CONCERTA ®（盐酸哌甲酯）缓释片 初步U. S.认证：2000 生产商：扬森制药公司 适应症 CONCERTA ®是一种中枢神经兴奋剂治疗多动症（ADHD）的6岁及以上的儿童，青少年和成年人65岁的指示。   剂量和用法 应采取CONCERTA ®每日一次，在早晨和吞噬整个液体援助。 CONCERTA ®不应咀嚼或压碎。 CONCERTA ®可采取带或不带食物。 对于儿童和青少年的新的哌甲酯，推荐起始剂量是18毫克，每天一次。剂量可增至18毫克/天，每周一班，不应超过54毫克/天在儿童和青少年每天72毫克/。 新哌甲酯的成年患者，推荐起始剂量是18或36毫克/天。剂量可增至18毫克/天，每周一班，不应超过成人每天72毫克/。 对于目前使用盐酸哌甲酯的患者，剂量是基于目前的剂量方案及临床判断。 剂型和优势 片剂：18，27，36，54毫克   禁忌 过敏的产品 明显的焦虑，紧张，或激越 青光眼 抽动或有家族史或诊断Tourette综合征. 在目前使用的患者或使用MAO抑制剂2个星期内不要使用CONCERTA ® 警告和注意事项 结构性心脏异常或其他严重心脏问题的儿童和青少年的常规剂量的中枢神经兴奋剂治疗严重心血管事件：据报道，在协会与猝死。据报道，在成人多动症的常规剂量服用兴奋剂猝死，中风，心肌梗死。兴奋剂产品一般不应使用众所周知的结构性心脏异常，心肌病，严重心律异常，冠状动脉疾病，或其他严重心脏问题的患者。 增加血压监测病人的心率和血压的变化和使用，对他们来说，血压或心率增加会是有问题的的患者慎用。 精神科不良事件：使用兴奋剂，可能会导致无病史的患者在治疗突发精神病或躁狂症状，或与预先存在的精神病患者的症状加重。狂躁抑郁症的临床评价建议之前，兴奋剂的使用。监视攻击行为。 癫痫发作：兴奋剂，可能会降低惊厥阈值。中止癫痫发作的存在。 视觉障碍：住宿和视力模糊的困难已经报道兴奋剂治疗。 长期压抑的增长：在适当的时间间隔在儿科患者的显示器的高度和重量。 与先前存在的胃肠道缩小消化道梗阻。 血液监测：定期的央行，差，和血小板计数是在长时间的治疗建议。 在双盲临床试验的儿童和青少年（> 5％）最常见的不良反应是腹痛上。最常见的不良反应在成年患者在双盲临床试验（> 5％）分别下降食欲不振，头痛，口干，恶心，失眠，焦虑，头晕，体重下降，烦躁不安，以及多汗症。停止从儿童或成人的临床试验（≥1％）与相关的最常见的不良反应，焦虑，易怒，失眠，血压升高。 药物相互作用 在目前使用的患者或使用MAO抑制剂2个星期内不要使用CONCERTA ® CONCERTA ®可能会增加血压，使用升压药谨慎. 香豆素类抗凝血剂，抗惊厥药，和一些抗抑郁药的代谢抑制 在特殊人群中使用 注意如果哺乳期的母亲应行使 安全性和疗效尚未建立，在小于6岁的儿童或老年患者大于65岁. 修订日期：11/2010 Once-daily CONCERTA® offers many benefits. These benefits are outlined below to help you to better understand the CONCERTA® difference.  Children with ADHD showed improvement in math tests Research has demonstrated that children who took CONCERTA® for their ADHD treatment performed better on math tests by completing more math problems accurately throughout the day. Adolescents showed improved attention A medical study has shown that CONCERTA® significantly improved attention in adolescents, which may allow more focus on tasks such as class participation, driving and chores. Social interaction was improved Medical studies have also shown that methylphenidate, the medication in CONCERTA® , helped children with ADHD behave appropriately outside of the classroom, such as participating appropriately in activities on the playground and staying in assigned areas. CONCERTA® can help improve peer-to-peer interactions forchildren with ADHD.  CONCERTA® can help improve interactions between adolescents with ADHD and their parents. An established profile CONCERTA® is the #1 prescribed ADHD medication for children and adolescents with ADHD. Methylphenidate-the medication in CONCERTA®-has been used for over 50 years. The medication in CONCERTA® is recommended among first-line therapies by the American Academy of Pediatrics, as part of a comprehensive treatment program.  CONCERTA® is generally well tolerated in children and adolescents. A unique OROS® delivery system Among all prescription ADHD medications, CONCERTA® is different in that it combines a medication calledmethylphenidate with the unique OROS® delivery system. This delivery system provides your child with an "extended release" of methylphenidate, which is slowly released at an increasing rate throughout the day. One dose of CONCERTA®, taken in the morning, deliversADHD symptom management at the start of the day, and continues delivery through the school day into after-school hours.  A special child's diet has no effect Initial blood levels of some ADHD medications can be affected by what a child eats for breakfast, specifically a high-fat breakfast. The rate of absorption for once-daily CONCERTA® was not affected by food-even after eating a high-fat breakfast-so children taking CONCERTA® can eat what they want, when they want. CONCERTA®- An Established Safety Profile Many parents worry or feel guilty about medications in general-if they are safe, if they will work, and if they will last long enough during the day. Your concerns are valid and understandable. Below is an established profile on the efficacy and safety of CONCERTA®. The most commonly prescribed ADHD medication today is methylphenidate-the medicine in CONCERTA®. Guidelines issued by the American Academy of Pediatrics recommend medications like CONCERTA® among first-line therapies for children with ADHD as part of a comprehensive treatment program.  CONCERTA® is generally well tolerated in children and adolescents with ADHD. The most common adverse events reported in children receiving up to 54 mg of CONCERTA® were headache (14%), upper respiratory tract infection (8%) and abdominal pain (7%). The most common adverse events reported by adolescents receiving up to 72 mg of CONCERTA® were headache (9%), accidental injury (6%) and insomnia (5%). IMPORTANT NOTE ON ADHD MEDICATIONS: There are a number of ADHD medications on the market. Their history and safety record are extremely important to consider when you and your child's doctor are selecting the course of therapy that's right for your child. If you see reports in the media about ADHD medications that concern you, you should discuss these issues with your child's doctor. A doctor is best qualified to help you decide what is right for you and your child. 研究发现，Concerta能有效治疗注意力缺陷多动障碍的癫痫患儿 癫痫儿童中注意力缺陷多动障碍（ADHD）的发病率较高，约为12%~39%。近期的一项研究发现，一种渗透型的缓释哌甲酯复合制剂（Concerta）能在不增加ADHD患者癫痫和抽搐发生风险的基础上有效提高应答率。 共有27名同时患有ADHD和癫痫的患者入组该项交叉研究，患者的平均年龄为10.7岁，常规服用抗癫痫药物，且无抽搐发作至少1个月。研究人员将患者随机分入Concerta治疗组和安慰剂组，随后在双盲的情况下交叉组别。有3名患者的目前用量为18mg/日，8人为36mg/日，16人为54mg/日。采用临床综合印象量表（CGI）的得分改善情况来评估患者的应答情况，再根据应答情况评定患者是“明显改善”还是“改善非常明显”。 结果显示，在27名服用18mg Concerta的患者中，治疗组和安慰剂组中分别有11人和2人出现了应答，且停药率为0；在24名用药量为36mg的患者中，治疗组和安慰剂组中分别有13人和3人出现了应答，8人停药；在12名用药量为54mg的患者中，治疗组和安慰剂组中分别有9人和1人出现了应答，2人停药。研究过程中未发现严重的不良反应事件，与基线相比，每周癫痫的发生率并没有明显的上升，患者对该药的耐受性普遍较好