部份中文伊布利特处方资料（仅供参考） 药品英文名 Ibutilide 药品别名 富马酸伊布利特、Ibutilide Fumarate、Corvert 药物剂型 伊布利特注射剂：1mg/10ml/瓶。 药理作用 本品为甲基磺酰胺的衍生物，具有延长复极的作用。对心脏电生理的研究表明：抑制复极时K 外向电流，通过对K 外向电流的抑制，可延长动作电位时间，延长QT间期，延长心肌的有效不应期。促进平台期缓慢内向Na 电流及平台期内向Ca2 电流，延长动作电位时间，延长心肌的有效不应期和QT间期，减慢传导，使折返激动不易形成。整体动物实验结果表明，本品可终止犬动物模型的持续房扑和房颤，延长QT间期，减少犬急性心肌梗死模型室颤和室速的发生率，并降低室颤时除颤阈值。临床研究表明，本品起效快，在10min内快速静滴本品0.03mg/kg时或在8h内缓慢静滴0.1mg/kg时，可使QT间期延长38%～43%。QT间期延长的幅度与伊布利特的血浆浓度成正相关。本品对QRS时间无明显影响。本品对心率、血压及其他血流动力学指标无明显影响。本品无明显负性肌力作用。 药动学 本品口服有较强的首关效应，生物利用度低，故采用静滴。静脉应用后，迅速分布于细胞外液。41%的药物与血浆蛋白结合，本品大部分药物在肝脏代谢。代谢产物共8个，除其中一个代谢产物有活性外，其余7个均无活性。本品t1/2为3～6h，主要通过尿液排出体外。 适应证 本品用于治疗快速心房颤动、心房扑动。 禁忌证 严重心动过缓、哺乳期、严重心衰、低钾血症、低镁血症、妊娠期妇女原有QT间期延长和扭转型室性心动过速发作史患者禁用。 注意事项 1.用药前应检查患者血清钾、镁浓度，并开始抗凝治疗。 2.患者应该住院治疗，并进行连续心电监护，至少应监护4h或至QT间期恢复到基线值。 3.肝功能异常患者，使用本品时，其清除率减低，药物作用时间延长。 4.使用本品后至少4h内不得并用其他延长QT间期的药物。 5.儿童用药安全性尚未评价。 6.老年人由于肝肾、心脏功能降低，用药剂量应谨慎，从低剂量开始。 7.本品可用5%葡萄糖或0.9%氯化钠注射液稀释。稀释液可室温放置24h，或2～8℃放置48h。 不良反应 本品耐受良好，可引起尖端扭转型室速，持续单形态室速，非持续单形态室速，AV传导阻滞，束支传导阻滞，室性期前收缩，室上性期前收缩，低血压，体位性低血压，心动过缓，窦性心动过缓，结性心律失常，充血性心衰，心动过速，窦性心动过速，室上性心动过速，心室自身节律，高血压，QT间期延长，心悸，晕厥，肾衰。其他不良反应为恶心、头痛。 用法用量 静脉给药，推荐剂量：体重＞60kg，首剂1mg，10min内静脉滴注，如需要，10min后第二次滴注，剂量仍为1mg；体重＜60kg，首剂0.01mg/kg，若需要，再用相同剂量给予第二次治疗。 药物相应作用 由于室性心律失常有可能掩盖地高辛过量引起的心脏毒性，血浆地高辛浓度高于或怀疑高于正常水平的患者使用本品应谨慎。β受体阻滞剂和钙拮抗剂对本品无影响。本品与酚噻嗪类、三环类抗抑郁药、四环类抗抑郁药、抗组胺药等能延长QT间期的药物合用，导致心律失常的危险性增加。 CORVERT VIAL 10ML IBUTILIDE FUMARATE  PFIZER INC INJECTABLE  00009-3794-01             CORVERT (Ibutilide fumarate) Standard Dilutions[Amount of drug] [Infusion volume] [Infusion rate] [0 to 1mg] [50ml] [10min] See comments below. Dosing: patient wt >60kg: 1 mg over 10min. If < 60kg: 0.01 mg/kg over 10 min. If the arrhythmia does not terminate within 10 minutes after the 1st dose, a 2nd dose may be given 10 minutes after the completion of the first infusion. Mechanism of action : prolongs action potential duration and increases both atrial & ventricular refractoriness (class III agent). DOSAGE AND ADMINISTRATION The recommended dose based on controlled trials (see CLINICAL STUDIES) is outlined in the Table below. Ibutilide infusion should be stopped as soon as the presenting arrhythmia is terminated or in the event of sustained or nonsustained ventricular tachycardia, or marked prolongation of QT or QTc. Recommended Dose of CORVERT Injection In a trial comparing ibutilide and sotalol (see package insert for CLINICAL STUDIES), 2 mg ibutilide fumarate administered as a single infusion to patients weighing more than 60 kg was also effective in terminating atrial fibrillation or atrial flutter. In the post-cardiac surgery study (see package insert for CLINICAL STUDIES), one or two intravenous infusions of 0.5 mg (0.005 mg/kg per dose for patients weighing less than 60 kg) was effective in terminating atrial fibrillation or atrial flutter. Patients should be observed with continuous ECG monitoring for at least 4 hours following infusion or until QTc has returned to baseline. Longer monitoring is required if any arrhythmic activity is noted. Skilled personnel and proper equipment (see package insert for WARNINGS, Proarrhythmia), such as a cardioverter/defibrillator, and medication for treatment of sustained ventricular tachycardia, including polymorphic ventricular tachycardia, must be available during administration of CORVERT and subsequent monitoring of the patient. Dilution CORVERT Injection may be administered undiluted or diluted in 50 mL of diluent. CORVERT may be added to 0.9% Sodium Chloride Injection or 5% Dextrose Injection before infusion. The contents of one 10 mL vial (0.1 mg/mL) may be added to a 50 mL infusion bag to form an admixture of approximately 0.017 mg/mL ibutilide fumarate. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit. Compatibility and Stability The following diluents are compatible with CORVERT Injection (0.1 mg/mL): 5% Dextrose Injection 0.9% Sodium Chloride Injection The following intravenous solution containers are compatible with admixtures of CORVERT Injection (0.1 mg/mL): polyvinyl chloride plastic bags polyolefin bags Admixtures of the product, with approved diluents, are chemically and physically stable for 24 hours at room temperature (15° to 30° C or 59° to 86° F) and for 48 hours at refrigerated temperatures (2° to 8°C or 36° to 46°F). Strict adherence to the use of aseptic technique during the preparation of the admixture is recommended in order to maintain sterility. HOW SUPPLIED CORVERT Injection (ibutilide fumarate injection) is supplied as an acetate-buffered isotonic solution at a concentration of 0.1 mg/mL that has been adjusted to approximately pH 4.6 in 10mL clear glass, single-dose, flip-top vials. Single-dose 10mL vial, 1mg/10mL (0.1mg/mL) NDC 0009-3794-22 Store at controlled room temperature 20° to 25°C (68° to 77°F) [see USP]. Store vial in carton until used