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Diclegis是目前FDA批准的唯一一个治疗女性孕吐的药物
DICLEGIS (琥珀酸多西拉敏[doxylamine succinate]和盐酸吡哆醇[pyridoxine hydrochloride])为口服使用缓释片
美国初始批准：1976
适应证和用途
DICLEGIS是一种琥珀酸多西拉敏，一种抗组胺，和盐酸吡哆醇，一种维生素B6类似物固定剂量组合的药品，适用为治疗对保守处理反应不佳的妊娠发恶心和呕吐妇女。
剂量和给药方法
每天睡前服用2片。如不能适当控制症状，剂量可增加至最大推荐剂量每天4片(早晨1片，中午1片和睡前2片)如完整处方资料所述。
剂型和规格
缓释片含10mg琥珀酸多西拉敏和10mg盐酸吡哆醇。
禁忌证
(1) 已知对琥珀酸多西拉敏，其他乙醇胺衍生抗组胺药，盐酸吡哆醇或任何制剂中无活性成分超敏性
(2) 单胺氧化酶(MAO)抑制剂
警告和注意事项
(1) 活动需要精神警觉性：避免从事需要完全精神警觉性活动，例如驾驶或操作重型机械，而使用DICLEGIS直至被卫生保健提供者清除
(2) 中枢神经系统(CNS)抑制剂：建议不同时使用酒精或其他CNS抑制剂
(3) 抗胆碱能作用：Use with caution in患者有哮喘，眼内压增加，窄角型青光眼, 狭窄性消化性溃疡，幽门梗阻和膀胱颈梗阻
不良反应
用DICLEGIS最常见不良反应(≥5 %和超过安慰剂率)是睡意。
报告怀疑不良反应, 联系Duchesnay Inc. 电话1-855-722-7734或medicalinfo@duchesnayusa.com或FDA电话1-800-FDA-1088或www.fda.gov/medwatch.
药物相互作用
(1) 当与酒精或其他镇静药物联用可能发生严重睡意。
特殊人群中使用
妊娠类别A. DICLEGIS意向为妊娠妇女中使用。
Pharmacological Class:
Antihistamine + Vit. B6 analog.
Active Ingredient(s):
Doxylamine succinate 10mg, pyridoxine HCl 10mg; delayed-release tablets.
Company
Duchesnay USA, Inc.
Indication(s):
Treatment of nausea and vomiting of pregnancy (NVP) in women who do not respond to conservative management.
Limitations of use: has not been studied in women with hyperemesis gravidarum.
Pharmacology:
The mechanism of action of Diclegis is unknown.
Clinical Trials:
A double-blind, randomized, multi-center, placebo-controlled study was conducted to support the safety and efficacy of Diclegis in the treatment of NVP. Adult women ≥18 years of age and 7–14 weeks gestation (median 9 weeks of gestation) with nausea and vomiting of pregnancy were randomized to 14 days of Diclegis or placebo. Two tablets of Diclegis were administered at bedtime on Day 1. If symptoms of nausea and vomiting persisted into the afternoon hours of Day 2, the woman was directed to take her usual dose of two tablets at bedtime that night and, beginning on Day 3, to take one tablet in the morning and two tablets at bedtime. Based upon assessment of remaining symptoms at her clinic visit on Day 4 (± 1 day), the woman may have been directed to take an additional tablet mid-afternoon. A maximum of four tablets (one in the morning, one in the mid-afternoon and two at bedtime) were taken daily. Over the treatment period, 19% of Diclegis-treated patients remained on two tablets daily, 21% received three tablets daily, and 60% received four tablets daily.
The primary efficacy endpoint was the change from baseline at Day 15 in the Pregnancy Unique-Quantification of Emesis (PUQE) score. The PUQE score incorporates the number of daily vomiting episodes, number of daily heaves, and length of daily nausea in hours, for an overall score of symptoms rated from 3 (no symptoms) to 15 (most severe). Baseline was defined as the PUQE score completed at the enrollment visit.
At baseline, the mean PUQE score was 9 in the Diclegis arm and 8.8 in the placebo arm. There was a 0.7 (95% confidence interval 0.2 to 1.2; P= 0.006) mean decrease (improvement in nausea and vomiting symptoms) from baseline in PUQE score at Day 15 with Diclegis vs. placebo.
Legal Classification:
Rx
Adults:
Swallow whole. Take on empty stomach with water. Day 1: initially 2 tabs at bedtime; continue same dose next day if symptoms adequately controlled. If symptoms persist into afternoon of Day 2, take usual dose of 2 tabs at bedtime that night, and then starting on Day 3 take 3 tabs (1 tablet in AM and 2 tabs at bedtime); continue if symptoms adequately controlled. If symptoms persist, starting on Day 4 take 4 tabs (1 tab in the AM, 1 tab mid-afternoon, and 2 tabs at bedtime). Max 4 tabs daily.
Children:
<18 years: not established.
Contraindication(s):
Concomitant MAOIs; may prolong and intensify anticholinergic effects.
Warnings/Precautions:
Asthma. Increased intraocular pressure. Narrow angle glaucoma. Stenosing peptic ulcer. Pyloroduodenal obstruction. Urinary bladder-neck obstruction. Reassess for continued need of treatment as pregnancy progresses. Pregnancy (Category A). Nursing mothers: not recommended.
Interaction(s)
See Contraindications. Concomitant alcohol, other CNS depressants (eg, hypnotic sedatives, tranquilizers): not recommended. Concomitant food may delay onset of action and reduce absorption.
Adverse Reaction(s)
Somnolence, severe drowsiness, falls, other accidents.
How Supplied:
Tabs—100
LAST UPDATED:
7/3/2013
FDA批准新的抗孕吐药Diclegis上市
2013年4月8日，美国食品与药物管理局（FDA）批准了Diclegis缓释片（有效成分为多西拉敏和维他命B6）用于治疗妊娠妇女的恶心和呕吐症状。这给很多常规治疗妊娠恶心呕吐无效的妇女带来了福音。
妊娠剧吐又称孕妇晨吐。常规的治疗方法主要为分餐疗法、减少高脂易消化食物的摄入、以及避免异味接触。FDA药物评估研究中心生殖和泌尿外科产品部主任Hylton V. Joffe博士认为，很多时候这些方法的效果并不是很好。目前，Diclegis是FDA批准的唯一一个治疗女性妊娠呕吐的药物，它为减轻妊娠妇女的痛苦提供了新方法。FDA推荐的初始剂量为睡前空腹一次。如果需要，可以增加到每天4次：早晨和中午各1片，临睡前2次。
在1956年至1983年期间，Diclegis曾以Bendectin为商标名出现在美国市场上，后因被质疑会影响胎儿发育遭起诉而退市。虽然现行的研究已经证明这些顾虑是多余的，但之前的产商Merrell Dow Pharmaceuticals由于担心市场前景，仍然拒绝生产这种药物。
事实上，很多年来医师一直在使用这两种有效成分。吡多辛属于维生素B6，多西拉敏只是一种抗组胺药。新通过的这种复方药的优势是延长药物作用时间，所以可以将晨吐扼杀在摇篮中。
据Diclegis的产商Duchesnay透露，9年前这种合成药就被美国发产科协会（ACOG）推荐为一线用药。加拿大也在生产销售一款名为Diclectin的类似产品。
为了评估Diclegis治疗妊娠期间恶心和呕吐的疗效，FDA进行了一项纳入261名孕妇的临床试验。这些孕妇被随机分配接受为期2周的Diclegis治疗或安慰剂治疗。结果显示，与服用安慰剂的受试者相比，服用Diclegis受试者的恶心和呕吐症状有明显缓解。另外，流行病学研究显示，Diclegis的有效成分的对胎儿无副作用。
另外，服用Diclegis的常见不良反应为嗜睡。 | 
