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Generic Name and Formulations:
Doxylamine succinate 10mg, pyridoxine HCl 10mg; delayed-release tablets.
Company:
Duchesnay USA, Inc.
Indications for DICLEGIS:
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.
Adult Dose for DICLEGIS:
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's Dose for DICLEGIS:
<18yrs: not established.
Pharmacological Class:
Antihistamine + Vit. B6 analog.
Contraindications:
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 (Cat.A). Nursing mothers: not recommended.
Interactions:
See Contraindications. Concomitant alcohol, other CNS depressants (eg, hypnotic sedatives, tranquilizers): not recommended. Concomitant food may delay onset of action and reduce absorption.
Adverse Reactions:
Somnolence, severe drowsiness, falls, other accidents.
How Supplied:
Tabs—100
2013年4月8日，美国食品与药物管理局（FDA）批准了Diclegis缓释片【有效成分为琥珀酸多西拉敏（doxylamine succinate）和维生素B6】用于治疗妊娠女性的恶心和呕吐。
该药预期用于那些经保守治疗（如饮食和生活方式调整）无效的妊娠期女性恶心和呕吐。其中，生活方式调整包括少吃多餐和平淡低脂易消化饮食，同时避免触发恶心的气味。
FDA药物评估与研究中心生殖和泌尿外科产品部主任Hylton V. Joffe博士表示，目前，Diclegis是FDA批准的唯一一个治疗女性孕吐的药物，为缓解妊娠女性的这些症状提供了另一项选择。
一项纳入261名妊娠期间有恶心和呕吐的临床试验评估了Diclegis的疗效。这些女性至少18岁且孕周7—17周，她们被随机分为接受为期两周的Diclegis 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的受试者的恶心和呕吐有明显改善。另外，流行病学观察研究显示，Diclegis有效成分的联合对胎儿未增加产生损害的风险。
Diclegis需妊娠女性每日完全空腹时服用。推荐的起始剂量为临睡前1片。如果症状未充分控制，可增加至最大推荐剂量（4片/日，早晨和中午各1片，临睡前2片）。
因孕吐在妊娠期的头3个月后常会改善，所以应随着妊娠的进展重新评估继续服用Diclegis的必要性。
服用 Diclegis的女性报告的最常见不良反应为嗜睡，有时候可能很严重，因此女性在进行高度警觉的活动时应避免服用该药，如驾驶或大型机械操作时。
由总部在加拿大，魁北克，Blainville Duchesnay公司上市 Diclegis。
请参阅下文为DICLEGIS缓释片的处方资料
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。
DICLEGIS Rx
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 | 
