英文药名: Daytrana(Methylphenidate Transdermal Patches) 中文药名: 哌醋甲酯贴剂 药品介绍 2010年7月6日,Shire plc公司宣布FDA批准Daytrana(methylphenidate transdermal sys-tem,哌甲酯皮肤贴剂)上市,用于治疗13~17岁青少年的注意力缺陷/多动障碍(ADHD),这是第一个治疗ADHD的非口服药,此前已经获批用于6~12岁儿童治疗ADHD。Daytrana贴在髋部(两侧交替使用),每天1贴 DAYTRANA（哌醋甲酯透皮系统）—是唯一一类用于治疗注意力不足过动障碍症（ADHD）的非口服药物。   DAYTRANA 这种日用一次的哌醋甲酯透皮贴片配方将以10 mg、15 mg、20 mg 和 30 mg 的剂量推出。   DAYTRANA 的药效通过两个受控的临床试验进行了验证，这两项试验是针对6-12岁的儿童 ADHD 患者进行的。DAYTRANA 结合了哌醋甲酯和 Noven 获得专利的 DOT Matrix（TM） 透皮技术。哌醋甲酯是一种有50年应用历史的药物。这种透皮给药系统直接将药物通过皮肤提供给血液，旨在于全天提供持续且均衡的药物释放。该贴片旨在在儿童正常的日常活动中停留在皮肤上，包括游泳、锻炼和洗澡。因为 DAYTRANA 是一种贴片，医师可以通过让患者贴的时间少于建议的一天9个小时来控制药效持续时间和潜在的副作用。在临床试验中，贴9个小时的贴片提供的药效持续时间为12小时。   临床试验第二阶段和第三阶段的数据显示，使用 DAYTRANA 进行治疗的儿童在第一个和第二个被分析的端点上比使用安慰剂的儿童效果明显。 DAYTRANA 在临床研究中通常具有很好的耐受性。与其他含有哌醋甲酯（DAYTRANA 的活性成分）产品一样，接受 DAYTRANA 治疗的儿童所报告的常见副作用为食欲下降、失眠、反胃、呕吐、体重下降、抽搐和情绪不稳定（心绪不定）。 Generic Name for DAYTRANA Methylphenidate 10mg, 15mg, 20mg, 30mg; delivered over 9 hours; transdermal patches. Legal Classification: CII Pharmacological Class for DAYTRANA CNS stimulant. Manufacturer of DAYTRANA Noven Therapeutics Indications for DAYTRANA Attention deficit hyperactivity disorder (ADHD). Adult dose for DAYTRANA Not applicable. Children's dosing for DAYTRANA <6yrs: not recommended. 6–17yrs: Initial: apply one 10mg patch to hip 2 hours before desired effect, remove 9 hours after application; may remove earlier if shorter duration of effect or late day side effects appear. May titrate dose at 1-week intervals. Reevaluate periodically. Rotate application sites. Contraindications for DAYTRANA Marked anxiety, tension, agitation. Glaucoma. Motor tics. History of Tourette's syndrome in patient or family. During or within 14 days of MAOIs. Warnings/Precautions for DAYTRANA Discontinue if contact sensitization is suspected; may develop systemic sensitization with other MPH formulations (see literature). Avoid exposing patch to direct external heat sources. Structural cardiac abnormalities. Psychosis. Seizure disorders. EEG abnormalities. Hypertension. Heart failure. Recent MI. Arrhythmias. History of drug dependence or alcoholism. Monitor growth, BP, CBCs, differential, and platelet counts. Pregnancy (Cat.C). Nursing mothers. Interactions for DAYTRANA See Contraindications. May potentiate oral anticoagulants, anticonvulsants (eg, phenobarbital, phenytoin, primidone), tricyclics (eg, imipramine, clomipramine, desipramine), SSRIs. Caution with pressor agents, α2-agonists (eg, clonidine). Adverse Reactions for DAYTRANA Application site reactions (eg, erythema), decreased appetite, insomnia, GI upset, weight loss, anorexia, nasal congestion, affect lability, tics, headache, irritability, nasopharyngitis, blurred vision (follow up if occurs). How is DAYTRANA supplied? Patches—30 Related Disease: ADD ADHD {ADHD} Attention deficit disorders~stimulants Attention deficit hyperactivity disorder Daytrana (methylphenidate transdermal system) is a central nervous system stimulant. It affects chemicals in the brain and nerves that contribute to hyperactivity and impulse control. Daytrana is used to treat attention deficit hyperactivity disorder (ADHD). It is a transdermal skin patch that is applied to a clean, dry site on the hip. Daytrana patches may also be used for other purposes not listed in this medication guide. Most important: Do not use a Daytrana patch if you have used an MAO inhibitor such as furazolidone (Furoxone), isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate) within the past 14 days. Do not use Daytrana if you are allergic to methylphenidate or if you have glaucoma, tics (muscle twitches) or Tourette’s syndrome, or severe anxiety, tension, or agitation (methylphenidate can make these symptoms worse). Methylphenidate is a drug of abuse and may be habit-forming. Keep track of how many Daytrana patches have been used from each new package you receive. You should be aware if anyone is using your medicine improperly or without a prescription. Using this medication improperly can cause death or serious side effects on the heart. Children using Daytrana should be warned never to remove the skin patch and place it onto another person. Serious side effects may result.