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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->麻醉药
处方药:保健药品
包装规格: 240ml/bottle 6bottles/box
计价单位:
  点击放大  
生产厂家中文参考译名:
Baxter (US).
生产厂家英文名:
Baxter (US).
该药品相关信息网址1:
http://www.baxter.com/healthcare_professionals/products/suprane.html
该药品相关信息网址2:
http://www.rxlist.com/suprane-drug.htm
原产地英文商品名:
SUPRANE
原产地英文药品名:
desflurane
中文参考商品译名:
地氟烷溶液
中文参考药品译名:
地氟烷
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
inhalation agent for induction and/or maintenance of general anesthesia for inpatient and outpatient surgery in adults.
临床试验期:
完成
中文适应病症参考翻译1:
成年人作住院或门诊手术时的诱导和维持麻醉
药品信息:
药品名称】 药品名:地氟烷溶液 汉语拼音:Difuwan Rongye 英文名:Desflurane,Suprane,I-653 剂型:溶液剂 【主要成份】地氟烷 【性 状】 【药理毒性】 【药代动力学】 【适 应 症】本品适用于成年人作住院或门诊手术时的诱导和维持麻醉;对婴儿和儿童只可作维持麻醉,不可作为诱导麻醉。 【用法用量】诱导常用起始浓度为3%,每隔2-3次呼吸增加0.5-1%的浓度,吸进4-11%的优宁,2-4分钟可以产生外科麻醉。维持同氧化亚氮混合,吸进2-6%的浓度可维持在外科麻醉期水平,而同氧气或空气氧气混合吸进,则需2.8-8.5%的浓度,在小儿用或不用氧化亚氮,浓度需达5.2-10%,才能维持外科麻醉期水平。慢性肝肾功能损害或肾移植病人用氧化亚氮/氧混合吸进,优宁的浓度为1-4%。 【不良反应】可以引起剂量依靠性血压下降和呼吸抑制,麻醉诱导时可出现咳嗽、屏气、分泌物增多、呼吸暂停和喉痉挛。术后可有恶心和呕吐。本药麻醉可以触发骨骼肌代谢亢进,导致氧耗增加,引起恶性高热。 【禁 忌】已知对氟类吸进敏感者,已知或者怀疑恶性高热的遗传易感者,以前用过氟类后发生肝功能不良、不明原因的发热和白细胞增多者。 【留意事项】本药不被推荐用于12岁以下小儿麻醉的吸进诱导。对存在冠心病或不希看有心率加快和血压增高危险者,本药不应作为唯一的麻醉诱导药。不推荐使用于神经外科和产科手术。本药可以升高脑脊液压力和颅内占位性病变病人的颅内压。衰弱的病人应使用较低浓度。假如忽然发生恶性高热,应立即停用,并给予坦曲洛林治疗。短期内重复麻醉应谨慎。麻醉后24hr内应避免驾驶和机械操纵。 【孕妇和哺乳期妇女用药】妊娠及哺乳妇女慎用。 【儿童用药】 【老年患者用药】 【药物相互作用】本药可增强常用肌肉松驰剂的作用。接受阿片类、苯丙二氮卓类和其它镇静药物的病人,应减量使用本药。氧化亚氮可降低本药的MAC。 【规 格】每瓶含本品240ml 【包 装】240 mL x 1 瓶 【贮躲】置干燥处,防蛀。 SUPRANE - desflurane liquid Baxter Healthcare Corporation ---------- SUPRANE (desflurane, USP) Rx only Volatile Liquid for Inhalation DESCRIPTION SUPRANE (desflurane, USP), a nonflammable liquid administered via vaporizer, is a general inhalation anesthetic. It is (±)1,2,2,2-tetrafluoroethyl difluoromethyl ether: Some physical constants are: Molecular weight 168.04 Specific gravity (at 20°C/4°C) 1.465 Vapor pressure in mm Hg 669 mm Hg @ 20°C 731 mm Hg @ 22°C 757 mm Hg @ 22.8°C (boiling point;1atm) 764 mm Hg @ 23°C 798 mm Hg @ 24°C 869 mm Hg @ 26°C Partition coefficients at 37°C: Blood/Gas 0.424 Olive Oil/Gas 18.7 Brain/Gas 0.54 Mean Component/Gas Partition Coefficients: Polypropylene (Y piece) 6.7 Polyethylene (circuit tube) 16.2 Latex rubber (bag) 19.3 Latex rubber (bellows) 10.4 Polyvinylchloride (endotracheal tube) 34.7 Desflurane is nonflammable as defined by the requirements of International Electrotechnical Commission 601-2-13. Desflurane is a colorless, volatile liquid below 22.8°C. Data indicate that desflurane is stable when stored under normal room lighting conditions according to instructions. Desflurane is chemically stable. The only known degradation reaction is through prolonged direct contact with soda lime producing low levels of fluoroform (CHF3). The amount of CHF3 obtained is similar to that produced with MAC-equivalent doses of isoflurane. No discernible degradation occurs in the presence of strong acids. Desflurane does not corrode stainless steel, brass, aluminum, anodized aluminum, nickel plated brass, copper, or beryllium. CLINICAL PHARMACOLOGY SUPRANE (desflurane, USP) is a volatile liquid inhalation anesthetic minimally biotransformed in the liver in humans. Less than 0.02% of the SUPRANE absorbed can be recovered as urinary metabolites (compared to 0.2% for isoflurane). Minimum alveolar concentration (MAC) of desflurane in oxygen for a 25 year-old adult is 7.3%. The MAC of SUPRANE (desflurane, USP) decreases with increasing age and with addition of depressants such as opioids or benzodiazepines (see DOSAGE AND ADMINISTRATION for details). Pharmacokinetics Due to the volatile nature of desflurane in plasma samples, the washin-washout profile of desflurane was used as a surrogate of plasma pharmacokinetics. Eight healthy male volunteers first breathed 70% N2O/30% O2 for 30 minutes and then a mixture of SUPRANE (desflurane, USP) 2.0%, isoflurane 0.4%, and halothane 0.2% for another 30 minutes. During this time, inspired and end-tidal concentrations (FI and FA) were measured. The FA/FI (washin) value at 30 minutes for desflurane was 0.91, compared to 1.00 for N2O, 0.74 for isoflurane, and 0.58 for halothane (See Figure 1). The washin rates for halothane and isoflurane were similar to literature values. The washin was faster for desflurane than for isoflurane and halothane at all time points. The FA/FAO (washout) value at 5 minutes was 0.12 for desflurane, 0.22 for isoflurane, and 0.25 for halothane (See Figure 2). The washout for SUPRANE was more rapid than that for isoflurane and halothane at all elimination time points. By 5 days, the FA/FAO for desflurane is 1/20th of that for halothane or isoflurane. Pharmacodynamics Changes in the clinical effects of SUPRANE (desflurane, USP) rapidly follow changes in the inspired concentration. The duration of anesthesia and selected recovery measures for SUPRANE are given in the following tables: In 178 female outpatients undergoing laparoscopy, premedicated with fentanyl (1.5-2.0 µg/kg), anesthesia was initiated with propofol 2.5 mg/kg, desflurane/N2O 60% in O2 or desflurane/O2 alone. Anesthesia was maintained with either propofol 1.5-9.0 mg/kg/hr, desflurane 2.6-8.4% in N2O 60% in O2, or desflurane 3.1-8.9% in O2. EMERGENCE AND RECOVERY AFTER OUTPATIENT LAPAROSCOPY 178 FEMALES, AGES 20-47 TIMES IN MINUTES: MEAN ± SD (RANGE) * Differences were statistically significant (p < 0.05) by Dunnett’s procedure comparing all treatments to the propofol-propofol/N2O (induction and maintenance) group. Results for comparisons greater than one hour after anesthesia show no differences between groups and considerable variability within groups. Induction: Propofol Propofol Desflurane/N2O Desflurane/O2 Maintenance: Propofol/N2O Desflurane/N2O Desflurane/N2O Desflurane/O2 Number of Pts: N = 48 N = 44 N = 43 N = 43 ——— ——— ——— ——— Median age 30 (20 - 43) 26 (21 - 47) 29 (21 - 42) 30 (20 - 40) Anesthetic Time 49 ± 53 (8 - 336) 45 ± 35 (11 - 178) 44 ± 29 (14 - 149) 41 ± 26 (19 - 126) Time to open eyes 7 ± 3 (2 - 19) 5 ± 2* (2 - 10) 5 ± 2* (2 - 12) 4 ± 2* (1 - 11) Time to state name 9 ± 4 (4 - 22) 8 ± 3 (3 - 18) 7 ± 3* (3 - 16) 7 ± 3* (2 - 15) Time to stand 80 ± 34 (40 - 200) 86 ± 55 (30 - 320) 81 ± 38 (35 - 190) 77 ± 38 (35 - 200) Time to walk 110 ± 6 (47 - 285) 122 ± 85 (37 – 375) 108 ± 59 (48 - 220) 108 ± 66 (49 - 250) Time to fit for discharge 152 ± 75 (66 - 375) 157 ± 80 (73 - 385) 150 ± 66 (68 - 310) 155 ± 73 (69 - 325) In 88 unpremedicated outpatients, anesthesia was initiated with thiopental 3-9 mg/kg or desflurane in O2. Anesthesia was maintained with isoflurane 0.7-1.4% in N2O 60%, desflurane 1.8-7.7% in N2O 60%, or desflurane 4.4-11.9% in O2. EMERGENCE AND RECOVERY TIMES IN OUTPATIENT SURGERY 46 MALES, 42 FEMALES, AGES 19-70 TIMES IN MINUTES: MEAN ± SD (RANGE) * Differences were statistically significant (p < 0.05) by Dunnett’s procedure comparing all treatments to the thiopental-isoflurane/N2O (induction and maintenance) group. Results for comparisons greater than one hour after anesthesia show no differences between groups and considerable variability within groups. Induction: Thiopental Thiopental Thiopental Desflurane/O2 Maintenance: Isoflurane/N2O Desflurane/N2O Desflurane/O2 Desflurane/O2 Number of Pts: N = 23 N = 21 N = 23 N = 21 ——– ——– ——– ——– Median age 43 (20 - 70) 40 (22 - 67) 43 (19 - 70) 41 (21-64) Anesthetic Time 49 ± 23 (11 - 94) 50 ± 19 (16 - 80) 50 ± 27 (16 - 113) 51 ± 23 (19 - 117) Time to open eyes 13 ± 7 (5 - 33) 9 ± 3* (4 - 16) 12 ± 8 (4 - 39) 8 ± 2* (4 - 13) Time to state name 17 ± 10 (6 - 44) 11 ± 4* (6 - 19) 15 ± 10 (6 - 46) 9 ± 3* (5 - 14) Time to walk 195 ± 67 (124 - 365) 176 ± 60 (101 - 315) 168 ± 34 (119 - 258) 181 ± 42 (92 - 252) Time to fit for discharge 205 ± 53 (153 - 365) 202 ± 41 (144 - 315) 197 ± 35 (155 - 280) 194 ± 37 (134 - 288) Recovery from anesthesia was assessed at 30, 60, and 90 minutes following 0.5 MAC desflurane (3%) or isoflurane (0.6%) in N2O 60% using subjective and objective tests. At 30 minutes after anesthesia, only 43% of the isoflurane group were able to perform the psychometric tests compared to 76% in the desflurane group (p < 0.05). RECOVERY TESTS: PERCENT OF PREOPERATIVE BASELINE VALUES 16 MALES, 22 FEMALES, AGES 20-65 PERCENT: MEAN ± SD 60 minutes After Anesthesia 90 minutes After Anesthesia Maintenance: Desflurane/N2O Isoflurane/N2O Desflurane/N2O Isoflurane/N2O Confusion Δ 66 ± 6 47 ± 8 75 ± 7* 56 ± 8 Fatigue Δ 70 ± 9* 33 ± 6 89 ± 12* 47 ± 8 Drowsiness Δ 66 ± 5* 36 ± 8 76 ± 7* 49 ± 9 Clumsines Δ 65 ± 5 49 ± 8 80 ± 7* 57 ± 9 Comfort Δ 59 ± 7* 30 ± 6 60 ± 8* 31 ± 7 DSST+ score 74 ± 4* 50 ± 9 75 ± 4* 55 ± 7 Trieger Tests++ 67 ± 5 74 ± 6 90 ± 6 83 ± 7 Δ Visual analog scale (values from 0-100; 100 = baseline) + DSST = Digit Symbol Substitution Test ++ Trieger Test = Dot Connecting Test * Differences were statistically significant (p < 0.05) using a two-sample t-test SUPRANE (desflurane, USP) was studied in twelve volunteers receiving no other drugs. Hemodynamic effects during controlled ventilation (PaCO2 38mm Hg) were: HEMODYNAMIC EFFECTS OF DESFLURANE DURING CONTROLLED VENTILATION 12 MALE VOLUNTEERS, AGES 16-26 MEAN ± SD (RANGE) Differences were statistically significant (p < 0.05) compared to awake values, Newman-Keul’s method of multiple comparison. Heart Rate (beats/min) Mean Arterial Pressure & (mm Hg) Cardiac Index (L/min/m2) Total MAC Equivalent End- Tidal % Des/O2 End-Tidal % Des/N2O O2 N2O O2 N2O O2 N2O ———— ———— ———— — ––– — ––– — — 0 0% / 21% 0% / 0% 69 ± 4 70 ± 6 85 ± 9 85 ± 9 3.7 ± 0.4 3.7 ± 0.4 (63 - 76) (62 - 85) (74 - 102) (74 - 102) (3.0 - 4.2) (3.0 - 4.2) 0.8 6% / 94% 3% / 60% 73 ± 5 77 ± 8 61 ± 5* 69 ± 5* 3.2 ± 0.5 3.3 ± 0.5 (67 - 80) (67 - 97) (55 - 70) (62 - 80) (2.6 - 4.0) (2.6 - 4.1) 1.2 9% / 91% 6% / 60% 80 ± 5* 77 ± 7 59 ± 8* 63 ± 8* 3.4 ± 0.5 3.1 ± 0.4* (72 - 84) (67 - 90) (44 - 71) (47 - 74) (2.6 - 4.1) (2.6 - 3.8) 1.7 12% / 88% 9% / 60% 94 ± 14* 79 ± 9 51 ± 12* 59 ± 6* 3.5 ± 0.9 3.0 ± 0.4* (78 - 109) (61 - 91) (31 - 66) (46 - 68) (1.7 - 4.7) (2.4 - 3.6) When the same volunteers breathed spontaneously during desflurane anesthesia, systemic vascular resistance and mean arterial blood pressure decreased; cardiac index, heart rate, stroke volume, and central venous pressure (CVP) increased compared to values when the volunteers were conscious. Cardiac index, stroke volume, and CVP were greater during spontaneous ventilation than during controlled ventilation. During spontaneous ventilation in the same volunteers, increasing the concentration of SUPRANE (desflurane, USP) from 3% to 12% decreased tidal volume and increased arterial carbon dioxide tension and respiratory rate. The combination of N2O 60% with a given concentration of desflurane gave results similar to those with desflurane alone. Respiratory depression produced by desflurane is similar to that produced by other potent inhalation agents. The use of desflurane concentrations higher than 1.5 MAC may produce apnea. CLINICAL TRIALS SUPRANE (desflurane, USP) was evaluated in 1,843 patients including ambulatory (N=1,061), cardiovascular (N=277), geriatric (N=103), neurosurgical (N=40), and pediatric (N=235) patients. Clinical experience with these patients and with 1,087 control patients in these studies not receiving desflurane are described below. Although desflurane can be used in adults for the inhalation induction of anesthesia via mask, it produces a high incidence of respiratory irritation (coughing, breathholding, apnea, increased secretions, laryngospasm). For incidence, see ADVERSE REACTIONS. Oxyhemoglobin saturation below 90% occurred in 6% of patients (from pooled data, N = 370 adults). Ambulatory Surgery SUPRANE (desflurane, USP) plus N2O was compared to isoflurane plus N2O in multicenter studies (21 sites) of 792 ASA physical status I, II, or III patients aged 18-76 years (median 32).
调控比例: 100%
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