英文名称：ZYFLO CR®(zileuton)

中文名称：齐留通12小时缓释片

品牌生产商：CORNERSTONE THERAPEUTICS INC.

药品介绍

英国SkyePharma公司已与美国私营公司CriticalTherapeutics达成协议，开发口服齐留通(zileuton)(Ⅰ)的控释(CR)配方，用于治疗哮喘和慢性阻塞性肺病(COPD)。                        
齐留通每日四次的速释配方已由AbbottLaboratories公司以商品名ZyfloFilmtab上市。SkyePharma公司已采用Geomatrix技术开发了该化合物的CR配方，Abbott公司已完成了Ⅲ期试验。            
SkyePharma公司将与CriticalTherapeutics公司协作进一步开发(Ⅰ)的控释配方用于中至重度哮喘和COPD。

ZYFLO CR（齐留通）缓释片
初始美国批准：1996

适应症
ZYFLO CR是一种白三烯合成抑制剂对预防和成人和儿童12岁以上的哮喘治疗慢性表示。

不要使用ZYFLO CR治疗急性哮喘发作
 
剂量和用法
成人和儿童12岁以上：对ZYFLO CR推荐剂量为两台600毫克缓释片，每天两次一小时内，经过上午和晚上吃饭，共计每日2400毫克的剂量。

监测：评估肝功能酶之前，ZYFLO CR启动和治疗期间定期监测。
 
剂型和规格
缓释片：600毫克
 
禁忌
活动性肝病或持续肝功能酶升高≥3倍正常上限
史或过敏性反应，齐留通的ZYFLO CR的任何一种成分。
 
警告和注意事项
肝毒性：一个或多个肝功能酶和胆红素升高可能会出现ZYFLO CR。评估肝功能酶之前，ZYFLO CR，为前3个月每月，为今年余下的每首2-3个月开始，并在此后定期。使用与患者谁消耗的酒精和/大批量或有肝病史慎用ZYFLO CR。

神经精神活动：神经精神事件，包括睡眠障碍和行为的改变，可能会出现ZYFLO CR。指导患者为神经精神事件的警报。评估与ZYFLO CR持续治疗的风险和收益，如果这样的事件发生。
 
不良反应
最常见（≥5％）的不良反应包括：鼻窦炎，恶心，咽喉疼痛。 
 
药物相互作用
齐留通增加茶碱水平。降低茶碱剂量和监测水平。 
齐留通加华法令水平。监测凝血酶原时间及相应的调整华法林剂量。
齐留通加普萘洛尔水平和β-阻断剂的活性。监视器适当。

特殊族群使用
肝功能不全：ZYFLO CR是在活动性肝病和肝功能酶升高≥3倍正常上限的患者禁忌。
修订：10/2009
附件：该药品相关信息网址1:
http://www.drugs.com/cons/zyflo.html
该药品相关信息网址2:
http://www.rxlist.com/zyflo-drug.htm

【用　　途】用于风湿性关节炎、过敏性鼻炎、哮喘病和溃疡性结肠炎。
Zyflo和Zyflo CR (齐留通)是一种白三烯合成抑制剂。白三烯合成抑制剂通过终止某些可引起气道内水肿、收缩和黏液产生的物质形成而起效。Zyflo和Zyflo CR也是用于治疗哮喘。

【原产地英文商品名】ZYFLO CR 12HR 600mg/tab 120tabs/bottle
【原产地英文药品名】ZILEUTON
【原产地英文化合物名称】Urea, N-(1-Benzo[b]thien-2-ylethyl)-N-hydroxy-
中文参考商品译名】ZYFLO 12小时缓释片 600毫克/片 120片/瓶
【中文参考药品译名】齐留通
【生产厂家中文参考译名】CORNERSTONE THERAPEUTICS INC.
【生产厂家英文名】CORNERSTONE THERAPEUTICS INC.

ZyfloZYFLO CR®(zileuton) Extended-Release Tablets

Partner: Cornerstone Therapeutics, Inc.
SkyePharma developed a controlled-release formulation of zileuton for Cornerstone Therapeutics. ZYFLO CR® is a leukotriene synthesis inhibitor oral anti-inflammatory asthma drug, utilizing SkyePharma’s Geomatrix™ technology that allows the dosing to be reduced from four times a day to twice a day. ZYFLO CR® received FDA approval in 2007 and was launched in the US in September 2007 for the prevention and chronic treatment of asthma in adults and children 12 years of age and older. ZYFLO CR® is not indicated for use in the reversal of bronchospasm in acute asthma attacks. Therapy with ZYFLO CR® and ZYFLO® can be continued during acute exacerbations of asthma.
Generic Name: zileuton (Oral route)
zye-LOO-tonCommonly used brand name(s):In the U.S.
Zyflo
Zyflo CR

Available Dosage Forms:
Tablet
Tablet, Extended Release

Therapeutic Class: Anti-Inflammatory

Pharmacologic Class: Leukotriene Pathway Inhibitor

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Uses For Zyflo
Zileuton is used by patients with mild-to-moderate chronic asthma to decrease the symptoms of asthma and the number of acute asthma attacks. However, this medicine should not be taken to relieve an asthma attack that has already started.

This medicine is available only with your doctor's prescription.

Zileuton immediate-release tablets (Zyflo(R)) were withdrawn from the U. S. market by Critical Therapeutics on February 12, 2008. The extended-release formulation of zileuton (Zyflo CR(R)), also manufactured by Critical Therapeutics, Inc, is still available.

Before Using Zyflo
In deciding to use a medicine, the risks of taking the medicine must be weighed against the good it will do. This is a decision you and your doctor will make. For this medicine, the following should be considered:

Allergies
Tell your doctor if you have ever had any unusual or allergic reaction to this medicine or any other medicines. Also tell your health care professional if you have any other types of allergies, such as to foods, dyes, preservatives, or animals. For non-prescription products, read the label or package ingredients carefully.

Pediatric
Appropriate studies have not been performed on the relationship of age to the effects of zileuton in children younger than 12 years of age. Safety and efficacy have not been established.

Geriatric
Appropriate studies performed to date have not demonstrated geriatric-specific problems that would limit the usefulness of zileuton in the elderly. However, elderly patients are more likely to have age-related liver disease, and this medicine should not be used in patients with this condition.

Pregnancy
All Trimesters
Pregnancy Category：C
Explanation：Animal studies have shown an adverse effect and there are no adequate studies in pregnant women OR no animal studies have been conducted and there are no adequate studies in pregnant women.

Breast Feeding
There are no adequate studies in women for determining infant risk when using this medication during breastfeeding. Weigh the potential benefits against the potential risks before taking this medication while breastfeeding.

Interactions with Medicines
Using this medicine with any of the following medicines is not recommended. Your doctor may decide not to treat you with this medication or change some of the other medicines you take.

Dihydroergotamine
Ergoloid Mesylates
Ergonovine
Ergotamine
Methylergonovine

Using this medicine with any of the following medicines is usually not recommended, but may be required in some cases. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Astemizole
Eltrombopag
Pimozide
Terfenadine
Theophylline
Tizanidine

Using this medicine with any of the following medicines may cause an increased risk of certain side effects, but using both drugs may be the best treatment for you. If both medicines are prescribed together, your doctor may change the dose or how often you use one or both of the medicines.

Propranolol
Warfarin

Interactions with Food/Tobacco/Alcohol
Certain medicines should not be used at or around the time of eating food or eating certain types of food since interactions may occur. Using alcohol or tobacco with certain medicines may also cause interactions to occur. Discuss with your healthcare professional the use of your medicine with food, alcohol, or tobacco.

Other Medical Problems
The presence of other medical problems may affect the use of this medicine. Make sure you tell your doctor if you have any other medical problems, especially:
Alcohol use, severe or
Liver disease, history of—Use with caution. The chance of serious side effects may be increased.
Liver disease, active—This medicine should not be used with this condition.

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Proper Use of zileuton
This section provides information on the proper use of a number of products that contain zileuton. It may not be specific to Zyflo. Please read with care.

Zileuton is used to prevent asthma attacks. It is not used to relieve an attack that has already started. For relief of an asthma attack that has already started, you should use another inhaled medicine that works quickly. If you have any questions about this, check with your doctor.

Swallow the extended-release tablet whole. Do not crush, break, or chew it.

To work properly, zileuton must be taken every day at regularly spaced times, even if your asthma seems better.

Dosing
The dose of this medicine will be different for different patients. Follow your doctor's orders or the directions on the label. The following information includes only the average doses of this medicine. If your dose is different, do not change it unless your doctor tells you to do so.

The amount of medicine that you take depends on the strength of the medicine. Also, the number of doses you take each day, the time allowed between doses, and the length of time you take the medicine depend on the medical problem for which you are using the medicine.

For oral dosage form (extended-release tablets):
For asthma prevention:
Adults and children 12 years of age and older—Two 600 milligram (mg) tablets two times a day, within one hour after morning and evening meals.
Children up to 12 years of age—Use and dose must be determined by your doctor.
Missed Dose
If you miss a dose of this medicine, take it as soon as possible. However, if it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not double doses.

Storage
Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep from freezing.

Keep out of the reach of children.

Do not keep outdated medicine or medicine no longer needed.

Ask your healthcare professional how you should dispose of any medicine you do not use.

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Precautions While Using Zyflo
It is very important that your doctor check your progress at regular visits. This will allow your doctor to see if the medicine is working properly and to check for unwanted effects.

Check with your doctor if you are using more inhalations (puffs) than usual of your inhaled bronchodilator to relieve an acute asthma attack.

You may be taking other medicines for asthma along with zileuton. Do not stop taking or reduce the dose of the other medicines, even if your asthma seems better, unless you are told to do so by your doctor.

You should limit the amount of alcohol you drink while you are taking this medicine.

This medicine may cause some people to be agitated, irritable, or display other abnormal behaviors. It may also cause some people to have suicidal thoughts and tendencies or to become more depressed and have problems with sleep. If you or your caregiver notice any of these side effects, tell your doctor right away.

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Zyflo Side Effects
Along with its needed effects, a medicine may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur:

Rare
Flu-like symptoms
itching
right upper stomach pain
unusual tiredness or weakness
yellow eyes or skin

Incidence not known
Attack, assault, or force
attempts at killing oneself
discouragement
dry mouth
fear or nervousness
feeling sad or empty
hyperventilation
irregular heartbeats
irritability
lack of appetite
loss of interest or pleasure
restlessness
seeing, hearing, or feeling things that are not there
shakiness in the legs, arms, hands, or feet
shortness of breath
sleeplessness
tiredness
trembling or shaking of the hands or feet
trouble with concentrating
trouble with sleeping
unable to sleep

Some side effects may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects. Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

More common
Cough
fever
headache
nausea
pain or tenderness around the eyes and cheekbones
stuffy or runny nose
tightness of the chest or wheezing
troubled breathing
upset stomach

Less common
Abdominal or stomach pain
sore throat
weakness

Other side effects not listed may also occur in some patients. If you notice any other effects, check with your healthcare professional.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

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