美国FDA批准Cotempla XR-ODT为第一个也是唯一的用于治疗注意力缺陷/多动症
近日，美国食品和药物管理局（FDA）批准了第一个也是唯一的哌醋甲酯缓释口服崩解片剂Cotempla XR-ODT，用于治疗注意力缺陷/多动症（ADHD） 6至17岁的患者。
适应症：
Cotempla XR-ODT是一种中枢神经系统（CNS）兴奋剂，用于治疗6至17岁儿童ADHD。
剂量/给药：6至17岁的儿科患者建议起始剂量为17.3毫克，每天早晨口服一次。剂量可以每周增加8.6mg至17.3mg每天增加。不建议每日剂量高于51.8毫克。建议患者持续食用或不食用Cotempla XR-ODT。
不良反应：
根据其他哌甲酯产品的累积数据，最常见的（安慰剂的5％和2倍）不良反应是食欲下降，失眠，恶心，呕吐，消化不良，腹痛，体重减轻，焦虑，头晕，烦躁不安，影响不稳定，心动过速和血压升高。
Cotempla XR ODT(Methylphenidate Extended-Release Orally Disintegrating Tablets)
COTEMPLA XR-ODT CII
Generic Name and Formulations:
Methylphenidate 8.6mg, 17.3mg, 25.9mg; ext-rel orally disintegrating tabs.
Company:
Neos Therapeutics
Indications for COTEMPLA XR-ODT:
Attention deficit hyperactivity disorder.
Adults and Children:
<6yrs: not established. Place tab on tongue and allow it to disintegrate; do not chew or crush. 6–17yrs: Individualize. Initially 17.3mg once daily in the AM. May titrate in increments of 8.6–17.3mg weekly; max 51.8mg daily. Discontinue if no improvement seen after dose adjustment over 1 month.
Contraindications:
During or within 14 days of MAOIs.
Warnings/Precautions:
High potential for abuse and dependence; 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 heart rhythm abnormalities, coronary artery disease, other cardiac problems. Pre-existing psychotic disorder. Bipolar disorder. Screen for risk factors in developing a manic episode prior to initiating. Consider discontinuing if psychotic/manic symptoms occur. Peripheral vasculopathy, including Raynaud’s phenomenon; monitor for digital changes. Monitor growth (in children), BP, HR. Reduce dose or discontinue if paradoxical aggravation of symptoms occur. Reevaluate periodically. Pregnancy. Nursing mothers: monitor infants.
Interactions:
See Contraindications. Concomitant gastric pH modulators (eg, omeprazole, famotidine, sodium bicarbonate): not recommended.
Pharmacological Class:
CNS stimulant.
Adverse Reactions:
Appetite decreased, insomnia, nausea, vomiting, dyspepsia, abdominal pain, weight decreased, anxiety, dizziness, irritability, affect lability, tachycardia, BP increased; priapism.
Note:
Register pregnant patients exposed to Cotempla XR-ODT by calling (866) 961-2388.
Generic Availability:
NO
How Supplied:
Blister pack—30 (5x6)