2013年4月8日，美国食品与药物管理局（FDA）批准了Diclegis缓释片用于治疗妊娠女性的恶心和呕吐。该药有效成分为琥珀酸多西拉敏和盐酸吡哆醇（维生素B6），将会用于经饮食和生活方式改变等保守治疗无效的妊娠期女性的恶心和呕吐。
Diclegis是目前FDA批准的唯一一个治疗女性孕吐的药物。观察性（流行病学）研究显示，该药有效成分未增加发生胎儿损害的风险。
值得注意的是，妊娠期恶心、呕吐症状在妊娠3个月后常会改善，因此届时应重新评估是否继续服用该药。 

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