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  药店国别: 加拿大药房
产地国家: 加拿大
所属类别: 耳鼻喉及口腔科药物->鼻炎
处方药:处方药
包装规格: 5毫克/片 20片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
先灵葆雅
生产厂家英文名:
Schering Plough
该药品相关信息网址1:
http://www.aerius.ca/
该药品相关信息网址2:
http://www.drugs.com/cons/aerius.html
原产地英文商品名:
AERIUS 5mg/tab 20tabs/box
原产地英文药品名:
DESLORATADINE
中文参考商品译名:
恩理思 5毫克/片 20片/盒
中文参考药品译名:
地氯雷他定
中文参考化合物名称:
8-氯-6,11-二氢-11-(4-氮己环叉) -5H-苯-[5,6]环庚[1,2-b]吡啶
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Rhinitis
英文适应病症2:
Urticaria
临床试验期:
完成
中文适应病症参考翻译1:
鼻炎
中文适应病症参考翻译2:
荨麻疹
药品信息:

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 详细处方信息以本药内容附件PDF文件(201142419022728.pdf)的“原文Priscribing Information”为准
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部分中文地氯雷他定处方资料(仅供参考)

恩理思(薄膜衣片)
Aerius

性状   
地氯雷他定的化学名称为 :8-氯-6,11-二氢-11-(4-氮己环叉) -5H-苯-[5,6]环庚[1,2-b]吡啶,分子式 :C19H19ClN2,分子量 :310.83。
本品为浅蓝色圆形薄膜衣片,有压痕。 
 
药理作用   
地氯雷他定是一种非镇静性的长效组胺拮抗剂,具有强效、选择性的拮抗外周H1 受体的作用。已证实地氯雷他定具有抗过敏、抗组胺及抗炎作用。
地氯雷他定是氯雷他定的主要活性代谢产物。地氯雷他定和氯雷他定的临床前对比研究表明 :在与地氯雷他定相当的剂量水平下,两者的毒理学表现在质和量上均无差别。
对地氯雷他定所进行的常规临床前研究,包括安全性药理、重复给药毒性、遗传毒性和生殖毒性研究,其结果表明地氯雷他定对人没有特别的危害。由氯雷他定的致癌性研究可以证明地氯雷他定也没有潜在的致癌作用。
口服后,地氯雷他定被有效地拒于中枢神经系统(CNS)之外,因此可选择性地阻断外周组胺H1受体。
大量体内和体外(主要是人体组织细胞)试验研究表明,除抗组胺作用外,地氯雷他定还显示出抗过敏和抗炎作用。这些研究表明地氯雷他定可以抑制过敏性炎症初期及进展期的多个环节,包括 :
炎症细胞因子IL-4,IL-6,IL-8,IL-13的释放 ;
重要的炎症趋化因子的释放,如RANTES(正常T 细胞表达或分泌的活性调节因子) ;
多形核嗜中性粒细胞激活时产生的活性氧自由基 ;
嗜酸性粒细胞粘附及趋化作用 ;
粘附分子如选择蛋白P的表达 ;
组胺、前列腺素PGD2、白三烯LTC4 的IgE 依赖性释放 ;
动物模型中的急性过敏性支气管痉挛反应和过敏性咳嗽。
在地氯雷他定20 mg/日×14日的多剂量的临床试验中,未发现有统计学或临床相关意义的心血管作用。在临床药理学试验中,服用地氯雷他定45 mg/日(临床剂量的9 倍)×10 日,未见QTc 间期延长。
地氯雷他定不易透过中枢神经系统。在推荐剂量5 mg/日下嗜睡反应发生率不超过安慰剂。临床试验中,即使在7.5 mg/日剂量下,地氯雷他定也不会影响智力操作性能。
临床药理学试验中,地氯雷他定与酒同服并不增加酒精所引起的行为能力的损害或嗜睡。无论是单独服用还是与酒同服,地氯雷他定组和安慰剂组在精神运动试验方面均无显著差别。
对于季节性过敏性鼻炎患者,本品可有效缓解季节性过敏性鼻炎的症状,如打喷嚏、流涕和鼻痒 ;鼻粘膜充血/鼻塞 ;眼痒、流泪和充血 ;腭痒。本品可在24 小时内有效地控制以上症状。
在两项为期4周的对季节性过敏性鼻炎并发哮喘患者进行的临床试验中,地氯雷他定能有效缓解季节性过敏性鼻炎的症状(流涕、鼻塞、鼻痒及打喷嚏 ;眼痒及烧灼感 ;流泪 ;充血 ;腭痒及耳痒)及哮喘的症状(咳嗽、喘鸣及呼吸困难),并能减少β受体激动剂的用量。
地氯雷他定组和安慰剂组的第1秒最大呼气量(FEV1)均未改变。
在对慢性特发性荨麻疹患者进行的临床试验中,服用本品1天后即可有效缓解瘙痒并减少荨麻疹的数量及大小。在各项试验中,地氯雷他定在24小时的服药间隔内能够维持疗效。
服用地氯雷他定能够减少嗜睡对日间生活的影响,提高患者睡眠及日常生活质量。
对过敏性鼻-结膜炎患者的问卷调查表明,地氯雷他定片能够有效缓解季节性过敏性鼻炎患者的负担,能够显著改善症状所造成的日常不便。 
 
药代动力学   
地氯雷他定口服后30分钟可测得其血浆浓度,吸收较好,约3 小时后达到血药峰浓度,终末半衰期约为27小时。地氯雷他定的蓄积程度与其半衰期(约27小时)及每日1次的服药间隔一致。地氯雷他定的生物利用度在5-20 mg 范围内与剂量成正比。
地氯雷他定可与血浆蛋白中等程度结合(83-87%)。每日1次地氯雷他定(5-20 mg)服用14 天,未见有临床相关意义的药物蓄积。
在一项服用7.5 mg地氯雷他定的单剂量试验中,食物(高脂肪、高热量早餐)对地氯雷他定的分布没有影响。 
 
毒理研究   
给予34 倍人体临床推荐剂量的地氯雷他定,未发现对大鼠的总体生育能力有影响,在动物试验中未发现地氯雷他定有致畸和致突变作用。 
 
适应症   
本品用于快速缓解季节性过敏性鼻炎的相关症状,如打喷嚏、流涕和鼻痒 ;鼻粘膜充血/鼻塞;以及眼痒、流泪和充血 ;腭痒及咳嗽。
本品还用于缓解慢性特发性荨麻疹的相关症状如瘙痒,并可减少荨麻疹的数量及大小。 
 
用法用量   
成人及12岁或以上的青少年:口服,每日1次,每次1 片。进食不影响服药效果。 

不良反应   
在一系列以季节性过敏性鼻炎和慢性特发性荨麻疹为适应症的临床试验中,患者按每天5 mg的推荐剂量服用地氯雷他定,试验组不良反应发生率比安慰剂组高3%。超过安慰剂组的最常见不良反应为疲倦(1.2%),口干(0.8%)和头痛(0.6%)。 

禁忌症   
对本品活性成分或辅料过敏者禁用。 
 
注意事项   
未见地氯雷他定对驾驶及操作机器的能力造成影响。严重肾功能不全患者慎用。 
 
孕妇及哺乳期妇女用药   
由于尚无孕妇使用地氯雷他定的临床资料,孕期内使用地氯雷他定的安全性尚未确定。除非潜在的益处超过可能的风险,孕期内不应使用地氯雷他定。
地氯雷他定可经乳汁排泌,因此不建议哺乳期妇女服用地氯雷他定。 
 
儿童用药   
地氯雷他定对12岁以下的儿童患者的有效性和安全性尚未确定。 
 
老年患者用药   
尚缺乏老年患者用药的研究资料。 
 
药物相互作用   
临床试验中未发现地氯雷他定存在有临床相关意义的相互作用。地氯雷他定在与酮康唑和红霉素的多剂量药物相互作用试验中,血浆浓度未出现有临床相关意义的改变。然而,地氯雷他定的代谢酶尚未确定,因此与其他药物的相互作用尚不能完全排除。
进食或饮用葡萄柚汁对地氯雷他定的分布没有影响。
地氯雷他定与酒精同时使用时不会加强酒精对人行为能力的损害作用。 
 
用药须知   
服药过量时应考虑采取标准治疗措施去除未吸收的活性物质。建议进行对症及支持治疗。
在一项对成人和青少年进行的多剂量临床试验中,受试者接受高达45 mg的地氯雷他定(临床实际用量的9倍),未见临床相关副反应。
地氯雷他定不能通过血液透析排除 ;能否通过腹膜透析排除尚不可知。 
 
贮藏/有效期   
2-30°C干燥处保存。有效期2年。

Brand Name
Aerius

Common Name
desloratadine

DIN (Drug Identification Number)
02243919  AERIUS 5MG TABLET
02247193  AERIUS KIDS 0.5MG / ML SYRUP

How does this medication work? What will it do for me?
Desloratadine belongs to a group of medications known as antihistamines, specifically the class known as H1-receptor antagonists. During an allergic reaction, the body produces a chemical called histamine, which causes allergy symptoms such as hives, runny nose, sneezing, itchy throat, congestion, and itchy watery eyes. Desloratadine works by blocking the action of histamine in the body.

This medication is used to relieve the symptoms of seasonal and year-round allergies including nasal congestion, sneezing, runny nose, itchy nose, itchy palate, coughing, and itchy watery red eyes. It is also use to relieve the symptoms of allergic skin conditions (e.g., chronic idiopathic urticaria) such as skin itch and hives. Desloratadine usually starts to work within 75 minutes and lasts for 24 hours.

Your doctor may have suggested this medication for conditions other than those listed in these drug information articles. As well, some forms of this medication may not be used for all of the conditions discussed here. If you have not discussed this with your doctor or are not sure why you are taking this medication, speak to your doctor. Do not stop taking this medication without consulting your doctor.

Do not give this medication to anyone else, even if they have the same symptoms as you do. It can be harmful for people to take this medication if their doctor has not prescribed it.

How should I use this medication?
Tablets: The usual recommended dose of desloratadine tablets for adults and children 12 years of age and older is 5 mg once daily. It may be taken with or without food.

Syrup: The usual recommended dose of desloratadine syrup for adults and children 12 years of age and older is 10 mL (5 mg) once daily. For children 6 to 11 years of age, the usual recommended dose is 5 mL (2.5 mg) once daily. For children 2 to 5 years of age, the usual recommended dose is 2.5 mL (1.25 mg) once daily. It may be taken with or without food. Children between 2 to 12 years of age should not take this medication for longer than 14 days unless recommended by a doctor.

Many things can affect the dose of a medication that a person needs, such as body weight, other medical conditions, and other medications. If your doctor has recommended a dose different from the ones listed here, do not change the way that you are taking the medication without consulting your doctor.

It is important to take this medication exactly as prescribed by your doctor. If you miss a dose, take it as soon as possible and continue with your regular schedule. If it is almost time for your next dose, skip the missed dose and continue with your regular dosing schedule. Do not take a double dose to make up for a missed one. If you are not sure what to do after missing a dose, contact your doctor or pharmacist for advice.

Store this medication at room temperature, protect it from moisture, and keep it out of the reach of children.

This medication is available under multiple brand names and/or in several different forms. Any specific brand name of this medication may not be available in all of the forms listed here. The forms available for the specific brand you have searched are listed under "What form(s) does this medication come in?"

Do not dispose of medications in wastewater (e.g. down the sink or in the toilet) or in household garbage. Ask your pharmacist how to dispose of medications that are no longer needed or have expired.

What form(s) does this medication come in?
Tablet
Each blue, round, film-coated tablet for immediate release contains desloratadine 5 mg. Nonmedicinal ingredients: carnauba wax, cornstarch, dibasic calcium phosphate dihydrate, FD&C Blue No. 2 Lake, hydroxypropyl methylcellulose, lactose monohydrate, microcrystalline cellulose, polyethylene glycol, talc, titanium dioxide, and white beeswax.

Syrup
Each mL of clear, orange colored liquid with bubblegum flavouring, contains desloratadine 0.5 mg. Nonmedicinal ingredients: bubblegum flavor, citric acid anhydrous, disodium edetate, FD&C Yellow No. 6, propylene glycol, purified water, sodium benzoate, sodium citrate dihydrate, sorbitol solution, and sucrose.

Some medications may have other generic brands available. Always ask your doctor or pharmacist about the safety of switching between brands of the same medication.

Who should NOT take this medication?
Desloratadine should not be taken by anyone who is allergic to desloratadine or to any of the ingredients of the medication.

What side effects are possible with this medication?
Many medications can cause side effects. A side effect is an unwanted response to a medication when it is taken in normal doses. Side effects can be mild or severe, temporary or permanent. The side effects listed below are not experienced by everyone who takes this medication. If you are concerned about side effects, discuss the risks and benefits of this medication with your doctor.

The following side effects have been reported by at least 1% of people taking this medication. Many of these side effects can be managed, and some may go away on their own over time.

Contact your doctor if you experience these side effects and they are severe or bothersome. Your pharmacist may be able to advise you on managing side effects.
dry mouth, nose, or throat
fatigue
headache

Although most of these side effects listed below don't happen very often, they could lead to serious problems if you do not check with your doctor or seek medical attention.

Check with your doctor as soon as possible if any of the following side effects occur:
difficult or painful urination (children)
pounding, fast, or irregular heartbeat
restlessness with increased body movement
symptoms of liver problems such as yellowing of the skin or eyes
unusual tiredness or weakness

Stop taking the medication and seek immediate medical attention if any of the following occur:
seizures
symptoms of a severe allergic reaction (e.g., difficulty breathing, hives, or swelling of the mouth or throat)

Some people may experience side effects other than those listed. Check with your doctor if you notice any symptom that worries you while you are taking this medication.

Are there any other precautions or warnings for this medication?
Before you begin using a medication, be sure to inform your doctor of any medical conditions or allergies you may have, any medications you are taking, whether you are pregnant or breast-feeding, and any other significant facts about your health. These factors may affect how you should use this medication.

Kidney function: People with severely reduced kidney function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Liver function: People with severely reduced liver function should discuss with their doctor how this medication may affect their medical condition, how their medical condition may affect the dosing and effectiveness of this medication, and whether any special monitoring is needed.

Pregnancy: Desloratadine should not be taken by women who are pregnant. If you become pregnant while taking this medication, contact your doctor immediately.

Breast-feeding: Desloratadine passes into breast milk. It should not be taken by women who are breast-feeding.

Children: The safety and effectiveness of using desloratadine tablets have not been established for children under 12 years of age. The safety and effectiveness of using desloratadine syrup have not been established for children under 2 years of age.

What other drugs could interact with this medication?
Tell your doctor or prescriber about all prescription, over-the-counter (non-prescription), and herbal medications that you are taking. Also tell them about any supplements you take. Since caffeine, alcohol, the nicotine from cigarettes, or street drugs can affect the action of many medications, you should let your prescriber know if you use them. Depending on your specific circumstances, your doctor may want you to:
stop taking one of the medications,
change one of the medications to another,
change how you are taking one or both of the medications, or
leave everything as is.

An interaction between two medications does not always mean that you must stop taking one of them. In many cases, interactions are intended or are managed by close monitoring. Speak to your doctor about how any drug interactions are being managed or should be managed.

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 详细处方信息以本药内容附件PDF文件(201142419022728.pdf)的“原文Priscribing Information”为准
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2011-4-25更新

更新日期: 2014-08-14
附件:




201142419022728.pdf    

 
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