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  药店国别: 美国药房
产地国家: 美国
所属类别: 神经系统药物->头痛药物
处方药:处方药
包装规格: 2.5毫克/片 9片/盒
计价单位:
  点击放大  
生产厂家中文参考译名:
ENDO PHARMS
生产厂家英文名:
ENDO PHARMS
该药品相关信息网址1:
http://www.frova.com/
该药品相关信息网址2:
http://www.drugs.com/cdi/frova.html
该药品相关信息网址3:
http://www.rxlist.com/frova-drug.htm
原产地英文商品名:
FROVA 2.5mg/tab 9tabs/box
原产地英文药品名:
FROVATRIPTAN SUCCINATE
中文参考商品译名:
FROVA 2.5毫克/片 9片/盒
中文参考药品译名:
琥珀酸夫罗曲坦
原产地国家批准上市年份:
2001/11/08
英文适应病症1:
Migraine
临床试验期:
完成
中文适应病症参考翻译1:
偏头痛
药品信息:

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 详细处方信息以本药内容附件PDF文件(2010102701494019.pdf)的“原文Priscribing Information”为准
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部分中文Frova处方资料(仅供参考)

  2001年11月FDA批准了Elan的Frova(Frovatriptan的琥珀酸盐)。
  Frova被批准用于成人的偏头痛发作,有或没有先兆都可使用此药。Frova的活性成分是Frovatriptan。一些科学家认为头部、颈部或头皮血管受压及其突然扩张是引发偏头痛的原因。Frovatriptan是5-HT受体激动剂,与5-HT1B和5-HT1D受体有高度的亲和力,而对GABA介导途径的活性没有影响,与苯二氮受体也没有亲和力。据信,此药通过抑制颅内外动脉的过渡扩张起效。在对麻醉状态下的狗和猫的试验中,此药具有选择性地收缩颈动脉血管床的作用,对血压和冠脉压没有影响
  Frova的优势在于它的半衰期较长。偏头痛发作持续的时间一般为4~72h。目前已经上市的Triptans半衰期为6h以下,而Frova 2.5mg片剂的半衰期为26h。
  支持FDA批准的是5项随机、双盲、安慰剂对照、门诊患者临床试验。其中2项为选择最佳剂量试验,另外3项为评价单一剂量(2.5mg)试验。
  在这些短期对照试验中,此药被用于治疗中到重度的偏头痛。治疗有效的定义为:用药24h内,头痛完全消失或减轻为轻度。其他观察指标包括一些伴随症状,如恶心、呕吐、畏光和畏声等。上述5项临床试验中的2项在初始治疗后给患者再次用药,以对抗24h内头痛复发。
  在这5项临床试验中,试验组患者服药2小时内的缓解率明显高于安慰剂组。试验数据表明,低剂量(如1mg或0.5mg)用药没有疗效;高剂量(如5mg或40mg)用药疗效与2.5mg相当,但副作用的发生率增高。与安慰剂组相比,试验组偏头痛的伴随症状减轻的程度也较大。
  此药可能引起的副作用包括:眩晕、疲劳、麻刺感、口干、潮热、感觉热或冷、胸痛、消化不良和骨痛。
  患有下列疾病的患者禁用此药:控制不良的高血压、心脏病、偏瘫或基底部偏头痛、有中疯病史和循环系统病变。

  Elan公司宣布,美国食品药物管理局批准了型号为2.5mg的片剂Frova(TM),该药物是用来治疗成人偏头痛的急性发作(无论是否有先兆)。
    Elan公司主席兼CEO Donal J. Geaney评论说:“美国食品药物管理局(FDA)对Frova审查的通过,是我们生产治疗神经障碍性疾病药物流水线的重要发展,这是一个具有重要里程碑意义的决定。我们非常兴奋地为那些饱受偏头痛之苦的病人提供了康复的机会,而Frova是治疗偏头痛的新药。我们正讨论寻求共同促进这项研究发展的可能的合作伙伴,并希望能在这个季度完成我们的开始计划。
    大约有10%的美国人受到偏头痛的侵扰。在这2700万患者群中,超过50%的没有诊断与治疗。2001年治疗偏头痛的所有阿米替林类药市场预期超过14亿美元,而口服阿米替林类药占12亿美元。
    Frova的药效和耐药性的测试被随机分为5组,采用双盲与安慰剂对照试验。纽约州Mt. Vernon的Elkind头痛中心的负责人Arthur Elkind博士说:“通过对frovatriptan长期和公开对照组实验表明,是一种有效的治疗药物,得到病人较高程度的满意。
    市场调查表明,只有29%的病人声称对他们的偏头痛治疗非常满意,对许多病人来说,Frova可以作为治疗偏头痛的重要的选择药物。偏头痛发作一般持续4—72小时。Frova 2.5 mg片剂的半衰期为26小时。在当前治疗偏头痛triptan类其他药物的半衰期低于6小时的情况下,Frova是一个重要的突破。费城的Jefferson头痛中心负责人Stephen Silberstein说:“frovatriptan具有较长的半衰期,为临床医生治疗偏头痛提供了进一步可选择的药物。”
    Frova是一种5-HT受体促效药,对5HT(1B)和5HT(1D)受体具有高亲和力,并且在偏头痛病人中作用于脑外与颅内动脉,抑制这些血管过度扩张。Frova在临床试验中具有良好的耐受性。副作用表现在Frova 2.5 mg片剂给药后经常出现(至少2%病人,与对照组相比发生率远高于1%)眩晕、感觉异常、头痛、口干、疲乏、脸色潮红、热或冷的感觉和胸痛。
    1998年10月Elan公司从Vernalis Group公司(LSE: VER)得到了在北美州独家销售、分配Frova的权利。
    Elan公司是一家世界领先的、业务十分广泛的制药公司,总部位于爱尔兰,主要的研究、开发、制造和销售机构位于爱尔兰、美国和英国。Elan公司致力于开发和销售治疗神经病、疼痛、肿瘤、传染病和皮肤病方面的产品和设备,并商业化,利用其专利药品广泛的应用范围来实施流水线工艺。Elan分别在纽约、伦敦和都柏林上市。

药品名称
抗偏头痛新药——夫罗曲坦
商品名:Allegro,Frova,Migard

药理作用
本品为选择性5HT1受体激动剂,与5HT1D受体有高度亲和力,对GABAA介导的通道活性无明显作用,与苯二氮卓类结合位点无明显亲和力。目前认为,本品主要作用于脑外动脉和颅内动脉,并抑制这些血管的过度扩张。
本品口服吸收略差,单次口服本品2.5mg后,达峰时间约为2~4小时,绝对生物利用度约为20%~30%,食物对本品的生物利用度无明显影响,平均稳态分布容积约为3.0~4.2L/kg。与血浆蛋白结合率较低,约为15%。本品主要由细胞色素P450(CYP)1A2代谢,代谢物主要随尿液和粪便排出。静脉注射本品后,平均清除率为220~130ml/min,肾清除率占总清除率的40%~45%。
与其他曲普坦类药物相比,本品的优点是消除t1/2最长,约为26小时(约为其他曲普坦类药物的4~8倍),由此可认为,本品可能对持续时间较长的偏头痛发作有特殊疗效。

临床评价
5项随机双盲安慰剂对照研究评价了本品治疗2000多例平均年龄为42(18~69岁)的中至重度偏头痛成年患者的疗效,其中2项研究为多剂量研究,使用剂量为0.5~40mg,另3项研究的使用剂量均为2.5mg。在服药后2小时判定受试者的头痛反应即是否由中或重度头痛转为轻微头痛或无疼痛。此外,对伴随症状如恶心、呕吐、畏光和畏声亦予以评定。结果发现,2小时内头痛症状改善的患者经例,所有治疗组(37%~46%)明显高于安慰剂组(21%~27%);头痛症状完全缓解者的比例,分别为9%~14%和1%~5%;复发率分别为7%~25%和20%~31%。此外,与安慰剂相比,治疗组的偏头痛伴随症状如畏光、畏声和恶心等减少。其中一项研究将本品与舒马普坦(sumatriptan)相比,结果发现,2小时治疗反应率本品组为47%,而舒马普坦组为37%,但在预防复发方面,本品组疗效(25%)不如舒马普坦组(32%)。
研究还发现,低剂量组(1或0.5mg)在服药后2小时未获得疗效,而高剂量组(5~40mg)获得的疗效与2.5mg组相似,但不良反应发生率较高。
由于本品的t1/2长,理论上认为本品对持续时间长的偏头痛发作有特殊的疗效。

适应症
本品适用于成人有或无先兆性偏头痛急性发作的治疗。

用法用量
推荐剂量为单剂2.5mg,给药2小时后头痛复发者可再次服用,24小时内最大剂量为7.5mg。或遵医嘱!

不良反应
本品耐受性通常较好,多数不良反应轻微,且为一过性,其中最常见的不良反应有眩晕、感觉异常、头痛、口干、无力、潮红、胸痛、消化不良和骨痛等。本品严重不良反应为心脏疾病,如冠状动脉痉挛、一过性心肌局部缺血、心肌梗死、脑卒中、血压升高、室性心动过速、心室纤颤等。特别是对有心脏疾病易患因素者,本品甚至可能引起死亡,但发生率很低。若在服药后出现胸部、喉和颈部压迫感,则可能为心脏疾病的前兆,应立即采取措施。

注意事项
本品禁用于以下人群:局部缺血性心脏疾病如心绞痛、心肌梗死等患者;脑血管疾病如卒中等患者;外周血管疾病如局部缺血性肠疾病患者;血压未得到控制的高血压患者,偏瘫型或基底型偏头痛患者;对本品及其制剂成分过敏者;严重肝功能损害者。
本品不能与单胺氧化酶抑制剂或含贯叶连翘(Hypericum perforatum)的制剂合用;与其他含麦角类药物以及其他5HT1受体激动剂合和时应至少间隔24小时;与选择性5-羟色胺再摄取抑制剂如氟西汀、氟伏沙明和口服避孕药等合用应谨慎。
本品仅用于确诊的偏头痛患者,不宜作为偏头痛的预防用药;除非在全程心脏监护下,本品一般不适用于有心脏疾病易患因素(高血压、高胆固醇血症、吸烟、肥胖、糖尿病、冠心病家族史等)的患者;本品首次给药应在专业人士监督下进行;不推荐在65岁以上和18岁以下人群中使用本品;不推荐孕妇和哺乳期妇女使用本品。
通常,本品如单次给药未获得疗效,则再次给药一般也无效。

规格
薄膜包衣片剂,规格为2.5mg 琥珀酸盐单水合物。

Frova
Generic Name: Frovatriptan (FROE-va-TRIP-tan)
Brand Name: Frova

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Frova is used for:
Treating acute migraine headache with or without aura (flashing lights, wavy lines, dark spots) in adults. It should not be used to prevent migraines.

Frova is a serotonin 5-HT1 receptor agonist ("triptan"). It works by narrowing the blood vessels in the brain and, thereby, reducing pressure and pain in the brain. A migraine headache is thought to be caused by widened blood vessels exerting pressure on the brain.

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Do NOT use Frova if:
you are allergic to any ingredient in Frova
you have a history of ischemic heart disease (eg, angina, heart attack), coronary artery disease (CAD), other moderate to severe heart problems, brain blood vessel disease (eg, stroke, transient ischemic attack), or other blood vessel disease (eg, Raynaud syndrome, ischemic bowel disease)
you have uncontrolled high blood pressure
you have certain types of migraines (eg, hemiplegic, basilar)
you are taking an ergot alkaloid (eg, ergotamine) or have taken another 5-HT1 receptor agonist (eg, sumatriptan, rizatriptan) within the past 24 hours
you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine) within the past 14 days
you are taking sibutramine

Contact your doctor or health care provider right away if any of these apply to you.

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Before using Frova:
Some medical conditions may interact with Frova. Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:
if you are pregnant, planning to become pregnant, or are breast-feeding
if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
if you have allergies to medicines, foods, or other substances
if you have history of liver or kidney problems, seizures (eg, epilepsy), heart problems, other types of headaches (eg, cluster headaches), shortness of breath, chest pain, heart attack, stroke, or irregular heartbeat, or if a family member has had heart disease
if you have high blood pressure, high cholesterol, diabetes, or if you smoke
if you are a woman past menopause or you have had a hysterectomy
if you are a man over 40 years old
if you are very overweight

Some MEDICINES MAY INTERACT with Frova. Tell your health care provider if you are taking any other medicines, especially any of the following:
Selective serotonin reuptake inhibitors (SSRIs) (eg, fluoxetine), serotonin norepinephrine reuptake inhibitors (SNRIs) (eg, duloxetine), or sibutramine because the risk of a serious side effect called serotonin syndrome may be increased. Symptoms of serotonin syndrome may include mental or mood changes, hallucinations, fast heartbeat, fever, loss of coordination, muscle spasms, increased sweating, nausea, vomiting, or diarrhea
Beta-blockers (eg, propranolol) or MAOIs (eg, phenelzine) because they may increase the risk of Frova's side effects
Ergot alkaloids (eg, ergotamine) or another 5-HT1 receptor agonist (eg, sumatriptan or rizatriptan) because the actions and side effects of Frova or these medicines may be increased when taken together

This may not be a complete list of all interactions that may occur. Ask your health care provider if Frova may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

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How to use Frova:
Use Frova as directed by your doctor. Check the label on the medicine for exact dosing instructions.

An extra patient leaflet is available with Frova. Talk to your pharmacist if you have questions about this information.
Take Frova by mouth with or without food.
Take a single dose of Frova with fluids as soon as migraine symptoms appear. A second dose may be taken if there is only a partial response or symptoms of the migraine return. However, do not take it sooner than 2 hours following the first dose. Do not take a second dose if your symptoms do not get better after your first dose. Do not take more than 3 tablets in a 24-hour period.
If you miss a dose of Frova and you still have a headache, follow your doctor's dosing instructions. Contact your doctor if you are unsure of what to do if you miss a dose. Do not take Frova more often than prescribed. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Frova.

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Important safety information:
Frova may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Use Frova with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
Frova may cause dizziness or fainting. If dizziness occurs, sit or stand up slowly.
If Frova does not stop or decrease the severity of your migraine attack or if your symptoms become worse, check with your doctor.
Frova is intended to relieve acute migraine headaches. Do not use it to prevent or reduce the number of attacks you experience. Use Frova only to treat an actual migraine attack. If you have a headache that is different from your usual migraine attacks, check with your doctor before using Frova.
Overuse of Frova can cause your headache to become worse. Do NOT take more than the recommended dose or use more often than prescribed without checking with your doctor.
Rarely, serious heart problems (eg, heart attack, irregular heartbeat) have been reported within a few hours of using Frova. Contact your doctor at once if fast or irregular heartbeat; chest, jaw, or neck pain or numbness; numbness of an arm or leg; severe stomach pain, dizziness, or vomiting; fainting; or vision changes occur. Discuss any questions or concerns with your doctor.
Serotonin syndrome is a possibly fatal syndrome that can be caused by Frova. Your risk may be greater if you take Frova with certain other medicines (eg, SSRIs, SNRIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; loss of coordination; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
Tell your doctor or dentist that you take Frova before you receive any medical or dental care, emergency care, or surgery.
Lab tests, including heart function tests, may be performed while you use Frova. These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
Use Frova with caution in the ELDERLY; they may be more sensitive to its effects.
Frova is not recommended for use in CHILDREN younger than 18 years old; safety and effectiveness in these children have not been confirmed.
PREGNANCY and BREAST-FEEDING: If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Frova while you are pregnant. It is not known if Frova is found in breast milk. If you are or will be breast-feeding while you use Frova, check with your doctor. Discuss any possible risks to your baby.

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Possible side effects of Frova:
All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:
Dizziness; drowsiness; dry mouth; fatigue; flushing; headache; hot or cold sensations; indigestion; numbness or tingling in the arms, legs, hands, or feet.

Seek medical attention right away if any of these SEVERE side effects occur:
Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); bloody diarrhea; bone or joint pain; confusion, slurred speech, or changes in vision; hallucinations; irregular or rapid heartbeat; loss of coordination; mental or mood changes (eg, agitation); muscle spasms; one-sided weakness; pain or unusual coldness in feet, legs, hands, or arms; pain, tightness, pressure, and heaviness in the chest, throat, neck, or jaw; pale or blue-colored fingers or toes; persistent numbness or tingling in the arms, legs, hands, or feet; seizures; severe stomach pain; sudden severe dizziness, fainting, headache, or vomiting; sudden shortness of breath.

This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your health care provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

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If OVERDOSE is suspected:
Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center, or emergency room immediately. Symptoms may include blurred vision; severe dizziness; unusually fast or irregular heartbeat.

Proper storage of Frova:
Store Frova at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Frova out of the reach of children and away from pets.

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General information:
If you have any questions about Frova, please talk with your doctor, pharmacist, or other health care provider.
Frova is to be used only by the patient for whom it is prescribed. Do not share it with other people.
If your symptoms do not improve or if they become worse, check with your doctor.

This information is a summary only. It does not contain all information about Frova. If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

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 详细处方信息以本药内容附件PDF文件(2010102701494019.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-2-10
附件:
 
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