FDA批准Diclegis治疗妊娠相关恶心呕吐

圣路易斯(MD Consult)——2013年4月8日，美国食品药品管理局(FDA)和Duchesnay USA宣布，Diclegis(琥珀酸多西他敏10 mg和盐酸吡哆醇10 mg)已获准用于恶心、呕吐的妊娠女性。

Diclegis是一种缓释片剂，用于妊娠期恶心、呕吐而保守治疗(例如调整饮食和生活方式，包括少食多餐、吃清淡低脂易消化食物、避开可诱发恶心的味道)效果不佳的女性。

Diclegis在261名妊娠相关恶心、呕吐女性中接受了评估。这项临床试验的受试者年龄均≥18岁，妊娠7~14周，被随机分为Diclegis组和安慰剂组，治疗2周。结果显示，Diclegis组患者的恶心、呕吐改善更明显。此外，观察性(流行病学)研究显示，Diclegis中的活性成分并不增加胎儿风险。

Diclegis的用法为每日服用。这种片剂必须在空腹状态下整片吞下。推荐的初始剂量为晚上睡前服2片。假如症状未能得到充分控制，可将剂量增至最大推荐值——每日4片(早上服1片，中午服1片，晚上睡前服2片)。

困倦或嗜睡(可以较严重)是服用Diclegis的女性最常报告的不良反应。女性应避免在参与需要保持警觉的活动(例如驾驶车辆或操作重型机械)时服用Diclegis。患有哮喘、眼内压增高、狭角性青光眼、狭窄性消化性溃疡、幽门十二指肠梗阻或膀胱颈梗阻的女性应避免服用Diclegis。

爱思唯尔版权所有  未经授权请勿转载

ST LOUIS (MD Consult) - On April 8, 2013, the US Food and Drug Administration (FDA) and Duchesnay USA announced the approval of Diclegis (doxylamine succinate 10 mg and pyridoxine hydrochloride 10 mg) for the treatment of pregnant women experiencing nausea and vomiting. Diclegis is a delayed-release tablet intended for women who have not adequately responded to conservative management of nausea and vomiting during pregnancy, such as dietary and lifestyle modifications. These modifications include eating several small meals instead of 3 large meals, eating bland foods that are low in fat and easy to digest, and avoiding smells that can trigger nausea.

Diclegis was studied in 261 women experiencing nausea and vomiting related to pregnancy. Study participants in the clinical trial were at least 18 years old and had been pregnant for at least 7 weeks and up to 14 weeks. Women were randomly assigned to receive 2 weeks of treatment with Diclegis or placebo. The study results showed that patients receiving Diclegis experienced greater improvement in nausea and vomiting than patients receiving placebo. Additionally, observational (epidemiologic) studies have shown that the combination of active ingredients in Diclegis does not pose an increased risk of harm to the fetus.

Diclegis is taken daily. Tablets must be taken whole on an empty stomach. The recommended starting dose is 2 tablets taken at bedtime. If symptoms are not adequately controlled, the dose can be increased to a maximum recommended dose of 4 tablets daily (1 in the morning, 1 mid-afternoon, and 2 at bedtime).

Drowsiness or sleepiness, which can be severe, is the most common adverse effect reported by women taking Diclegis. Women should avoid using Diclegis when engaging in activities requiring mental alertness, such as driving or operating heavy machinery. Diclegis should be used with caution in women with asthma, increased intraocular pressure, narrow angle glaucoma, stenosing peptic ulcer, pyloroduodenal obstruction, or bladder-neck obstruction.