加巴喷丁NEURONTIN(gabapentin)是一种新型抗癫痫药,加巴喷丁在 治疗包括带状疱疹后神经痛的慢性疼痛方面有很好的作用,加巴喷丁不经肝脏降解经肾脏代谢,不与血浆蛋白结合,药物间作用轻微、副作用少。加巴喷丁为口服给药,在小肠快速、可靠地吸收。 处方新修改批准日期：2015年9月 公司：辉瑞公司（Pfizer） NEURONTIN（加巴喷丁 gabapentin）胶囊，口服使用 NEURONTIN（加巴喷丁 gabapentin）片剂，口服使用 NEURONTIN（加巴喷丁 gabapentin）口服液 最初美国批准：1993年 目前的主要变化 警告和注意事项： 过敏反应和血管性水肿：停止加巴并立即评估病人 9/2015 作用机理 由加巴喷丁产生镇痛和抗癫痫行动的确切机制尚不清楚。加巴喷丁是结构上与神经递质γ-氨基丁酸（GABA），但对GABA的结合，吸收，或降解无影响。体外研究已经表明，加巴喷丁与高亲和力电压激活钙通道的α2δ亚基结合;然而，在此结合于加巴喷丁的治疗效果的关系是未知的。 适应症和用法 适应症为： 在成人带状疱疹后神经痛 辅助疗法中局部癫痫发作，有和没有继发性泛化的治疗，在成人和儿童患者3岁的年龄较大的癫痫 用法用量 带状疱疹后遗神经痛 剂量可根据需要的剂量1800毫克/天的滴定向上 第1天：单300毫克剂量 第2天：600毫克/天（即，300毫克一天两次） 第3天：900毫克/天（即，300毫克一天三次） 癫痫部分性发作 患者12岁及以上：起始剂量每日300毫克的三倍;可以每日三次滴定高达600毫克 例3至11岁的年龄：起始剂量范围为10至15mg/kg /天，分3剂量给予;患者3至4岁的推荐剂量是40毫克/公斤/天，分3剂量给予;在患者的推荐剂量5至11岁的年龄为25至35毫克/公斤/天，在三个分开的剂量给予。推荐剂量是由向上滴定历时约3天达到 剂量应在减少患者的肾功能进行调整 剂型和规格 胶囊：100毫克，300毫克和400毫克 片剂：600毫克和800毫克 口服液：250毫克/5毫升 禁忌症 已知过敏加巴喷丁或其成分 警告和注意事项 药物反应的嗜酸粒细胞增多和全身症状（多器官超敏反应）：停止加巴如果替代病因不能成立 过敏反应和血管性水肿：停止加巴并立即评估病人 驾驶障碍：提醒患者不要开车，直到他们获得了与加巴足够的经验来评估它是否会损害他们的驾驶能力 嗜睡/镇静和头晕：Neurontin的可能损害患者的操作复杂机械的能力 如果加巴突然停药的患者癫痫发作可能出现增加的发作频率 自杀行为和意念：监视自杀想法和行为 儿童3-12岁年龄的神经精神不良反应监测此类事件 不良反应 最常见的不良反应（发生率≥8％和至少两次，对于安慰剂）为： 带状疱疹后遗神经痛：头晕，嗜睡和外周性水肿 癫痫患者> 12岁：嗜睡，头晕，走路不稳，疲劳及眼球震颤 癫痫患者的3至12岁的年龄：病毒感染，发热，恶心和/或呕吐，嗜睡，和敌意 药物相互作用 吗啡增加加巴喷丁的浓度;可能需要调整剂量 特殊人群中使用 妊娠：根据动物实验数据，可能会对胎儿造成伤害。 儿童用药： 有效性，治疗的儿童患者为3岁以下的部分性发作的辅助治疗尚未确定。 包装规格 注：以下产品是不同的规格和不同的价格，采购请以咨询为准 ·NEURONTIN混悬剂 250毫克/5毫升 470毫升/瓶 ·NEURONTIN 800毫克/片 100片/盒 ·NEURONTIN 600毫克/片 100片/盒 ·NEURONTIN 400毫克/胶囊 100胶囊/盒 ·NEURONTIN 300毫克/胶囊 100胶囊/盒 ·NEURONTIN 100毫克/胶囊 100胶囊/盒 ·加巴喷丁(NEURONTIN仿制药)800毫克/片 30片/盒 ·加巴喷丁(NEURONTIN仿制药)600毫克/片 30片/盒 ·加巴喷丁(NEURONTIN仿制药)400毫克/胶囊 30胶囊/盒 ·加巴喷丁(NEURONTIN仿制药)300毫克/胶囊 30胶囊/盒 ·加巴喷丁(NEURONTIN仿制药)100毫克/胶囊 30胶囊/盒 储存与处理 Neurontin的片剂和胶囊，在25°C（77°F）; 15℃之间允许到30°C（59°F至86°F）游览[见USP控制室温。 加巴口服液冷藏，2°C至8°C（36°F至46°F）。 Neurontin Generic Name: gabapentin (GA ba PEN tin) Brand Names: Gabarone, Neurontin ------------------------------------------------------------------- What is Neurontin? Neurontin is an anti-epileptic medication, also called an anticonvulsant. It affects chemicals and nerves in the body that are involved in the cause of seizures and some types of pain. Neurontin is used alone or in combination with other medications to treat seizures caused by epilepsy in adults and children who are at least 12 years old. Neurontin is also used with other medications to treat partial seizures in children who are 3 to 12 years old. Neurontin is also used to treat nerve pain caused by herpes virus or shingles. ------------------------------------------------------------------- Important information about Neurontin You should not use Neurontin if you are allergic to gabapentin. Before taking Neurontin, tell your doctor if you have kidney, liver, or heart disease. You may have thoughts about suicide while taking Neurontin. 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 Neurontin for seizures without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking Neurontin 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 Neurontin. Carry an ID card or wear a medical alert bracelet stating that you are taking Neurontin, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication. ------------------------------------------------------------------- Before taking Neurontin You should not use Neurontin if you are allergic to gabapentin. If you have any of these other conditions, you may need a dose adjustment or special tests to safely take Neurontin. kidney disease; liver disease; or heart disease. You may have thoughts about suicide while taking this medication. 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 scheduled appointments. FDA pregnancy category C. It is not known whether Neurontin is harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment. Neurontin 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. ------------------------------------------------------------------- How should I take Neurontin? Take Neurontin 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. Neurontin can be taken with or without food. If you break a tablet and take one half of it, take the other half at your next dose. Any tablet that has been broken should be used as soon as possible or within a few days. Measure liquid medicine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist for one. Neurontin can cause you to have unusual results with certain medical tests. Tell any doctor who treats you that you are using Neurontin. Do not stop taking Neurontin for seizures without first talking to your doctor, even if you feel better. You may have increased seizures if you stop taking Neurontin 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 Neurontin. Carry an ID card or wear a medical alert bracelet stating that you are taking Neurontin, in case of emergency. Any doctor, dentist, or emergency medical care provider who treats you should know that you are taking a seizure medication. It is important to use Neurontin regularly for best seizure control. Get your prescription refilled before you run out of medicine completely. Store Neurontin tablets and capsules at room temperature away from light and moisture. Store the liquid medicine in the refrigerator. Do not freeze. ------------------------------------------------------------------- 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. ------------------------------------------------------------------- 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, drowsiness, weakness, slurred speech, or diarrhea. ------------------------------------------------------------------- What should I avoid while taking Neurontin? Neurontin 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. Avoid taking an antacid within 2 hours before or after you take Neurontin. Antacids can make it harder for your body to absorb Neurontin. ------------------------------------------------------------------- Neurontin side effects Get emergency medical help if you have any of these signs of an allergic reaction to Neurontin: hives; fever; swollen glands; painful sores in or around your eyes or mouth; 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, 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: increased seizures; fever, chills, body aches, flu symptoms; swelling of your ankles or feet; confusion; rapid back and forth movement of your eyes; tremor; or easy bruising. Some side effects are more likely in children taking Neurontin. Contact your doctor if the child taking this medication has any of the following side effects: changes in behavior; memory problems; trouble concentrating; or acting restless, hostile, or aggressive. Less serious Neurontin side effects may include: dizziness, drowsiness, weakness, tired feeling; lack of coordination; blurred vision; nausea, vomiting, stomach pain, loss of appetite; diarrhea, constipation; dry mouth; runny or stuffy nose, sore throat; headache; sleep problems (insomnia), unusual dreams; or acne, mild skin rash. This is not a complete list of side effects and others may occur. Tell your doctor about any unusual or bothersome side effect. You may report side effects to FDA at 1-800-FDA-1088. ------------------------------------------------------------------- What other drugs will affect Neurontin? The following drugs can interact with Neurontin. Tell your doctor if you are using any of these: hydrocodone (Lortab, Vicodin, Vicoprofen, and others); morphine (Kadian, MS Contin, Oramorph, and others); or naproxen (Naprosyn, Aleve, Anaprox, and others). This list is not complete and there may be other drugs that can interact with Neurontin. 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. ------------------------------------------------------------------- Where can I get more information? Your pharmacist can provide more information about Neurontin. Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use Neurontin 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. 完整处方资料附件： 1）：http://labeling.pfizer.com/ShowLabeling.aspx?id=630 2）：https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=ee9ad9ed-6d9f-4ee1-9d7f-cfad438df388