·         通用名：肾上腺素自动注射器

·         品牌：Epipen

什么是EpiPen和EpiPen Jr？

·         EpiPen和EpiPen Jr是一次性的，预填充的自动注射器，用于治疗有严重过敏紧急情况的风险或有严重过敏历史的人，包括危及生命的过敏性紧急情况。每个装置都包含单剂量的肾上腺素。

·         EpiPen和EpiPen Jr用于即时自我（或照料者）管理，不能代替紧急医疗服务。使用EpiPen和EpiPen Jr后，您应该立即获得紧急帮助。

·         EpiPen和EpiPen Jr适用于由其医疗保健提供者处方了这种药物的人。

·         EpiPen自动注射器（0.3毫克）适用于体重66磅或以上（30公斤或以上）的患者。

·         EpiPen Jr自动注射器（0.15毫克）适用于体重约33至66磅（15至30千克）的患者。

·         目前尚不清楚EpiPen和EpiPen Jr对于体重不足33磅（15公斤）的儿童是否安全有效。

EpiPen和EpiPen Jr可能会导致严重的副作用。

·         EpiPen或EpiPen Jr仅应注射到大腿外侧（大腿）的中间。不要 将EpiPen或EpiPen Jr注入您的：

如果您不小心将EpiPen或EpiPen Jr注射到身体的其他部位，请立即前往最近的急诊室。告诉医疗保健提供者意外注射在您身体上的哪个位置。

·         脉

·         臀部

·         手指，脚趾，手或脚

·         很少有使用EpiPen或EpiPen Jr的患者在注射后几天内会在注射部位感染。其中一些感染可能很严重。如果注射部位有以下任何情况，请立即致电您的医疗保健提供者：

·         不会消失的发红

·         肿胀

·         压痛

·         该地区摸起来很温暖

·         注射后不配合，踢脚或移动的幼儿发生皮肤割伤，弯曲的针头以及注射后残留在皮肤上的针头。如果给幼童注射EpiPen或EpiPen Jr，则在注射之前和注射过程中将其腿牢牢固定，以防止受伤。请您的医疗保健提供者向您展示如何：

1.     将幼儿牢固地固定在位（约束）。

2.     用一只手握住自动进样器，使橙色尖端朝下。

3.     用另一只手将蓝色安全释放器垂直向上拉出，使其脱离自动进样器。

·         如果您患有某些疾病或服用某些药物，则在使用EpiPen或EpiPen Jr时，您的病情可能会变得更糟或副作用更长。 与您的医疗保健提供者谈谈您的所有医疗状况。

EpiPen和EpiPen Jr的常见副作用包括：

 

·         快速，不规则或“剧烈”的心跳

·         出汗

·         头痛

·         弱点

·         颤抖

·         苍白

·         过度兴奋，紧张或焦虑的感觉

·         头晕

·         恶心或呕吐

·         呼吸问题

这些副作用可能会随着休息而消失。 告诉您的医疗保健提供者，如果您有任何困扰您或不会消失的副作用。

这些并非EpiPen或EpiPen Jr的所有可能的副作用。有关更多信息，请咨询您的医疗保健提供者或药剂师。

打电话给您的医生，征求有关副作用的医疗建议。 您可以通过1-800-FDA-1088向FDA报告副作用。

 

描述

EpiPen（肾上腺素注射液，USP）0.3 mg和EpiPen Jr（肾上腺素注射液，USP）0.15 mg ar e自动注射器和包含药物和器械成分的组合产品。

每个0.3 mg EpiPen自动注射器在无菌溶液中从肾上腺素注射液中以USP 1：1000（0.3 mL）的剂量注射0.3 mg肾上腺素。

0.15 mg的每个EpiPen Jr自动注射器在无菌溶液中从肾上腺素注射液USP 1：2000（0.3 mL）递送单剂量的0.15 mg肾上腺素。

EpiPen和EpiPen Jr各自包含2 mL肾上腺素溶液。激活后，自动进样器中大约剩余1.7 mL，但不可再使用，应将其丢弃。

EpiPen自动注射器中的每0.3 mL都包含0.3 mg肾上腺素，1.8 mg氯化钠，0.5 mg焦亚硫酸钠，用于调节pH的盐酸和注射用水。 pH范围是2.2-5.0。

EpiPen Jr自动注射器中的每0.3 mL都包含0.15 mg肾上腺素，1.8 mg氯化钠，0.5 mg焦亚硫酸钠，用于调节pH的盐酸和注射用水。 pH范围是2.2-5.0。

肾上腺素是一种拟交感神经儿茶酚胺。化学上，肾上腺素是具有以下结构的（-）-3,4-二羟基-α-[（甲基氨基）甲基]苄醇：

肾上腺素溶液在暴露于空气或光线下会迅速变质，从氧化变成粉红色到肾上腺色素，从黑色素形成变成棕色。如果肾上腺素溶液变色（粉红色或棕色），浑浊或含有颗粒，请更换EpiPen和EpiPenJr。

 

适应症

EpiPen和EpiPen Jr用于过敏性反应（I型）的紧急治疗，包括对刺痛昆虫（例如，膜翅目，包括蜜蜂，黄蜂，黄蜂，黄夹克和火蚁）的过敏反应和咬虫（例如三角藻，蚊子），过敏原免疫疗法，食品，药物，诊断测试物质（例如，放射造影剂）和其他过敏原，以及特发性过敏反应或运动引起的过敏反应。

EpiPen和EpiPen Jr适用于确定患有过敏反应风险增加的患者（包括具有过敏反应史的患者）立即给药。

过敏反应可能在暴露后数分钟内发生，包括潮红，忧虑，晕厥，心动过速，与血压下降有关的细丝或无法获得的脉搏，抽搐，呕吐，腹泻和腹部绞痛，非自愿排尿，喘息，喉痉挛引起的呼吸困难，瘙痒，皮疹，荨麻疹或血管性水肿。

EpiPen和EpiPen Jr仅可作为紧急支持疗法立即给药，不能替代即时医疗服务。

 剂量 

剂量和给药

根据患者体重确定适当的剂量强度（EpiPen 0.3 mg或EpiPen Jr 0.15 mg）的选择。

·         大于或等于30千克（约66磅或更多）的患者：EpiPen 0.3毫克

·         15至30公斤（33磅至66磅）的患者：EpiPen Jr 0.15毫克

必要时通过衣服向大腿前外侧肌肉内或皮下注射EpiPen或EpiPenJr。指导年幼儿童的看护人，他们应给他们开处方的EpiPen或EpiPen Jr，他们在注射过程中可能会不合作并踢脚或移动，以将腿牢牢地固定在位，并限制注射前和注射过程中的运动[请参见 警告和注意事项 ]。

每个EpiPen或EpiPen Jr均包含单剂量肾上腺素，可用于单次注射。由于从EpiPen或EpiPen Jr递送的肾上腺素的剂量是固定的，因此如果认为必要剂量低于0.15 mg，请考虑使用其他形式的可注射肾上腺素。

处方者应仔细评估每位患者，以确定最合适的肾上腺素剂量，同时应认识到使用该药会危及生命。对于严重的持续过敏反应，可能需要重复注射额外的EpiPen或EpiPenJr。连续两次以上剂量的肾上腺素只能在直接医疗监督下给药[见 警告和注意事项 ]。

应目测检查EpiPen自动进样器透明窗口中的肾上腺素溶液是否有颗粒物和变色。肾上腺素对光敏感，应存放在提供的载管中以保护其免受光照[请参见 供应方式 ]。

 

剂型和优势

·         EpiPen：注射液，0.3 mg / 0.3 mL肾上腺素注射液，USP，预填充自动注射器

·         EpiPen Jr：注射剂，0.15 mg / 0.3 mL肾上腺素注射剂，USP，预填充自动注射器

EpiPen自动注射器（肾上腺素注射液，USP 0.3毫克/0.3毫升） 可作为EpiPen 2Pak， 国家发展中心 49502-500-02，一种包装，其中包含两个EpiPen自动注射器（肾上腺素注射液，USP 0.3 mg / 0.3 mL）和一个EpiPen自动注射器训练仪设备。

EpiPen Jr自动注射器（肾上腺素注射液，USP 0.15 mg / 0.3 mL） 可作为EpiPen Jr 2-Pak， 国家发展中心 49502-501-02，一种包装，其中包含两个EpiPen Jr自动注射器（肾上腺素注射液，USP 0.15 mg / 0.3 mL）和一个EpiPen自动注射器训练仪设备。

EpiPen 2-Pak和EpiPen Jr 2-Pak还包括一个S形夹，可将两个承载管夹在一起。

储存和处理

避光。肾上腺素对光敏感，应保存在提供的载管中以保护其免受光照。储存在20°至25°C（68°至77°F）;允许在15°至30°C（59°至86°F）的范围内进行偏移[请参阅USP控制的室温]。不要冷藏。在使用之前，请检查以确保自动注射器中的溶液干净无色。如果溶液变色（粉红色或棕色），浑浊或有颗粒，请更换自动进样器。

正确处置所有使用过的，不需要的或已过期的EpiPen和EpiPen Jr自动进样器[请参见 患者信息 ]。

制造商：辉瑞公司美国哥伦比亚的Meridian Medical Technologies，Inc.，医学博士21046。修订日期：2020年1月

 副作用与药物相互作用 

副作用

由于缺乏肾上腺素用于过敏性反应的随机对照临床试验，因此很难确定与全身使用肾上腺素相关的不良反应的真实发生率。下面列出了观察性试验，病例报告和研究中报告的不良反应。

全身注射肾上腺素的常见不良反应包括焦虑症；忧虑不安;震颤弱点;头晕;出汗;心pit苍白恶心和呕吐;头痛;和/或呼吸困难。这些症状发生在接受肾上腺素治疗剂量的某些人中，但更可能发生在高血压或甲状腺功能亢进症的患者中[见 警告和注意事项 ]。

据报道心律不齐，包括致命性心室纤颤，特别是在患有基础性心脏病或接受某些药物的患者中[见 警告和注意事项 和 药物相互作用 ]。

血压的迅速升高已引起脑出血，特别是在患有心血管疾病的老年患者中[见 警告和注意事项 ]。

冠心病患者可发生心绞痛[见 警告和注意事项 ]。

据报道，肾上腺素治疗的患者很少出现应激性心肌病。

意外注射手指，手或脚可能会导致流向患处的血液流失[请参见 警告和注意事项 ]。

意外注射导致的不良事件可能包括心律加快，局部反应（包括注射部位苍白），寒冷和感觉不足或注射部位受伤，导致瘀伤，出血，变色，红斑或骨骼损伤。

当将EpiPen注射到不合作并在注射过程中踢脚或移动的幼儿的大腿中时，据报道有裂伤，弯曲的针头和埋入的针头[请参见 警告和注意事项 ]。

注射到臀部会导致坏疽性气体的发生[请参见 警告和注意事项 ]。

肾上腺素注射后，包括大腿上注射EpiPen的罕见病例出现严重的皮肤和软组织感染，包括坏死性筋膜炎和梭状芽胞杆菌（坏疽性气体坏死）引起的肌坏死[见 警告和注意事项 ]。

 

 

药物相互作用

在同时服用强心苷，利尿剂或抗心律不齐的同时接受肾上腺素的患者，应仔细观察其发生心律不齐的情况[请参见 警告和注意事项 ]。

三环类抗抑郁药，单胺氧化酶抑制剂，左甲状腺素钠和某些抗组胺药（尤其是扑尔敏，三烯胺和苯海拉明）可增强肾上腺素的作用。

肾上腺素的心脏刺激和支气管扩张作用被β-肾上腺素能阻断药如普萘洛尔所拮抗。

肾上腺素的血管收缩和高血压作用被α-肾上腺素能阻断药物如苯妥拉明拮抗。

麦角生物碱也可能逆转肾上腺素的升压作用。

 警告和注意事项 

警告

包含在 '防范措施' 部分

防范措施紧急治疗

EpiPen和EpiPen Jr旨在作为紧急支持疗法立即给药，而不是替代即时医疗服务。 与肾上腺素一起给药，患者应立即就医或住院治疗。 连续两次以上剂量的肾上腺素只能在直接医疗监督下给药[见 适应症 ， 剂量和给药 和 患者信息 ]。

注射相关并发症

EpiPen和EpiPen Jr应该 只要 被注射到大腿的前外侧[请参阅 剂量和给药 和 患者信息 ]。

·         不要静脉注射。 大剂量或意外静脉注射肾上腺素可能会因血压急剧上升而导致脑出血。如果不小心服用，速效血管舒张药可以抵消肾上腺素显着的升压作用。

·         不要注入臀部。 注射到臀部可能无法提供有效的过敏反应治疗。建议患者立即去最近的急诊室进行进一步的过敏反应治疗。另外，向臀部注射与梭菌感染（坏疽性气体）有关。用酒精清洗不会杀死细菌的孢子，因此不会降低这种风险。

·         请勿注入手指，手或脚。 由于肾上腺素是强血管收缩剂，因此意外注射到手指，手或脚可能会导致流向患处的血流减少。建议患者立即去最近的急诊室，并告知急诊室的医疗人员意外注射的位置。除了进一步适当的过敏反应治疗外，这种疏忽性给药的治疗还应包括血管舒张[请参见 不良反应 ]。

·         在注射过程中牢牢握住腿。 将EpiPen和EpiPen Jr注射到不合作并在注射过程中踢动或移动的幼儿的大腿中时，据报道有裂伤，弯曲的针头和埋入的针头。为了最大程度地减少对年幼的孩子服用EpiPen时与注射相关的伤害风险，请指示护理人员将孩子的腿牢牢固定在位，并在注射之前和注射过程中限制运动。

注射部位严重感染

在肾上腺素注射后，注射部位发生过敏反应的罕见病例有严重的皮肤和软组织感染病例，包括坏死性筋膜炎和梭状芽胞杆菌（坏疽性气体引起的）坏死。 梭菌 孢子可以存在于皮肤上，并通过皮下或肌内注射引入深层组织。尽管用酒精清洁可能会减少皮肤上细菌的存在，但是酒精清洁并不会杀死皮肤 梭菌 孢子。降低风险 梭菌 感染，请勿将EpiPen注入臀部[请参阅 警告和注意事项 ]。如果患者在肾上腺素注射部位出现感染迹象或症状，例如持续发红，发热，肿胀或压痛，则建议患者就医。

与亚硫酸盐有关的过敏反应

即使患者对亚硫酸盐敏感，该产品中亚硫酸盐的存在也不能阻止该药物用于治疗严重的过敏或其他紧急情况。

肾上腺素是严重过敏反应或其他紧急情况的首选治疗方法，即使该产品含有偏亚硫酸氢钠，亚硫酸氢盐在其他产品中也可能引起过敏型反应，包括过敏性症状或危及生命或在某些易感人群中发作较轻的哮喘发作人。

在危及生命的情况下使用肾上腺素的替代方案可能并不令人满意。

疾病相互作用

服用肾上腺素后，某些患者发生不良反应的风险可能更大。尽管存在这些担忧，但是应该认识到，在急性，威胁生命的情况下，这些条件的存在并不是肾上腺素给药的禁忌症。因此，应仔细指导有这些情况的患者和/或可能对经历过敏性反应的患者使用EpiPen或EpiPen Jr的任何其他人员，以了解应使用肾上腺素的情况。

心脏病患者

对患有心脏病的患者，包括患有心律不齐，冠状动脉或器质性心脏病或高血压的患者，应谨慎服用肾上腺素。在此类患者中，或在使用可能使心脏对心律不齐敏感的药物的患者中，肾上腺素可能会沉淀或加重心绞痛，并产生室性心律失常[请参见 药物相互作用 和 不良反应 ]。

其他患者和疾病

甲亢，糖尿病，老年人和孕妇应谨慎服用肾上腺素。帕金森氏病患者可能会注意到症状暂时恶化。

 

医疗保健提供者应与患者或护理人员一起详细阅读患者的说明和EpiPen和EpiPen Jr的操作。

肾上腺素对于过敏反应的治疗至关重要。应仔细指导有危险或对昆虫的叮咬，叮咬，食物，药物和其他过敏原有严重过敏反应（过敏反应）的病史，以及特发性和运动引起的过敏反应的患者，在这种情况下应谨慎指导应该使用肾上腺素。

行政与培训

指导患者和/或看护者正确使用EpiPen和JR EpiPen。应将EpiPen注射到大腿外侧中间（如有必要，通过衣服）。每个设备都是一次性注射剂。建议患者在EpiPen的管理下立即就医。

指导护理人员将幼儿的腿牢牢固定在位，并在注射之前和注射过程中限制运动。当将EpiPen和EpiPen Jr注射到不合作并在注射过程中踢脚或移动的幼儿的大腿中时，据报道有裂伤，弯曲的针头和埋入的针头[请参见 警告和注意事项 ]。

指导患者和/或看护者在使用EpiPen和EpiPen Jr后立即丢弃蓝色安全释放剂。这一小部分可能对儿童造成窒息危险。

可以在每个EpiPen或EpiPen Jr纸盒内找到完整的患者信息，包括剂量，正确使用说明和注意事项。 EpiPen表面上的印刷标签显示使用说明和描绘注射过程的示意图。

指导患者和/或护理人员与培训师一起使用和练习，以使他们熟悉在过敏性紧急情况下使用EpiPen。培训师可以多次使用。 2-Pak纸箱中提供了Trainer设备。

指示患者和/或护理人员立即将蓝色安全释放器放回培训师上，并在练习后将其复位。这小部分可能对儿童造成窒息危险。

不良反应

肾上腺素可能产生的症状和体征包括心律加快，心跳加快，心pit，出汗，恶心和呕吐，呼吸困难，面色苍白，头晕，虚弱或发抖，头痛，忧虑，神经质或焦虑。这些体征和症状通常会很快消退，尤其是在休息，安静和躺卧的情况下。患有高血压或甲状腺功能亢进症的患者可能会出现更严重或持续的影响，患有冠状动脉疾病的患者可能会出现心绞痛。服用肾上腺素后，糖尿病患者的血糖水平可能升高。帕金森氏病患者可能会发现症状暂时恶化[请参阅 警告和注意事项 ]。

意外注射

建议患者在意外注射的情况下立即就医。由于肾上腺素注射到手指，手或脚时是强血管收缩剂，因此如果意外注射到这些区域，应针对血管舒张进行治疗[参见 警告和注意事项 ]。

注射部位严重感染

在肾上腺素注射后，注射部位发生过敏反应的罕见病例有严重的皮肤和软组织感染病例，包括坏死性筋膜炎和梭状芽胞杆菌（坏疽性气体引起的）坏死。如果患者在肾上腺素注射部位出现感染迹象或症状，例如持续发红，发热，肿胀或压痛，建议患者就医[请参见 警告和注意事项 ]。

储存和处理

指导患者定期通过自动注射器的透明窗口目视检查肾上腺素溶液。如果肾上腺素溶液变色（粉红色或棕色），浑浊或含有颗粒，请更换EpiPen和EpiPenJr。肾上腺素对光敏感，应保存在提供的载管中以保护其免受光照。承载管不防水。告知患者，一旦移除蓝色安全释放器或使用后，必须使用EpiPen和EpiPen Jr或妥善处置[请参阅 储存和处理 ]。

劝告患者和护理人员及时处置不再需要的药物。将过期的，不需要的或未使用的EpiPen和EpiPen Jr自动注射器放入FDA清洁的尖锐容器中。指示患者不要将EpiPen或EpiPen Jr丢入家庭垃圾中。告知患者，如果他们没有FDA批准的锐器处置容器，则可以使用由重型塑料制成的家用容器，可以用紧密安装且防刺破的盖子将其封闭，而锐器则不能出来，在使用过程中保持直立稳定，防漏，并贴有适当标签，以警告容器内的危险废物。通知患者他们可以访问FDA网站，以获取有关未使用药物处置的更多信息。

完整的患者信息，包括剂量，正确使用说明和注意事项，可在每个EpiPen自动注射器纸箱内找到。

非临床毒理学致癌，诱变，生育力受损

尚未进行评估肾上腺素致癌潜力的长期研究。

肾上腺素和其他儿茶酚胺已被证明具有诱变潜力 体外 。肾上腺素在 沙门氏菌 细菌反向突变检测，小鼠淋巴瘤检测为阳性，而小鼠淋巴瘤检测为阴性 体内 微核分析。肾上腺素是一种氧化诱变剂，基于 大肠杆菌 WP2 Mutoxitest细菌反向突变测定法。在下列情况下，这不应阻止肾上腺素的使用： 适应症 。

尚未评估肾上腺素损害生殖能力的潜力，但已证明肾上腺素在妊娠第3天皮下注射1.2 mg / kg / day（人类最高肌内或皮下每日剂量的40倍）时减少了其植入率

 

在特定人群中使用怀孕风险摘要

肾上腺素对孕妇的急性影响尚无充分且得到良好控制的研究。在动物生殖研究中，在器官发生期间通过皮下途径向兔子，小鼠和仓鼠施用的肾上腺素具有致畸性，其剂量是人推荐的肌肉和皮下最大推荐剂量的7倍，甚至高于mg / m二基础。肾上腺素是治疗妊娠期过敏反应的首选一线药物。肾上腺素在妊娠期间应以与非妊娠患者相同的方式用于过敏性反应的治疗。

在美国一般人群中，临床公认的怀孕中主要先天缺陷和流产的背景风险估计分别为2％至4％和15％至20％。

临床注意事项

与疾病相关的孕产妇和胚胎/胎儿风险

怀孕期间，过敏反应可能是灾难性的，并可能导致低氧缺血性脑病，并在母亲（更常见的是在胎儿或新生儿）中导致永久性中枢神经系统损害或死亡。据报道，怀孕期间发生过敏反应的患病率约为每100,000例分娩3例。

怀孕期间过敏反应的管理与普通人群的管理相似。肾上腺素是治疗过敏反应的首选药物。孕妇和非孕妇应以相同的方式使用它。与肾上腺素一起给药，患者应立即就医或住院治疗。

数据

动物资料

在胚胎发育研究中，在器官发生期间给兔子服用剂量，肾上腺素被证明具有致畸性（包括胃痉挛和胚胎致死率），其剂量约为最大推荐肌注或皮下剂量（毫克/米）的40倍二母体皮下注射剂量为1.2毫克/千克/天，持续2至3天）。

在一项胚胎胎儿发育研究中，在器官发生期间给予了小鼠剂量，肾上腺素被证明具有致畸性（包括胚胎致死性），其剂量约为推荐的最大肌内或皮下剂量（mg / m 3）的八倍。二母体皮下剂量1毫克/千克/天，持续10天）。在大约每日建议的最大肌内或皮下剂量（以mg / m计）的4倍的小鼠中未观察到这些作用二皮下孕产妇剂量为0.5 mg / kg /天，持续10天）。

在胚胎胎儿发育研究中，从妊娠第7天到第10天的器官形成期间服用仓鼠，肾上腺素被证明具有致畸性，其剂量约为最大推荐肌肉内或皮下剂量（mg / m 2）的7倍。二母体皮下注射剂量为0.5 mg / kg /天）。

哺乳期风险摘要

没有关于人乳中肾上腺素的存在，对母乳喂养婴儿的影响或对牛奶产量的影响的信息。肾上腺素是治疗过敏反应的首选药物。母乳喂养和非母乳喂养患者应以相同的方式使用。

小儿用药

EpiPen或EpiPen Jr可以以适合体重的剂量施用于小儿患者[请参见 剂量和给药 ]。使用肾上腺素的临床经验表明，儿童中观察到的不良反应的性质和程度与成人预期和报告的相似。由于从EpiPen和EpiPen Jr输送的肾上腺素的剂量是固定的，因此，如果认为必要剂量低于0.15 mg，请考虑使用其他形式的可注射肾上腺素。

老人用

尚未在65岁及以上的受试者中进行过敏性反应的临床研究，以确定它们是否与年轻受试者反应不同。但是，其他有关使用肾上腺素治疗过敏性反应的临床经验也表明，老年患者可能对肾上腺素的作用特别敏感。因此，对于老年患者，应谨慎使用EpiPen，他们在肾上腺素给药后可能出现不良反应的风险更大[请参见 警告和注意事项 ， 过量 ]。

 药物过量和禁忌症 

过量

肾上腺素的过量使用可能产生极高的动脉压，这可能导致脑血管出血，特别是在老年患者中。过量使用还可能由于周围血管收缩和心脏刺激而导致肺水肿。治疗由速效血管扩张药或α-肾上腺素阻断药和/或呼吸支持药组成。

肾上腺素的过量使用也会导致短暂性心动过缓，继而引起心动过速，并且可能伴有致命的心律失常。注射后一分钟内可能会出现室性早搏，随后可能会发生多灶性室性心动过速（心律失常）。心室作用的消沉可能继之以房性心动过速，有时是房室传导阻滞。心律不齐的治疗包括给予β-肾上腺素阻断药如心得安。

过量使用有时会导致皮肤苍白，发冷，代谢性酸中毒和肾功能衰竭。在这种情况下必须采取适当的纠正措施。

 

禁忌症

没有

 临床药理学 

临床药理学作用机理

肾上腺素对α-和β-肾上腺素受体均起作用。

药效学

通过对α-肾上腺素受体的作用，肾上腺素减轻了在过敏反应期间发生的血管舒张和血管通透性的增加，这可导致血管内液量减少和低血压。

通过对β-肾上腺素受体的作用，肾上腺素引起支气管平滑肌松弛，并有助于减轻过敏性反应期间可能发生的支气管痉挛，喘息和呼吸困难。

肾上腺素还可以缓解瘙痒，荨麻疹和血管性水肿，并可以缓解与过敏反应有关的胃肠道和泌尿生殖道症状，因为它对胃，肠，子宫和膀胱的平滑肌具有松弛作用。

皮下或肌内注射时，肾上腺素起效快，作用时间短。

 用药指南 

患者信息

使用说明

IP
（肾上腺素注射液，USP）
自动注射器0.3毫克
EpiPen =一剂0.3 mg肾上腺素，USP 0.3 mg / 0.3 mL

埃皮本
（肾上腺素注射液，USP）
自动注射器0.15毫克
EpiPen Jr = 0.15毫克肾上腺素一剂，USP 0.15毫克/0.3毫升

对于过敏性紧急情况（过敏反应）

患者信息

在使用EpiPen或EpiPen Jr自动注射器之前，以及每次获得笔芯时，请仔细阅读此患者信息传单。可能有新的信息。您，您的父母，照料者或其他有可能可以使用EpiPen或EpiPen Jr自动注射器的人，在发生过敏性紧急情况之前，应该知道如何使用它。

此信息不能代替您与医疗保健提供者讨论您的医疗状况或治疗方法。

关于EpiPen和EpiPen Jr，我应该了解的最重要信息是什么？

如果您需要其他单位来保持工作，学校或其他地点的位置，请与您的医疗保健提供者联系。告诉您的家庭成员，护理人员和其他人，您将EpiPen或EpiPen Jr保存在何处以及在需要之前如何使用它。在过敏紧急情况下，您可能无法说话。

1.     EpiPen和EpiPen Jr包含肾上腺素，这是一种用于治疗过敏性紧急情况（过敏反应）的药物。过敏反应可能会危及生命，可能在几分钟内发生，并且可能是由刺痛，咬虫，过敏性注射，食物，药物，运动或未知原因引起的。

过敏反应的症状可能包括：

·         呼吸困难

·         喘息

·         声音嘶哑（声音发声方式的变化）

·         荨麻疹（发红的皮疹可能会痒）

·         严重的瘙痒

·         脸，嘴唇，嘴或舌头肿胀

·         皮疹，发红或肿胀

·         快速的心跳

·         弱脉冲

·         感到很着急

·         困惑

·         肚子疼

·         失去对尿液或肠蠕动的控制（失禁）

·         腹泻或胃痉挛

·         头晕，昏厥或“昏倒”（失去知觉）

2.     始终随身携带EpiPen或EpiPen Jr，因为您可能不知道什么时候发生过敏反应。

3.     当您有过敏性紧急情况（过敏反应）时

·         立即使用EpiPen或EpiPenJr。

·         立即获得紧急医疗帮助。 您可能需要进一步的医疗护理。如果症状持续或复发，则可能需要使用第二个EpiPen或EpiPenJr。如果单个过敏反应发作需要两次以上注射，则只有医疗服务提供者应给予更多剂量的肾上腺素。

 

什么是EpiPen和EpiPen Jr？

·         EpiPen和EpiPen Jr是一次性的，预填充的自动注射装置（自动注射器），用于治疗威胁生命危险或有严重过敏史的人的危及生命的过敏性紧急情况，包括过敏反应。每个装置都包含单剂量的肾上腺素。

·         EpiPen和EpiPen Jr用于即时自我（或照料者）管理，不能代替紧急医疗服务。使用EpiPen和EpiPen Jr后，您应该立即获得紧急帮助。

·         EpiPen和EpiPen Jr适用于由其医疗保健提供者处方了这种药物的人。

·         EpiPen自动注射器（0.3毫克）适用于体重66磅或以上（30公斤或以上）的患者。

·         EpiPen Jr自动注射器（0.15毫克）适用于体重约33至66磅（15至30千克）的患者。

·         目前尚不清楚EpiPen和EpiPen Jr对于体重不足33磅（15公斤）的儿童是否安全有效。

在使用EpiPen或EpiPen Jr之前，我应该告诉我的医疗保健提供者什么？

在使用EpiPen或EpiPen Jr之前，请告知您的医疗保健提供者您的所有医疗状况，尤其是如果您：

·         有心脏问题或高血压。

·         患有糖尿病。

·         有甲状腺问题。

·         患有哮喘。

·         有抑郁症的历史。

·         患有帕金森氏病。

·         正在怀孕或打算怀孕。目前尚不清楚肾上腺素是否会损害未出生的婴儿。

·         正在母乳喂养或计划母乳喂养。不知道肾上腺素是否会进入母乳。

告诉您的医护人员您所服用的所有药物， 包括处方药和非处方药，维生素和草药补品。告诉您的医疗保健提供者您所有已知的过敏情况。

尤其要告诉您的医疗保健提供者您是否服用某些哮喘药物。

EpiPen或EpiPen Jr和其他药物可能会相互影响，引起副作用。 EpiPen或EpiPen Jr可能会影响其他药物的工作方式，而其他药物可能会影响EpiPen或EpiPen Jr的工作方式。

知道你吃的药。保留一份清单，以在您购买新药时向您的医疗保健提供者和药剂师显示。

无论您的医疗状况或所服用的药物如何，均应按照医疗保健提供者的规定使用EpiPen或EpiPen Jr进行过敏性反应的治疗。

我应该如何使用EpiPen和EpiPen Jr？

针从橙色尖端伸出。意外注射到手指，手或脚可能会导致这些区域的血液流失。 如果发生这种情况，请立即前往最近的急诊室。 告诉医疗保健提供者意外注射在您身体上的哪个位置。

·         每个EpiPen或EpiPen Jr自动注射器仅包含1剂药物。

·         EpiPen或EpiPen Jr应该注射到大腿外侧（大腿）的中间。如果需要，可以通过衣服注射。

·         阅读此患者信息手册末尾的使用说明，了解正确使用EpiPen和EpiPen Jr的方法。

·         您的医疗保健提供者将向您展示如何安全使用EpiPen或EpiPen Jr自动注射器。

·         完全按照医疗保健提供者的指示使用您的EpiPen或EpiPenJr。如果症状持续或复发，则可能需要使用第二个EpiPen或EpiPenJr。如果单个过敏反应发作需要两次以上注射，则只有医疗服务提供者应给予更多剂量的肾上腺素。

·         警告：切勿将拇指，手指或手放在橙色尖端上。切勿用拇指，手指或手按压或推动橙色笔尖。

·         您的EpiPen和EpiPen Jr自动注射器可能与EpiPen培训师和单独的培训师包装在一起包装。 EpiPen Trainer具有灰色。灰色EpiPen Trainer不含药物和针头。 发生过敏性紧急情况之前，请定期与EpiPen Trainer练习，以确保您能够在紧急情况下安全地使用真正的EpiPen和EpiPen Jr自动注射器。如果发生过敏性紧急情况，请始终随身携带真正的EpiPen或EpiPen Jr自动注射器。其他培训资源可在以下网址获得： www.epipen.com。

·         请勿使载管或自动进样器掉落。如果载管或自动注射器掉落，请检查是否有损坏和泄漏。丢弃（处置）自动注射器和输送管，如果发现或怀疑有损坏或泄漏，请进行更换。

 

EpiPen和EpiPen Jr可能产生哪些副作用？

EpiPen和EpiPen Jr可能会导致严重的副作用。

如果您不小心将EpiPen或EpiPen Jr注射到身体的其他部位，请立即前往最近的急诊室。告诉医疗保健提供者意外注射在您身体上的哪个位置。

·         EpiPen或EpiPen Jr仅应注射到大腿外侧（大腿）的中间。不要 将EpiPen或EpiPen Jr注入您的：

·         脉

·         臀部

·         手指，脚趾，手或脚

·         很少有使用EpiPen或EpiPen Jr的患者在注射后几天内会在注射部位感染。其中一些感染可能很严重。如果注射部位有以下任何情况，请立即致电您的医疗保健提供者：

·         不会消失的发红

·         肿胀

·         压痛

·         该地区摸起来很温暖

·         注射后不配合，踢脚或移动的幼儿发生皮肤割伤，弯曲的针头以及注射后残留在皮肤上的针头。如果给幼童注射EpiPen或EpiPen Jr，则在注射之前和注射过程中将其腿牢牢固定，以防止受伤。请您的医护人员告诉您如何在注射过程中正确握住年幼的孩子的腿。

·         如果您患有某些疾病或服用某些药物，则在使用EpiPen或EpiPen Jr时，您的病情可能会变得更糟或副作用更长。 与您的医疗保健提供者谈谈您的所有医疗状况。

EpiPen和EpiPen Jr的常见副作用包括：

·         快速，不规则或“剧烈”的心跳

·         出汗

·         头痛

·         弱点

·         颤抖

·         苍白

·         过度兴奋，紧张或焦虑的感觉

·         头晕

·         恶心或呕吐

·         呼吸问题

这些副作用可能会随着休息而消失。 告诉您的医疗保健提供者，如果您有任何困扰您或不会消失的副作用。

这些并非EpiPen或EpiPen Jr的所有可能的副作用。有关更多信息，请咨询您的医疗保健提供者或药剂师。

致电您的医疗保健提供者以获取有关副作用的医疗建议。 您可以通过1-800-FDA-1088向FDA报告副作用。

我应该如何存储EpiPen和EpiPen Jr？

·         将EpiPen和EpiPen Jr存放在68°F至77°F（20°C至25°C）的室温下。

·         避光。

·         不要 暴露于极冷或极热的环境中。例如， 不要 存放在车辆的杂物箱中， 不要 存放在冰箱或冰柜中。

·         定期检查自动注射器的空白窗口中的内容。解决方案应该清楚。如果溶液变色（粉红色或棕色）或含有固体颗粒，请更换装置。

·         始终将EpiPen或EpiPen Jr自动进样器放在输送管中，以防止损坏。承载管不防水。

·         蓝色安全释放装置有助于防止意外注射。保持蓝色安全释放，直到需要使用EpiPen或EpiPenJr。

·         您的EpiPen或EpiPen Jr有有效期限。在到期日期之前将其更换。将过期，不需要或未使用的EpiPen和EpiPen Jr丢弃（丢弃）在FDA许可的锐器处置容器中。请勿将EpiPen或EpiPen Jr丢入家庭垃圾中。如果您没有FDA批准的锐器处置容器，则可以使用以下家用容器：

·         由重型塑料制成

·         可以用紧密的防刺破盖封闭，而不会掉出尖锐的东西

·         使用过程中直立稳定

·         防漏，和

·         正确贴标签以警告容器内的危险废物

访问FDA网站（ www.fda.gov/drugs/safe-disposal-medicines/disposalunused-medicines-what-you-should-know ），以获取有关如何丢弃（处置）未使用药物的更多信息。

将EpiPen和EpiPen Jr以及所有药品放在儿童接触不到的地方。

有关安全有效使用EpiPen和EpiPen Jr的一般信息

有时出于患者信息手册中列出的目的以外的目的开出处方药。请勿在未规定的条件下使用EpiPen或EpiPenJr。请勿将您的EpiPen或EpiPen Jr交给他人。

此患者信息单张总结了有关EpiPen和EpiPen Jr的最重要信息。如果您需要更多信息，请与您的医疗保健提供者联系。您可以向您的药剂师或医疗保健提供者咨询有关为医疗专业人员编写的EpiPen和EpiPen Jr的信息。

有关使用EpiPen和EpiPen Jr的更多信息和视频说明，请访问： www.epipen.com 或致电1-800-395-3376。

EpiPen和EpiPen Jr有哪些成分？

有效成分： 肾上腺素

非活性成分： 氯化钠，焦亚硫酸钠，盐酸和水

重要信息

·         EpiPen自动进样器带有黄色标签。

·         EpiPen Jr自动进样器带有绿色标签。

·         EpiPen Trainer为灰色，不含药物和针头。

·         您的自动注射器设计用于通过衣物工作。

·         EpiPen和EpiPen Jr自动进样器上的蓝色安全释放器有助于防止意外注入设备。在准备使用蓝色安全释放器之前，请勿将其卸下。

·         窒息危险：蓝色安全释放装置很小，可能会对儿童造成窒息危险。使用EpiPen和EpiPen Jr自动进样器后，立即丢弃蓝色安全释放器。

·         仅注入大腿外侧（大腿）的中间。切勿将其注射到身体的任何其他部位。

·         切勿将拇指，手指或手放在橙色尖端上。针从橙色尖端伸出。

·         如果发生意外注射，请立即获得紧急医疗帮助。

·         请勿使用自动注射器将患者信息或任何其他异物放置在承载管中，因为这可能会阻止您卸下自动注射器以进行使用。

 

使用说明

IP
（肾上腺素注射液，USP）
自动注射器0.3毫克
EpiPen =一剂0.3 mg肾上腺素，USP 0.3 mg / 0.3 mL

埃皮本
（肾上腺素注射液，USP）
自动注射器0.15毫克
EpiPen Jr = 0.15毫克肾上腺素一剂，USP 0.15毫克/0.3毫升

对于过敏性紧急情况（过敏反应）

在使用EpiPen或EpiPen Jr之前，请仔细阅读本使用说明。在需要使用EpiPen或EpiPen Jr之前，请确保您的医疗保健提供者为您提供正确的使用方法。家长，看护人和其他可能可以使用EpiPen或EpiPen Jr自动注射器的人也应了解如何使用它。如有任何疑问，请咨询您的医疗保健提供者。

您的EpiPen和EpiPen Jr自动进样器

一定剂量的EpiPen或EpiPen Jr需要3个步骤：准备，管理和获取紧急医疗帮助

步骤1.准备EpiPen或EpiPen Jr进行注射

从透明的运输管中取出EpiPen或EpiPenJr。

翻转打开EpiPen的黄色盖或EpiPen Jr载管的绿色盖。

倾斜自动注射器并将其从载管中滑出。

用另一只手 向上拉动以卸下蓝色安全释放器 不会弯曲或扭曲它。握住自动注射器的拳头，橙色尖端（针尖）指向下方。

笔记：重要提示：蓝色安全释放装置很小，可能会对儿童造成窒息危险。使用EpiPen或EpiPen Jr后立即丢弃蓝色安全释放器。

·         针从橙色尖端伸出。

·         为避免意外注射，切勿将拇指，手指或手放在橙色尖端上。如果发生意外注射，请立即获得紧急医疗帮助。

步骤2.管理EpiPen或EpiPen Jr

如果您要对年幼的孩子使用EpiPen或EpiPen Jr，则在注射时应牢牢固定腿部。

将橙色笔尖以与大腿成直角（垂直）的方式靠在大腿外侧（大腿）的中间。

牢牢固定3秒钟（缓慢计数1,2,3）。 注射现已完成。摆动并推动自动进样器 直到“点击”为止。单击表示已开始注射。

按摩注射区域10秒钟。从大腿上取下自动注射器。 橙色尖端将延伸以覆盖针头。如果针仍然可见，请勿尝试重复使用它。

您可能需要进一步的医疗护理。 如果症状持续或复发，则可能需要使用第二个EpiPen或EpiPen Jr自动注射器。

步骤3.立即获得紧急医疗帮助。

·         去看医疗保健提供者时，请带上使用过的自动注射器。

·         告诉医疗保健提供者您已经注射了肾上腺素。向医疗服务提供者显示您在哪里注射。

·         将您使用过的EpiPen或EpiPen Jr自动注射器交给医疗保健提供者进行检查和正确处理。

·         如有需要，请补充笔芯。

笔记：

·         使用过的带有延长的针头盖的自动进样器将无法装入载管。

·         EpiPen和EpiPen Jr是一次性注射设备，可提供固定剂量的肾上腺素。自动注射器不能重复使用。激活设备后，请勿尝试重复使用EpiPen。在注射剂量后，大多数药物保留在自动注射器中是正常的。如果橙色针尖已伸出且窗口被挡住，则已正确剂量给药。

·         您的EpiPen和EpiPen Jr自动注射器可能与EpiPen培训师和单独的培训师包装在一起包装。 EpiPen Trainer具有灰色。灰色EpiPen Trainer不含药物和针头。与EpiPen Trainer一起练习，但是在过敏紧急情况下，请始终携带真正的EpiPen或EpiPen Jr自动注射器。

·         如果您要对年幼的孩子使用EpiPen或EpiPen Jr，请让您的医疗保健提供者向您展示如何在给药时正确地将腿固定在适当的位置。

·         不要试图拆开EpiPen或EpiPen Jr自动进样器。

IP
（肾上腺素注射液，USP）
自动注射器0.3毫克
EpiPen =一剂0.3 mg肾上腺素，USP 0.3 mg / 0.3 mL

 

 

埃皮本
（肾上腺素注射液，USP）
自动注射器0.15毫克
EpiPen Jr = 0.15毫克肾上腺素一剂，USP 0.15毫克/0.3毫升

MyEpiPen.com

在以下位置注册您的EpiPen或EpiPen Jr自动进样器 MyEpiPen.com 并了解更多有关以下内容的信息：

·         免费EpiPen自动进样器 补充提醒程序。 保持自动注射器最新是很重要的。

最多注册6个EpiPen或EpiPen Jr自动进样器并自动接收 补充提醒警报。

·         接收有关过敏和过敏原的定期信息。

·         教学视频

有关EpiPen或EpiPen Jr自动注射器以及产品正确使用的更多信息，请致电1-877-446-3679或致电Mylan或访问 www.epipen.com。

EpiPen培训师

使用说明

EpiPen Trainer使用说明

在紧急情况下：请勿使用灰色的Trainer。使用真正的黄色EpiPen或绿色EpiPen Jr自动进样器。

重要信息

·         培训师标签为灰色。

·         培训师不带药也不带针。

·         发生过敏性紧急情况（过敏反应）之前，请定期与灰色的Trainer练习，以确保在紧急情况下您能够安全地使用真正的黄色EpiPen或绿色EpiPen Jr自动注射器。

·         紧急情况下，请始终携带真正的黄色EpiPen或绿色EpiPen Jr自动注射器。

·         诸如蓝色安全释放装置之类的小零件可能对儿童造成窒息危险。将蓝色安全释放器放回训练器上，并在练习后立即将其复位。

EpiPen培训师

熟悉这个灰色的Trainer。练习直到您习惯使用它。

您的灰色教练员：

·         橙色提示是针从EpiPen或EpiPen Jr自动进样器中伸出的位置。·         切勿将拇指，其他手指或橘子尖移交。

实务指示

·         握紧拳头中的灰色教练，橙色尖端朝下。1.     准备 模拟注射训练师

·         用另一只手 笔直向上拉出蓝色安全释放器 不会弯曲或扭曲它。

·         卸下蓝色安全释放器可将培训师解锁。

2.     管理 培训师模拟

·         如果要带小孩练习，请在使用EpiPen Trainer时将腿牢牢固定在位。 请您的医疗保健提供者向您展示如何正确地握住腿部进行练习，以便在过敏性紧急情况发生之前为您做好准备。

·         笔记：

·         将橙色笔尖以与大腿成直角（垂直）的方式靠在大腿外侧（大腿）的中间。

·         摆动并稳固地推动训练器 直到它发出“喀哒”声为止。喀哒声表明注射已经开始。

·         牢牢固定3秒钟（缓慢计数1,2,3）。

·         从大腿上取下训练器 并按摩注射区域10秒钟。使用后，橙色笔尖会自动伸出。

·         在实际紧急情况下，您需要立即寻求紧急医疗帮助

·         实际的自动注射器是通过衣物工作的

·         不要注入身体的任何其他部位

3.     重设教练员

·         将蓝色安全释放器放回教练机上

·         将橙色笔尖放在坚硬的表面上

·         挤压橙色笔尖的侧面，并用另一只手将其向下压在Trainer上

注意：使用真正的黄色EpiPen或绿色EpiPen Jr自动进样器时，橙色针尖在自动进样后会覆盖针头，以帮助防止意外粘住您自己或他人。

练习课信息

如果发生过敏性紧急情况，请使用真正的黄色EpiPen或绿色EpiPen Jr自动进样器，而不要使用灰色的Trainer。

请按照上面的说明进行操作。根据需要重复多次，直到您能够快速正确地进行自我注射。

 

·         培训师的使用说明

·         EpiPen或EpiPen Jr自动进样器随附的“患者信息”

培训其他可以在紧急情况下为您提供帮助的人：

·         您的父母，照顾者以及其他可能可以管理EpiPen或EpiPen Jr的人，应该知道在过敏紧急情况（过敏反应）期间如何为您提供帮助。在紧急情况发生之前，请让他们：

·         练习激活教练

·         阅读这些培训师说明和“患者信息”

有关EpiPen和EpiPen Jr自动进样器以及正确使用产品的更多信息，请访问： www.epipen.com。

警告：

培训师与真正的黄色EpiPen或绿色EpiPen Jr自动进样器之间的重要区别

训练师（灰色）	EpiPen Jr（绿色）
包含药物？	不	是的	是的
有针吗？	不	是的	是的
进载波管吗？	不	是的	是的
标签颜色？	灰色的	黄色的	绿色的
有有效期限吗？	不	是的	是的
可以重复使用吗？	是的	不 （仅使用一次）	不 （仅使用一次）
可以卸下并更换安全释放装置吗？	是的	不 （仅在使用前取出一次）	不 （仅在使用前取出一次）
压住大腿需要压力吗？	缓和	强的	强的

本培训师使用说明已获得美国食品药品监督管理局的批准。

 

EPIPEN®- epinephrine injection EPIPEN Jr®- epinephrine injection Mylan Specialty L.P.

 

----------

 

 

EpiPen®

(epinephrine) Auto-Injector 0.3 mg

EpiPen® = one dose of 0.30 mg epinephrine (USP, 1:1000, 0.3 mL)

EpiPen Jr®

(epinephrine) Auto-Injector 0.15 mg

EpiPenJr® = one dose of 0.15 mg epinephrine (USP, 1:2000, 0.3 mL)

 

 

DESCRIPTION

 

Each EpiPen® Auto-Injector delivers a single dose of 0.3 mg epinephrine injection, USP, 1:1000 (0.3 mL) in a sterile solution.

 

Each EpiPen Jr® Auto-Injector delivers a single dose of 0.15 mg epinephrine injection, USP, 1:2000 (0.3 mL) in a sterile solution.

 

The EpiPen and EpiPen Jr Auto-Injectors each contain 2 mL epinephrine solution. Approximately 1.7 mL remains in the auto- injector after activation and cannot be used.

 

Each 0.3 mL in the EpiPen Auto-Injector contains 0.3 mg epinephrine,

1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection.

The pH range is 2.2-5.0. Each 0.3 mL in the EpiPen Jr Auto-Injector contains 0.15 mg epinephrine, 1.8 mg sodium chloride, 0.5 mg sodium metabisulfite, hydrochloric acid to adjust pH, and Water for Injection. The pH range is 2.2-5.0.

 

Epinephrine is a sympathomimetic catecholamine. Chemically, epinephrine is B-(3, 4-dihydroxyphenyl)-a-methyl-aminoethanol, with the following structure:

 

 

 

Epinephrine solution deteriorates rapidly on exposure to air or light, turning pink from oxidation to adrenochrome and brown from the

formation of melanin. Replace EpiPen and EpiPen Jr Auto-Injectors if the epinephrine solution appears discolored.

 

EpiPen and EpiPen Jr Auto-Injectors do not contain latex.

 

 

CLINICAL PHARMACOLOGY

 

Epinephrine is the drug of choice for the emergency treatment of severe allergic reactions (Type I) to insect stings or bites, foods, drugs, and other allergens. It can also be used in the treatment of anaphylaxis of unknown cause (idiopathic anaphylaxis) or exercise- induced anaphylaxis. When given intramuscularly or subcutaneously it has a rapid onset and short duration of action. Epinephrine acts on both alpha and beta adrenergic receptors. Through its action on alpha adrenergic receptors, epinephrine lessens the vasodilation and increased vascular permeability that occurs during anaphylaxis, which can lead to loss of intravascular fluid volume and hypotension. Through its action on beta-adrenergic receptors, epinephrine causes bronchial smooth muscle relaxation that helps alleviate bronchospasm, wheezing and dyspnea that may occur during anaphylaxis. Epinephrine also alleviates pruritus, urticaria, and angioedema and may be effective in relieving gastrointestinal and genitourinary symptoms associated with anaphylaxis because of its relaxer effects on the smooth muscle of the stomach, intestine, uterus, and urinary bladder.

 

 

INDICATIONS AND USAGE

 

EpiPen and EpiPen Jr Auto-Injectors are indicated in the emergency treatment of allergic reactions (Type I) including anaphylaxis to stinging insects (e.g., order Hymenoptera, which include bees, wasps, hornets, yellow jackets and fire ants) and biting insects (e.g., triatoma, mosquitos), allergen immunotherapy, foods, drugs, diagnostic testing substances (e.g., radiocontrast media) and other allergens, as well as idiopathic anaphylaxis or exercise-induced anaphylaxis. EpiPen and EpiPen Jr Auto-Injectors are intended for immediate administration in patients, who are determined to be at increased risk for anaphylaxis, including individuals with a history of anaphylactic reactions. Selection of the appropriate dosage strength is determined according to patient body weight (see DOSAGE AND ADMINISTRATION section).

 

Such reactions may occur within minutes after exposure and consist of flushing, apprehension, syncope, tachycardia, thready or unobtainable pulse associated with a fall in blood pressure, convulsions, vomiting, diarrhea and abdominal cramps, involuntary voiding, wheezing,

dyspnea due to laryngeal spasm, pruritus, rashes, urticaria or angioedema.

 

EpiPen and EpiPen Jr Auto-Injectors are intended for immediate self- administration as emergency supportive therapy only and are not a substitute for immediate medical care.

 

 

CONTRAINDICATIONS

 

There are no absolute contraindications to the use of epinephrine in a life-threatening situation.

 

 

WARNINGS

 

EpiPen and EpiPen Jr Auto-Injectors should only be injected into the anterolateral aspect of the thigh. DO NOT INJECT INTO BUTTOCK. Injection into the buttock may not provide effective treatment of anaphylaxis. Advise the patient to go immediately to the nearest emergency room for further treatment of anaphylaxis.

 

Since epinephrine is a strong vasoconstrictor, accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area. Treatment should be directed at vasodilation in addition to further treatment of anaphylaxis (see ADVERSE REACTIONS). Advise the patient to go immediately to the nearest emergency room and to inform the healthcare provider in the emergency room of the location of the accidental injection.

 

DO NOT INJECT INTRAVENOUSLY. Large doses or accidental intravenous injection of epinephrine may result in cerebral hemorrhage due to sharp rise in blood pressure. Rapidly acting vasodilators can counteract the marked pressor effects of epinephrine if there is such inadvertent administration.

 

Epinephrine is the preferred treatment for serious allergic reactions or other emergency situations even though this product contains sodium metabisulfite, a sulfite that may, in other products, cause allergic-type reactions including anaphylactic symptoms or life-threatening or less severe asthmatic episodes in certain susceptible persons. The alternatives to using epinephrine in a life-threatening situation may not be satisfactory. The presence of a sulfite in this product should not deter administration of the drug for treatment of serious allergic or other emergency situations even if the patient is sulfite-sensitive.

 

Epinephrine should be administered with caution in patients who have heart disease, including patients with cardiac arrhythmias, coronary

artery or organic heart disease, or hypertension. In such patients, or in patients who are on drugs that may sensitize the heart to arrhythmias, e.g., digitalis, diuretics, or anti-arrhythmics, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias. It should be recognized that the presence of these conditions is not a contraindication to epinephrine administration in an acute, life-threatening situation.

 

Epinephrine is light sensitive and should be stored in the carrier tube provided. Store at 25°C (77°F); excursions permitted to 15°C-30°C (59°F-86°F) (See USP Controlled Room Temperature). Do not refrigerate. Before using, check to make sure the solution in the auto- injector is not discolored. Replace the auto-injector if the solution is discolored or contains a precipitate.

 

 

PRECAUTIONS

 

(1)  General

 

EpiPen and EpiPen Jr Auto-Injectors are not intended as a substitute for immediate medical care. In conjunction with the administration of epinephrine, the patient should seek immediate medical or hospital care. More than two sequential doses of epinephrine should only be administered under direct medical supervision.

 

Epinephrine is essential for the treatment of anaphylaxis. Patients with a history of severe allergic reactions (anaphylaxis) to insect stings or bites, foods, drugs, and other allergens as well as idiopathic and exercise-induced anaphylaxis should be carefully instructed about the circumstances under which epinephrine should be used. It must be clearly determined that the patient is at risk of future anaphylaxis, since the following risks may be associated with epinephrine administration (see DOSAGE and ADMINISTRATION).

 

Epinephrine should be used with caution in patients who have cardiac arrhythmias, coronary artery or organic heart disease, hypertension, or in patients who are on drugs that may sensitize the heart to arrhythmias, e.g., digitalis, diuretics, quinidine, or other antiarrhythmics. In such patients, epinephrine may precipitate or aggravate angina pectoris as well as produce ventricular arrhythmias.

 

The effects of epinephrine may be potentiated by tricyclic antidepressants and monoamine oxidase inhibitors.

 

Some patients may be at greater risk of developing adverse reactions after epinephrine administration. These include: hyperthyroid

individuals, individuals with cardiovascular disease, hypertension, or diabetes, elderly individuals, pregnant women, pediatric patients under 30 kg (66 lbs.) body weight using EpiPen Auto-Injector, and pediatric patients under 15 kg (33 lbs.) body weight using EpiPen Jr Auto- Injector.

 

Despite these concerns, epinephrine is essential for the treatment of anaphylaxis. Therefore, patients with these conditions, and/or any other person who might be in a position to administer EpiPen or EpiPen Jr Auto-Injector to a patient experiencing anaphylaxis should be carefully instructed in regard to the circumstances under which epinephrine should be used.

 

(2)  Information for Patients

 

Complete patient information, including dosage, direction for proper administration and precautions can be found inside each EpiPen/EpiPen Jr Auto-Injector carton.

 

Epinephrine may produce symptoms and signs that include an increase in heart rate, the sensation of a more forceful heartbeat, palpitations, sweating, nausea and vomiting, difficulty breathing, pallor, dizziness, weakness or shakiness, headache, apprehension, nervousness, or anxiety. These symptoms and signs usually subside rapidly, especially with rest, quiet and recumbency. Patients with hypertension or hyperthyroidism may develop more severe or persistent effects, and patients with coronary artery disease could experience angina.  Patients with diabetes may develop increased blood glucose levels following epinephrine administration. Patients with Parkinson's disease may notice a temporary worsening of symptoms.

 

In case of accidental injection, the patient should be advised to immediately go to the emergency room for treatment. Since the epinephrine in the EpiPen Auto-Injector is a strong vasoconstrictor when injected into the digits, hands or feet, treatment should be directed at vasodilation if there is such an inadvertent administration to these areas (see ADVERSE REACTIONS).

 

The carrier tube is not waterproof.

 

The blue safety release helps prevent accidental injection and should be kept on until it will be used.

 

(3)  Drug Interactions

 

Patients who receive epinephrine while concomitantly taking cardiac glycosides or diuretics should be observed carefully for the development of cardiac arrhythmias.

The effects of epinephrine may be potentiated by tricyclic antidepressants, monoamine oxidase inhibitors, levothyroxine sodium, and certain antihistamines, notably chlorpheniramine, tripe-lennamine and diphenhydramine.

 

The cardiostimulating and bronchodilating effects of epinephrine are antagonized by beta-adrenergic blocking drugs, such as propranolol. The vasoconstricting and hypertensive effects of epinephrine are antagonized by alpha-adrenergic blocking drugs, such as phentoloamine. Ergot alkaloids may also reverse the pressor effects of epinephrine.

 

(4)  Carcinogenesis, Mutagenesis, Impairment of Fertility

 

Epinephrine and other catecholamines have been shown to have mutagenic potential in vitro and to be an oxidative mutagen in a WP2 bacterial reverse mutation assay. Epinephrine had a moderate degree of mutagenicity, and was positive in the DNA Repair test with B. subtilis (REC) assay, but was not mutagenic in the Salmonella bacterial reverse mutation assay.

Studies of epinephrine after repeated exposure in animals to evaluate the carcinogenic and mutagenic potential or the effect on fertility have not been conducted. This should not prevent the use of epinephrine under the conditions noted under INDICATIONS AND USAGE.

 

(5)  Usage in Pregnancy

 

Pregnancy Category C: There is no study on the acute effect of epinephrine on pregnancy. Epinephrine has been shown to have developmental effects when administered subcutaneously in rabbits at a dose of 1.2 mg/kg daily for two to three days (approximately 30 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis), in mice at a subcutaneous dose of 1 mg/kg daily for 10 days (approximately 7 times the maximum daily subcutaneous or intramuscular dose on a mg/m2 basis) and in hamsters at a subcutaneous dose of 0.5 mg/kg daily for 4 days (approximately 5 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). These effects were not seen in mice at a subcutaneous dose of 0.5 mg/kg daily for 10 days (approximately 3 times the maximum recommended daily subcutaneous or intramuscular dose on a mg/m2 basis). Although, there are no adequate and well-controlled studies in pregnant women, epinephrine should be used in pregnancy only if the potential benefit justifies the potential risk to the fetus.

 

It is not known if epinephrine passes into your breast milk.

ADVERSE REACTIONS

 

Adverse reactions to epinephrine include transient, moderate anxiety; apprehensiveness; restlessness; tremor; weakness; dizziness; sweating; palpitations; pallor; nausea and vomiting; headache; and/or respiratory difficulties. These symptoms occur in some persons receiving therapeutic doses of epinephrine, but are more likely to occur in patients with hypertension or hyperthyroidism. Arrhythmias, including fatal ventricular fibrillation, have been reported in patients with underlying cardiac disease or certain drugs (see PRECAUTIONS, Drug Interactions). Rapid rises in blood pressure have produced cerebral hemorrhage, particularly in elderly patients with cardiovascular disease. Angina may occur in patients with coronary artery disease. The potential for epinephrine to produce these types of adverse reactions does not contraindicate its use in an acute life- threatening allergic reaction.

 

Accidental injection into the digits, hands or feet may result in loss of blood flow to the affected area (see WARNINGS). Adverse events experienced as a result of accidental injections may include increased heart rate, local reactions including injection site pallor, coldness and hypoaesthesia or injury at the injection site resulting in bruising, bleeding, discoloration, erythema or skeletal injury.

 

 

OVERDOSAGE

 

Epinephrine is rapidly inactivated in the body and treatment following overdose with epinephrine is primarily supportive. If necessary, pressor effects may be counteracted by rapidly acting vasodilators or alpha-adrenergic blocking drugs. If prolonged hypotension follows such measure, it may be necessary to administer another pressor drug.

 

Overdosage of epinephrine may produce extremely elevated arterial pressure, which may result in cerebrovascular hemorrhage, particularly in elderly patients.

 

Overdosage may also result in pulmonary edema because of peripheral vascular constriction together with cardiac stimulation. Treatment consists of a rapidly acting alpha-adrenergic blocking drug and/or respiratory support.

 

Epinephrine overdosage can also cause transient bradycardia followed by tachycardia and these may be accompanied by potentially fatal cardiac arrhythmias. Premature ventricular contractions may appear within one minute after injection and may be followed by multifocal ventricular tachycardia (prefibrillation rhythm). Subsidence of the

ventricular effects may be followed by atrial tachycardia and occasionally by atrioventricular block. Treatment of arrhythmias consists of administration of a beta-blocking drug such as propranolol.

 

Overdosage sometimes results in extreme pallor and coldness of the skin, metabolic acidosis and kidney failure. Suitable corrective measures must be taken in such situations.

 

 

DOSAGE AND ADMINISTRATION

 

EpiPen or EpiPen Jr Auto-Injector prescribers should ensure that the patient or caregiver understands the indications and use of this product. A health care provider should review the patient instructions and operation of the EpiPen or EpiPen Jr Auto-Injector, in detail, with the patient or caregiver. Inject EpiPen or EpiPen Jr intramuscularly or subcutaneously into the anterolateral aspect of the thigh, through clothing if necessary. See detailed Directions for Use on the accompanying Patient Instructions.

 

Selection of the appropriate dosage strength is determined according to patient body weight.

 

EpiPen Auto-Injector delivers 0.3 mg epinephrine injection (0.3 mL, 1:1000) and is intended for patients who weigh 30 kg or more (approximately 66 pounds or more).

 

EpiPen Jr Auto-Injector delivers 0.15 mg epinephrine injection (0.3 mL, 1:2000) and is intended for patients who weigh 15 to 30 kg (33 - 66 pounds).

 

Each EpiPen or EpiPen Jr Auto-Injector contains a single dose of epinephrine. Since the doses of epinephrine delivered from EpiPen or EpiPen Jr Auto-Injector are fixed, consider using other forms of injectable epinephrine if doses lower than 0.15 mg are deemed necessary. The prescriber should carefully assess each patient to determine the most appropriate dose of epinephrine, recognizing the life-threatening nature of the reactions for which this drug is indicated. With severe persistent anaphylaxis, repeat injections with an  additional EpiPen Auto-Injector may be necessary.

 

Patients should be instructed to periodically visually inspect the epinephrine solution for particulate matter and discoloration. If the solution contains particulate matter or develops a pinkish or brown color, the patient should immediately contact their physician for a replacement, since these changes indicate that the effectiveness of the drug product may be decreased.

HOW SUPPLIED

 

EpiPen Auto-Injectors (epinephrine injections, USP, 1:1000, 0.3 mL) are available in individual cartons, NDC 49502-500-01, and as EpiPen 2-Pak®, NDC 49502-500-02, a pack that contains two EpiPen Auto- Injectors (epinephrine injections, USP, 1:1000, 0.3 mL) and one EpiPen Auto-Injector trainer device.

 

EpiPen Jr Auto-Injectors (epinephrine injection, USP, 1:2000, 0.3 mL) are available in individual cartons, NDC 49502-501-01, and as EpiPen Jr 2-Pak®, NDC 49502-501-02, a pack that contains two EpiPen Jr Auto-Injectors (epinephrine injections, USP, 1:2000, 0.3 mL) and one EpiPen Auto-Injector trainer device.

 

EpiPen 2-Pak® and EpiPen Jr 2-Pak® also includes an S-clip to clip two cases together.

 

Store at 20° to 25°C (68° to 77°F); excursions permitted to 15°C­ 30°C (59°F-86°F) (See USP Controlled Room Temperature). Contains no latex. Protect from light.

 

Rx only.

 

MANUFACTURED FOR Mylan Specialty L.P.,

Napa, CA 94558, USA

by Meridian Medical Technologies, Inc., Columbia, MD 21046, USA, a Pfizer company

 

EpiPen®, EpiPen Jr®, EpiPen 2-Pak®, and EpiPen Jr 2-Pak®  are registered trademarks of Mylan Inc. licensed exclusively to its wholly- owned affiliate, Mylan Specialty L.P. of Napa, CA 94558, USA

 

08/12

0001600

03-914-01

PATIENT INFORMATION

 

 

 

 

For allergic emergencies (anaphylaxis)

 

 

Read this Patient Information Leaflet carefully before using the EpiPen® Auto-Injector or EpiPen Jr® Auto-Injector and each time you get a refill. There may be new information. You should know how to use the EpiPen or EpiPen Jr Auto-Injector before you have an allergic emergency.

 

 

This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

 

 

What is the most important information I should know about the EpiPen and EpiPen Jr Auto-Injector?

 

 

1.                EpiPen and EpiPen Jr Auto-Injectors contain epinephrine, a medicine used to treat allergic emergencies (anaphylaxis). Anaphylaxis can be life threatening, can happen within minutes, and can be caused by stinging and biting insects, allergy injections, foods, medicines, exercise, or unknown causes. Symptoms of anaphylaxis may include:

·                  trouble breathing

·                  wheezing

·                  hoarseness (changes in the way your voice sounds)

·                  hives (raised reddened rash that may itch)

·                  severe itching

·                  swelling of your face, lips, mouth, or tongue

·                  skin rash, redness, or swelling

·                  fast heartbeat

·                  weak pulse

·                  feeling very anxious

·                  confusion

·                  stomach pain

·                  losing control of urine or bowel movements (incontinence)

·                  dizziness, fainting, or “passing out” (unconsciousness)

 

2.                Always carry your EpiPen or EpiPen Jr Auto-Injector with you because you may not know when anaphylaxis may happen. Talk to your healthcare provider if you need additional units to keep at work, school, or other locations.  Tell your family members and

others where you keep your EpiPen or EpiPen Jr Auto-Injector and how to use it before you need it. You may be unable to speak in an allergic emergency.

 

 

3.                When you have an allergic emergency (anaphylaxis) use the EpiPen or EpiPen Jr Auto-Injector right away. Get emergency medical help right away. You may need further medical attention. You may need a second EpiPen or EpiPen Jr Auto-Injector should symptoms persist or recur. More than two sequential doses of epinephrine for a single episode should only be administered by a healthcare provider.

 

 

What are the EpiPen and EpiPen Jr Auto-Injectors?

 

 

·                              EpiPen and EpiPen Jr Auto-Injector are disposable, prefilled automatic injection devices used to treat life-threatening, allergic emergencies including anaphylaxis in people who are at risk for or have a history of serious allergic emergencies. They contain a single dose of epinephrine.

·                              EpiPen and EpiPen Jr Auto-Injector are for immediate self (or caregiver) administration and do not take the place of emergency medical care. You should get emergency help right away after using the EpiPen and EpiPen Jr Auto Injector.

·                              EpiPen and EpiPen Jr Auto-Injector are for people who have been prescribed this medication by their healthcare provider.

•          The EpiPen Auto-Injector (0.3 mg) is for patients who weigh 66 pounds or more (30

kilograms or more).

•          The EpiPen Jr Auto-Injector (0.15 mg) is for patients who weigh about 33 to 66 pounds (15 to 30 kilograms).

•          It is not known if EpiPen and EpiPen Jr Auto-Injectors are safe and effective in children who weigh less than 33 pounds (15 kilograms).

 

 

What should I tell my healthcare provider before using the EpiPen or EpiPen Jr Auto- Injector?

 

Before you use EpiPen or EpiPen Jr Auto-Injector, tell your healthcare provider about all your medical conditions, but especially if you:

·                              have heart problems or high blood pressure

·                              have diabetes

·                              have thyroid conditions

·                              have asthma

·                              have a history of depression

·                              have Parkinson’s disease

·                              have any other medical conditions

·                              are pregnant or plan to become pregnant. It is not known if epinephrine will harm your unborn baby.

·                              are breastfeeding or plan to breastfeed. It is not known if epinephrine passes into your breast milk.

 

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins, and herbal supplements. Inform your healthcare provider

of all known allergies.

 

Especially tell your healthcare provider if you take certain asthma medications.

 

EpiPen or EpiPen Jr Auto-Injector and other medicines may affect each other, causing side effects. EpiPen or EpiPen Jr Auto-Injector may affect the way other medicines work, and other medicines may affect how the EpiPen or EpiPen Jr Auto-Injector works.

 

Know the medicines you take.   Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine.

 

 

Use your EpiPen or EpiPen Jr Auto-Injector for treatment of anaphylaxis as prescribed by your healthcare provider, regardless of medical conditions or medication.

 

 

How should I use the EpiPen and EpiPen Jr Auto-Injector?

 

 

·                              Each EpiPen or EpiPen Jr Auto-Injector contains only 1 dose of medicine.

·                              The EpiPen or EpiPen Jr Auto-Injector should be injected into the muscle of your outer thigh. It can be injected through your clothing if needed.

·                              Read the Instructions for Use at the end of this Patient Information Leaflet about the right way to use EpiPen and EpiPen Jr Auto-Injector.

·                              Use your EpiPen or EpiPen Jr Auto-Injector exactly as your healthcare provider tells you to use it.

·                              Caution: Never put your thumb, fingers, or hand over the orange tip. Never press or push the orange tip with your thumb, fingers, or hand. The needle comes out of the orange tip. Accidental injection into finger, hands or feet may cause a loss of blood flow to these areas. If this occurs, go immediately to the nearest emergency room. Tell the healthcare provider where on your body you received the accidental injection.

·                              Your EpiPen and EpiPen Jr Auto-Injector may come packaged with an EpiPen Auto- Injector Trainer and separate Trainer Instructions for Use. The EpiPen Auto-Injector Trainer has a grey color. The grey EpiPen Auto-Injector Trainer contains no medicine and no needle. Practice with your EpiPen Auto-Injector Trainer before an allergic emergency happens to make sure you are able to safely use the real EpiPen and EpiPen Jr Auto-Injector in an emergency. Always carry your real EpiPen or EpiPen Jr Auto-Injector with you in case of an allergic emergency. Additional training resources are available at www.epipen.com.

·                              Do not drop the carrier tube or auto-injector. If the carrier tube or auto-injector is dropped, check for damage and leakage. Discard the auto-injector and carrier tube, and replace if damage or leakage is noticed or suspected.

 

 

What are the possible side effects of the EpiPen and EpiPen Jr Auto-Injector? EpiPen and EpiPen Jr Auto-Injector may cause serious side effects.

·                                                The EpiPen or EpiPen Jr Auto-Injector should only be injected into the middle of your

outer thigh (upper leg).  Do not inject the EpiPen or EpiPen Jr Auto-Injector into

your:

·                              vein

·                              buttock

·                              fingers, toes, hands, or feet

 

If you accidentally inject EpiPen or EpiPen Jr Auto-Injector into any other part of your body, go immediately to the nearest emergency room. Tell the healthcare provider where on your body you received the accidental injection.

 

 

If you have certain medical conditions, or take certain medicines, your condition may get worse or you may have longer lasting side effects when you take the EpiPen or EpiPen Jr Auto-Injector. Talk to your healthcare provider about all your medical conditions.

 

Common side effects of the EpiPen and EpiPen Jr Auto-Injector include:

·                              fast, irregular or “pounding” heartbeat

·                              sweating

·                              headache

·                              weakness or shakiness

·                              paleness

·                              feelings of over excitement, nervousness or anxiety

·                              dizziness

·                              nausea and/or vomiting

·                              breathing problems

 

 

These side effects may go away with rest. Tell your healthcare provider if you have any side effect that bothers you or that does not go away.

 

 

These are not all the possible side effects of the EpiPen or EpiPen Jr Auto-Injector.  For more information, ask your healthcare provider or pharmacist.

 

 

Call your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

 

 

How should I store the EpiPen and EpiPen Jr Auto-Injector?

 

 

·                                    Store at 68° to 77° F (20° to 25° C)

·                                    Protect from light.

·                                    Do not expose to extreme cold or heat.  For example, do not store in your vehicle’s glove box and do not store in the refrigerator or freezer.

·                                    Examine contents in the clear window of your auto-injector periodically. The solution should be clear. If the solution is discolored (pinkish or brown color) or contains solid particles, replace the unit.

·                                    Always keep your EpiPen or EpiPen Jr Auto-Injector in the carrier tube to protect it from damage; however, the carrier tube is not waterproof.

·                                    The blue safety release helps to prevent accidental injection of the device. Keep the

blue safety release on until you need to use it.

·                                    Your EpiPen or EpiPen Jr Auto-Injector has an expiration date.  Replace it before the expiration date.

 

General information about the safe and effective use of the EpiPen and EpiPen Jr Auto- Injector:

 

Do not use the EpiPen or EpiPen Jr Auto-Injector for a condition for which it was not prescribed. Do not give your EpiPen or EpiPen Jr Auto-Injector to other people.

 

This Patient Information Leaflet summarizes the most important information about the EpiPen and EpiPen Jr Auto-Injectors. If you would like more information, talk to your healthcare provider. You can ask your pharmacist or healthcare provider for information about the EpiPen and EpiPen Jr Auto-Injector that is written for health professionals.

 

For more information and video instructions on the use of the EpiPen and EpiPen Jr Auto- Injector, go to www.epipen.com or call 1-800-395-3376.

 

What are the ingredients in EpiPen and EpiPen Jr Auto-Injector?

Active Ingredients: Epinephrine

Inactive Ingredients: sodium chloride, sodium metabisulfite, hydrochloric acid, and water. The EpiPen and EpiPen Jr Auto-Injector contain no latex.

 

 

 

Important Information

•          The EpiPen Auto-Injector has a yellow colored label.

•          The EpiPen Jr Auto-Injector has a green colored label.

•          The EpiPen Trainer has a grey color, and contains no medicine and no needle.

•          Your auto-injector is designed to work through clothing.

•          The blue safety release on the EpiPen and EpiPen Jr Auto-Injector helps to prevent accidental injection of the device. Keep the blue safety release on until you need to use it.

•          Only inject into outer thigh. Never inject into any other part of the body.

•          Never put your thumb, fingers, or your hand over the orange tip. The needle comes out of the orange tip.

•          If an accidental injection happens, get medical help right away.

•          Do not place patient information or any other foreign objects in carrier with Auto-Injector, as this may prevent you from removing the Auto-Injector for use

 

 

Instructions for Use

Carefully read these Instructions for Use before you need to use your EpiPen or EpiPen Jr Auto- Injector.         Before you use your EpiPen or EpiPen Jr Auto-Injector, make sure your healthcare provider shows you the right way to use it. If you have any questions, ask your healthcare pro­ vider.

Your EpiPen and EpiPen Jr Auto-Injector

 

 

3‐Step Easy To Follow Instructions:

 

 

1. Prepare the EpiPen or EpiPen Jr Auto-Injector For Injection 2. Administer the EpiPen or EpiPen Jr Auto-Injector

 

3. Finalize the Injection Process

 

 

(See detailed instructions below)

 

 

 

1.      Prepare the EpiPen or EpiPen Jr Auto-Injector For Injection

 

Remove the auto-injector from the clear carrier tube.

 

 

 

 

 

 

Flip open the yellow cap of your EpiPen

or the green cap of your EpiPen Jr Auto-Injector carrier tube.

 

 

 

 

 

 

 

 

 

Tip and slide the auto-injector out of the carrier tube.

 

 

 

 

Grasp  the  auto-injector  in   your   fist   with            the orange tip pointing downward.

 

 

With your other hand, remove the blue safety release by pulling straight up without bending or twisting it.

 

 

 

Note:

·                  The needle comes out of the orange tip.

·                  Never put your thumb, fingers or hand over the orange tip.

 

 

 

2.Administer the EpiPen or EpiPen Jr Auto-Injector

 

 

Hold the auto-injector with orange tip near the outer thigh.

 

 

Swing and firmly push the orange tip against the outer thigh until it ‘clicks’. Keep the auto-injector firmly pushed against the thigh at a 90° angle (perpendicular) to the thigh.

 

 

 

 

 

 

 

 

 

 

3.Finalize the Injection Process

 

 

 

 

 

 

Hold firmly against the thigh for approximately 10 seconds to deliver the drug. The injection is now complete.

 

 

 

Remove the auto-injector from the thigh. The orange tip will extend to cover the needle.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Massage the injection area for 10 seconds.

 

 

 

 

 

 

 

 

Get emergency medical help right away. You may need further medical attention. You may need a second EpiPen or EpiPen Jr Auto-Injector should symptoms persist or recur.

 

 

Note:

·                  Take your used auto-injector with you when you go to see the healthcare provider.

·                  Tell the healthcare provider that you have received an injection of epinephrine. Show the healthcare provider where you received the injection.

·                  Give your  used EpiPen  or EpiPen Jr Auto-Injector  to  a healthcare provider  for inspection and proper disposal.

·                  Ask for a refill, if needed.

•        The used auto-injector with extended needle cover will not fit in the carrier tube.

•        Most of the liquid medicine stays in the auto-injector and cannot be reused. You have received the correct dose of the medicine if the orange needle tip is extended and the window is blocked.

•        Your EpiPen and EpiPen Jr Auto-Injector may come packaged with an EpiPen Auto- Injector Trainer and separate Trainer Instructions for Use. The EpiPen Trainer has a grey color. The grey EpiPen Trainer contains no medicine and no needle. Practice with your EpiPen Trainer, but always carry your real EpiPen or EpiPen Jr Auto-Injector in case of an allergic emergency.

•        Do not attempt to take the EpiPen or EpiPen Jr Auto-Injector apart.

 

This Patient Information and Instructions for Use has been approved by the U.S. Food and Drug Administration.

 

 

Manufactured for: Mylan Specialty L.P., Napa, CA 94558, USA by Meridian Medical Technologies, Inc., Columbia, MD 21046, USA, a Pfizer company

EpiPen® and EpiPen Jr® are registered trademarks of Mylan Inc. licensed exclusively to its wholly- owned affiliate, Mylan Specialty L.P. of Napa, CA 94558, USA

 

©2012 by Meridian Medical Technologies®, Inc.                          8/2012 03-855-03 0001726

 

 

 

 

 

 

 

 

 

Register your EpiPen or EpiPen Jr Auto-Injector at MyEpiPen.com and find out more about:

 

 

•  Free EpiPen Auto-Injector Refill Reminder Program. It is important to keep your auto-injector up-to­ date.

 

Register up to 6 EpiPen or EpiPen Jr Auto-Injectors and receive automatic Refill Reminder Alerts.

 

•  Receive periodic information related to allergies and allergens.

 

 

•  Instructional Video

 

 

For more information about EpiPen or EpiPen Jr Auto-Injectors and proper use of the product, visit

www.epipen.com.

1679

 

 

 

 

EpiPen® Trainer Instructions For Use 0001679

 

EpiPen Trainer Instructions for Use

 

 

 

 

In an emergency: Do not use the grey Trainer.  Use your yellow EpiPen®  or green EpiPen Jr® Auto-Injector.

 

Important Information

·                  The Trainer label has a grey color.

·                  The Trainer contains no medicine and no needle.

·                  Practice with the grey colored Trainer before an allergic emergency (anaphylaxis) happens to make sure you are able to safely use the real yellow EpiPen or green EpiPen Jr Auto-Injector in case of an emergency.

·                  Always carry your real EpiPen or EpiPen Jr Auto-Injector in case of an allergic emergency.

 

 

Practice Instructions

 

Familiarize yourself with this grey Trainer. Practice until you are comfortable using it.

 

Your grey colored Trainer:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

·                  Never put your thumb, other fingers, or hand over the Orange Tip.

·                  The Orange Tip is where the needle comes out of your EpiPen or EpiPen Jr Auto-Injector.

3-Step Easy to Follow Instructions

 

 

 

1 Prepare the Trainer For Simulated Injection

 

·     Grasp the grey Trainer in your fist with the orange tip pointing downward

·      With your other hand, remove blue safety release by pulling straight up without bending or twisting it

·     Removing the blue safety release unlocks the Trainer

 

 

 

 

 

 

 

 

2 Administer the Trainer Simulation

 

·      Hold the Trainer with the orange tip near the outer thigh.

·      Swing and firmly push the orange tip against the outer thigh until it ‘clicks.’ Keep the Trainer firmly pushed against the thigh at a 90º angle (perpendicular) to the thigh. Hold firmly against the thigh for approximately 10 seconds

·      Remove  the  Trainer  from  the  thigh.    The orange tip automatically extends out after use

 

Note:

·      The actual auto-injector is made to work through clothing

·      Do not inject into any other part of the body

 

 

 

3   To reset the Trainer

 

·      Put the blue safety release back on the Trainer

·      Place the orange tip on a hard surface.

·      Squeeze the sides of the orange tip and push down on the Trainer with the other hand

 

 

Note: With the actual yellow EpiPen or green EpiPen Jr Auto-Injector, the orange tip covers the needle after self-injection to help protect you from accidentally sticking yourself or others.

Practice Session Information

 

 

In case of an allergic emergency, use the real yellow EpiPen or green EpiPen Jr Auto- Injector and not the grey Trainer.

 

Follow instructions above. Repeat as often as needed until you are able to self-inject quickly and correctly.

 

Reread:

•     These Trainer Instructions for Use

•     The “Patient Information” that comes with your EpiPen or EpiPen Jr Auto-Injector

 

Train others who could help you in an emergency:

•          Your parents, teachers, or friends should know how to help you during an allergic emergency (anaphylaxis). Before an emergency occurs, have them:

•     Practice activating the Trainer

•     Read these Trainer Instructions and the “Patient Information”

 

For more information about the EpiPen and EpiPen Jr Auto-Injector and the proper use of the products, go to www.epipen.com.

 

 

 

Caution:

 

Important differences between the Trainer and your yellow EpiPen or green EpiPen Jr Auto-Injector

 

 

Contains medication? --No --------------------------------------------- Yes

Has needle? -------------No --------------------------------------------- Yes

Comes in Carrier Tube?-No --------------------------------------------- Yes

Color of label ----------- Grey ---------------------------------------Yellow (EpiPen)

Green (EpiPen Jr) Has expiration date? --- No --------------------------------------------- Yes

Can be reused? ---------Yes -----------------------------------------No (use only once) Okay to remove and

Replace safety release? -Yes ----------------------------------No (remove just once before use)

Pressure needed to hold

against thigh -------------Moderate ------------------------------------ Strong

 

 

 

This Trainer Instructions for Use has been approved by the U.S. Food and Drug Administration.