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。
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。

下文为DICLEGIS的处方资料
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)
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)

Diclegis® is a fixed-dose combination drug product of doxylamine succinate, an antihistamine, and pyridoxine hydrochloride, a vitamin B6 analog, indicated for the treatment of nausea and vomiting of pregnancy in women who do not respond to conservative management.
Limitations of Use
Diclegis has not been studied in women with hyperemesis gravidarum.
Important Safety Information
Diclegis is contraindicated in women with known hypersensitivity to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride, or any inactive ingredient in the formulation. Diclegis is also contraindicated in combination with monoamine oxidase (MAO) inhibitors as MAOs intensify and prolong the adverse CNS effects of Diclegis. Use of MAOs may also prolong and intensify the anticholinergic (drying) effects of antihistamines.
Diclegis may cause somnolence due to the anticholinergic properties of doxylamine succinate, an antihistamine. Women should avoid engaging in activities requiring complete mental alertness, such as driving or operating heavy machinery, while using Diclegis until cleared to do so by their healthcare provider.
Use of Diclegis is not recommended if a woman is concurrently using CNS depressants, such as alcohol or sedating medications, including other antihistamines (present in some cough and cold medications), opiates, and sleep aids. The combination of Diclegis and CNS depressants could result in severe drowsiness leading to falls or other accidents.
Diclegis has anticholinergic properties and should be used with caution in women who have: (1) asthma, (2) increased intraocular pressure, (3) an eye problem called narrow angle glaucoma, (4) a stomach problem called stenosing peptic ulcer, (5) pyloroduodenal obstruction, or (6) a bladder problem called bladder-neck obstruction.
Fatalities have been reported from doxylamine overdose in children. Children appear to be at a high risk for cardiorespiratory arrest. However, the safety and effectiveness of Diclegis in children under 18 years of age have not been established.
Diclegis is a delayed-release formulation; therefore, signs and symptoms of intoxication may not be apparent immediately. Signs and symptoms of overdose may include restlessness, dryness of mouth, dilated pupils, sleepiness, vertigo, mental confusion, and tachycardia. If you suspect an overdose or seek additional overdose information, you can contact a poison control center at 1-800-222-1222.
The FDA granted Diclegis Pregnancy Category A status, which means that the results of controlled studies have not shown risk to an unborn baby during pregnancy.
Women should not breast-feed while using Diclegis because the antihistamine component (doxylamine succinate) in Diclegis can pass into breast milk. Excitement, irritability, and sedation have been reported in nursing infants presumably exposed to doxylamine succinate through breast milk. Infants with apnea or other respiratory syndromes may be particularly vulnerable to the sedative effects of Diclegis resulting in worsening of their apnea or respiratory conditions.