药品名称 英文药名: Axert (Almotriptan Tablets) 中文药名: 阿莫曲坦片 生产厂家: Janssen-Ortho 药品介绍 阿莫曲坦（almotriptan,Axert），适用于有无先兆的急性偏头痛成人患者。本品通常耐受性良好，多数副作用轻微。有6 .25 mg和12.5 mg两种规格的片剂。 阿莫曲坦（almotriptan），对颅内血管5-HT 1B/1D 受体有高度选择性，对冠状动脉的致痉作用较其他曲坦类药物小，对脑动脉的作用比舒马曲坦强25倍。口服给药有效率为66%～88%，皮下给药有效率超过90% . ２００９年６月３日，Ａｌｍｉｒａｌｌ公司宣称美国食品和药物管理局已经批准Ａｘｅｒｔ（阿莫曲普坦）治疗青少年（１２～１７岁）急性偏头痛。该药是Ａｌｍｉｒａｌｌ公司开发的产品，曾经在２００１年被ＦＤＡ批准用于治疗成人偏头痛，目前该药在美国和加拿大市场有售。Ａｘｅｒｔ是最早被ＦＤＡ批准用于治疗青少年偏头痛的药物。这对于Ａｌｍｉｒａｌｌ公司来说是一个重要的里程碑，因为它给青少年带来了福音。这项批准将积极推动了阿莫曲普坦在美国市场的发展。 该药在美国市场以Ａｘｅｒｔ形式销售，在欧洲以Ａｌｍｏｇｒａｎ销售，它主要作用于５－ＨＴ受体，导致疼痛信号的减少和与头痛有关的血管改变。偏头痛主要与三叉神经和血管系统异常改变有关，三叉神经节点包含有血清素，血管收缩介质。至少有４２项临床试验，包括了超过１８０００名病人的研究结果证实了该药的安全性和有效性。最近有研究显示，在头痛间期继续服用该药能有效减少头痛发作。这个由Ａｌｍｉｒａｌｌ公司自主研究与开发的药物是第一个被ＦＤＡ批准的西班牙自己开发的药物，并且现在远销１５个国家，包括美国、加拿大和欧洲，同时该药也于２００９年１月在南朝鲜上市。 【原产地英文商品名】AXERT 12.5mg/tab 12tabs/box 【原产地英文药品名】ALMOTRIPTAN MALATE 【中文参考商品译名】 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！ ·阿莫曲坦 12.5毫克/片 12片/盒 ·AXERT 6.25毫克/片 6片/盒 【中文参考药品译名】苹果酸阿莫曲普坦 【生产厂家中文参考译名】ORTHO 麦尔尼克 杨森制药公司 【生产厂家英文名】ORTHO MCNEIL JANSSEN Axert Generic name: Almotriptan Why is Axert prescribed? Axert is a migraine treatment. It relieves the type of migraine that's accompanied by an aura (a set of symptoms that includes visual disturbances, speech difficulties, tingling, numbness, and weakness), as well as the kind that lacks an aura. Axert is a member of a family of drugs called selective serotonin receptor agonists. These medications are thought to work by stopping abnormal dilation of blood vessels in the head, fighting inflammation, and reducing pain transmissions along certain nerve pathways near the brain. Axert relieves migraines already in progress, but it won't prevent them from starting. It has not been tested for other types of headache, such as cluster headache, and should be used only for migraine attacks. Most important fact about Axert In people with heart disease, this type of drug has been known to trigger irregular heartbeat and heart attacks, sometimes leading to death. Do not take this medication if you have angina, a history of heart attack, or any other serious heart problem. How should you take Axert? Take one Axert tablet when a migraine begins. If the headache comes back, consult your doctor. You may be able to take a second dose 2 hours after the first one. Do not take more than 2 tablets in 24 hours. If you miss a dose... Axert should be used only when needed. Do not take it on a regular basis. Storage instructions... Axert should be stored at room temperature. What side effects may occur? Side effects cannot be anticipated. If any develop or change in intensity, inform your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking Axert. Side effects may include: Dry mouth, headache, nausea, sleepiness, tingling or burning feeling Why should Axert not be prescribed? Do not take Axert if you have a history of heart attack, chest pain (angina), or any other condition that diminishes the supply of blood to the muscle of the heart. Axert could cause the coronary arteries to constrict, triggering an attack. Do not use Axert if you have uncontrolled high blood pressure. The drug could cause your pressure to rise. Do not use Axert within 24 hours of taking another serotonin agonist drug such as naratriptan, rizatriptan, sumatriptan, or zolmitriptan. Also avoid Axert within 24 hours of taking an ergot-based drug such as ergotamine, dihydroergotamine, or methylsergide. Ask your doctor what kind of migraine headache you have. If it is categorized as hemiplegic or basilar migraine, you should not take Axert. If Axert gives you an allergic reaction, you will not be able to use this drug. Special warnings about Axert Some patients taking serotonin agonists have suffered strokes, though it's unclear whether the drug was at fault. If you've ever had a stroke or mini-stroke, make sure the doctor is aware of it. Symptoms such as tightness, pain, pressure, or a heavy feeling in the chest, throat, neck, or jaw may occur after taking Axert. If you develop any of these symptoms, or develop circulatory problems such as pale or blue fingers, notify your doctor. You will probably need to have a complete cardiac exam. Let your doctor know if you have liver or kidney problems. Axert should be used with caution. Axert is not for children under 18 years of age. Possible food and drug interactions when taking Axert Remember that Axert must never be used within 24 hours of taking another drug in its class, including naratriptan, rizatriptan, sumatriptan, or zolmitriptan. You should also avoid taking Axert within 24 hours of an ergot-based migraine remedy such as ergotamine, dihydroergotamine, or methylsergide. If Axert is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Axert with any of the following. Antidepressants that boost serotonin levels, including, fluoxetine hydrochloride, paroxetine hydrochloride, and sertraline. Erythromycin Itraconazole Ketoconazole Ritonavir Special information if you are pregnant or breastfeeding Axert has not been studied in pregnant women. Consult your doctor if you are pregnant or plan to become pregnant. It is not known whether Axert appears in breast milk. If you are breastfeeding, caution is advised. Recommended dosage for Axert ADULTS Take one tablet (either 6.25 or 12.5 milligrams) at the onset of the headache. If the headache returns, a second dose can be taken 2 hours later with your doctor's approval. Do not take more than 2 doses in 24 hours. Inform your doctor if you experience more than 4 headaches in a one-month period. If you have liver or kidney problems, you should use the 6.25-milligram tablets and should not exceed 12.5 milligrams per day. Overdosage Little is known about Axert overdose, but the most likely results would be a rise in blood pressure and other heart and circulatory problems. If you suspect an overdose, seek medical attention immediately. Axert is a medication used to treat migraine attacks in adults. Axert belongs to a class of drugs called selective serotonin receptor agonists. Axert reduces the swelling of blood vessels that surround your brain. This swelling is associated with the headache pain of a migraine attack. Axert blocks the release of substances from nerve endings that cause more pain and other migraine symptoms, and it also interrupts the pain signals that are sent your brain. By doing all of these things, Axert helps to relieve the symptoms of your migraine. INDICATIONS Acute Treatment of Migraine Attacks Adults: AXERT (almotriptan malate) is indicated for the acute treatment of migraine attacks in patients with a history of migraine with or without aura. Adolescents age 12 to 17 years: AXERT is indicated for the acute treatment of migraine headache pain in patients with a history of migraine attacks with or without aura usually lasting 4 hours or more (when untreated). Important Limitations AXERT should only be used where a clear diagnosis of migraine has been established. If a patient has no response for the first migraine attack treated with AXERT, the diagnosis of migraine should be reconsidered before AXERT is administered to treat any subsequent attacks. In adolescents age 12-17 years, efficacy of AXERT on migraine associated symptoms (nausea, photophobia and phonophobia) was not established. AXERT is not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine [see CONTRAINDICATIONS]. Safety and effectiveness of AXERT have not been established for cluster headache which is present in an older, predominantly male population. DOSAGE AND ADMINISTRATION Acute Treatment of Migraine Attacks The recommended dose of AXERT in adults and adolescents age 12 to 17 years is 6.25 mg to 12.5 mg, with the 12.5 mg dose tending to be a more effective dose in adults. As individuals may vary in their response to different doses of AXERT, the choice of dose should be made on an individual basis. If the headache is relieved after the initial AXERT dose but returns, the dose may be repeated after 2 hours. The effectiveness of a second dose has not been established in placebo-controlled trials. The maximum daily dose should not exceed 25 mg. The safety of treating an average of more than four migraines in a 30-day period has not been established. Hepatic Impairment The recommended starting dose of AXERT in patients with hepatic impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. Renal Impairment The recommended starting dose of AXERT in patients with severe renal impairment is 6.25 mg. The maximum daily dose should not exceed 12.5 mg over a 24-hour period [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. HOW SUPPLIED Dosage Forms And Strengths AXERT (almotriptan malate) Tablets are available as white, coated, circular, biconvex tablets in the following dosage strengths: 6.25 mg tablet with red code imprint “2080” 12.5 mg tablet with blue stylized imprint “A.” AXERT® (almotriptan malate) Tablets are available as follows: 6.25 mg: White, coated, circular, biconvex tablets with red code imprint “2080.” Unit Dose (aluminum blister pack) 6 tablets.............NDC 0062-2080-06 12.5 mg: White, coated, circular, biconvex tablets with blue stylized imprint “A.” Unit Dose (aluminum blister pack) 12 tablets.............NDC 0062-2085-12 Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F) [see USP Controlled room temperature]. AXERT Tablets are manufactured by: Janssen-Ortho, LLC Gurabo, Puerto Rico 00778. AXERT Tablets are manufactured for: Ortho-McNeil Neurologics, Division of Ortho-McNeil-Janssen Pharmaceuticals, Inc. Raritan, NJ 08869. Licensed from: Laboratorios Almirall, S.A.