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 详细处方信息以本药内容附件PDF文件（2011122017381232.pdf）的“原文Priscribing Information”为准
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部分中文加巴喷丁处方资料（仅供参考）

【中文品名】加巴喷丁

【通用药名】GABAPENTIN

【化学名称】1-(Aminomethyl)cyclohexaneacetic acid，1-(氨甲基)-环己烷乙酸。

【药理毒理】
　　Gabapentin是美国Warner-Lanbert公司首先开发的抗癫痫药，于1993年首次在英国上市。加巴喷丁是一种新颖的抗癫痫药，它是γ－氨基丁酸（GABA）的衍生物，其药理作用与现有的抗癫痫药不同，最近研究表明加巴喷丁的作用是改变GABA代谢产生的。加巴喷丁在各种动物模型中均显示预防癫痫的作用，另外，在动物痉挛、镇痛和肌萎缩性测索硬化模型中也显示作用。加巴喷丁对脑组织的新颖结合点有高的亲和性，它能通过氨基酸转移体通过体内一些屏障，同其它抗惊厥药相比，加巴喷丁具有较小的行为和心血管副作用。

【药理作用】
　　加巴喷丁抗惊厥作用的机制尚不明确，但动物试验提示，与其他上市的抗惊厥药物相似，加巴喷丁可抑制癫痫发作。小鼠和大鼠最大电休克试验、苯四唑癫痫发作试验以及其他动物试验（如遗传性癫痫模型等）结果提示，加巴喷丁具有抗癫痫作用，但这些癫痫模型与人体的相关性尚不清楚。 　　
    加巴喷丁在结构上与神经递质GABA相关，但不与GABA受体产生相互作用，它既不能代谢转化为GABA或GABA激动剂，也不是GABA摄取或降解的抑制剂。放射性配体结合试验发现，加巴喷丁浓度达到100μM时，对许多常见受体位点无亲和力，包括苯二氮受体、谷氨酸受体、NMDA受体、quisqualate受体、海人草酸受体、番木鳖碱-不敏感性或-敏感性的氨基乙酸受体、α1、α2或β受体、腺苷A1或A2受体、M或N受体、多巴胺D1或D2受体、H1受体、5-羟色胺S1或S2受体、阿片μ，δ或k受体、尼群地平或地尔硫标记的电压敏感钙通道位点、蛙毒素A　20-α-苯甲酸盐标记的电压敏感的钠通道位点。由于在评价药物对NMDA受体作用的几个常用试验所得出的结果是相反，故目前尚无任何关于加巴喷丁对NMDA受体作用的统一认识。 　　
    体外研究显示加巴喷丁在大鼠脑内的结合位点分布于新皮层和海马，其高亲和力的结合蛋白被证实为电压激活钙通道的辅助亚单位，相关功能尚未阐明。

【适应症】
　　难治的不全性癫痫。有报道，抗焦虑药加巴喷丁（gabapentin）和抗病毒药伐昔洛韦（valacyclovir）联用可减少急性带状疱疹后遗神经痛的危险。

【不良反应】
　　包括嗜睡，眩晕，行走不稳，疲劳感。这些副作用常见于用药早期。只要从小剂量开始，缓慢地增加剂量，多数人都能耐受。儿童偶尔会急躁易怒，停药以后会消失。

【用法用量】
　　第一次睡前服300毫克。以后每天增加300毫克，用量可以高达每天3600毫克上述剂量需分三次服用。

【注意事项】
　　对本药过敏者禁用。

Gralise
Generic Name: gabapentin
Date of Approval: January 28, 2011
Company: Abbott Laboratories

FDA Approves Gralise
The United States Food and Drug Administration has approved Gralise (gabapentin) Tablets for once-daily treatment of post-herpetic neuralgia (PHN), which is pain following healing of the rash associated with shingles.

Gralise Medication Guide
Read this Medication Guide before you start taking Gralise and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment. If you have any questions about Gralise, ask your healthcare provider or pharmacist.

Important information about Gralise
Do not stop taking Gralise without first talking with your healthcare provider. Stopping Gralise suddenly can cause serious problems.

Like other antiepileptic drugs, gabapentin, the active ingredient in Gralise, may cause suicidal thoughts or actions in a very small number of people, about 1 in 500. However, it is not known if Gralise is safe and effective in people with seizure problems (epilepsy). Therefore, Gralise should not be used in place of other gabapentin products.

Call a healthcare provider right away if you have any of these symptoms, especially if they are new, worse, or worry you:
•thoughts about suicide or dyingattempts to commit suicide
•new or worse depression
•new or worse anxiety
•feeling agitated or restless
•panic attacks
•trouble sleeping (insomnia)
•new or worse irritability
•acting aggressive, being angry, or violent
•acting on dangerous impulses
•an extreme increase in activity and talking (mania)
•other unusual changes in behavior or mood

How can I watch for early symptoms of suicidal thoughts and actions?
•Pay attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings.
•Keep all follow-up visits with your healthcare provider as scheduled.
•Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

Do not stop taking Gralise without first talking with your healthcare provider.
•Stopping Gralise suddenly can cause serious problems.

What is Gralise?
Gralise is a prescription medicine used in adults, 18 years and older, to treat pain from damaged nerves (neuropathic pain) that follows healing of shingles (a painful rash that comes after a herpes zoster infection).

It is not known if Gralise is safe and effective in people with seizure problems (epilepsy).

It is not known if Gralise is safe and effective in children under 18 years of age with postherpetic pain.

Gralise is not interchangeable with other gabapentin products.

Who should not take Gralise?
Do not take Gralise if you are allergic to gabapentin or any of the ingredients in Gralise.

See the end of this Medication Guide for a complete list of ingredients in Gralise.

Before taking Gralise
Before taking Gralise, tell your healthcare provider if you:
•have or have had depression, mood problems or suicidal thoughts or behavior
•have seizures
•have kidney problems or get kidney dialysis
•are pregnant or plan to become pregnant. It is not known if Gralise can harm your unborn baby. Tell your healthcare provider right away if you become pregnant while taking Gralise. You and your healthcare provider will decide if you should take Gralise while you are pregnant.
◦If you become pregnant while taking Gralise, talk to your healthcare provider about registering with the North American Antiepileptic Drug (NAAED) Pregnancy Registry. The purpose of this registry is to collect information about the safety of antiepileptic drugs, including gabapentin, the active ingredient in Gralise, during pregnancy. You can enroll in this registry by calling 1-888-582-233-2334.
•are breastfeeding or plan to breastfeed. Gralise can pass into your breast milk. You and your healthcare provider should decide how you will feed your baby while you take Gralise.

Tell your healthcare provider about all the medicines you take including prescription and non-prescription medicines, vitamins or herbal supplements.

Taking Gralise with certain other medicines can cause side effects or affect how well they work. Do not start or stop other medicines without talking to your healthcare provider.

Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take Gralise?
•Take Gralise exactly as prescribed. Your healthcare provider will tell you how much Gralise to take and when to take it. Take Gralise at the same time each day.
•Do not change your dose or stop taking Gralise without talking with your healthcare provider. If you stop taking Gralise suddenly, you may experience side effects. Talk with your healthcare provider about how to stop Gralise slowly.
•Take Gralise with food one time each day with your evening meal.
•Take Gralise tablets whole. Do not split, crush, or chew Gralise tablets before swallowing.
•Your healthcare provider may change your dose of Gralise. Do not change your dose of Gralise without talking to your healthcare provider.
•If you miss a dose, take it as soon as you remember with food. If it is almost time for your next dose, just skip the missed dose. Take the next dose at your regular time. Do not take two doses at the same time.
•If you take too much Gralise, call your healthcare provider or poison control center, or go to the nearest emergency room right away.
•If you are taking an antacid containing aluminum hydroxide and magnesium hydroxide, it is recommended that Gralise be taken at least 2 hours following administration of the antacid.

What should I avoid while taking Gralise?
•Do not drink alcohol or take other medicines that make you sleepy or dizzy while taking Gralise without first talking to your healthcare provider. Taking Gralise with alcohol or medicines that cause sleepiness or dizziness may make you sleepiness or dizziness worse.
•Do not operate heavy machines or do other dangerous activities until you know how Gralise affects you. Gralise can slow your thinking and motor skills.

Gralise side effects
The most common side effect of Gralise is:
•dizziness

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of Gralise. For more information, ask your healthcare provider or pharmacist.

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

How should I store Gralise?
Store Gralise at 59°F to 86°F (15°C to 30°C)

Keep Gralise and all medicines out of the reach of children.

General information about the safe and effective use of Gralise
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide.

Do not use Gralise for a condition for which it was not prescribed. Do not give Gralise to other people, even if they have the same symptoms you have. It may harm them.

This Medication Guide summarizes the most important information about Gralise. If you would like more information, talk with your healthcare provider. You can ask your healthcare provider or pharmacist for information about Gralise that is written for health professionals.

For more information about Gralise, call 1-800-241-1643.

What are the ingredients in Gralise?
Active ingredient: gabapentin

Inactive ingredients:
300 mg tablet: copovidone, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene oxide, and Opadry® II white. Opadry® II white contains polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol 3350, and lecithin (soya).
600 mg tablet: copovidone, hypromellose, magnesium stearate, polyethylene oxide, and Opadry® II beige. Opadry® II beige contains polyvinyl alcohol, titanium dioxide, talc, polyethylene glycol 3350, iron oxide yellow, and iron oxide red.

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 详细处方信息以本药内容附件PDF文件（2011122017381232.pdf）的“原文Priscribing Information”为准
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