——每日服用一颗Mydayis的长效缓释胶囊，治疗注意缺陷多动障碍（ADHD）患者 近日，美国FDA批准Mydayis（SHP465，苯丙胺单一实体混合盐产品[Amphetamine,Dextroamphetamine]）长效药物，用于13岁及以上注意缺陷多动障碍（ADHD）患者的治疗。 缺陷多动障碍又称多动症，是儿童期常见的一类心理障碍，主要特征（核心症状）是注意力不集中，有的孩子有多动行为，但是注意力很专注，一般不认为有多动症。多动症的诊断有两个标准，一个是症状学标准，一个是严重程度，如果出现多动、注意力不集中等症状没有妨碍到他的学习，引起学习困难，也就是说没有达到疾病的严重程度，一般不诊断为多动症。 Mydayis是一种每日一次的药物，包含3种不同类型的药物缓释珠，用于13岁及以上注意缺陷多动障碍（ADHD）患者的治疗，不适用于12岁及以下儿童ADHD患者。 FDA批准Mydayis，是基于来自16项临床研究的数据。这些研究涉及超过1600例受试者，包括青少年（13-17岁）及成人ADHD患者。在关键性、安慰剂对照临床研究中，采用ADHD评定量表（ADHD-RS-IV）评分及永久产品性能指标（PERMP）评价，Mydayis显着改善了青少年及成人ADHD患者的相关症状。PERMP是一种客观的、经过验证的、机能调整数学测试工具，用于评价ADHD患者的注意力，数据显示，在Mydayis给药后仅仅2-4小时PERMP改善即达到了统计学意义的显着差异，并且能一直维持至给药后16小时。 此次批准，将为ADHD群体提供一种每日一次的治疗选择：患者每日服用一颗Mydayis胶囊，从服药后2-4小时开始见效，并且疗效持续时间能长达16小时。 包装规格 缓释胶囊剂 12.5毫克、25毫克、37.5毫克、50毫克*100粒/瓶 制药商：Shire Mydayis ER Capsules(mixed salts of a single-entity amphetamine) MYDAYIS ADHD  Only 4 drugs may be compared at once Generic Name and Formulations: Mixed salts of a single-entity amphetamine product (each cap contains equal parts dextroamphetamine saccharate, dextroamphetamine sulfate, amphetamine aspartate monohydrate, amphetamine sulfate); 12.5mg, 25mg, 37.5mg, 50mg; ext-rel caps. Company: Shire US, Inc. Select therapeutic use: ADHD Indications for MYDAYIS: Attention deficit hyperactivity disorder. Limitations Of use: Higher plasma exposure and rates of adverse reactions (eg, insomnia, decreased appetite) in patients ≤12yrs than ≥13yrs at the same dose. Adult: Swallow caps whole or may open and sprinkle contents onto applesauce, then consume immediately; do not chew beads. Individualize. Avoid late evening doses; give in the AM upon awakening. 13–17yrs: initially 12.5mg once daily; may increase by 12.5mg at weekly intervals; max 25mg/day.18–55yrs: initially 12.5mg or 25mg once daily; may increase by 12.5mg at weekly intervals; max 50mg/day. Severe renal impairment (GFR 15–<30mL/min/1.73m2): initially 12.5mg daily; max 25mg/day or 12.5mg/day (for 13–17yrs) if tolerated. ESRD (GFR <15mL/min/1.73m2): not recommended. Do not substitute for other amphetamine products on a mg-per-mg basis. Switching from other amphetamine products: see full labeling. Children: ≤12yrs: not established. Contraindications: During or within 14 days of MAOIs. Warnings/Precautions: Abuse potential (monitor). Increased risk of sudden death, stroke, and MI; assess for presence of cardiac disease before initiating. Avoid in known structural cardiac abnormalities, cardiomyopathy, serious arrhythmias, coronary artery disease, and other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing manic episode prior to initiating. Consider discontinuing if new psychotic/manic symptoms occur. Seizure disorder; discontinue if occurs. Monitor for serotonin syndrome; discontinue and treat if occurs. Peripheral vasculopathy, including Raynaud’s phenomenon; monitor for digital changes. Monitor BP, HR, growth in children. Reevaluate periodically. Renal impairment: see full labeling. Labor & delivery. Pregnancy: monitor for neonatal withdrawal symptoms. Nursing mothers: not recommended. Interactions: See Contraindications. Hypertensive crisis with MAOIs (eg, selegiline, isocarboxazid, phenelzine, tranylcypromine). Increased risk of serotonin syndrome with serotonergic drugs (eg, SSRIs, SNRIs, TCAs, triptans, fentanyl, lithium, tramadol, tryptophan, buspirone, St. John's wort), CYP2D6 inhibitors (eg, paroxetine, fluoxetine, quinidine, ritonavir); consider alternatives; if needed, initiate with lower doses and monitor. Potentiated by alkalinizers (eg, sodium bicarbonate, PPIs, acetazolamide, some thiazides); caution. Antagonized by acidifiers (eg, guanethidine, reserpine, glutamic acid HCl, ascorbic acid, ammonium chloride, sodium acid phosphate, methenamine salts); increase dose. May potentiate TCAs, sympathomimetics (eg, desipramine, protriptyline); adjust dose or use alternatives. Monitor effects when concomitant PPIs or cimetidine. May interfere with urinary steroid levels. Pharmacological Class: CNS stimulant. Adverse Reactions: Insomnia, decreased appetite, decreased weight, irritability, nausea; also adults: dry mouth, increased heart rate, anxiety. Generic Availability: NO How Supplied: Caps—100