| 广谱三唑类抗真菌药voriconazole（商标名：VFEND）获美国批准上市 2002年，Pfizer公司开发的广谱三唑类抗真菌药Vfend(voriconazole，伏立康唑）静脉注射制剂、片剂和口服混悬剂的已在美国批准治疗非中性白细胞减少患者的念珠菌血症；皮肤传染性念珠菌感染和腹腔、肾脏、膀胱壁及伤口念珠菌感染。Vfend是2002年首个在美国被批准用于治疗侵入性曲霉病的药物。Vfend已成为临床治疗真菌病的一种新的有效药物。 Vfend（伏立康唑[Voriconazole]）片剂，口服混悬液，和IV 初步U. S.批准：2002年 适应症 本品是三唑类抗真菌的药物，在治疗中使用的表示： 侵袭性曲霉病 念珠菌（nonneutropenics）和皮肤念珠菌病的传播，腹部，肾脏，膀胱壁，和创伤。 食道念珠菌。 Scedosporium apiospermum和镰刀菌引起的严重感染。包括茄病镰刀菌，患者不能耐受的，或难治性外，其他治疗。 剂量和用法 推荐的给药方案 感染负荷剂量维持剂量*四*第四口腔 查看完整的处方信息用于静脉注射的指示。 增加剂量时，本品与苯妥英或依非韦伦共同管理;减少剂量与肝功能不全患者 口服和静脉注射维持剂量不产生相同的伏立康唑的风险。200毫克的剂量口服提供了一个接触类似3毫克/公斤IV剂量300毫克剂量口服提供了一个类似4毫克/公斤的四剂量的暴露。 体重不到40公斤的成人患者应接受口服维持剂量的一半。 在临床研究中，四，本品治疗的时间中位数为10天;口服本品治疗的中位数时间为76天。 与念珠菌的患者接受3毫克/公斤q12h;与其他深部组织的念珠菌感染的患者接受4毫克/公斤q12h。 侵袭性曲霉病 6毫克/公斤q12h第一个24小时4毫克/公斤q12h 200毫克q12h 念珠菌在第一个24小时3-4毫克/公斤q12h＃200毫克q12h nonneutropenics和其他深部组织的念珠菌感染6毫克/公斤q12h 食道念珠菌没有评估不评估200毫克q12h Scedosporiosis和Fusariosis 6毫克/公斤为第一个24小时q12h 4毫克/公斤200毫克q12h q12h 剂型和优势 粉末注射液：200毫克伏立康唑和3200毫克磺丁基醚β-环糊精钠（SBECD）。 薄膜衣片：50毫克，200毫克伏立康唑。 粉口服混悬液：40伏立康唑毫克/毫升。 禁忌 伏立康唑或辅料过敏。 为了减少严重不良事件的风险，不使用，本品与特非那定，阿司咪唑，西沙必利，匹莫齐特或奎尼丁，西罗莫司。 为了防止损失，本品疗效，不要使用与利福平，卡马西平，长效巴比妥类药物，利托那韦，利福布丁，麦角生物碱，和圣约翰草。 警告和注意事项 药物交互作用：审查病人的合并用药。几种药物可能会大大改变伏立康唑的浓度。伏立康唑可能会改变PK几种药物或PD。 肝毒性：严重肝反应的报道。评估期间，在启动和伏立康唑治疗过程中的肝功能检查 视力障碍：显示器的视觉功能，如果继续治疗超过28天 妊娠D类：不给孕妇管理 半乳糖不耐受：没有管理与半乳糖的不容忍现象，拉普乳糖酶缺乏或葡萄糖 - 半乳糖吸收不良的患者 心律失常，QT间期延长：管理与心律失常的条件患者慎用 输注相关反应：过敏性反应已有报道 皮肤病反应：剥脱性皮肤反应和光敏性已报告 不良反应 最常见的（所有的伤亡，发生率≥2％）：视觉障碍，发热，恶心，皮疹，呕吐，寒战，头痛，肝功能检测异常，心动过速，幻觉。 药物相互作用 CYP3A4，CYP2C9和CYP2C19的抑制剂和诱导剂，可能会改变本品的浓度。调整本品剂量的不良事件或缺乏有效性和显示器。 本品会增加浓度的药物，CYP3A4，CYP2C9和CYP2C19基板和活动。减少剂量，缺乏疗效或这些酶的底物与药物相关的不良事件的监控 在特殊人群中使用 怀孕或哺乳妇女：本品不应该在怀孕或哺乳妇女使用 儿科：<12岁患者的安全性/有效性尚未确定 肝功能损害：使用一半的患者有轻度至中度肝功能不全（Child - Pugh分级A和B）的维持剂量 肾损害：静脉给药避免在中度至严重肾功能不全患者（肌酐清除率<50毫升/分钟） 修订日期：06/2011 ----------------------------------------------------- 【原产地英文商品名】VFEND for oral suspension 400mg/ml 75ml/bottle 【原产地英文药品名】VORICONAZOLE 【中文参考商品译名】威凡口服液 40毫克/毫升 75毫升/瓶 【中文参考药品译名】伏立康唑 【生产厂家中文参考译名】辉瑞 【生产厂家英文名】PFIZER 【产 地 国 家】美国 Voriconazole-Vfend®-Renal Dosing 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. -------------------------------------------------------------------------- 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. -------------------------------------------------------------------------- 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. -------------------------------------------------------------------------- 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. -------------------------------------------------------------------------- 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). -------------------------------------------------------------------------- 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. -------------------------------------------------------------------------- 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. -------------------------------------------------------------------------- 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. -------------------------------------------------------------------------- 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. |