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LAMICTAL ODT(利必通口腔崩解片起始套装)

2013-01-17 22:19:24  作者:新特药房  来源:互联网  浏览次数:213  文字大小:【】【】【
简介: 部分中文LAMICTAL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 ...

部分中文LAMICTAL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。

The US Food and Drug Administration (FDA) has approved EUR-1048, to be marketed as GlaxoSmithKline's Lamictal Orally Disintegrating Tablets (ODT).
Co-developed by Eurand NV and GSK, Lamictal (lamotrigine) ODT uses Eurand's AdvaTab orally disintegrating tablet and Microcaps taste-masking technologies to provide Lamictal in a pleasant-tasting tablet that disintegrates on the tongue and that may be taken with or without liquid.
Lamictal ODT is indicated for the long-term treatment of Bipolar I Disorder to lengthen the time between mood episodes in people 18 years or older, that have been treated for mood episodes with other medicine.
Lamictal ODT uses a combination of two of Eurand's novel drug delivery technologies.
AdvaTab orally disintegrating tablet technology uses Eurand's proprietary granulation and tabletting processes that allow the tablet to disintegrate rapidly in the mouth without chewing or the need for liquid.
Key features of AdvaTab include: excellent mouth-feel; tablets that can be packaged in bottles or blisters; rapid disintegration in the oral cavity; ability to incorporate microencapsulated drug particles; and the capacity to incorporate larger drug doses than conventional ODT technologies.
AdvaTab is distinct from conventional ODT technologies because it can be combined with Microcaps taste-masking technology. Microcaps taste-masking technology provides a coating that encapsulates drug particles, forming a barrier between the medication and the taste buds while still allowing the drug to dissolve in the stomach.
Eurand's microencapsulation technology, known as Microcaps, employs versatile and precise coating techniques to encapsulate individual drug particles using solvent- and aqueous-based coacervation. This includes taste and odour masking, customized release profiles, conversion of liquids to solids and the separation of incompatible materials. Microcaps is incorporated in more than 12 marketed products.


WARNING: SERIOUS SKIN RASHES
See full prescribing information for complete boxed warning.
Cases of life-threatening serious rashes, including Stevens-Johnson syndrome, toxic epidermal necrolysis, and/or rash-related death, have been caused by LAMICTAL. The rate of serious rash is greater in pediatric patients than in adults. Additional factors that may increase the risk of rash include:
coadministration with valproate
exceeding recommended initial dose of LAMICTAL
exceeding recommended dose escalation of LAMICTAL
Benign rashes are also caused by LAMICTAL; however, it is not possible to predict which rashes will prove to be serious or life threatening. LAMICTAL should be discontinued at the first sign of rash, unless the rash is clearly not drug related.
Discontinuation of treatment may not prevent a rash from becoming life threatening or permanently disabling or disfiguring.
Contraindication
LAMICTAL is contraindicated in patients who have demonstrated hypersensitivity to the drug or its ingredients.
Serious Skin Rashes
Serious rashes requiring hospitalization and discontinuation of treatment have been reported in association with the use of LAMICTAL, some of which have included Stevens-Johnson syndrome.
Epilepsy clinical trials: The incidence of these rashes is approximately 0.8% (8/1000) in pediatric patients (2 to 16 years of age) receiving LAMICTAL as adjunctive therapy for epilepsy and 0.3% (3/1000) in adults on adjunctive therapy for epilepsy. In a prospectively followed cohort of 1983 pediatric patients with epilepsy taking adjunctive LAMICTAL, there was 1 rash-related death.
Mood disorders: In clinical trials of bipolar and other mood disorders, the incidence of these rashes was 0.08% (0.8/1000) in adult patients receiving LAMICTAL as initial monotherapy and 0.13% (1.3/1000) in adult patients receiving LAMICTAL as adjunctive therapy.
In worldwide postmarketing experience, rare cases of toxic epidermal necrolysis and/or rash-related death have been reported in adult and pediatric patients, but their numbers are too few to permit a precise estimate of the rate.
Multiorgan Hypersensitivity Reactions and Organ Failure
Multiorgan hypersensitivity reactions, also known as Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS), have occurred with LAMICTAL. Some have been fatal or life threatening. Early signs may include rash, fever, and lymphadenopathy. These reactions may be associated with other organ involvement, such as hepatitis, hepatic failure, blood dyscrasias, or acute multiorgan failure.
Fatalities associated with acute multiorgan failure and various degrees of hepatic failure have been reported in 2 of 3796 adult patients and 4 of 2435 pediatric patients who received LAMICTAL in epilepsy clinical trials. Rare fatalities from multiorgan failure have also been reported in postmarketing use. Isolated liver failure without rash or involvement of other organs has also been reported with LAMICTAL.
Early signs of hypersensitivity (eg, fever, lymphadenopathy) may present without rash; if signs present, the patient should be evaluated immediately.
LAMICTAL should be discontinued if alternate etiology for hypersensitivity signs is not found.
Prior to initiation of treatment with LAMICTAL, the patient should be instructed that a rash or other signs or symptoms of hypersensitivity (eg, fever, lymphadenopathy) may herald a serious medical event and that the patient should report any such occurrence to a physician immediately.
Blood Dyscrasias
Blood dyscrasias (eg, neutropenia, thrombocytopenia, pancytopenia) may occur, either with or without an associated hypersensitivity syndrome.
Suicidal Thoughts or Behavior
Antiepileptic drugs (AEDs), including LAMICTAL, increase the risk of suicidal thoughts or behavior in patients taking these drugs for any indication.
Patients treated with any AED for any indication should be monitored for the emergence or worsening of depression, suicidal thoughts or behavior, and/or any unusual changes in mood or behavior.
Anyone considering prescribing LAMICTAL or any other AED must balance the risk of suicidal thoughts or behavior with the risk of untreated illness. Epilepsy and many other illnesses for which AEDs are prescribed are themselves associated with morbidity and mortality and an increased risk of suicidal thoughts and behavior. Should suicidal thoughts and behavior emerge during treatment, the prescriber needs to consider whether the emergence of these symptoms in any given patient may be related to the illness being treated.
Patients, their caregivers, and families should be informed that antiepileptic drugs increase the risk of suicidal thoughts and behavior and should be advised of the need to be alert for the emergence or worsening of the signs and symptoms of depression, any unusual changes in mood or behavior, or the emergence of suicidal thoughts, behavior, or thoughts about self-harm. Behaviors of concern should be reported immediately to healthcare providers.
Aseptic Meningitis
LAMICTAL increases the risk of developing aseptic meningitis. Aseptic meningitis has been reported in pediatric and adult patients. Because of the potential for serious outcomes of untreated meningitis due to other causes, patients should also be evaluated for other causes of meningitis and treated as appropriate.
Symptoms have been reported to occur within 1 day to one and a half months following the initiation of treatment. Some patients also had new onset of signs and symptoms of involvement of other organs (predominantly hepatic and renal involvement), which may suggest that in these cases the aseptic meningitis observed was part of a hypersensitivity reaction. In most cases, symptoms were reported to resolve after discontinuation of LAMICTAL.
Patients should be advised that LAMICTAL may cause aseptic meningitis and to notify their physician immediately if they develop signs and symptoms of meningitis.
Medication Errors
Medication errors involving LAMICTAL have occurred. To reduce the potential for medication errors,
please write and say "LAMICTAL," "LAMICTAL ODT," and "LAMICTAL CHEWABLE TABLETS" clearly.
Important Note: The name LAMICTAL or lamotrigine can be confused with the names of other commonly used medications, including Lamisil®,* lamivudine, Ludiomil®,* labetalol, and Lomotil®.* Medication errors may also occur between the different formulations of LAMICTAL. To avoid the medication error of using the wrong drug or formulation, patients should be strongly advised to visually inspect their tablets to verify that the tablets are LAMICTAL, as well as the correct formulation, each time they fill their prescription.
*
Lamisil (terbinafine HCl tablets) and Ludiomil (maprotiline HCl) are registered trademarks of Novartis Pharmaceuticals Corporation. Lomotil (diphenoxylate HCl, atropine sulfate) is a registered trademark of G.D. Searle LLC.
Withdrawal Seizures
As with other AEDs, LAMICTAL should not be abruptly discontinued. In patients with epilepsy there is a possibility of increasing seizure frequency. In clinical trials in patients with Bipolar Disorder, two patients experienced seizures shortly after abrupt withdrawal of LAMICTAL; however, there were confounding factors that may have contributed to the occurrence of seizures in these bipolar patients. Unless safety concerns require a more rapid withdrawal, the dose of LAMICTAL should be tapered over a period of at least 2 weeks (approximately 50% reduction per week).
Most Common Adverse Reactions
Most common adverse reactions (incidence >10% and numerically more frequent than placebo) in placebo-controlled adjunctive trials in adults with epilepsy were dizziness (38% vs 13%), headache (29% vs 19%), diplopia (28% vs 7%), ataxia (22% vs 6%), nausea (19% vs 10%), blurred vision (16% vs 5%), somnolence (14% vs 7%), rhinitis (14% vs 9%), pharyngitis (10% vs 9%), and rash (10% vs 5%).
Adverse reactions (incidence >5% and numerically more frequent than the valproate group) in a controlled monotherapy trial where adult patients with partial seizures were converted to LAMICTAL or low-dose valproate monotherapy from concomitant therapy with carbamazepine or phenytoin were vomiting (9% vs 0%), dyspepsia (7% vs 2%), nausea (7% vs 2%), coordination abnormality (7% vs 0%), dizziness (7% vs 0%), rhinitis (7% vs 2%), pain (5% vs 0%), infection (5% vs 2%), chest pain (5% vs 2%), weight decrease (5% vs 2%), anxiety (5% vs 0%), insomnia (5% vs 2%), and dysmenorrhea (5% vs 0%).
Adverse reactions (incidence >10% and numerically more frequent than placebo) in placebo-controlled adjunctive trials in children (>2 years of age) with partial seizures or generalized seizures of Lennox-Gastaut syndrome were vomiting (20% vs 16%), infection (20% vs 17%), somnolence (17% vs 15%), fever (15% vs 14%), accidental injury (14% vs 12%), rash (14% vs 12%), pharyngitis (14% vs 11%), dizziness (14% vs 4%), diarrhea (11% vs 9%), ataxia (11% vs 3%), abdominal pain (10% vs 5%), nausea (10% vs 2%), and tremor (10% vs 1%).
Most common adverse reactions (incidence >5% and numerically more frequent than placebo) in placebo-controlled clinical studies of adults with Bipolar I Disorder were nausea (14% vs 11%), insomnia (10% vs 6%), somnolence (9% vs 7%), back pain (8% vs 6%), fatigue (8% vs 5%), rash (7% vs 5%), rhinitis (7% vs 4%), abdominal pain (6% vs 3%), and xerostomia (6% vs 4%).
Adverse Reactions Leading to Withdrawal
Approximately 11% of the 3378 adult patients who received LAMICTAL as adjunctive therapy in premarketing clinical trials of epilepsy discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were rash (3.0%), dizziness (2.8%), and headache (2.5%).
Approximately 10% of the 420 adult patients who received LAMICTAL as monotherapy in premarketing clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were rash (4.5%), headache (3.1%), and asthenia (2.4%).
Approximately 11.5% of the 1081 pediatric patients 2 to 16 years of age who received LAMICTAL as adjunctive therapy in premarketing epilepsy clinical trials discontinued treatment because of an adverse reaction. The adverse reactions most commonly associated with discontinuation were rash (4.4%), reaction aggravated (1.7%), and ataxia (0.6%).
Approximately 16% of 2401 patients who received LAMICTAL (50 to 500 mg/day) for Bipolar Disorder in premarketing trials discontinued therapy because of an adverse reaction, most commonly due to rash (5%) and mania/hypomania/mixed mood adverse reactions (2%).
Important Dosing Considerations
Dosing is based on concomitant medications, indication, and patient age.
To avoid an increased risk of rash, the recommended initial dose and subsequent dose escalations should not be exceeded. The risk of rash may also be increased by coadministration with valproate. Patient Titration Kits are available for the first 5 weeks of treatment.
Do not restart LAMICTAL in patients who discontinued due to rash unless the potential benefits clearly outweigh the risks.
LAMICTAL should be discontinued over a period of at least 2 weeks (approximately 50% reduction per week).
Dose adjustments are recommended for patients with moderate and severe hepatic impairment.
Reduced maintenance doses may be effective for patients with significant renal impairment. LAMICTAL should be used with caution in renally impaired patients.
Some estrogen-containing oral contraceptives have been shown to decrease serum concentrations of lamotrigine.
Adjustments to maintenance doses will in most cases be required in patients starting or stopping estrogen-containing oral contraceptives.
During the week of inactive hormone preparation ("pill-free" week) of oral contraceptive therapy, plasma lamotrigine levels are expected to rise, as much as doubling at the end of the week. Adverse events consistent with elevated levels of lamotrigine (such as dizziness, ataxia, and diplopia) could occur.
Adjustments also may be necessary during pregnancy and following delivery.
Drug Interactions
Valproate increases lamotrigine concentrations more than 2-fold.
Carbamazepine, phenytoin, phenobarbital, and primidone decrease lamotrigine concentrations by approximately 40%.
Oral estrogen-containing contraceptives decrease lamotrigine concentrations by approximately 50%.
Rifampin decreases lamotrigine concentrations by approximately 40%.
Pregnancy and Nursing Mothers
Pregnancy Category C. There are no adequate and well-controlled studies in pregnant women. Based on animal data, LAMICTAL may cause fetal harm. LAMICTAL should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.
Pregnancy Registry: To provide information on in utero exposure, recommend that pregnant patients taking LAMICTAL enroll themselves in the North American Antiepileptic Drug (NAAED) Pregnancy Registry by calling toll-free 1-888-233-2334. Information is also available at
www.aedpregnancyregistry.org.
Lamotrigine is present in milk from lactating women taking LAMICTAL. Data from multiple small studies indicate that lamotrigine plasma levels in human milk-fed infants have been reported to be as high as 50% of the maternal serum levels. Events including apnea, drowsiness, and poor sucking have been reported in infants who have been human milk-fed by mothers using lamotrigine; whether or not these events were caused by lamotrigine is unknown. Human milk-fed infants should be closely monitored for adverse events resulting from lamotrigine. Human milk-feeding should be discontinued in infants with lamotrigine toxicity. Caution should be exercised when LAMICTAL is administered to a nursing woman.


---------------------------------------------------------------
产地国家: 美国
原产地英文商品名:
LAMICTAL ODT START KIT (ORANGE) 35Tablets/box
原产地英文药品名:
LAMOTRIGINE
中文参考商品译名:
利必通口腔崩解片起始套装(橘色装) 35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 START KIT (BLUE) 28Tablets/box
原产地英文药品名:
LAMOTRIGINE
中文参考商品译名:
利必通口腔崩解片起始套装((蓝色装) 28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 START KIT (GREEN) 56Tablets/box
原产地英文药品名:
LAMOTRIGINE
中文参考商品译名:
利必通口腔崩解片起始套装(绿色装) 56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 START KIT (GREEN) 98Tablets/box
原产地英文药品名:
LAMOTRIGINE
中文参考商品译名:
利必通口腔崩解片起始套装(绿色装) 98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

责任编辑:admin


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