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 详细处方信息以本药内容附件PDF文件(2009111302200823.pdf）的“原文Priscribing Information”为准
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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。

阿莫曲普坦简介：
　　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。

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.

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 详细处方信息以本药内容附件PDF文件(2009111302200823.pdf）的“原文Priscribing Information”为准
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