产地国家：瑞士
处方药：是
所属类别： 25毫克/毫升/瓶
包装规格： 25毫克/毫升/瓶
计价单位：盒
生产厂家英文名：Pfizer AG
原产地英文商品名：Methotrexat Injektionslösung 25mg/ml/vial
原产地英文药品名：Methotrexat
中文参考药品译名：甲氨蝶呤
简介：
部份中文甲氨蝶呤处方资料（仅供参考）通用名：甲氨蝶呤注射液英文名：Methotrexate lnjection药物类别抗肿瘤抗代谢类成分甲氨蝶呤注射液主要成分为甲氨蝶呤。描述甲氨蝶呤注射剂为甲氨蝶呤BP在注射用水BP中的无菌溶液，包含氯化钠是为了平衡渗透压，除了在1g/ml的小瓶外。甲氨蝶呤注射液不含防腐剂。甲氨蝶呤注射液PH为7．5至9．0。甲氨蝶呤片剂含甲氨蝶呤BP2．5mg。2．5mg片剂无刻痕。
药理学：甲氨蝶呤是抗代谢性抗癌药，它通过竞争性抑制二氢叶酸还原酶（DHFR）面起细胞毒作用，该酶能将叶酸还原成四氢叶酸。抑制四氢叶酸导致DNA合成及细胞增殖受干扰。有很高的细胞增殖率的组织，如恶性细胞、骨髓，胚胎细胞，上皮，颊部及小肠粘膜及膀胱细胞一般地均对甲氨蝶呤的作用较敏感。在牛皮癣病人的皮肤上皮细胞的增殖率一般比正常皮肤大为增加。这种增殖率的差异提供了应用甲氨蝶呤控制牛皮癣过程的基础。
药动学：甲氨蝶呤低剂量（<25mg/m2）时，从胃肠道吸收很好；剂量较大时，吸收会变反常及不完全。口服后血清峰浓度可在1-4小时达到，静注后（IV）或肌注（IM）后可在0．5～2小时达峰。吸收的甲氨蝶呤约50%可逆性地与血清蛋白结合。甲氨蝶呤在躯体组织中广泛广布中，并浓集于肾、肝及胃肠道。它亦分布于第三空间液体的积聚中，如腹水及胸水。甲氨蝶呤口服或注射时在脑脊液（CSF）达不到治疗浓度。如需高浓度则须作鞘内注射。甲氨蝶呤看来代谢不多。药物主要由肾排泄，小量出现于粪中，肾功能不良者甲氨蝶呤的排泄减少。适应症抗癌化疗甲氨蝶呤有广泛的抗癌活性谱。
适应症：适用于治疗乳癌、滋养叶绒毛上皮癌及对破坏性绒毛膜腺瘤及葡萄胎病人。甲氨蝶呤可与其他化疗剂联合用于急性白血病的姑息治疗，尤其急性淋巴细胞性白血病。它亦可用于治疗Burkitt氏淋巴瘤，晚期（Peter氏分期系统的III及IV期）淋巴肉瘤，尤其对儿童及用于蕈样肉芽肿的晚期病例。在高剂量方案下，甲氨蝶呤单用或联合治疗头颈上皮样癌、成骨肉瘤及运气管癌会有效。甲酰四氢叶酸钙（Leucovorin Calcium）必须在甲氨蝶呤高剂量疗法中合并使用。牛皮癣的化疗甲氨蝶呤在症状性控制严重的、顽固的、残废的牛皮癣上有价值，尤当用其他方式治疗疗效不足者为然。然而，由于其使用所伴随的高度危险，甲氨蝶呤必须用于诊断确定之后，如经过活检和/或皮肤科会诊之后。
禁忌症：甲氨蝶呤一般禁用于肾功能不良的病人。 治疗牛皮癣时，甲氨蝶呤禁忌用于孕妇及营养不良的病人、严重肝、肾功能不良者或原有血液病，如骨髓增生低下、白细胞减少症、血小板减少症或贫血的病人。 甲氨蝶呤忌用于明显或实验室证据表明免疫不良综合症者。妇女口服甲氨蝶呤者禁忌哺乳。
警告：甲氨蝶呤必须由熟练掌握抗代谢化疗的医生来应用。甲氨蝶呤一般禁用于肾功能不良病人。必须充分告知病人关于涉及甲氨蝶呤应用的严重性反应或死亡的危险，并必须在医生经常监督下应用。只有无防腐剂的甲氨蝶呤才可作鞘内应用。用甲氨蝶呤治疗牛皮癣曾报告死亡病例。甲氨蝶呤的应用必须限制于严重、顽固的、致残废的牛皮癣，而对其他治疗方式无足够疗效者，且只当诊断已经活检和/或皮肤科会诊确定之后。 甲氨蝶呤可引起骨髓抑制、贫血、白细胞减少，血小板减少及出血。当用高剂量或长期用时，甲氨蝶呤可能有肝毒性。肝萎缩、坏死、硬化、脂肪变性及门脉周围纤维化，都曾报告过。开始甲氨蝶呤治疗前必须测定肝功能，而在治疗过程中经常监测。原来存在肝损害或肝功能不良者，必须特别小心，应避免同时应用其他有肝毒可能性的药物与酒精。与甲氨蝶呤（常为高剂量者）同用某些非甾体抗炎药（NSAIDS），曾报告严重不良反应，包括死亡。 下泻及溃疡性口腔炎是常见的毒性作用，而要求中断治疗，否则可发生出血性肠炎及死于肠穿孔。肺毒性包括进展迅速的肺炎及肺纤维化，且可能是致死性的，均曾伴随于甲氨蝶呤治疗。在病人发生肺毒性症状（如干的、无痰的咳嗽，呼吸困难）的病人，甲氨蝶呤必须停用，而进行小心的临床估价。对甲氨蝶呤所致肺毒性的处理主要是支持性的。甲氨蝶呤引起的肺毒性的处理可能是不能完全恢复的。甲氨蝶呤曾以高剂量方案应用，继以甲酰四氢叶酸钙（Leucovorin Calcium），用于某些肺瘤疾病的辅助治疗。这种过程是复杂的，而且是危险的。除非由高度有经验的医疗队伍根据小心设计的计划应用，否则不能尝试。必须经常阅读刊出的文献。用于孕妇属D范畴。 这一范畴指明药物曾引起人胚胎畸形或不可逆损害的发生率增加。这些药物也可能有不良的药理作用。 甲氨蝶呤曾引起胚胎死亡和/或先天性畸形。它不应该用于孕妇或有可能怀孕者，除非可能的好处，可预期能超过考虑到的危险性。甲氨蝶呤忌用于孕妇来治疗牛皮癣。有怀孕可能的妇女必须充分告知，在甲氨蝶呤治疗期间，如果他们怀孕对胎儿可能的危险性。 用于儿童除了用于癌瘤化疗所已确定者外，在儿童应用甲氨蝶呤的安全性及疗效尚未完全阐明。
注意事项：甲氨蝶呤有很大可能性发生毒性，这常是剂量依赖性。医生必须熟悉该药的各种特性及其已确立的临床用途。病人必须保持于适当的监督下，以便可能的毒性或不良反应的体征或症状可以尽早测出。治疗前及定期的血液学估价对于化疗中应用甲氨蝶呤是首要的。因为它有造血系统抑制作用。这点可以突然发生及在看来安全的剂量下发生，而任何血细胞计数显著的下降表明要立即停药，及作适当的治疗。 总的来说，恶性肿瘤病人已有原存在的骨髓增生不良者，甲氨蝶呤必须小心应用。因为甲氨蝶呤主要由肾排泄，在肾功能不良时应用，可导致药物蓄积，从而引起毒性，或甚至增加肾损害。在甲氨蝶呤治疗之前及过程中，必须测定病人的肾脏状态。如存在明显的肾功能不良必须小心行事，药物剂量必须减少或停药，直至肾功能改善或恢复为止。甲氨蝶呤曾伴有肺毒性，它可能是致死性。病人发生肺部表现（见警告项下）者，必须停药及必须进行小心的临床估价。必须进行下列实验室试验，作为临床估价的一部分，及要在甲氨蝶呤治疗中监测病人。这包括：全血象、血细胞压积、尿分析、肾及肝功能试验。推荐作胸部X线检查。这些试验必须在治疗前，过程中及治疗后进行。 如用高剂量及长时治疗后要追踪的话，重要的是作肝活检或骨髓试验。如怀疑有甲氨蝶呤引致的肺疾病，则肺功能试验可能有用。特别如果有基线测量则更为必要。有感染、消化性溃疡，溃疡性结肠炎、衰弱者、很幼小及老年人应用甲氨蝶呤必须极端小心。如在治疗期间存在深度白细胞减少，则可发生细菌性感染或引起危险。此时，必须停药并应用适当的抗生素治疗。如发生严重的骨髓抑制，则可能要求输血、输血小板。当考虑用甲氨蝶呤于化疗时，临床医生必须估计其需要及药物可能的价值与危险性、不良反应或毒性作用的对比。如及早发现则大多数不良反应是可逆的。如这些反应确已发生，剂量必须减少或停药，而适当的纠正措施应予采取。 当再用甲氨蝶呤治疗时，必须小心，而对进一步用药的必要性要作足够的改变，且对毒性可能再发，应保持警觉性。肾功能不良者，或有第三储库如腹水或大量胸水存在的病人，不应使用大剂量。必须小心监测肾功能及血清药物水平，以便发现可能的毒性及延长使用甲酰四氢叶酸钙的必要性。推荐对尿液进行碱化及增加尿量，以便防止芗在酸性尿中沉积于肾脏。致癌性、致突变性及生殖功能不良甲氨蝶呤被考虑为可以致癌。然而，仍要求大量流行病学研究以确定其致癌可能性的大小。曾报告甲氨蝶呤可引起染色体损伤。 甲氨蝶呤可引起卵子生成及精子生成不良。因此，在育龄男女应采取适当步骤避免在甲氨蝶呤治疗期间怀孕。停用甲氨蝶呤后遗传异常的危险仍存在。因此，建议停用甲氨蝶呤一定期间（小8周）内，男女应避免性交而导致怀孕，从而保证正常性细胞的再确立。哺乳期的应用建议妇女在用甲氨蝶呤治疗期间勿哺乳。
药物相互作用：因为有部分甲氨蝶呤与血清蛋白结合，由于被某些药物，如水杨酸类、磺胺类，苯妥英、四环素，氯霉素及对氨苯甲酸等所置换，而导致毒性可增加。这些药物，尤其水杨酸类与磺胺类不能同时给予，直至这些影响的意义已确定为止。合用青霉素时，甲氨蝶呤从体内排泄可明显减少，有甲氨蝶吟中毒的一定危险性。含有叶酸或其衍生物的维生素制剂可减低甲氨蝶呤的效力。用高剂量甲氨蝶呤之前或同时不得使用非甾体抗炎药（NSAIDS）。此类药可提高并延长甲氨蝶呤血清水平，导致严重血液学肠胃及毒性而死亡。当非甾体抗炎药或水杨酸类与低剂量甲氨蝶呤同时用时，仍要小心。 这些药物曾报告在动物模型中可减低甲氨蝶呤从肾小管分泌，而可增强毒性。丙磺舒（Probenecid）可引起甲氨蝶呤血浆半衰期及其以后的血中水平增加。别嘌呤醇（Allopurinol）与甲氨蝶呤与可能有肾毒性的化疗剂，如顺铂合用，则必须小心。
对病人的指导：1、 病人必须被告知应用甲氨蝶呤可能的好处与危险。对生殖作用的危险性必须与用甲氨蝶呤的男及女病人讨论过。2、 病人必须被告知毒性的早期体征及症状，告知如这些症状发生时必须迅速去找医生，以及必须密切追踪，包括定期的实验室试验，以监测毒性。
不良反应：溃疡性口腔炎、白细胞减少、恶心及腹部不适是常见不良反应。其他报告的症状有全身不适、非常疲倦、寒战发热、眩晕及对感染的抵抗力减低。不良反应的发生率及严重程度一般看来是剂量依赖性的。 曾报告过各系统的不良反应。皮肤：红斑疹、搔痒、荨麻疹、对光敏感、皮肤脱色、脱发、鱼鳞癣、末梢血管扩张、痤疮、疖疮。在牛皮癣病人曾报告皮肤溃疡。血液：骨髓抑制、白细胞减少、血小板减少、贫血、球蛋白过低症，各部位的出血、败血症。消化系统：齿龈炎、喉炎、口腔炎、厌食、下泻、吐血、黑便、胃肠溃疡及出血、肠炎、肝毒性导致急性肝萎缩、坏死、脂肪变性、门脉周围纤维化或肝硬化。偶见甲氨蝶呤作用干肠粘膜而导致吸收不良或毒性巨结肠。泌尿生殖系统：肾功能不良、氮质血症、膀胱炎、血尿、卵子生成或精子生成不良、暂时性精子缺乏症、月经功能不良、不育、流产、胚胎缺损、严重肾病。 肺脏系统：间质性肺炎、慢性间质性阻塞性肺病，呼吸困难、胸痛、低血氧症、死亡。中枢神经系统：头痛、嗜唾、视蒙、失语、偏瘫及惊劂均可发生，可能与动脉内插管的出血及合并症有关。惊厥、麻痹、格林巴利（Guillain-Barre）综合症及脑脊液压升高则见于鞘内注射之后。用低剂量后，偶有病人报告暂时性、敏锐的识别障碍、情绪改变及不常见的颅部感觉异常。对高剂量甲氨蝶呤静注于曾用脑脊髓照射过的病人曾报告有白质脑病。与应用甲氨蝶呤有关的或可归咎于它的其他反应，如代谢的改变、引起糖尿病。骨质疏松作用、组织细胞的异常改变及甚至猝死均曾报告过。用量及用法（a）抗癌化疗较宜选用甲氨蝶呤片剂口服，由于吸收快，且可达到效血清水平，推荐口服甲氨蝶呤应空腹服用。甲氨蝶呤钠盐可肌注、静脉、动脉或鞘内注射。非等渗的甲氨蝶呤注射不能作鞘内用。将mg/kg体表面积的比率为1：30，可作一个指南。转化因子依年龄及躯体组成而变动于1：20至1：40。 滋养细胞肿瘤常用剂量为15～30mg口服或肌注，连用5天。如果所有毒性体征均已消失。经过一或多周期，可给予次一疗程。一般应用3～5疗程。治疗的疗效一般由24小时尿中绒毛膜促性腺激素（CGH）的定量分析来估价，此值必须恢复到正常或低于每24小时50IU，一般经3～4疗程后达到，一般在4～6周后可测量的病变发生完全消散。 一般推荐在CGH正常化后再用1～2疗程。每个用药疗程前，小心的临床估价是必要的。甲氨蝶呤与其他化疗药合用循环联合化疗均曾报告作为很常用的。因为葡萄胎可先于绒癌。用甲氨蝶呤的预防性化疗曾被推荐使用。侵袭性绒毛膜腺瘤被考虑为葡萄胎的侵袭性形式。甲氨蝶呤用于此病，剂量与推荐于滋养叶肿瘤所用者相似。乳癌持久的循环联合化疗用环磷酰胺、甲氨蝶呤、氟尿嘧啶曾得良好疗效，当用于原发性乳癌而有阳性腋窝淋巴结者，作根治性乳癌切除术后，作鞘助化疗。甲氨蝶呤剂量为40mg/m2，第1及第8天静注。 白血病急性（淋巴母细胞性）白血病在儿童及青春期者为目前化疗中疗效者。在青年在人及较老病人，较难达到临床缓解，且较常发生早期复发，在慢性淋巴白血病有适当疗效的预后不大鼓舞。口服甲氨蝶呤3．3mg/m2 加上泼尼松每日60mg/m2 ，曾在淋巴母细胞白血病用于诱导缓解。当缓解及全身临床改善已经达到，则用甲氨蝶呤30mg/m2 口服或肌注，每周2次，可作维持用。这种疗法一般4～6周之内预期在50%病人产生缓解。交替地，每14天静脉注射2．5mg/kg。如发生复发，重复开始的诱导缓解方案常可再获得诱导缓解。近来介绍了各种烷化剂与抗叶酸剂的各种联合，供诱导缓解及维持解有各种剂量方案。包括甲氨蝶呤同时给各种药物的多药治疗，看来供急性及慢性白血病都获得更多的支持。 急性粒细胞白血病在儿童较少见，而在成人则常见。白血病对化疗反应差的类型缓解期短而复发常见。对药物的抗药性迅速发生。 脑膜白血病白血病病人可发生白血病侵袭中枢神经系统。这可表现为特证性体征与症状或无症状，而只能通过检查脑脊液（CSF），在这类病例可含白血病细胞而得到诊断。因此，在所有白血病病人的CSF必须检查。由于甲氨蝶呤从血清透入CSF很少，为了适当的治疗，必须鞘内注射药物。只有无防腐剂的甲氨蝶呤才可作鞘呤才可作鞘内注射。现常实用甲氨蝶呤鞘内注射以作预防用于所有急性淋巴细胞性白血病病例。 作鞘内注射后，甲氨蝶呤在CSF中分布，其溶积取于年龄非体表面积。出生时CSF约为成人的40%，几年后达到成人的体积。按年龄推荐的剂量如下：年龄（岁）＜1岁 1 2 3岁以上剂量（mg）4 8 10 12有某些指示看来用推荐量在小于4个月的婴儿及70岁以上成人的急性毒性会增加，因而要减量。用于治疗脑膜白血病，可以2-5天间隔应用甲氨蝶呤鞘内注射，然而有些资料指出，在少于一周再用可导致毒性增加。应用甲氨蝶呤直至CSF中细胞数目恢复正常，然后再应用一剂药物。为了预防脑膜白血病病人所用剂量与治疗相同，不过用药间隔不同。在这方面建议医生参考医学文献。 大剂量可引起惊厥。 任何作销内注射均可发生不良反应，且其性质常属神经学性。鞘内注射甲氨蝶呤后，可在全身循环中以明显的浓度出现，并可引起全身性的甲氨蝶呤毒性。因此，用本药作全身抗白血病治疗时，必须适当调整剂量，减量或停药。中枢神经系统灶性白血病侵犯可能对鞘内化疗无效，用放射治疗来治疗。淋巴瘤治疗I及II期Burkilt淋巴瘤，甲氨蝶呤的常用剂量为每天10～25mg，用4～8天。对III期者，甲氨蝶呤常与其他抗癌药物同用，对各期常用几个疗程的药物治疗，以7～10天休息期相间歇。III期淋巴瘤可能对加有甲氨蝶呤每天0.625mg～2.5mg/kg的联合治疗有效。甲氨蝶呤用于治疗霍奇金病无价值。蕈样肉芽肿用于治疗蕈样肉芽肿甲氨蝶呤剂量一般为25～10mg每天口服，用数周至数月。根据病人的疗效反应及血象监测决定起始剂量及剂量的调整。甲氨蝶呤亦可以50mg每周一次肌注，或25mg每周2次肌注应用。甲氨蝶呤看来可在受治病人的50%引起临床缓解。高剂量治疗必须阅读近期出版的文献以了解详细。在不同研究中，取决于疾病的性质与严重性，研究者的经验不同，剂量方案可以有相当大的变动。必须强调高剂量必须只可由资格的专家，并在具有必须设备的医院中应用。 为了防止甲氨蝶呤在肾小管中沉淀，病人必须在注射大剂量（＞200mg）后，2天内饮入大量液体，以保持足够尿量，并在以后连续用碳酸氢钠少24小时，以保持尿液碱化。（b）牛皮癣化疗对病人必须充分告知治疗所涉及的危险，并由医生持续监察。在开始用甲氨蝶呤，甲氨蝶呤治疗期间及在休息期后再开始甲氨蝶呤治疗前，必须根据病史、医生检查及实验室试验，以测定肾功能、肝功能及血液细胞（如血细胞汁、尿分析、血清肌肝、肝功能研究，如有需要则作肝活检）。要采取措施避免甲氨蝶呤治疗后少8周不能怀孕。 有3种常用的剂量方案形式：（1）每周口服或注射间歇的大剂量；（2）分次剂量在36小时期间间歇口服；（3）每日口服中间休息一段时间；所有方案必须根据个别病人不断调整。推荐在开始治疗前一周，注射单一试验剂量5～10mg，以测定有无任何异性反应。对70kg体重成人的剂量方案：（1）每周一次方案10～25mg，口服、肌注或静注，每周用直至达到适当疗效。每周剂量不得超过50mg。（2)分次剂量方案：每隔12小时口服25mg，连用3剂，或每隔8小时用4剂，每周一次。每周剂量不得超过30mg。（3)每天给药方案：每日口服2．5mg，连用5天，继而休息少2天。每日剂量不得超过6．25mg。每个方案的剂量可逐步调整，以获得临床疗效，而不超过耐受量。达到疗效后，每个剂量方案必须减到可能的剂量，及长的休息期，普通的局部治疗尽可能必须等待恢复。稳定性液体安瓶无防腐剂，因而必只用一次，剩馀即弃去。甲氨蝶呤注射可用氯化钠0．9%，5%葡萄糖液，Hartmann氏液，林格氏液及5%葡萄糖溶于氯化钠注射液稀释到1mg/ml浓度，如贮存在室温，有或无萤光下，可保持效价24小时。 然而，由于有微生物污染危险，混合后溶液的输注必须配合即用，在任何情况下，此过程必须24小时内完成。混合后溶液必须保存于2-80C。小心药剂师：因其可引起严重毒性，甲氨蝶呤治疗要求医生密切监察病人。药剂师一次不得发药超过7天，同一处方再给药只能由医生的直接医嘱（口头或出面）。过量一旦看见消化道溃疡或出血、下泻或造血系统明显的抑制，应立即停用甲氨蝶呤。甲酰四氢叶酸钙（Lcucovorin Calcium）是中和甲氨蝶呤对造血系统即发毒性很强的药物。在一般情况下，当怀疑有过量时，甲酰四氢叶酸用量必须等于或高于所给的甲氨蝶呤剂量，并应用越快越好，在小时之内，在这以后疗效就差得多。甲酰四氢叶酸钙可作静脉输注，剂量在12小时内可达75mg，继以每6小时12mg肌注，用4济。当甲氨蝶呤平均剂量看来有不良反应，则用甲酰四氢叶酸钙每6小时肌注6～12mg.，用4剂。推荐水化及用碳酸氢钠碱化尿液，用以防止甲氨蝶呤或其代谢物在肾小管中沉淀。用甲氨蝶呤治疗的病人应该建议增加摄入液体。
贮存：甲氨蝶呤注射液应贮存于25C之下，避光，甲氨蝶呤片剂应贮存于30C之下。
英文版说明书：
Methotrexate Injectionpronounced as (meth” oh trex’ ate)IMPORTANT WARNING: Expand SectionMethotrexate may cause very serious， life-threatening side effects. You should only receive methotrexate injection to treat life-threatening cancer， or certain other conditions that are very severe and that cannot be treated with other medications.Talk to your doctor about the risks of receiving methotrexate injection for your condition.Tell your doctor if you have or have ever had excess fluid in your stomach area or in the space around your lungs and if you have or have ever had kidney disease. Also tell your doctor if you are taking nonsteroidal anti-inflammatory drugs (NSAIDs) such as aspirin， choline magnesium trisalicylate (Tricosal， Trilisate)， ibuprofen (Advil， Motrin)， magnesium salicylate (Doan’s)， naproxen (Aleve， Naprosyn)， or salsalate.These conditions and medications may increase the risk that you will develop serious side effects of methotrexate. Your doctor will monitor you more carefully and may need to give you a lower dose of methotrexate or stop your treatment with methotrexate.Methotrexate may cause a decrease in the number of blood cells made by your bone marrow.Tell your doctor if you have or have ever had a low number of any type of blood cells or any other problem with your blood cells. Call your doctor immediately if you experience any of the following symptoms: sore throat， chills， fever， ongoing cough and congestion， or other signs of infection; unusual bruising or bleeding; unusual tiredness or weakness; pale skin; or shortness of breath.Methotrexate may cause liver damage， especially when it is taken for a long period of time.Tell your doctor if you drink or have ever drunk large amounts of alcohol or if you have or have ever had liver disease. Your doctor may not want you to receive methotrexate injection unless you have a life-threatening form of cancer because there is a higher risk that you will develop liver damage. The risk that you will develop liver damage may also be higher if you are elderly， obese， or have diabetes. Ask your doctor about the safe use of alcoholic beverages while you are receiving methotrexate injection.Tell your doctor if you are taking any of the following medications: acitretin (Soriatane)， azathioprine (Imuran)， isotretinoin (Accutane)， sulfasalazine (Azulfidine)， or tretinoin (Vesanoid). Call your doctor immediately if you experience any of the following symptoms: nausea， extreme tiredness， lack of energy， loss of appetite， pain in the upper right part of the stomach， yellowing of the skin or eyes， or flu-like symptoms.Your doctor may order liver biopsies (removal of a small piece of liver tissue to be examined in a laboratory) before and during your treatment with methotrexate.Methotrexate may cause lung damage.Tell your doctor if you have or have ever had lung disease. Call your doctor immediately if you experience any of the following symptoms: dry cough， fever， or shortness of breath.Methotrexate may cause damage to the lining of your mouth， stomach or intestines.Tell your doctor if you have or have ever had stomach ulcers or ulcerative colitis (a condition which causes swelling and sores in the lining of the colon [large intestine] and rectum).Call your doctor immediately if you experience any of the following symptoms: mouth sores， diarrhea， black， tarry， or bloody stools， and vomiting， particularly if vomit is bloody or looks like coffee grounds.Using methotrexate may increase the risk that you will develop lymphoma (cancer that begins in the cells of the immune system). If you do develop lymphoma， it might go away without treatment when you stop taking methotrexate， or it might need to be treated with chemotherapy.If you are taking methotrexate to treat cancer， you may develop certain complications that may be serious or life-threatening as methotrexate works to destroy the cancer cells. Your doctor will monitor you carefully and treat these complications if they occur.Methotrexate may cause serious or life-threatening skin reactions. If you experience any of the following symptoms， call your doctor immediately: fever， rash， blisters， or peeling skin.Methotrexate may decrease the activity of your immune system， and you may develop serious infections. Tell your doctor if you have any type of infection and if you have or have ever had any condition that affects your immune system. Your doctor may tell you that you should not receive methotrexate unless you have life-threatening cancer.If you experience signs of infection such as a sore throat， cough， fever， or chills， call your doctor immediately.If you receive methotrexate while you are being treated with radiation therapy for cancer， methotrexate may increase the risk that the radiation therapy will cause damage to your skin， bones， or other parts of your body.Keep all appointments with your doctor and the laboratory. Your doctor will order certain lab tests before， during， and after your treatment to check your body’s response to methotrexate and to treat side effects before they become severe.Tell your doctor if you or your partner is pregnant or plan to become pregnant.If you are female， you will need to take a pregnancy test before you receive methotrexate. Use a reliable method of birth control so that you or your partner will not become pregnant during or shortly after your treatment.If you are male， you and your female partner should continue to use birth control for 3 months after you stop using methotrexate. If you are female， you should continue to use birth control until you have had one menstrual period that began after you stopped using methotrexate.If you or your partner become pregnant， call your doctor immediately. Methotrexate may cause harm or death to the fetus.Why is this medicationExpand SectionMethotrexate injection is used alone or in combination with other medications to treat gestational trophoblastic tumors (a type of tumor that forms inside a woman’s uterus while she is pregnant)， breast cancer， lung cancer， certain cancers of the head and neck; certain types of leukemia (cancer of the white blood cells)， including acute lymphocytic leukemia (ALL) and meningeal leukemia (cancer in the covering of the spinal cord and brain); certain types of non-Hodgkin’s lymphoma (types of cancer that begin in a type of white blood cells that normally fights infection); cutaneous T-cell lymphoma (CTCL， a group of cancers of the immune system that first appear as skin rashes); and osteosarcoma (cancer that forms in bones) after surgery to remove the tumor.Methotrexate injection is also used to treat severe psoriasis (a skin disease in which red， scaly patches form on some areas of the body) that cannot be controlled by other treatments. Methotrexate injection is also used along with rest， physical therapy and sometimes other medications to treat severe active rheumatoid arthritis (RA; a condition in which the body attacks its own joints， causing pain， swelling， and loss of function) that cannot be controlled by certain other medications. Methotrexate is in a class of medications called antimetabolites. Methotrexate treats cancer by slowing the growth of cancer cells. Methotrexate treats psoriasis by slowing the growth of skin cells to stop scales from forming. Methotrexate may treat rheumatoid arthritis by decreasing the activity of the immune system.How should this medicine be used?Expand SectionMethotrexate injection comes as a powder to be mixed with liquid to be injected intramuscularly (into a muscle)， intravenously (into a vein)， intra-arterially (into an artery)， or intrathecally (into the fluid-filled space of the spinal canal).The length of treatment depends on the types of drugs you are taking， how well your body responds to them， and the type of cancer or condition you have.Ask your pharmacist or doctor for a copy of the manufacturer’s information for the patient.Other uses for this medicineExpand SectionMethotrexate is also sometimes used in combination with other medications to treat bladder cancer.It is also sometimes used to treat Crohn’s disease (condition in which the immune system attacks the lining of the digestive tract， causing pain， diarrhea， weight loss and fever) and other autoimmune diseases (conditions that develop when the immune system attacks healthy cells in the body by mistake). Ask your doctor about the risks of using this medication for your condition.This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.What special precautions should I follow?Expand SectionBefore receiving methotrexate injection，•tell your doctor and pharmacist if you are allergic to methotrexate， any other medications， or any of the ingredients in methotrexate injection. Ask your pharmacist for a list of the ingredients.•tell your doctor and pharmacist what prescription and nonprescription medications， vitamins， nutritional supplements， and herbal products you are taking or plan to take.Be sure to mention the medications listed in the IMPORTANT WARNING section and any of the following: certain antibiotics such as chloramphenicol (Chloramycetin)， penicillins， and tetracylcines; folic acid (available alone or as an ingredient in some multivitamins); other medications for rheumatoid arthritis; phenytoin (Dilantin); probenecid (Benemid); proton pump inhibitors (PPIs) such as esomeprazole (Nexium)， omeprazole (Prilosec， Prilosec OTC， Zegerid)， pantoprazole (Protonix); sulfonamides such as co-trimoxazole (Bactrim， Septra)， sulfadiazine， sulfamethizole (Urobiotic)， and sulfisoxazole (Gantrisin); and theophylline (Theochron， Theolair).Your doctor may need to change the doses of your medications or monitor you carefully for side effects.•tell your doctor if you have or have ever had any of the conditions mentioned in the IMPORTANT WARNING section or a low level of folate in your blood.•do not breastfeed while you are receiving methotrexate injection.•you should know that methotrexate may cause dizziness or make you feel drowsy. Do not drive a car or operate machinery until you know how this medication affects you.•plan to avoid unnecessary or prolonged exposure to sunlight or ultraviolet light (tanning beds and sunlamps) and to wear protective clothing， sunglasses， and sunscreen. Methotrexate may make your skin sensitive to sunlight or ultraviolet light.If you have psoriasis， your sores may get worse if you expose your skin to sunlight while you are receiving methotrexate.•do not have any vaccinations during your treatment with methotrexate without talking to your doctor.What special dietary instructions should I follow?Expand SectionUnless your doctor tells you otherwise， continue your normal diet.What side effects can this medication cause?Expand SectionMethotrexate may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:•joint or muscle pain•reddened eyes•swollen gums•hair lossSome side effects can be serious.If you experience any of these symptoms or those listed in the IMPORTANT WARNING section， call your doctor immediately or get emergency medical treatment:•vomiting•blurred vision or sudden loss of vision•sudden fever， severe headache， and stiff neck•seizures•confusion or memory loss•weakness or difficulty moving one or both sides of the body•difficulty walking or unsteady walking•loss of consciousness•impaired speech•decreased urination•swelling of the face， arms， hands， feet， ankles， or lower legs•hives•itching•skin rash•difficulty breathing or swallowingMethotrexate may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.If you experience a serious side effect， you or your doctor may send a report to the Food and Drug Administration’s (FDA) MedWatch Adverse Event Reporting program online or by phone (1-800-332-1088).In case of emergency/overdoseExpand SectionIn case of overdose， call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing， call local emergency services at 911.Symptoms of overdose may include the following:•sores in the mouth and throat•sore throat， chills， fever， ongoing cough and congestion， or other signs of infection•unusual bruising or bleeding•black and tarry or bloody stools•bloody vomit•vomited material that looks like coffee groundsWhat other information should I know?Expand SectionIt is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking， as well as any products such as vitamins， minerals， or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.