (use as a\nmask inhalation agent):
Maintenance\nor Recovery:
Frequency of Events\nOccurring in Less Than 1% of Patients (in Reports Deemed���Probably\nCausally Related���):
Reported in 3 or\nmore patients, regardless of severity: Adverse\nreactions reported only from postmarketing experience or in the\nliterature, not seen in clinical trials, are considered rare and are italicized.
Frequency of Events\nOccurring in Less Than 1% of Clinical Trial Patients (in Reports\nDeemed���Causal Relationship Unknown���):
Reported in 3 or\nmore patients, regardless of severity: SeeWARNINGS for information regarding pediatric use and\nmalignant hyperthermia. SUPRANE\n(desflurane, USP) has been associated with perioperative\nhyperkalemia . There have\nbeen rare post-marketing reports of hepatic failure and hepatic\nnecrosis associated with the use of potent volatile anesthetic agents, including SUPRANE (desflurane USP). Due to the\nspontaneous nature of these reports, the actual incidence and\nrelationship of SUPRANE (desflurane USP) to these events cannot\nbe established withcertainty.
Laboratory Findings: Transient\nelevations in glucose and white blood cell count may occur as\nwith use of other anesthetic agents.", "type" : "literal" } ], "http://www.w3.org/1999/02/22-rdf-syntax-ns#type" : [ { "value" : "http://www4.wiwiss.fu-berlin.de/drugbank/vocab/resource/class/Offer", "type" : "uri" }, { "value" : "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/drugs", "type" : "uri" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/contraindication" : [ { "value" : "SUPRANE\n(desflurane, USP) should not be used in patients with a known or\nsuspected genetic susceptibility to malignant hyperthermia. Known sensitivity\nto SUPRANE (desflurane, USP) or to other halogenated agents.", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/precaution" : [ { "value" : "During the\nmaintenance of anesthesia, increasing concentrations of SUPRANE\n(desflurane, USP) produce dose-dependent decreases in blood pressure.\nExcessive decreases in blood pressure may be related to depth of\nanesthesia and in such instances may be corrected by decreasing the\ninspired concentration of SUPRANE. Concentrations of\ndesflurane exceeding 1 MAC may increase heart rate. Thus an increased\nheart rate may not be a sign of inadequate anesthesia. In patients with\nintracranial space occupying lesions, SUPRANE (desflurane, USP) should\nbe administered at 0.8 MAC or less, in conjunction with a barbiturate\ninduction and hyperventilation (hypocapnia). Appropriate measures should\nbe taken to maintain cerebral perfusion pressure (seeCLINICAL STUDIES,\nNeurosurgery). In patients with\ncoronary artery disease, maintenance of normal hemodynamics is important\nto the avoidance of myocardial ischemia. Desflurane should not be used\nas the sole agent for anesthetic induction in patients with coronary\nartery disease or patients where increases in heart rate or blood pressure are undesirable. It should be used with other medications,\npreferably intravenous opioids and hypnotics (seeCLINICAL STUDIES,\nCardiovascular Surgery). Inspired\nconcentrations of SUPRANE (desflurane, USP) greater than 12% have been\nsafely administered to patients, particularly during induction of\nanesthesia. Such concentrations will proportionately dilute the\nconcentration of oxygen; therefore, maintenance of an adequate\nconcentration of oxygen may require a reduction of nitrous oxide or air\nif these gases are used concurrently. The recovery from\ngeneral anesthesia should be assessed carefully before patients are\ndischarged from the post anesthesia care unit (PACU). SUPRANE\n(desflurane, USP), like some other inhalational anesthetics, can react\nwith desiccated carbon dioxide (CO) absorbents to produce\ncarbon monoxide which may result in elevated levels of carboxyhemoglobin\nin some patients. Case reports suggest that barium hydroxide lime and\nsoda lime become desiccated when fresh gases are passed through the\nCOabsorber cannister at high flow rates over many hours\nor days. When a clinician suspects that COabsorbent may be\ndesiccated, it should be replaced before the administration of SUPRANE\n(desflurane, USP). As with other\nhalogenated anesthetic agents, SUPRANE (desflurane, USP) may cause\nsensitivity hepatitis in patients who have been sensitized by previous\nexposure to halogenated anesthetics .
Drug Interactions: No\nclinically significant adverse interactions with commonly used\npreanesthetic drugs, or drugs used during anesthesia (muscle\nrelaxants, intravenous agents, and local anesthetic agents) were\nreported in clinical trials. The effect of desflurane on the\ndisposition of other drugs has not been determined. Like\nisoflurane, desflurane does not predispose to premature\nventricular arrhythmias in the presence of exogenously infused\nepinephrine in swine.
Benzodiazepines and Opioids (MAC Reduction): Benzodiazepines (midazolam 25-50��g/kg) decrease the\nMAC of desflurane by 16% as do the opioids (fentanyl 3-6��g/kg) by 50% .
Neuromuscular Blocking Agents: Anesthetic concentrations of desflurane at equilibrium\n(administered for 15 or more minutes before testing)\nreduced the EDof succinylcholine by\napproximately 30% and that of atracurium and pancuronium\nby approximately 50% compared to NO/opioid\nanesthesia. The effect of desflurane on duration of\nnondepolarizing neuromuscular blockade has not been\nstudied. Dosage reduction of neuromuscular blocking agents\nduring induction of anesthesia may result in delayed\nonset of conditions suitable for endotracheal intubation\nor inadequate muscle relaxation, because potentiation of\nneuromuscular blocking agents requires equilibration of\nmuscle with the delivered partial pressure of\ndesflurane. Among nondepolarizing drugs, only pancuronium and\natracurium interactions have been studied. In the\nabsence of specific guidelines: 1.\nFor endotracheal intubation, do not reduce the dose of\nnondepolarizing muscle relaxants or succinylcholine. 2.\nDuring maintenance of anesthesia, the dose of\nnondepolarizing muscle relaxants is likely to be reduced\ncompared to that during NO/opioid\nanesthesia. Administration of supplemental doses of\nmuscle relaxants should be guided by the response to\nnerve stimulation.
Renal or Hepatic Insufficiency: Nine\npatients receiving SUPRANE (desflurane, USP) (N=9) were compared\nto 9 patients receiving isoflurane, all with chronic renal\ninsufficiency (serum creatinine 1.5-6.9 mg/dL). No differences\nin hematological or biochemical tests, including renal function\nevaluation, were seen between the two groups. Similarly, no\ndifferences were found in a comparison of patients receiving\neither SUPRANE (desflurane, USP) (N=28) or isoflurane (N=30)\nundergoing renal transplant. Eight\npatients receiving SUPRANE (desflurane, USP) were compared to\nsix patients receiving isoflurane, all with chronic hepatic\ndisease (viral hepatitis, alcoholic hepatitis, or cirrhosis). No\ndifferences in hematological or biochemical tests, including\nhepatic enzymes and hepatic function evaluation, were\nseen.
Carcinogenesis,\nMutagenesis, Impairment of Fertility: Animal\ncarcinogenicity studies have not been performed with SUPRANE\n(desflurane, USP). In\nvitro and in vivo genotoxicity studies did not demonstrate\nmutagenicity or chromosomal damage by SUPRANE. Tests for\ngenotoxicity included the Ames mutation assay, the metaphase\nanalysis of human lymphocytes, and the mouse micronucleus assay. Fertility\nwas not affected after 1 MAC-Hour per day exposure (cumulative\n63 and 14 MAC-Hours for males and females, respectively). At\nhigher doses, parental toxicity (mortalities and reduced weight\ngain) was observed which could affect fertility.
Pregnancy:
Teratogenic\nEffects: No\nteratogenic effect was observed at approximately 10 and\n13 cumulative MAC-Hour exposures at 1 MAC-Hour per day\nduring organogenesis in rats or rabbits. At higher doses\nincreased incidences of post-implantation loss and\nmaternal toxicity were observed. However, at 10\nMAC-Hours cumulative exposure in rats, about 6% decrease\nin the weight of male pups was observed at preterm\ncaesarean delivery.
Labor and Delivery: The safety\nof desflurane during labor or delivery has not been\ndemonstrated.
Nursing Mothers: The\nconcentrations of desflurane in milk are probably of no clinical\nimportance 24 hours after anesthesia. Because of rapid washout,\ndesflurane concentrations in milk are predicted to be below\nthose found with other volatile potent anesthetics.
Pediatric Use: SUPRANE (desflurane, USP) is approved for maintenance of anesthesia in\ninfants and children after induction of anesthesia with agents\nother than SUPRANE, and tracheal intubation. SUPRANE is\nnot recommended for induction of general anesthesia via mask in\nchildren because of the high incidence of moderate to severe\nrespiratory adverse reactions, including laryngospasm (50%),\ncoughing (72%), breathholding (68%), increase in secretions\n(21%) and oxyhemoglobin desaturation\n(SpO<90%) (26%) seen in clinical studies. SUPRANE is\nnot approved for maintenance of anesthesia in non-intubated\nchildren due to an increased incidence of respiratory adverse\nreactions (see below). In a\nclinical safety trial conducted in children aged 2 to 16 years\n(mean 7.4 years), following induction with another agent,\nSUPRANE and isoflurane (in NO/O) were\ncompared when delivered via face mask or laryngeal mask airway\n(LMA) for maintenance of anesthesia, after induction with\nintravenous propofol or inhaled sevoflurane, in order to assess\nthe relative incidence of respiratory adverse events. SUPRANE was\nassociated with higher rates (compared with isoflurane) of\ncoughing, laryngospasm and secretions with an overall rate of\nrespiratory events of 39%. Of the pediatric patients exposed to\ndesflurane, 5% experienced severe laryngospasm (associated with\nsignificant desaturation; i.e. SpOof<90% for>15\nseconds, or requiring succinylcholine), across all ages, 2-16\nyears old. Individual age group incidences of severe\nlaryngospasm were 9% for 2-6 years old, 1% for 7-11 years old,\nand 1% for 12-16 years old. Removal of LMA under deep anesthesia\n(MAC range 0.6���2.3 with a mean of 1.12 MAC) was associated\nwith a further increase in frequency of respiratory adverse\nevents as compared to awake LMA removal or LMA removal under\ndeep anesthesia with the comparator. The frequency and severity\nof non-respiratory adverse events were comparable between the\ntwo groups. The\nincidence of respiratory events under these conditions was\nhighest in children aged 2-6 years. Therefore, similar studies\nin children under the age of 2 years were not\ninitiated.
Geriatric Use: The average\nMAC for SUPRANE (desflurane, USP) in a 70 year old patient is\ntwo-thirds the MAC for a 20 year old patient (seeDOSAGE AND\nADMINISTRATION).
Neurosurgical Use: SUPRANE\n(desflurane, USP) may produce a dose-dependent increase in\ncerebrospinal fluid pressure (CSFP) when administered to\npatients with intracranial space occupying lesions. Desflurane\nshould be administered at 0.8 MAC or less, and in conjunction\nwith a barbiturate induction and hyperventilation (hypocapnia)\nuntil cerebral decompression in patients with known or suspected\nincreases in CSFP. Appropriate attention must be paid to\nmaintain cerebral perfusion pressure (seeCLINICAL\nSTUDIES, Neurosurgery).", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/description" : [ { "value" : "SUPRANE\n(desflurane, USP), a nonflammable liquid administered via vaporizer, is\na general inhalation anesthetic. It is (��)1,2,2,2-tetrafluoroethyl\ndifluoromethyl ether:
Some physical\nconstants are::
Partition\ncoefficients at 37��C::
Mean Component/Gas\nPartition Coefficients:: Desflurane\nis nonflammable as defined by the requirements of International\nElectrotechnical Commission 601-2-13. Desflurane\nis a colorless, volatile liquid below 22.8��C. Data indicate that\ndesflurane is stable when stored under normal room lighting\nconditions according to instructions. Desflurane\nis chemically stable. The only known degradation reaction is\nthrough prolonged direct contact with soda lime producing low\nlevels of fluoroform (CHF). The amount of\nCHFobtained is similar to that produced with\nMAC-equivalent doses of isoflurane. No discernible degradation\noccurs in the presence of strong acids. Desflurane\ndoes not corrode stainless steel, brass, aluminum, anodized aluminum, nickel plated brass, copper, or beryllium.", "type" : "literal" } ], "http://www4.wiwiss.fu-berlin.de/dailymed/resource/dailymed/overdosage" : [ { "value" : "In the event of\noverdosage, or suspected overdosage, take the following actions:\ndiscontinue administration of SUPRANE (desflurane, USP), maintain a\npatent airway, initiate assisted or controlled ventilation with oxygen,\nand maintain adequate cardiovascular function.", "type" : "literal" } ] } }