部分中文LAMICTAL 口腔崩解片处方资料（仅供参考）

药品名称和成分
拉莫三嗪片,利必通.
外文名：Lamotrigine
药理作用
药理学研究的结果提示拉莫三嗪是一种电压性的钠离子通道阻滞剂。在培养的神经细胞中，它反复放电和抑制病理性释放谷氨酸（这种氨基酸对癫痫发作的形成起着关键性的作用），也抑制谷氨酸诱发的动作电位的爆发。在为评价药物对中枢神经系统作用而设计的试验中，健康志愿者服用拉莫三嗪240mg，所得结果与安慰剂无异；然而1000 mg苯妥英和10mg安定都显著地损害细微的视觉运动的协调和眼球运动，增加和产生主观的镇静作用。另一项研究中，单剂口服600mg的卡马西平明显地损害了细微视觉运动的协调和眼球运动，此时身体的摆动和心率均增加；然而，使用150 mg和300mg剂量的拉莫三嗪，结果与安慰剂无差异。
药代动力学
拉莫三嗪在肠道内迅速而完全地被吸收，没有明显的首过代谢。口服给药后在2.5小时达到血浆峰浓度，进食后的达峰时间稍延迟，但吸收的程度不受影响。实验表明，当单次最高给药剂量达450mg时，药代动力学曲线仍呈线性，稳态的最高血药浓度在个体之间差异颇大，但在同一个体浓度的差异很小。血浆蛋白结合率约为55%；从血浆蛋白置换出来而引起毒性的可能性极低，分布容积为0.92-1.22L/mg。在健康成人，平均稳态清除率是39±14 mL/分。
拉莫三嗪的清除主要是代谢为葡萄糖醛酸结合物，然后由尿中消除。尿中排出的原形药不足10%，在粪便中所排除的与药物有关的物质仅约2%，清除率和半衰期与剂量无关。健康成人平均消除半衰期是24-35小时。UDP-葡萄糖醛酸转移酶已被验明是负责拉莫三嗪的代谢酶。在一项Gilbert综合征的受试者研究中，平均表观清除率比正常对照者下降32%，但比值仍在一般人群的范围内。本药轻度诱导自身代谢取决于剂量，然而无本药影响其它抗癫痫药的药代动力学之证据。
本药与细胞色素P450酶代谢的药物之间的相互作用也未必可能发生，而本药的半衰期明显受到合用药物的影响，当与酶诱导剂如卡马西平和苯妥英合用时，平均半衰期缩短到14小时左右；当单独与丙戊酸钠合用时，平均半衰期增加到近70小时。清除率随体重调整，儿童高于成人，5岁以下的儿童最高。在一般情况下，拉莫三嗪的半衰期在儿童短于成人；当与酶诱剂如卡马西平和苯妥英同用时，平均值接近7小时；当单独与丙戊酸钠合用时，平均值增加到接近45-50小时。
迄今，拉莫三嗪在老年癫痫病人的药代动力学尚未进行专门研究。然而，12例年龄在65-76岁之间的健康志愿者的单剂量研究和144例包括25位65岁和超过65岁病人的群体分析都表明对老年人不需调整剂量。对肾衰病人服用拉莫三嗪没有经验，肾衰的受试者中，单剂量的药代动力学研究表明拉莫三嗪的药代动力学未受到很大影响；但是，由于肾清除率的下降血浆中主要的葡萄糖醛酸代谢物的浓度几乎增加了近8倍。
毒理研究
大范围致突变性试验的结果表明，本药对人类无遗传学危险。在大、小鼠的长期研究中，本药无致癌性。
适应症
癫痫：对12岁以上儿童及成人的单药治疗（简单部分性发作、复杂部分性发作、续发性全身强直-阵挛性发作和原发性全身强直-阵挛性发作）。目前暂不推荐对12岁以下儿童采用单药治疗，因为尚未得到对这类特殊目标人群所进行的对照试验的相应数据。
2岁以上儿童及成人的添加疗法（简单部分性发作、复杂部分性发作、续发性全身强直-阵挛性发作和原发性全身强直-阵挛性发作）。
也可用于治疗合并有Lennox-Gastaut综合征的癫痫发作。
不良反应
在本药作为单药治疗的试验中，不良反应的报导包括头痛、疲倦、皮疹、恶心、头晕、嗜睡和失眠。
在临床双盲、添加试验中，服用拉莫三嗪的病人中皮疹的发生率高达10%，服用安慰剂的病人为5%。2%的病人因皮疹导致停止拉莫三嗪的治疗。这种皮疹在外观上一般是斑丘疹，通常在治疗开始的前8周出现，停用拉莫三嗪后消失。罕见的、严重的皮疹，包括Stevens-Johnson综合征和中毒性表皮坏死溶解（Lyell综合征）已经有报道，曾出现过与死亡相关的罕见病例。
发生皮疹总的危险性与下列因素很有关系：
拉莫三嗪的初始剂量过大和拉莫三嗪治疗升级超过推荐剂量 ；同时应用丙戊酸钠，它能增加拉莫三嗪平均半衰期接近2倍。也有报导认为皮疹是过敏综合征的一部分，伴有多种形式的全身症状，包括发烧、淋巴腺病、颜面水肿和血液及肝的异常。这种综合征引起临床反应的严重程度有很大区别。罕见弥漫性血管内凝血（DIC）和多器官衰竭。即使皮疹不明显，注意过敏反应的早期表现（如发热、淋巴腺病）是十分重要的。
如早期反应的体征和症状出现，应立即评估病人 ；
如不能确定另有病因，应停用本药。
标准的抗癫痫药方案中添加拉莫三嗪时，其它的不良反应包括复视、视力模糊、结膜炎、头昏、瞌睡、头痛、疲倦、胃肠道紊乱（包括呕吐和腹泻）、激惹/攻击行为、共济失调、焦虑、精神混乱和血液学异常（包括白细胞减少和血小板减少）。
注意事项
曾有皮肤不良反应报告，一般发生在拉莫三嗪开始治疗的前8周。大多数皮疹是轻微的和自限性的；但是，曾罕见严重的、致命危险的皮疹，包括Stevens-Johnson综合征和毒性上皮坏死溶解的报道。严重皮疹的发生率在成人约为1:1000，12岁以下儿童比成人要高。有研究表明，12岁以下儿童中发生需住院治疗不良反应的比率为1:300-1:100。
在儿童，最初发生的皮疹可能会被误认为是感染 ；
在用本药治疗的前8周，如果儿童出现皮疹和发热症状，应该考虑有药物反应的可能性。
此外，发生皮疹总的危险性与下列因素很有关系：拉莫三嗪的初始剂量太高和随后增加的剂量超过推荐剂量；同时应用丙戊酸钠：它使拉莫三嗪的平均半衰期增加约2倍。
出现皮疹的所有病人（成人和儿童）都应迅速被评估，并立即停用拉莫三嗪，除非可确诊皮疹与此药无关。也有报告皮疹是过敏综合征的一部分，伴有多种形式的全身症状，包括发热、淋巴腺病、颜面水肿和血液及肝的异常。这种综合征引起的临床反应的严重性范围很大；罕见弥漫性血管内凝血和多器官衰竭。即使皮疹不明显，注意过敏反应的早期表现（即发热、淋巴腺病）是十分重要的。如出现这种体征和症状，应立即评估病人；如不能确定另有病因，需停用本药。
当与其它抗癫痫药同用时，突然停用本药可引起癫痫反弹发作。除非出于安全性的考虑（例如皮疹）要求突然停药，否则本药的剂量应该在2周内逐渐减少至停药。当欲停止使用其它合用的抗癫痫药物以便达到本药单药治疗，或在本药单药治疗中添加其它抗癫痫药物时，都应考虑对拉莫三嗪药代动力学的影响。
本药是弱的二氢叶酸还原酶的抑制剂，长期治疗有可能干扰叶酸的代谢。然而，人类长期给药达一年，拉莫三嗪对血红蛋白的浓度、红细胞平均容量和血清或红细胞的叶酸浓度没有引起明显的变化；用药长达五年对红细胞的叶酸浓度也无明显的影响。
在晚期肾衰病人的单剂量研究中，血浆中拉莫三嗪的浓度没有明显改变，但是，可以预计到葡萄糖醛酸代谢物会蓄积；因此，肾衰的病人用药需小心。本药主要是通过肝脏代谢而清除。尚未对肝功能严重损害病人使用本药进行研究。在没有这些资料之前，这种病人不推荐使用本药。
据文献中报道，严重的惊厥发作包括癫痫持续状态可导致横纹肌溶解，多器官功能失调和弥漫性血管内凝血，有时可以致死，应用本药也发生过类似的情况。但拉莫三嗪与上述反应的关系尚未建立。
如果您有任何疑问，请遵医嘱。
药物相互作用
没有证据表明拉莫三嗪能产生有临床意义的肝氧化药物代谢酶的诱导或抑制作用。拉莫三嗪可诱导自身代谢，但此作用是有限的，无明显的临床意义。与本药合用时其它抗癫病药的血浆浓度的改变虽有报道，但对照研究并未显示本药对其它抗癫痫药血浆浓度有任何影响。体外试验结果显示拉莫三嗪并不能从蛋白结合部位上置换其它抗癫痫药。在一项12名女性志愿者参加的研究中，给予口服避孕药后，拉莫三嗪不影响血浆中乙炔雌二醇和左炔诺孕酮的浓度。然而，在服用口服避孕药的病人采用其它慢性治疗时，应注意月经出血形式的任何变化。诱导肝药物代谢酶的抗癫痫药（例如苯妥英、卡马西平、苯巴比妥和扑痫酮）都能加强拉莫三嗪的代谢，而需增加使用剂量。丙戊酸钠与拉莫三嗪竟争肝药物代谢，可降低拉莫三嗪的代谢。对正服用卡马西平的病人，服用拉莫三嗪之后有中枢神经系统反应的报道，包括头晕、共济失调、复视、视力模糊和恶心，这些反应在减少卡马西平的剂量后通常都会消失。
药物过量
症状和体征
已报道吞服拉莫三嗪1.35-4g后，临床结果并不严重。体征和症状包括眼球震颤、共济失调、头昏、嗜睡、头痛和呕吐。一例服用了4-5g拉莫三嗪病人，住院后昏迷持续8-12小时，其后2-3天恢复，还有一例吞服拉莫三嗪5.6g后出现无意识。怀疑中毒后，用活性炭治疗，病人昏睡16小时。曾有急性摄入超过最大剂量10-20倍的报告。药物过量会引起眼球震颤、共济失调、意识受损和昏迷等症状。
处理
一旦发生药物过量，病人应住院治疗，并给予适当的支持疗法；如需要，应进行洗胃。
用药须知
为了保证维持治疗剂量，要监测病儿体重；在体重发生变化时要核查剂量。如果根据体重计算出的儿童剂量不是整片数，则所用的剂量应舍去非整数部分，取其整片数。
禁忌症
禁用于曾对拉莫三嗪过敏的患者。
规格
拉莫三嗪咀嚼片2mg; 5mg。
拉莫三嗪片25mg; 50mg; 100mg; 150mg; 200mg。

LAMICTAL
(lamotrigine) Tablets
LAMICTAL
(lamotrigine) Chewable Dispersible Tablets
LAMICTAL ODT
(lamotrigine) Orally Disintegrating Tablets
What is Lamictal?
Lamictal is an anti-epileptic medication, also called an anticonvulsant.
Lamictal is used alone or in combination with other medications to treat seizures in adults and children who are at least 2 years old. It is also used to delay mood episodes in adults with bipolar disorder.
Lamictal may also be used for other purposes not listed in this medication guide.
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Important information about Lamictal
Lamictal may cause severe or life-threatening skin rash, especially in children and in people who are allergic to other seizure medications. Serious skin rash may also be more likely to occur if you are taking Lamictal together with valproic acid (Depakene) or divalproex (Depakote). Seek emergency medical attention if you have a fever, sore throat, swollen glands, and headache with a severe blistering, peeling, and red skin rash.
If you have to stop taking Lamictal because of a serious skin rash, you may not be able to take it again in the future.
You may have thoughts about suicide while taking Lamictal.
Your doctor will need to check you at regular visits. Do not miss any scheduled
appointments.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Do not stop taking this medication without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking Lamictal suddenly. You will need
to use less and less before you stop the medication completely. Contact your doctor if your seizures get worse or you have them more often while taking Lamictal.
Taking this medication during early pregnancy can increase the risk of the baby being born with cleft lip or cleft palate.
Tell your doctor if you are pregnant or if you become pregnant during treatment.
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Before taking Lamictal
You should not use Lamictal if you are allergic to lamotrigine.
If you have any of these other conditions, you may need a dose adjustment or special tests to safely use Lamictal:
kidney disease;
liver disease; or
heart disease.
You may have thoughts about suicide while taking Lamictal.
Tell your doctor if you have new or worsening depression or suicidal thoughts during the first several months 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. Do not miss any scheduledappointments.
FDA pregnancy category C. Lamictal may be harmful to an unborn baby.
Taking this medication during early pregnancy can increase the risk of the baby being born with cleft lip or cleft palate. Tell your doctor if you are pregnant or plan to become pregnant during treatment.
Your name may need to be listed on a Lamictal pregnancy registry when you start using this medication.
Lamotrigine 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 Lamictal?
Take Lamictal exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.
The extended-release form of lamotrigine (Lamictal XR) may be used for different conditions than immediate-release lamotrigine is used for. Always check your refills to make sure you have received the correct brand and type of medicine prescribed by your doctor. Ask the pharmacist if you have any questions about the medicine you receive at the pharmacy.
Your doctor may occasionally change your dose over several weeks or months to make sure you get the best results from this medication.
To make sure you are taking the right dose of this medication, your blood may need to be tested on a regular basis. Do not miss any scheduled visits to your doctor.
If you are switching to Lamictal from another anticonvulsant medication, carefully follow your doctor's instructions about timing and dosage when switching from one drug to another.
Lamictal can be taken with or without food.
Take the regular Lamictal tablet with a full glass of water.
To take the chewable dispersible tablet, you may either swallow it whole with a glass of water, or chew it first and then swallow it. You may also place the tablet into 1 teaspoon
of water or diluted fruit juice and allow it to disperse in the liquid for about 1 minute. Gently swirl the liquid and then swallow all of the mixture right away. Do not save it for
later use.
Do not stop taking Lamictal without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking Lamictal suddenly. You will need to use less and less before you stop the medication completely. Contact your doctor if your seizures get worse or you have them more often while taking this medication. Carry an ID card or wear a medical alert bracelet stating that you are taking Lamictal, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication.
Birth control pills can make Lamictal less effective, which may result in increased seizures. Your Lamictal dose may need to be changed when you start or stop using birth control pills. You may also have side effects during the weeks when you are taking an inactive (placebo) pill from your birth control pack.
Tell your doctor if you plan to stop taking birth control pills.
It is important to use this medication regularly to get the most benefit. Get your prescription refilled before you run out of medicine completely.
Store this medication at room temperature away from light and moisture.
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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, skip the missed dose and take the medicine at your next regularly scheduled time. 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 medicine.
Overdose symptoms may include blurred vision, problems with coordination, increased seizures, feeling light-headed, or fainting.
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What should I avoid while taking Lamictal?
Lamictal can cause side effects that may impair your vision or reactions. Be careful if you drive or do anything that requires you to be alert and able to see clearly.
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Lamictal side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Lamictal: hives; fever; swollen glands; painful sores in or around your eyes or mouth;
difficulty breathing; swelling of your face, lips, tongue, or throat.
This medication may cause severe or life-threatening skin rash, especially in children and in people who are allergic to other seizure medications. Serious skin rash may also be more
likely to occur if you are taking Lamictal together with valproic acid (Depakene) or divalproex (Depakote). Seek emergency medical attention if you have a fever, sore throat,
swollen glands, and headache with a severe blistering, peeling, and red skin rash.
If you have to stop taking Lamictal because of a serious skin rash, you may not be able to take it again in the future.
Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, depression, anxiety, or if you feel agitated, hostile, restless, hyperactive (mentally or physically), or have thoughts about suicide or hurting yourself.
Call your doctor at once if you have any of these serious side effects:
the first sign of any skin rash;
fever, sore throat, and headache with a severe blistering, peeling, and red skin rash;
chest pain;
pale skin, easy bruising or bleeding;
fever, chills, body aches, flu symptoms;
muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Less serious Lamictal side effects may include:
dizziness or drowsiness;
blurred vision;
mild nausea, vomiting, diarrhea, upset stomach;
headache;
lack of coordination;
weight loss;
sleep problems (insomnia), unusual dreams; orrunny or stuffy nose.
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 Lamictal?
Birth control pills can make Lamictal less effective, resulting in increased seizures. Tell your doctor if you start or stop using birth control pills while you are taking this medicine. Your dose may need to be changed.Before taking Lamictal, tell your doctor if you are using any of the following drugs:
hormonal forms of birth control (pills, injections, implants, or skin patches);
carbamazepine (Carbatrol, Tegretol);
divalproex (Depakote);
oxcarbazepine (Trileptal);
phenobarbital (Luminal, Solfoton);
primidone (Mysoline);
phenytoin (Dilantin);
rifampin (Rifadin, Rifater, Rifamate, Rimactane); orvalproic acid (Depakene).
This list is not complete and there may be other drugs that can interact with Lamictal. 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 Lamictal.
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.

附件：

20108200070833.pdf

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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！
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产地国家: 美国
原产地英文商品名:
LAMICTAL ODT TABLET 25mg/Tablet 30Tablets/box
原产地英文药品名:
LAMOTRIGINE
中文参考商品译名:
利必通口腔崩解片 25毫克/片 30片/盒
中文参考药品译名:
拉莫三嗪
生产厂家中文参考译名:
史克必成
生产厂家英文名:
SMITHKLINE BEECHAM
---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
LAMICTAL ODT TABLET 50mg/Tablet 30Tablets/box
原产地英文药品名:
LAMOTRIGINE
中文参考商品译名:
利必通口腔崩解片 50毫克/片 30片/盒
中文参考药品译名:
拉莫三嗪
生产厂家中文参考译名:
史克必成
生产厂家英文名:
SMITHKLINE BEECHAM
---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
LAMICTAL ODT TABLET 100mg/Tablet 30Tablets/box
原产地英文药品名:
LAMOTRIGINE
中文参考商品译名:
利必通口腔崩解片 100毫克/片 30片/盒
中文参考药品译名:
拉莫三嗪
生产厂家中文参考译名:
史克必成
生产厂家英文名:
SMITHKLINE BEECHAM
---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
LAMICTAL ODT TABLET 200mg/Tablet 30Tablets/box
原产地英文药品名:
LAMOTRIGINE
中文参考商品译名:
利必通口腔崩解片 200毫克/片 30片/盒
中文参考药品译名:
拉莫三嗪
生产厂家中文参考译名:
史克必成
生产厂家英文名:
SMITHKLINE BEECHAM