赛诺非-安万特公司和Altana制药公司共同研发的环索奈德（ciclesonide，Alvesco）是具有新型释放和分布机制的吸入型糖皮质激素。吸入型糖皮质激素是哮喘治疗的基础，能缓解肺部和呼吸道的炎症。 
 
赛诺菲-安万特和Altana曾于2001年签订协议，共同进行该品美国市场的研发和上市，而Altana制药公司主要负责Alvesco的全球研发。2004年10月，FDA批准了Alvesco用于治疗成人、青少年以及4岁及4岁以上儿童的持续性哮喘。截至2005年11月初，Alvesco已经在32国家获批用于治疗成人持续性哮喘，包括德国、英国、荷兰、澳大利亚和巴西。2005年1月，Alvesco首次在英国上市，其他市场的上市时间预计在2005年第四季度~2006年上半年。此外，Altana公司预计，Alvesco用于治疗儿童和青少年哮喘将于2006年通过欧洲审批。 
 
哮喘是肺部和呼吸道的慢性疾病。症状有呼吸困难、咳嗽等，可引起呼吸急促，甚者危及生命。根据美国疾病预防与控制中心的调查，美国患有哮喘的人数有2000万以上。Alvesco上市后主要将面临的同类产品有葛兰素史克公司的氟替卡松（fluticasone，Flovent）和阿斯利康公司的布地奈德（budesonide，Pulmicort）。据Alvesco的临床研究显示，Alvesco一日1次给药320mg治疗中度哮喘患者改善肺功能的效果相似于一日2次给药200mg氟替卡松。在个比较研究中，服用Alvesco患者的生活质量参数高于氟替卡松组。比较儿童服用160mg剂量Alvesco和400mg剂量布地奈德的研究结果显示，每日160mg剂量的Alvesco改善肺功能和控制哮喘的效果相似于每日400mg剂量的布地奈德。Alvesco作用于下丘脑-垂体-肾上腺（HPA）轴的效果明显较低，这突出了Alvesco良好的安全性。该研究也记录了儿童的生长状况。与布地奈德疗法相比，在Alvesco疗法中儿童生长状况更好。

ALVESCO（环索奈德）气溶胶，计量
[Sunovion制药公司]

处方信息ALVESCO ®。
 
ALVESCO ®（环索奈德）吸入气雾剂80微克，160微克
只适用于口腔吸入

初步U. S.批准：2006年
 
适应症
ALVESCO是吸入皮质类固醇表示为：维持治疗，预防性治疗哮喘的成人和青少年患者的12岁及以上。

ALVESCO没有表示为缓解急性支气管痉挛。
 
剂量和用法
口腔吸入

1Prednisone应逐渐减少，不得高于2.5毫克/天每周一次的基础上，与ALVESCO至少治疗1周后开始。患者应仔细监测哮喘不稳定的迹象，包括气流监测串行客观措施，为肾上腺皮质功能减退的迹象的类固醇锥度和口服类固醇治疗的以下停止[见警告和注意事项]。
 
推荐

起始剂量

最高

推荐剂量
 
患者≥12岁的支气管扩张剂单独

80微克，每日两次

160微克，每日两次
患者≥12岁的人吸入皮质类固醇

80微克，每日两次

320微克，每日两次
 
患者≥12岁的人收到口头corticosteroids1

320微克，每日两次

320微克，每日两次
 
剂型和优势
吸入气雾剂80微克/驱动或160微克/驱动
 
禁忌
患者与哮喘持续状态或其他急性发作，哮喘需要密集的措施与已知的环索奈德或任何ALVESCO成分过敏的患者。
 
警告和注意事项

白色念珠菌感染，口腔和咽部。定期监测患者口腔的不利影响的迹象。提醒患者漱口以下吸入潜力，现有的结核病恶化：真菌，细菌，病毒或寄生虫感染;眼疱疹或单纯。更严重的甚至是致命的的过程中，易被患者接受水痘或麻疹。使用以上的患者由于存在潜在的谨慎，这些感染恶化

转移口服类固醇吸入皮质类固醇时，肾上腺皮质功能受损的风险。锥慢慢地从患者全身性类固醇，如果转移到ALVESCO Hypercorticism，抑制下丘脑 - 垂体 - 肾上腺（HPA）的功能具有非常高的剂量，或在易感个体常规剂量。如果发生这样的变化停止ALVESCO缓慢
制止孩子的成长。监视器常规的增长在儿科患者接受ALVESCO
发展青光眼，眼压增高和后侧包膜下白内障。监测与视力变化或与眼压增高的历史患者，青光眼，和/或白内障密切
 
不良反应
最常见的不良反应（≥3％），头痛，鼻咽炎，鼻窦炎，咽喉疼痛，上呼吸道感染，关节痛，鼻塞，下肢疼痛和背部疼痛

已报道的其他不良反应

修订日期：05/2011

【原产地英文商品名】ALVESCO 80mcg/dose 6.1g/inhaler
【原产地英文药品名】CICLESONIDE
【中文参考商品译名】
注：以下产品不同规格和不同价格，购买时请以电话咨询为准！
·ALVESCO 80微克/剂 6.1克/吸入器
·ALVESCO 160微克/剂 6.1克/吸入器
【中文参考药品译名】环索奈德
【生产厂家中文参考译名】Sepracor
【生产厂家英文名】Sepracor Inc

ALVESCO®
(ciclesonide) Inhalation Aerosol 80 mcg, 160 mcg

What is Alvesco?
Alvesco is a a man-made corticosteroid. It prevents the release of substances in the body that cause inflammation.

Alvesco is used to prevent asthma attacks in adults and children 12 years and older. When used regularly, as prescribed by your health care provider, it will help to prevent and control symptoms of asthma.

Alvesco may also be used for other purposes not listed in this medication guide.

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Important information about Alvesco
Do not use Alvesco inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking Alvesco, tell your doctor about any illness or infection you have had within the past several weeks.

You should not use Alvesco if you are allergic to ciclesonide.

Before using Alvesco, tell your doctor if you have tuberculosis, an infection of your mouth or throat (such as oral thrush), glaucoma or history of cataracts, herpes infection of your eyes, or a personal or family history of osteoporosis.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely. Call your doctor right away if you feel that Alvesco inhalation makes your condition worse.

Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

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Before using Alvesco
Steroid medication can weaken your immune system, making it easier for you to get an infection. Steroids can also worsen an infection you already have, or reactivate an infection you recently had. Before taking Alvesco, tell your doctor about any illness or infection you have had within the past several weeks.

You should not use Alvesco if you are allergic to ciclesonide.

If you have certain conditions, you may need a dose adjustment or special tests to safely use this medication. Before using Alvesco, tell your doctor if you have:
tuberculosis;
an infection of your mouth or throat (such as oral thrush);
glaucoma or history of cataracts;
herpes infection of your eyes; or
a personal or family history of osteoporosis.

FDA pregnancy category C. This Alvesco inhalation may be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. It is not known whether Alvesco inhalation passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Long-term use of steroid medication can slow a child's growth. Tell your doctor if the child using Alvesco is not growing or gaining weight properly.

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How should I use Alvesco?
Use Alvesco exactly as it was prescribed for you. Do not use the medication in larger amounts, or use it for longer than recommended by your doctor. Follow the instructions on your prescription label.

Do not use Alvesco inhalation to treat an asthma attack that has already begun. It will not work fast enough. Use only a fast-acting inhalation medicine to treat an asthma attack. Talk with your doctor if any of your asthma medications do not seem to work as well in treating or preventing asthma attacks.

Alvesco inhalation comes with patient instructions for safe and effective use, and directions for priming the inhaler device. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Alvesco inhalation is most often used once daily, in the morning or evening. Follow your doctor's instructions. Rinse your mouth after inhaling this medication.

The inhaler device must be primed before your first use or any time you have not used the inhaler for 10 days or longer. For instructions on how to prime the inhaler, refer to the patient instructions provided with your medication.

Your dosage needs may change if you have surgery, are ill, are under stress, or have recently had an asthma attack. Do not change your doses or medication schedule without advice from your doctor.

If you also use a steroid medication, do not stop using the steroid suddenly or you may have unpleasant withdrawal symptoms. Talk with your doctor about using less and less of the steroid before stopping completely.

It may take up to 4 weeks of using Alvesco inhalation before your symptoms improve. For best results, keep using the medication as directed. Talk with your doctor if your symptoms do not improve after 4 weeks of treatment.

Call your doctor right away if you feel that Alvesco inhalation makes your condition worse.

Asthma is usually treated with a combination of different drugs. To best treat your condition, use all of your medications as directed by your doctor. Be sure to read the medication guide or patient instructions provided with each of your medications.

Store Alvesco at room temperature away from moisture and heat. Keep the medicine canister away from open flame or high heat, such as in a car on a hot day. The canister may explode if it gets too hot.

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What happens if I miss a dose?
Use the medication as soon as you remember the missed dose. If it is almost time for your next dose, skip the missed dose and use the medicine at your next regularly scheduled time. Do not use extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine.

An overdose of Alvesco inhalation is not expected to produce life-threatening symptoms. However, long-term use of high steroid doses can lead to symptoms such as thinning skin, easy bruising, changes in the shape or location of body fat (especially in your face, neck, back, and waist), increased acne or facial hair, menstrual problems, impotence, or loss of interest in sex.

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What should I avoid while using Alvesco?
Avoid being near people who are sick or have infections. Call your doctor for preventive treatment if you are exposed to chicken pox or measles. These conditions can be serious or even fatal in people who are using steroid medication.

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Alvesco side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Call your doctor at once if you have any of these serious side effects:
wheezing, choking, or other breathing problems after using Alvesco;
sores or white patches in your mouth or throat;
vision problems, such as tunnel vision or blurred vision; or
worsening asthma symptoms.

Less serious Alvesco side effects may include:
unpleasant taste in your mouth;
dry mouth, burning or irritation in your mouth;
white patches or sores inside your mouth;
runny or stuffy nose, sore throat;
hoarse voice;
mild itching or skin rash;
joint pain, back pain; or
headache.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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What other drugs will affect Alvesco?
Tell your doctor about all other medications you use, especially:
conivaptan (Vaprisol);
an antibiotic such as clarithromycin (Biaxin), erythromycin (E.E.S., EryPed, Ery-Tab, Erythrocin), or telithromycin (Ketek);
an antifungal medication such as clotrimazole(Mycelex Troche), itraconazole (Sporanox), ketoconazole (Nizoral), or voriconazole (Vfend);
HIV/AIDS medicine such as atazanavir (Reyataz), delavirdine (Rescriptor), indinavir (Crixivan), nelfinavir (Viracept), saquinavir (Invirase, Fortovase), or ritonavir (Norvir); or
an antidepressant such as nefazodone, paroxetine (Paxil), or sertraline (Zoloft).

There may be other drugs that can interact with Alvesco inhalation. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about Alvesco inhalation.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Alvesco only for the indication prescribed.

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.