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Diclegis为经受恶心和呕吐妊娠妇女
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
批准日期：2013年4月8日；公司：Duchesnay公司。
http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm347087.htm
2013年4月8日美国食品和药品监督管理局(FDA)批准Diclegis(琥珀酸多西拉敏和盐酸吡哆醇)治疗妊娠妇女经受恶心和呕吐。
Diclegis是一种缓释片意向为对妊娠时恶心和呕吐对保守处理反应不佳妇女，例如饮食和生活方式修饰。这些修饰包括吃几小餐代替三大餐，吃低脂肪容易消化的刺激性食物和避免闻激发恶心的味道。
FDA 药物评价和研究中心生殖和泌尿系统部主任Hylton V. Joffe, M.D., M.M.Sc.说：“许多妇女在妊娠期间经受恶心和呕吐, 和有时这些症状通过建议的饮食和生活方式改变不能适当处理，”“现在Diclegis是唯一 FDA-批准的对由于妊娠恶心和呕吐治疗，为寻求缓解这些症状妊娠妇女提供一种治疗选择。”
在261例由于妊娠经受恶心和呕吐研究Diclegis。在临床试验中研究参加者至少18岁和已妊娠至少7周至14周。妇女随机赋予接受2周用 Diclegis或安慰剂。研究结果表明服用Diclegis 妇女经受恶心和呕吐的改善优于安慰剂。此外，观察性(流行病学)研究表明在Diclegis中活性成分组合对胎儿风险无增加。
每天服用Diclegis。必须空胃整服片。建议在睡前服起始剂量2片。如不能适当控制，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)。
由于妊娠恶心和呕吐通常在第一个三个月后改善。卫生保健专业人员应再评估他们的患者随着妊娠的进展是否继续需要Diclegis。
服用Diclegis妇女，睡意，可能严重，是最常报道副作用。妇女当从事需要精神警觉性活动，例如驾驶或操作重型机械避免用Diclegis直至被卫生保健提供者清除。
由总部在加拿大，魁北克，Blainville Duchesnay公司上市 Diclegis。
http://diclegis.com/pdf/Diclegis_Full_Prescribing_Information.pdf
处方资料重点
这些重点不包括安全和有效使用DICLEGIS所需所有资料。请参阅下文为DICLEGIS的完整处方资料
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。(2)
剂型和规格
缓释片含10 mg琥珀酸多西拉敏和10 mg盐酸吡哆醇。(3)
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(4)
(2) 单胺氧化酶(MAO)抑制剂(4, 7)
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(5.1)
(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(5.1)
(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(5.2)
不良反应
用DICLEGIS最常见不良反应(≥5 %和超过安慰剂率)是睡意。(6)
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。(7)
特殊人群中使用
妊娠类别A. DICLEGIS意向为妊娠妇女中使用。(8.1)
