微生物学
临床试验表明伏立康唑对曲霉属，包括黄曲霉、烟曲霉、土曲霉、黑曲霉、构巢曲霉；念珠菌属，包括白色念珠菌、以及部分都柏林念珠菌、光滑念珠菌、C.inconspicua、克柔念珠菌、近平滑念珠菌、热带念珠菌和吉利蒙念珠菌；足放线病菌属，包括尖端足分支霉和多育足分支霉和镰刀菌属有临床疗效。 
其他伏立康唑治疗有效（通常为治愈或好转）的真菌感染包括链格孢属、皮炎芽生菌、头分裂芽生菌、支孢霉属、粗球孢子菌、冠状耳霉、新型隐球菌、喙状明脐菌、棘状外瓶霉、裴氏着色霉、足菌肿马杜拉菌、拟青霉属、青霉菌属，包括马尼弗氏青霉菌、烂木瓶霉、短帚霉和毛孢子菌属，包括白色毛孢子菌感染。体外试验观察到伏立康唑对以下临床分离的真菌有抗菌作用，包括顶孢霉属、链格孢属、双极霉属、支孢瓶霉属、Cladophialophoraspp.、荚膜组织胞浆菌。0.05-2μg/ml的伏立康唑可以抑制大多数的菌株。体外试验表明伏立康唑对弯孢霉属和孢子丝菌属有抗菌作用，但其临床意义尚不清楚。治疗前应采集标本进行真菌培养，并进行其他相关的实验室检查（血清学检查和组织病理学检查），以便分离和鉴定病原菌。在获得培养结果和其他实验室检查结果以前必须先进行抗感染治疗，但是一旦获得结果，应据此调整用药方案。已发现对伏立康唑敏感性减低的临床菌株。
但是，最低抑菌浓度值的增高并不一定导致临床治疗失败，在对其他吡咯类药物耐药菌株所致的感染中，也有临床治疗有效者。由于临床试验中入选患者的复杂性，很难确定体外抗菌活性和临床治疗结果之间的关系。药敏试验中伏立康唑的临界浓度尚未确立。

耐药性
关于念珠菌、曲霉菌、足放线病菌以及镰刀菌属对伏立康唑的体外耐药情况尚无足够的研究。目前尚未知伏立康唑抗菌谱中的各类真菌耐药性发展的情况。对氟康唑和伊曲康唑敏感性降低的真菌对伏立康唑的敏感性亦有可能降低，提示在这些吡咯类药物中可能存在着交叉耐药。交叉耐药与临床疗效之间的关系尚未完全确立。如果临床病例的分离菌呈现交叉耐药，则可能需要更换其他抗真菌药物治疗。
 
药代动力学 
一般药代动力学特点分别在健康受试者、特殊人群和患者中进行了伏立康唑的药代动力学研究。对伴有曲霉病危险因素(主要为淋巴系统或造血组织的恶性肿瘤)的患者研究发现，每日2次口服伏立康唑，每次200mg或300mg，共14天，其药代动力学特点（包括吸收快，吸收稳定，体内蓄积和非线性药代动力学）与健康受试者一致。由于伏立康唑的代谢具有可饱和性，所以其药代动力学呈非线性，暴露药量增加的比例远大于剂量增加的比例。因此如果口服剂量从每日2次，每次200mg增加到每日2次，每次300mg时，估计暴露量（AUCτ）平均增加2.5倍。当给予受试者推荐的负荷剂量（静脉滴注或口服）后，24小时内其血药浓度接近于稳态浓度。如不给予负荷剂量，仅为每日2次，多剂量给药后大多数受试者的血药浓度约在第6天时达到稳态。 
吸收: 口服本品吸收迅速而完全，给药后1-2小时达血药峰浓度。口服后绝对生物利用度约为96%。当多剂量给药，且与高脂肪餐同时服用时，伏立康唑的血药峰浓度和给药间期的药时曲线下面积分别减少34%和24%。胃液pH值改变对本品吸收无影响。分布:稳态浓度下伏立康唑的分布容积为4.6l/kg，提示本品在组织中广泛分布。血浆蛋白结合率约为58%。
一项研究中，对8名患者的脑脊液进行了检测，所有患者的脑脊液中均可检测到伏立康唑。
代谢: 体外试验表明伏立康唑通过肝脏细胞色素P450同工酶，CYP2C19，CYP2C9和CYP3A4代谢。伏立康唑的药代动力学个体间差异很大。体内研究表明CYP2C19在本品的代谢中有重要作用，这种酶具有基因多态性，例如：15-2的亚洲人属于弱代谢者，而白人和黑人中的弱代谢者仅占3-5%。在健康白人和健康日本人中的研究表明：弱代谢者的药物暴露量（AUCτ）平均比纯合子强代谢者的暴露量高4倍，杂合子强代谢者的药物暴露量比纯合子强代谢者高2倍。伏立康唑的主要代谢产物为N-氧化物，在血浆中约占72%。该代谢产物抗菌活性微弱，对伏立康唑的药理作用无显著影响。 
排泄：伏立康唑主要通过肝脏代谢，仅有少于2%的药物以原形经尿排出。给予用放射性同位素标记过的伏立康唑后，多次静脉滴注给药者和多剂量口服给药者中分别约有80%和83%的放射活性在尿中回收。绝大多数的放射活性（〉94%）在给药（静脉滴注或口服）后96小时内经尿排出。伏立康唑的终末半减期与剂量有关。口服200mg后终末半减期约为6小时。由于其非线性药代动力学特点，终末半衰期值不能用于预测伏立康唑的蓄积或清除。

适应症 
威凡(伏立康唑片)适用于侵袭性曲霉病、对氟康唑耐药的念珠菌引起的严重侵袭性感染（包括克柔念珠菌）、足放线病菌属和镰刀菌属引起的严重感染、疫缺陷患者中进行性的、可能威胁生命的感染。
本品应主要用于治疗免疫缺陷患者中进行性的、可能威胁生命的感染。 
伏立康唑是治疗恶性血液病患者真菌感染较为安全的三唑类抗真菌药物，用伏立康唑治疗真菌感染者32例，男性20例，女性12例;中位年龄为37(14～75)岁.全组静脉用药中位时间3(1～11)d，序贯治疗总疗程中位时间11(2～99)d.16例患者发生不良事件，其中特殊感觉、神经系统、消化系统症状的构成比依次为25.00%、21.88%、18.75%.其他不良事件有皮疹、手指肿胀等.5例患者因严重不良反应停药.

不良反应 
在治疗试验中最为常见的不良事件为视觉障碍、发热、皮疹、恶心、呕吐、腹泻、头痛、败血症、周围性水肿、腹痛以及呼吸功能紊乱。与治疗有关的，导致停药的最常见不良事件包括肝功能试验值增高、皮疹和视觉障碍。
 
禁忌
本品禁用于已知对伏立康唑或任何一种赋形剂有过敏史者。
 
警告 
视觉障碍：疗程超过28天时伏立康唑对视觉功能的影响尚不清楚。如果连续治疗超过28天，需监测视觉功能，包括视敏度、视力范围以及色觉。
肝毒性：在临床试验中，伏立康唑治疗组中严重的肝脏不良反应并不常见（包括肝炎，胆汁淤积和致死性的暴发性肝衰竭）。有报道肝毒性反应主要发生在伴有严重基础疾病（主要为恶性血液病）的患者中。肝脏反应，包括肝炎和黄疸，可以发生在无其它确定危险因素的患者中。通常停药后肝功能异常即能好转。
监测肝功能：在伏立康唑治疗初及治疗中均需检查肝功能。患者在治疗初以及在治疗中发生肝功能异常时均必须常规监测肝功能，以防发生更严重的肝脏损害。监测应包括肝功能的实验室检查（特别是肝功能试验和胆红素）。如果临床症状体征与肝病发展相一致，应考虑停药。 
孕妇：伏立康唑应用于孕妇时可导致胎儿损害。生殖研究表明：在10mg/kg(按照mg/m2计算，相当于0.3倍的推荐维持剂量)的剂量下,伏立康唑对大鼠有致畸作用（腭裂、肾积水/输尿管积水）。在100mg/kg（6倍推荐维持剂量）的剂量下，伏立康唑对兔子具有胚胎毒性。对大鼠的其他影响包括骶尾骨、颅骨、耻骨、舌骨和多数肋骨的骨化减弱、胸骨节异常和输尿管/肾盂扩张。任何剂量的伏立康唑都可使怀孕大鼠血雌二醇水平降低。在10mg/kg剂量下，伏立康唑还可使大鼠妊娠时间延长，难产，导致围产期幼鼠死亡率增高。此外，伏立康唑可使兔子的胚胎死亡率增高，胎兔体重降低，骨骼变异率增高、颈肋和胸骨体外的骨化点增多。如在孕期使用伏立康唑，或在用药期间怀孕，应告知患者本品对胎儿的潜在危险。半乳糖不耐受：伏立康唑片剂中含有乳糖成分，罕见的，先天性的半乳糖不能耐受者、Lapp乳糖酶缺乏或葡萄糖－半乳糖吸收障碍者不宜应用本品。 
一般注意事项: 一些吡咯类类药物，包括伏立康唑，可引起心电图QT间期的延长。在伏立康唑临床研究及上市后的监测中，罕有发生尖端扭转性室速的报道。在伴有多种混合危险因素的重症患者中，例如伴有心肌病、低钾血症、曾进行具有心脏毒性的化疗以及同时应用其他可能引起尖端扭转性室速的药物，有发生尖端扭转性室速的报道。在上述有潜在心律失常危险的患者中需慎用伏立康唑。在应用伏立康唑治疗前必须严格纠正钾、镁和钙的异常。与静脉滴注有关的反应,健康受试者在静脉滴注过程中发生的与滴注相关的类过敏反应主要为脸红、发热、出汗、心动过速、胸闷、呼吸困难、晕厥、恶心、瘙痒以及皮疹，上述反应并不常见且多为即刻反应。一旦出现上述反应考虑停药。
 
患者须知
应当告知患者：伏立康唑片剂应在餐后或餐前至少1小时服用。伏立康唑可能引起视觉改变，包括视力模糊和畏光，因此使用伏立康唑期间不能在夜间驾驶，如果在用药过程中出现视觉改变，应避免从事有潜在危险性的工作，例如驾驶或操纵机器。用药期间应避免强烈的、直接的阳光照射。验室检查用伏立康唑前应纠正电解质紊乱，包括低钾血症、低镁血症和低钙血症。用药期间必须监测肾功能（主要为血肌酐）肝功能（主要为肝功能检查和胆红素）。

用法用量
本品在静脉滴注前先溶解成10mg/ml，再稀释至2-5mg/ml。本品不宜用于静脉推注。建议本品的静脉滴注速度最快不超过每小时3mg/kg，稀释后每瓶滴注时间须1至2小时以上。
成人用药，静脉滴注和口服的互换用法，无论是静脉滴注或口服给药，首次给药时第一天均应给予首次负荷剂量，以使其血药浓度在给药第一天即接近于稳态浓度。由于口服片剂的生物利用度很高（96%），所以在有临床指征时静脉滴注和口服两种给药途径可以互换。
口服: 患者体重≥40kg，患者体重〈40kg负荷剂量:每12小时给药1次，每次400mg每12小时给药1次，每次200mg（第1个24小时）(适用于第1个24小时)(适用于第1个24小时)维持剂量（开始用药每日给药2次，每次200mg每日给药2次，每次100mg24小时以后）。任何疑问，请遵医嘱！

孕妇及哺乳期妇女用药
孕妇: 目前伏立康唑在孕妇中的应用尚无足够资料。动物实验显示本品有生殖毒性（参见临床前安全性资料），但对人体的潜在危险性尚未确定。伏立康唑不宜用于孕妇，除非对母亲的益处显著大于对胎儿的潜在毒性。
育龄期妇女: 育龄期妇女应用伏立康唑期间需采取有效的避孕措施。
哺乳期妇女: 尚无伏立康唑在乳汁中分泌的资料。除非明显的利大于弊，否则哺乳期妇女不宜使用伏立康唑。

儿童用药
伏立康唑在12岁以下儿童的安全性和有效性尚未建立。在治疗性研究中共入选年龄为12-18岁的侵袭性曲霉病患者22例，分别给予伏立康唑的维持剂量，即每12小时1次，每次4mg/kg，12例（55％）患者治疗有效。
 
老人用药
静脉滴注或口服伏立康唑后，老年患者的血药浓度较年轻患者大约高80％-90％。但是，总的安全性老年人与年轻人相仿，因此无需调整剂量。
 
药物相互作用 

伏立康唑禁止与其他药物，包括肠道外营养剂（如Aminofusin10%Plus）在同一静脉通路中滴注。伏立康唑与Aminofusin10%Plus物理不相容，二者在4℃储存24小时后可产生不溶性微粒。
伏立康唑不宜与血制品或任何电解质补充剂同时滴注。伏立康唑注射剂可与全胃肠外营养液不在同一静脉通路中同时静脉滴注。4.2%的碳酸氢钠静脉注射液与伏立康唑存在配伍禁忌，该稀释剂的弱碱性可使伏立康唑在室温储存24小时后轻微降解。虽然稀释后的伏立康唑溶液推荐冷藏，但仍不推荐使用4.2%的碳酸氢钠注射液作为稀释剂。
本品与其它浓度碳酸氢钠溶液的相容性尚不清楚。
本品禁止与CYP3A4底物，特非那定，阿司咪唑，西沙必利，匹莫齐特或奎尼丁合用，因为本品可使上述药物的血浓度增高，从而导致Q-T间期延长，并且偶见尖端扭转性室性心动过速。
本品禁止与利福平，卡马西平和苯巴比妥合用，后者可以显著降低本品的血浓度。
本品不可与麦角生物碱类药物（麦角胺，二氢麦角胺）合用。麦角生物碱类为CYP3A4的底物，二者合用后麦角类药物的血药浓度增高可导致麦角中毒。
西罗莫司与伏立康唑合用时，前者的血浓度可能显著增高，因此这两种药物不可同时应用。
本品禁止与利托那韦（每次400mg，每12小时1次）合用。健康受试者同时应用利托那韦（每次400mg，每12小时1次）与伏立康唑，伏立康唑的血药浓度显著降低。利托那韦每次100mg，每12小时一次用于抑制CYP3A，从而使其他抗逆转录病毒药物浓度增高，但这种给药方案对伏立康唑浓度的影响尚无研究。本品禁止与依法韦伦同时应用。二者同时应用时，伏立康唑血药浓度显著降低，依法韦伦的血药浓度则显著增高。
本品禁止与利福布丁同时应用。二者合用，伏立康唑血药浓度显著降低，利福布丁的血药浓度则显著增高。

注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
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原产地英文商品名:
VORICONAZOLE(VFEND GENERIC) 50mg/tab 30tabs/box
原产地英文药品名:
VORICONAZOLE
中文参考商品译名:
伏立康唑(威凡仿制药) 50毫克/片 30片/盒
中文参考药品译名:
伏立康唑
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原产地英文商品名:
VORICONAZOLE UD PK(VFEND GENERIC) 200mg/tab 30tabs/box
原产地英文药品名:
VORICONAZOLE
中文参考商品译名:
伏立康唑板装(威凡仿制药) 200毫克/片 30片/盒
中文参考药品译名:
伏立康唑
---------------------------------------------------------------
原产地英文商品名:
VORICONAZOLE(VFEND GENERIC) 200mg/tab 30tabs/box
原产地英文药品名:
VORICONAZOLE
中文参考商品译名:
伏立康唑(威凡仿制药) 200毫克/片 30片/盒
中文参考药品译名:
伏立康唑
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What is VFEND?
VFEND (voriconazole) is an azole antifungal medication. It works by blocking fungal cell wall growth, resulting in the death of the fungus.

VFEND is used to treat infections caused by yeast or other types of fungus. It may also be used to treat patients with serious fungal infections who cannot tolerate other types of treatment.

VFEND may also be used for other purposes not listed here.

Important information about VFEND
Do not use VFEND without your doctor's consent if you are pregnant. It could cause harm to the unborn baby. Use an effective form of birth control, and tell your doctor if you become pregnant during treatment.

There are many other medicines that can cause serious or life-threatening drug interactions with VFEND. Tell your doctor about all the prescription and over-the-counter medications you use.

Before taking VFEND, tell your doctor if you have heart rhythm problems, an electrolyte imbalance, liver or kidney disease, or a history of allergy to other antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox).

Use this medicine for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

VFEND can cause problems with your vision. If you use this medicine for more than 28 days, you may need to have your eyes checked.

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Before taking VFEND
Do not take VFEND if you are allergic to voriconazole, or if you are taking any of the following drugs:quinidine (Cardioquin, Quinora, Quinidex, Quinaglute, Quin-Release, Quin-G);sirolimus (Rapamune);carbamazepine (Tegretol);pimozide (Orap);phenobarbital;ritonavir (Norvir);efavirenz (Sustiva);rifabutin (Mycobutin) or rifampin (Rifadin, Rimactane, Rifater);an ergot medicine such as ergotamine (Ergomar, Cafergot, Ercaf, Wigraine, others) or dihydroergotamine (D.H.E., Migranal); or(these drugs are no longer available in the U.S.) terfenadine (Seldane) or astemizole (Hismanal).

The drugs listed above can cause dangerous serious or life-threatening drug interactions with VFEND. Tell your doctor about all other medicines you are using.

If you have any of these conditions, you may need a dose adjustment or special tests to safely use VFEND:heart rhythm problems;a metabolic disorder such as high or low levels of calcium, potassium, or magnesium;liver disease; kidney disease; or a history of allergy to other antifungal medications such as fluconazole (Diflucan), ketoconazole (Nizoral), or itraconazole (Sporanox).

VFEND tablets contain lactose. Before taking a VFEND tablet, tell your doctor if you have a hereditary form of galactose intolerance, Lapp lactase deficiency, or glucose-galactose malabsorption.

FDA pregnancy category D. This medication can cause harm to an unborn baby. Do not use VFEND without your doctor's consent if you are pregnant. Tell your doctor if you become pregnant during treatment. Use an effective form of birth control while you are using this medication. It is not known if voriconazole passes into breast milk or if it could harm a nursing baby. Do not use VFEND without telling your doctor if you are breast-feeding a baby.

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How should I take VFEND?
Take VFEND exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Take VFEND at least one hour before or after eating a meal. Shake the oral suspension (liquid) well just before you measure a dose. To be sure you get the correct dose, measure the liquid with a marked measuring spoon or medicine cup, not with a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Do not mix the oral suspension with any other medicine or liquid. Take VFEND for the entire length of time prescribed by your doctor. Your symptoms may get better before the infection is completely treated.

To be sure VFEND is helping your condition, your blood will need to be tested on a regular basis. Your kidney or liver function may also need to be tested. Visit your doctor regularly.

VFEND can cause problems with your vision. If you use this medicine for more than 28 days, you may need to have your eyes checked.

Store the tablets at room temperature away from moisture and heat. Store the oral liquid at room temperature for up to 14 days. Throw away any unused liquid after 14 days.

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What happens if I miss a dose?
Use the medication as soon as you remember. If it is almost time for the next dose, skip the missed dose and use the medicine at the next regularly scheduled time. Do not use extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include vision problems, excessive mouth watering, enlarged pupils, weakness, loss of balance, shortness of breath, or seizure (convulsions).

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What should I avoid while taking VFEND?
VFEND may cause changes in vision including blurred vision and sensitivity to light. Wear sunglasses during the day to protect your eyes from bright light. Be careful if you drive or do anything that requires you to have clear vision. Avoid exposure to sunlight or artificial UV rays (sunlamps or tanning beds). VFEND can make your skin more sensitive to sunlight and sunburn may result. Use a sunscreen (minimum SPF 15) and wear protective clothing if you must be out in the sun.

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VFEND side effects
Get emergency medical help if you have any of these signs of an allergic reaction to VFEND: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:sudden behavior changes, problems with thinking or speech;stomach pain, loss of appetite, dark urine, jaundice (yellowing of the skin or eyes);urinating less than usual or not at all;fever, sore throat, and headache with a severe blistering, peeling, and red skin rash; oruneven heart rate, chest pain, general ill feeling.

Less serious VFEND side effects may include:vision problems such as blurred vision, eyes being more sensitive to light;fever;mild nausea, vomiting, or diarrhea;headache; orswelling in your hands, ankles, or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect VFEND?
Many drugs can interact with VFEND. Below is just a partial list. Tell your doctor if you are using:phenytoin (Dilantin);clopidogrel (Plavix);cyclosporine (Sandimmune, Neoral);tacrolimus (Prograf);warfarin(Coumadin);stomach acid reducers such as esomeprazole (Nexium), omeprazole (Prilosec), lansoprazole (Prevacid), or pantoprazole (Protonix);tranquilizers or sedatives such as alprazolam (Xanax), diazepam (Valium), midazolam (Versed), triazolam (Halcion), and others;cholesterol-lowering medicines such as atorvastatin (Lipitor), lovastatin (Mevacor), pravastatin (Pravachol), or simvastatin (Zocor);vinblastine (Velban), vincristine (Oncovin), or vinorelbine (Navelbine);a calcium channel blocker such as verapamil (Isoptin, Verelan, Calan, Covera), amlodipine (Norvasc), felodipine (Plendil), isradipine (DynaCirc), nicardipine (Cardene), nifedipine (Adalat, Procardia), nimodipine (Nimotop), or nisoldipine (Sular); oran oral diabetes medicine such as glipizide (Glucotrol), glyburide (DiaBeta, Micronase), tolbutamide (Orinase), tolazamide (Tolinase), or chlorpropamide (Diabinese).

This list is not complete and there may be other drugs that can interact with VFEND. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about VFEND.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use VFEND only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.