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 详细处方信息以本药内容附件PDF文件（201172419123714.pdf）的“原文Priscribing Information”为准
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部分中文司来吉兰处方资料（仅供参考）

美国FDA批准Emsam(Selegiline[司来吉兰])为用于抑郁症的首个皮肤贴片 
    ──最低剂量的使用不受对MAOI(单胺氧化酶抑制剂)类抑郁症药的限制要求
    美国FDA当天批准用于治疗重度抑郁（major depression）的首个皮肤贴片Emsam(通用名：Selegiline[司来吉兰])。该贴片每日1贴，通过输送selegiline（一种单胺氧化酶抑制剂或称MAOI）透过皮肤进入血液起作用。在最低浓度时，Emsam可以在无膳食限制的情况下使用，这种限制是所有被批准治疗重度抑郁症的口服型MAO抑制剂所必需的。

    “Emsam提供了一个重要进展，因为至少在其最低剂量下病人可以不受平常饮食限制的情况下用药，这种限制通常与已知的MAO抑制剂类药相关，”药品评价与研究中心主任Steven Galson博士称。

    重度抑郁障碍在美国人群中，是一种常见的精神症状。抑郁症状包括普遍情绪沮丧、病理性退隐（withdrawal）和不安，其干扰了日常机能，如：对平常活动的兴趣丧失，体重和/或胃口的重大变化，失眠，疲劳增加，内疚感和自卑感，思维缓慢或注意力不集中，以及某种自杀企图或自杀观念（ideation）。

    MAO抑制剂通常需要特殊的膳食限制，因为当和某些食物结合时，它们可能导致某种血压突然大幅度升高，或是“高血压危象”（hypertentive crisis）。高血压危象可能导致中风和死亡。高血压危象的症状包括：剧烈头痛的突然发作、呕吐、颈强直、心跳加快或称心跳方式改变（心悸）、出汗及意识错乱。具有这些症状的病人应该立即取得医疗照顾。

    MAOI贴片的最低剂量（24小时周期内给药6毫克）可在没有这样的饮食限制下使用。

    Emsam贴片可用的有以下3种规格：每24小时给药6、9或12毫克。该贴片是一个含有3层的骨架（matrix），由背衬层、压敏胶药物层（adhesive drug layer）和贴皮释放内层组成。

    在对病人进行的2个6－8周的研究和一个长期研究中，Emsam已显示其对治疗重度抑郁障碍的安全性和有效性。规格为6mg/24hr的EMSAM的数据，支持了该剂量不需要修改饮食的建议。病人被建议每天更换一次贴片。规格为9mg/24hr和12mg/24hr的EMSAM，其现有更多的受限数据不消除食物影响，所以服用这些较高剂量的病人应该遵从有关避免某些食品或饮料的饮食限制的建议，包括诸如成熟干酪（aged cheese）和酒这样的食物和饮品。

    在安慰剂对照试验中发现的唯一常见副作用，是贴处有轻微的皮肤反应。当贴片移除时，贴处可能轻微泛红。如果这种红色在贴片移除后数小时内没有消失，或者如果持续发炎或搔痒，则病人应该联系其医生。

    另一个不太常见的副作用是与血压下降相关的轻微头痛。

    这新产品的制造商和分销商已为病人和处方者计划了一次教育运动，以确保针对较高贴片浓度的膳食限制建议被遵循。他们计划对病人和医疗保健提供者都进行调查，以评估该教育运动的有效性。制造商和分销商也密切追踪了不良事件的报道，并对那些可能代表高血压危象的事件作跟进，以进一步保证该产品的安全使用。

    尽管贴片受热影响未知，但该药的标识就Emsam贴片直接受热的可能影响，对医疗保健提供者和病人作了警告。直接受热，可能导致从贴片吸收的药量的增加。病人应该避免将贴片暴露于加热板（heating pads）、电热毯、发热灯、桑拿浴、热浴盆或长时间的日光。

    如同所有批准的抗抑郁药，该产品具有关于儿童和青少年中自杀倾向增加的警告。

    EMSAM由Somerset Pharmaceuticals公司开发。2004年12月，Bristol-Myers Squibb公司和Somerset公司签订了协议，该协议为Bristol-Myers Squibb公司提供了在EMSAM获批后于美国上市该产品的分销权。Selegiline最初以胶囊剂被批准，用于帕金森病。

Emsam
Generic Name: selegiline (transdermal) (se LE ji leen (trans DERM al)
Brand Names: Emsam

What is Emsam?
Emsam (selegiline) prevents the breakdown of chemicals in the brain that are often imbalanced in people with depression. Selegiline is a monoamine oxidase inhibitor (MAOI.

Emsam is used to treat adult patients with depression, also known as major depressive disorder (MDD).

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

Important information about Emsam
There are many other medicines that can cause serious medical problems if you take them while using Emsam. Tell your doctor about all other prescription and over-the-counter medications you use, including vitamins, minerals, and herbal products.

While using Emsam 9-mg or 12-mg patches, do not drink alcohol or eat foods that are high in tyramine, listed in the "What should I avoid while using Emsam?" section of this leaflet. Eating tyramine while you are using Emsam can raise your blood pressure to dangerous levels and cause life-threatening symptoms.

You may have thoughts about suicide when you first start using an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Before using Emsam
Do not use Emsam if you are allergic to selegiline, if you have an adrenal gland tumor (also called pheochromocytoma), or if you plan to have any type of surgery. Do not use Emsam if you have taken any of the following drugs within the past 14 days:
•buspirone (BuSpar);
•carbamazepine (Tegretol) or oxcarbazepine (Trileptal);
•cyclobenzaprine (Flexeril);
•dextromethorphan (cough medicine);
•meperidine (Demerol), methadone (Dolophine, Methadose), propoxyphene (Darvon, Darvocet), or tramadol (Ultram, Ultracet);
•mirtazapine (Remeron);
•diet pills, ADHD medications, or cold medicines that contain dextromethorphan, ephedrine, pseudoephedrine, or phenylephrine;
•St. John's wort;
•antidepressants such as amitriptyline (Elavil), amoxapine (Asendin), bupropion (Wellbutrin, Zyban), citalopram (Celexa), clomipramine (Anafranil), desipramine (Norpramin), doxepin (Sinequan), duloxetine (Cymbalta), escitalopram (Lexapro), fluoxetine (Prozac), fluvoxamine (Luvox), imipramine (Tofranil), nortriptyline (Pamelor), paroxetine (Paxil), protriptyline (Vivactil), sertraline (Zoloft), venlafaxine (Effexor), or trimipramine (Surmontil); or
•other MAO inhibitors such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or oral selegiline (Eldepryl).

After you stop using Emsam, you must wait at least 14 days before taking any of the medications listed above.You must wait at least 5 weeks after stopping fluoxetine (Prozac) before you can start using Emsam.

Tell your doctor if you are allergic to any drugs, or if you have:
•heart disease, high or low blood pressure;
•seizures or epilepsy; or
•a personal or family history of bipolar disorder (manic depression) or suicide attempt.

You may have thoughts about suicide when you first start using an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. Emsam 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 Emsam 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.

How should I use Emsam?
Use Emsam exactly as directed on the label, or as it has been prescribed by your doctor. Do not use more of the skin patches or use them for longer than recommended. Follow the directions on your prescription label.

For patients using 9-mg or 12-mg patches: While you are using Emsam and for 14 days after you stop, you must not eat foods high in tyramine (listed in the "What should I avoid?" section of this leaflet. Eating these foods while you are using Emsam 9-mg or 12-mg skin patches can raise your blood pressure to dangerous levels.

Foods that you MAY eat include:
•fresh meat, poultry, or fish (including lunch meat, hot dogs, breakfast sausage, and cooked sliced ham);
•any vegetables except broad bean pods (fava beans);
•processed cheese, mozzarella, ricotta, cottage cheese;
•pizza made with cheeses low in tyramine;
•soy milk, yogurt; or
•Brewer's or baker's yeast.

This medication comes with patient instructions for safe and effective use. Follow these directions carefully. Ask your doctor or pharmacist if you have any questions.

Before applying a skin patch, wash the skin with soap and water and dry completely. The patch can be worn on a dry, smooth, and hairless area of your back, upper arm, chest, or thigh. Do not apply the patch to a skin wound or irritated skin, or wear it under tight clothing. Never cut a skin patch into smaller pieces.

Remove the patch after 24 hours, taking care not to touch the sticky side with your fingers. Fold the patch in half so that it sticks together. Throw the used patch away where children and pets cannot reach it.

Wash your hands with soap and water after applying a patch, and after removing one.
Use only one patch at a time. While you are wearing the patch, do not expose it to sunlight or other sources of heat such as a heating pad, electric blanket, hot tub, or sauna.

Do not stop using Emsam suddenly or you may have harmful side effects. It may take several weeks of using Emsam before your symptoms improve. For best results, keep using the medication as directed. Store the skin patches at room temperature away from heat and moisture. Keep each patch in the foil pouch until you are ready to apply one.

What happens if I miss a dose?
Apply a skin patch as soon as you remember. If it is almost time to apply your next patch, skip the missed dose and apply a patch at your next regularly scheduled time. Do not use extra patches to make up the missed dose.

If a patch becomes loose, press it back in place. If a patch falls off, apply a new one and go back to your regular schedule for patch changes.

What happens if I overdose?
Seek emergency medical attention if you think you have used too much of this medicine. Symptoms of a Emsam overdose may include severe headache, hallucinations, vision problems, sweating, cool or clammy skin, fast or uneven heart rate, feeling lightheaded, fainting, or seizure.

What should I avoid while using Emsam?
While using the 9-mg or 12-mg patches, you must NOT eat foods that are high in tyramine, including:
•air dried meats, aged or fermented meats, sausage or salami (including cacciatore and mortadella), pickled herring, and any spoiled or improperly stored beef, poultry, fish, or liver;
•beer from a tap, beer that has not been pasteurized;
•aged cheeses, including blue, boursault, brick, brie, camembert, cheddar, emmenthaler, gruyere, parmesan, romano, roquefort, stilton, and swiss;
•over-the-counter supplements or cough and cold medicines that contain tyramine;
•sauerkraut, soy beans, soy sauce, tofu, miso soup, bean curd, fava beans; or
•yeast extracts (such as Marmite).

Eating tyramine while you are using Emsam can raise your blood pressure to dangerous levels which could cause life-threatening side effects. You should become very familiar with the list of foods to avoid while you are using Emsam.

Avoid drinking alcohol while you are using this medication. Emsam can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

Emsam 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 new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Stop using Emsam and call your doctor at once if you have any of these serious side effects:
•sudden and severe headache, confusion, blurred vision, problems with speech or balance, nausea, vomiting, chest pain, seizure (convulsions), and sudden numbness or weakness (especially on one side of the body);
•feeling light-headed, fainting;
•twitching muscle movements; or
•painful or difficult urination.

Less serious side effects may include:
•constipation, gas, loss of appetite;
•swelling, numbness or tingling, easy bruising, muscle pain;
•dry mouth, sore throat, cough;
•redness or itching where the patch is worn; or
•impotence, loss of interest in sex, or trouble having an orgasm.

What other drugs will affect Emsam?
There are many other medicines that can cause serious medical problems if you take them while using Emsam. Do not use this medication before telling your doctor about all other prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Keep a list with you of all the medicines you use and show this list to any doctor, dentist, or other healthcare provider who treats you.

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 详细处方信息以本药内容附件PDF文件（201172419123714.pdf）的“原文Priscribing Information”为准
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