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  药店国别: 美国药房
产地国家: 美国
所属类别: 妇科药物->产妇补给
处方药:处方药
包装规格: (10毫克/10毫克)/片 100片/盒
计价单位:
   
生产厂家中文参考译名:
DUCHESNAY
生产厂家英文名:
DUCHESNAY
该药品相关信息网址2:
http://www.webmd.com/drugs/drug-163946-Diclegis+Oral.aspx?drugid=163946&drugname=Diclegis+Oral
原产地英文商品名:
DICLEGIS DR 10mg/10mg EC Tablets
原产地英文药品名:
DOXYLAMINE SUCCINATE/PYRIDOXINE HCL
中文参考商品译名:
DICLEGIS DR (10毫克/10毫克)/片 100片/盒
中文参考药品译名:
琥珀酸多西他敏和盐酸吡哆醇
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Nausea of pregnancy (NVP)
英文适应病症2:
Vomiting of pregnancy (NVP)
临床试验期:
完成
中文适应病症参考翻译1:
妊娠恶心和呕吐
中文适应病症参考翻译2:
妊呕吐
药品信息:

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 详细处方信息以本药内容附件PDF文件(201411223363311.pdf)的“原文Priscribing Information”为准
---------------------------------------------------------------
部分中文DICLEGIS处方资料(仅供参考)

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。

This combination medication (doxylamine with pyridoxine) is used to prevent or reduce nausea and vomiting caused by pregnancy. Decreasing nausea and vomiting may improve your health and nutrition during pregnancy. Doxylamine is an antihistamine that is thought to work by affecting certain natural substances (acetylcholine, serotonin) in your body or by acting directly on certain parts of the brain. Pyridoxine is a B vitamin that is important for good health. Most people get enough pyridoxine in their diet, but certain health conditions (e.g., pregnancy, poor diet, alcoholism) can result in a lack of this vitamin.

How to use Diclegis oral

Read the Patient Information Leaflet if available from your pharmacist before you start taking this medication and each time you get a refill. If you have any questions, ask your doctor or pharmacist.

Take this medication by mouth without food as directed by your doctor. If this medication is taken with food, it may take longer for it to start to work but will not decrease the effect.

Swallow the medication whole with a full glass of water. Do not crush, chew, or break the tablets.

Dosage is based on your medical condition and response to treatment. This medication is usually taken at bedtime to decrease nausea and vomiting in the morning. If nausea persists during the day, additional doses may be prescribed by your doctor. Talk with your doctor about your symptoms and the best dose schedule for you. Do not take more than 4 tablets in a day.

Do not stop using this medication or change your dose without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.

Use this medication regularly to get the most benefit from it. To help you remember, take it at the same times each day.

Drowsiness, dizziness, stomach upset, diarrhea, headache, and trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Before taking this product, tell your doctor or pharmacist if you are allergic to doxylamine or pyridoxine; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

更新日期: 2013-06-23
附件:
201411223363311.pdf    

 
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