英文药名:Concerta Tablets(Methylphenidate Hydrochloride)
中文药名:盐酸哌甲酯片
生产厂家:杨森制药
コンサータ錠18mg/コンサータ錠27mg/コンサータ錠36mg
类别名称 中枢神经兴奋剂 商標名 Concerta Tablets 一般名 メチルフェニデート塩酸塩 (Methylphenidate Hydrochloride) 化学名 Methyl α-phenyl-2-piperidineacetate hydrochloride 分子式 C14H19NO2・HCl 分子量 269.77 化学構造式
性状 白色或类白色粉末 可溶性 它易溶于水或甲醇,微溶于乙醇(95),微溶于氯仿或丙酮 审批条件 这种药物的管理,注意力缺陷/多动障碍(AD/HD),治疗诊断,有足够的管理医生和医疗机构管理药剂师也存在风险这种药物,包括药物依赖仅与药剂下完成,因此,在那些它被分配之前确认医生及医疗机构药房配药上完成后,采取在生产销售的必要措施。 适应症 6岁以上患注意缺陷多动障碍儿童. 用法用量 未满18岁的患者 初始剂量为18mg,早晨每日一次口服。如果增量剂是必需的,执行为9mg的增加或18mg的每日剂量一个星期或以上的时间间隔分开。此外,根据症状进行调整。然而,每日剂量不应超过54mg。 患者超过18岁 初始剂量为18mg,早晨每日一次口服。如果增量剂是必需的,执行为9mg的增加或18mg的每日剂量一个星期或以上的时间间隔分开。此外,根据症状进行调整。然而,每日剂量不超过72mg。 包装规格: 18mg:100片(10片×10) 27mg:100片(10片×10) 36mg:100片(10片×10) 生产厂商 杨森制药日本公司 完整资实附件:http://www.info.pmda.go.jp/go/pack/1179009G1022_1_13/ Announcement of release of 36mg of "Conserter ® tablet" remedy for hyperactivity/hyperactivity disorder(AD/HD) Janssen Pharma Co., Ltd. (Headquarters: Chiyoda-ku, Tokyo, President and CEO: Bruce Goodwin, hereinafter Jansen) will start offering attention-deficit/hyperactivity disorder (AD/HD) "(Generic name: methylphenidate hydrochloride) We started selling 36 mg dosage form. This product has been approved for manufacturing and marketing on January 17th this year. In October 2007, Consatter® tablets 18 mg and 27 mg were approved for manufacturing and marketing in Japan for the first time as "adaptive attention deficit/hyperactivity disorder (AD/HD) in childhood". Patients who started drug treatment with this drug in August 2011 will be able to continue use after 18 years of age, and in December 2013 they will receive approval expansion for adults over the age of 18 years did. The addition of 36mg dosage form to Concera®tablet 18mg·27mg makes it possible to adjust the dose with 1 to 2 tablets at all doses, thus reducing the burden of taking patients. Consatter® tablets 36 mg can be taken not only for adult patients but also for children. Product Summary Sales name Concerta ® tablets 36 mg Common name Methylphenidate hydrochloride Approval date January 17, 2014 Drug Price Listing Date April 17, 2014 Release date 20th May 2014 Effect/efficacy Attention Deficit/Hyperactivity Disorder (AD/HD) Dosage regimen Please refer to the attached document for the formal usage and dosage of this drug. Patients under the age of 18: 18mg as an initial dose, 18 to 45mg as a maintenance dose, orally daily in the morning. Daily dose should not exceed 54 mg. Patient 18 years or older: 18mg as an initial dose orally in the morning once a day. The daily dose should not exceed 72mg. Concerter ® tablets Concera ® tablets are attention deficit/hyperactivity disorder(AD /HD) remedies taken once in the morning with methylphenidate hydrochloride as the active ingredient. By adopting the osmotically controlled release control system (OROS®) and further containing the methylphenidate hydrochloride in the coating layer, the methylphenidate hydrochloride of the coating layer is released promptly after dosing and then about It is a controlled-release sustained-release tablet designed to release methylphenidate hydrochloride continuously over a 12-hour period. Methylphenidate hydrochloride is positioned as domestic guidelines for the first-line treatment of attention deficit/hyperactivity disorder (AD/HD) in children and adolescents, and in the UK and Canadian guidelines are considered one of the first-line treatments for children and adolescents, adulthood attention deficit/hyperactivity disorder (AD/HD). As of October 2013, Concera®tablets are approved for indications of childhood attention deficit/hyperactivity disorder(AD/HD) in 91 countries and regions. Adaptation to attention deficit/ hyperactivity disorder (AD/HD) in adulthood has been approved in 39 countries and regions. As of October 2013, 36mg dosage form has been approved in 86 countries and regions. |