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 详细处方信息以本药内容附件PDF文件（20096800230439.pdf）的“原文Priscribing Information”为准
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部分中文TERBINAFINE HCL信息资料（仅供参考）

【通用名】盐酸特比萘芬片
【英文名】Terbinafine Hydrochioride Tablets
【成份】盐酸特比萘芬
【药理】抗真菌药。
【适应症】用于足癣、手癣、体癣、股癣及花斑癣。
【用法用量】外用，一日2次，涂患处。疗程1～2周。
【禁忌症】已知对喹诺酮类过敏者，孕妇、哺乳期妇女及18岁以下患者禁用。
【不良反应】消化系统反应；过敏反应；中枢神经系统反应；影响一些实验室检查，如GOT、GPT、ALP、LDH、γ-GPT、BUN、血肌酐及总胆红素升高，也可致嗜酸性粒细胞增多及白血球、血红蛋白和血小板降低等；国外有QT轻度延长的报告。
【注意事项】对本品过敏者禁用。
【贮存】在阴凉处保存。　　
【主要成分】盐酸特比萘芬　其化学名称为：（E）-N-（6，6-二甲基-2-庚烯-4-炔基）-N-甲基-1-甲酰胺萘.盐酸盐
【药理作用】
　　盐酸特比萘芬是一种具有广谱抗真菌活性的丙烯胺类药物。本品能特异地干扰真菌麦角固醇的早期生物合成，高选择性地抑制真菌的角鲨烯环氧化酶，使真菌细胞膜形成过程中角鲨烯环氧化反应受阻，从而达到杀灭或抑制真菌的作用。
【适应症】
　　1．由毛癣菌(红色毛癣菌、须癣毛癣菌、疣状毛癣菌、断发癣菌和紫色毛癣菌等)、犬小孢子菌和絮状表皮癣菌等引起的皮肤、头发和甲的感染。
　　2．各种癣病(体癣、股癣、手足癣和头癣等)以及由念珠菌(白色念珠菌等)引起的皮肤酵母菌感染。
　　3．由皮霉菌引起的甲癣(甲真菌感染)。
　　本品仅用于治疗大面积、严重的皮肤癣菌感染（体癣、股癣、足癣、头癣）和念珠菌（如白色假丝酵母）引起的皮肤酵母菌感染，根据感染部位、严重性和范围考虑口服给药的必要性。 皮肤癣菌（丝状真菌）感染引起的甲癣
【用法用量】根据感染的严重程度和适应症调整疗程。
　　口服，成人每次0．25克，每日一次，疗程如下：皮肤感染的疗程：手足癣[趾(指)间型和跖型]：2—6周；体癣、股癣：2—4周：皮肤患珠菌病：2—4周。在真菌学治愈几周，才可见到皮肤外观完全正常以及感染症状消失。
　　成人：每次1片（0.25g）每天一次
　　青少年，体重＞40kg（通常年龄＞12岁）：每次1片（0.25g）每天一次
　　儿童，体重20-40kg（通常年龄5-12岁）：每次半片（0.125g）每天一次
　　儿童，体重＜20kg　通常年龄＜5岁：关于此组病人，从对照试验中获得的资料非常有限，所以药物只有在没有其它可选择的治疗方法以及潜在的治疗疗效益大于可能的危险情况才可使用。
　　由于没有关于年龄小于2岁儿童口服特比萘芬的治疗经验，因此本品不被推荐用于这个年龄组
　　皮肤感染
　　推荐疗程：
　　足癣（趾间，跖/拖鞋）：2至6周 体癣，股癣:2至4周
　　皮肤念珠菌病：2至4周
　　感染症状和体征的消失可能到真菌学治愈后数周才出现。
　　毛发和头皮感染
　　推荐疗程： 头癣主要见于儿童
　　头癣：4周
　　甲真菌病 ：对于大多数患者，治疗疗程为6-12周
　　指甲真菌病 ：大多数指甲真菌感染的病例，治疗疗程为12周 一些甲生长不良的患者所需疗程较长。在真菌学治愈后及停止治疗后数月，常可见到良好的临床疗效，这与健甲长出所需时间相关。
【不良反应】出现频率估计：很常见≥10%，常见1%-10%，不常见0.1%，罕见0.01%-0.1%，非常罕见<０.０１％
　　一般而言，特比萘芬的耐受性好，不良反应常为轻中度。最常见的是胃肠道症状（腹胀满、食欲降低、消化不良、恶心、轻微腹痛、腹泻），轻微的皮肤反应（皮疹、荨麻疹），骨骼肌反应（关节痛，肌痛）
　　不常见：味觉紊乱，包括味觉丧失，常常在停药数周内可以恢复
　　罕见：有报告与特比萘芬治疗有关的肝胆功能不良（实际为原发性胆汁淤积型），包括非常罕见的肝衰竭（见注意事项）
　　非常罕见：已报告有严重的皮肤反应（如Steven-Johnson综合征，中毒性表皮坏死）和过敏性反应。如果有进行性皮疹发生，应停止特比萘芬治疗
　　非常罕见：已报告的有血液系统疾病如中性粒细胞减少症，粒细胞缺乏症或血小板减少症
　　非常罕见，已报告的有脱发，尽管病因关系尚未确定
【禁忌】对盐酸特比萘芬及本品其它成分过敏者禁用
【注意事项】如果患者出现肝功能不全的体征或提示性症状，如无法解释的恶心、厌食或倦怠、或黄疸、黑尿或无色粪便时应当确认是否为肝源性，并中止特比萘芬治疗（见不良反应）。在已有肝病的患者中进行的单剂量药代动力学研究报名，特比萘芬的清除率降级50%，在前瞻性的临床试验中未开展伴有慢性或活动性肝病的患者使用特比萘芬的研究，因此不做推荐。肾功能受损的患者（肌酐清除率不足50ml/分钟或血肌酐超过300umot/l）应当服用正常剂量的一半 。体外研究表明特比萘芬抑制CYP2D6的代谢，因此，如果同时服用的药物的治疗窗较窄时，应该对接受主要由该酶代谢的药物，如三环类抗抑郁药（TCAs）β-阻滞剂、选择性5-羟色胺再摄取抑制剂（SSRIs）、以及单胺氧化酶抑制剂（MAO-ls）B型进行伴随治疗的患者，进行监测。（见药物相互作用）
　　口服本品对花斑癣无效
【孕妇及哺乳期妇女用药】胎儿毒性及生育能力动物实验研究发现，无不良反应。由于妊娠妇女中的临床经验非常有限，在妊娠期间，如果服药的益处不能超过风险，不应使用。特比萘芬可以分泌至乳汁当中，因此口服特比萘芬治疗的母亲不应哺乳。
【儿童用药】2岁以上的儿童口服特比萘芬耐受性好
【老年患者用药】尚无证据提示老年患者与年青患者需服不同剂量或发生不同的反应。开处方时，应当考虑到这一年龄组患者已存在肝、肾功能损害的可能性（见注意事项）
【药物相互作用】依照体外研究和健康志愿者中进行研究的结果，特比萘芬对大多数神经细胞色素P45
　　禁忌：对盐酸特比萘芬及本品其它成分过敏者禁用。
　　注意事项：
　　1．肝或肾功能不全(肌酐清除率<50ml／分，血清肌酐>300u mol／升)者，特比萘芬剂量应减少50％(见“不良反应”)。
　　2．妊娠与哺乳动物研究显示，本品对胎儿和生育力无不良影响。由于本品用于孕妇的经验极有限，因此，应权衡利弊，原则上孕妇不应使用。特比萘芬可经乳汁排泄，故接受特比萘芬口服治疗的母亲不应哺乳。
　　3．相互作用研究证明，特比萘芬几乎不影响经由细胞色素P450酶系代谢的药物(如环孢素、D860或口服避孕药)的清除。然而，使用口服避孕药的妇女应慎用本品，因为极少数人可能月经失调。此外，肝药酶诱导药(如利福平等)可加速特比萘芬的血浆清除，肝药酶抑制药(如西米替丁等)则可抑制其清除，故如果需要用以上药物，则需将特比萘芬的剂量作适当调整。
　　4．口服本品对花斑癣无效。
　　5．本品应置于儿童接触不到的地方。

Lamisil
Generic Name: terbinafine (ter BIN na feen)
Brand Names: Lamisil

What is Lamisil?
Terbinafine is an antifungal antibiotic.

Lamisil is used to treat infections caused by fungus that affect the fingernails or toenails. Lamisil oral granules are used to treat a fungal infection of scalp hair follicles in children who are at least 4 years old.

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

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Important information about Lamisil
Before using Lamisil, tell your doctor if you have liver or kidney disease, or an autoimmune disorder such as lupus or psoriasis.

Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Lamisil will not treat a viral infection such as the common cold or flu. Some people taking Lamisil have developed severe liver damage leading to liver transplant or death. It is not clear whether Lamisil actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking Lamisil.

Call your doctor at once if you have symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

It may take several months for your nails to return to their normal appearance after your treatment with Lamisil.

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What should I discuss with my healthcare provider before taking Lamisil?
You should not use Lamisil if you are allergic to terbinafine.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely use this medication:
liver disease;
kidney disease; or
an autoimmune disorder such as lupus or psoriasis.

FDA pregnancy category B. Lamisil is not expected to be harmful to an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant during treatment. Terbinafine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

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How should I take Lamisil?
Take this medication exactly as prescribed by your doctor. Do not take it in larger amounts or for longer than recommended. Follow the directions on your prescription label.

Take the Lamisil tablet with a full glass (8 ounces) of water.

Lamisil granules should be sprinkled into a spoonful of pudding or mashed potatoes (do not mix with applesauce, fruit juice, or other acidic foods). Swallow this mixture right away without chewing. Do not save the mixture for later use.

The Lamisil granule mixture should be taken with a meal. Lamisil is usually taken for 6 to 12 weeks. Take this medication for the full prescribed length of time. Your symptoms may improve before the infection is completely cleared. Lamisil will not treat a viral infection such as the common cold or flu.

To be sure this medication is not causing harmful effects, your blood may need to be tested on a regular basis. Your liver function may also need to be tested. Do not miss any scheduled appointments.

It may take several months for your nails to return to their normal appearance after your treatment with Lamisil.

Store Lamisil at room temperature away from moisture, heat, and light.

Keep the Lamisil oral granules in their sealed packet until you are ready to use.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. If it is almost time for your next dose, wait until then to take the medicine and skip the missed dose. Do not take 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 medication.

Overdose symptoms may include dizziness, stomach pain, nausea, vomiting, skin rash, or urinating more than usual.

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What should I avoid while taking Lamisil?
Follow your doctor's instructions about any restrictions on food, beverages, or activity while you are using Lamisil.

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Lamisil 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.

Some people taking Lamisil have developed severe liver damage leading to liver transplant or death. It is not clear whether Lamisil actually caused the liver damage in these patients. In most cases, the patient had a serious medical condition before taking Lamisil.

Call your doctor at once if you have symptoms of liver damage, such as nausea, stomach pain, loss of appetite, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes). These events can occur whether or not you have ever had liver problems before.

Stop taking Lamisil and call your doctor at once if you have a serious side effect such as:
joint pain or swelling, swollen glands, patchy skin color, or a butterfly-shaped skin rash over your cheeks and nose;
fever, chills, body aches, flu symptoms;
changes in your vision;
weight loss due to taste changes;
scaly, itchy, and flaky skin rash; or
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash.

Less serious side effects may include:
stomach pain, heartburn, diarrhea;
headache;
tired feeling;
runny or stuffy nose, sore throat, cold symptoms;
mild skin rash or itching;
unusual or unpleasant taste in your mouth; or
decreased taste sensation.

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 Lamisil?
Before taking Lamisil, tell your doctor if you are taking any of the following medicines:
cimetidine (Tagamet, Tagamet HB);
rifampin (Rifadin, Rimactane);
another antifungal antibiotic, such as fluconazole (Diflucan);
a blood thinner such as warfarin (Coumadin);
a heart rhythm medication such as propafenone (Rythmol) or flecainide (Tambocor);
an "SSRI" antidepressant such as fluoxetine (Prozac), fluvoxamine (Luvox), or paroxetine (Paxil);
a tricyclic antidepressant such as amitriptyline (Elavil, Etrafon), desipramine (Norpramin), imipramine (Janimine, Tofranil), and others;
an MAO inhibitor such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate); or
a beta-blocker such as atenolol (Tenormin, Tenoretic), bisoprolol (Zebeta, Ziac), labetalol (Normodyne, Trandate), metoprolol (Lopressor, Toprol), nadolol (Corgard), propranolol (Inderal, InnoPran), timolol (Blocadren), and others.

This list is not complete and there may be other drugs that can interact with Lamisil. Tell your doctor about all your prescription and over-the-counter medications, vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start a new medication without telling your doctor.

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

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. 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. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件（20096800230439.pdf）的“原文Priscribing Information”为准
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于2010-07-06更新