英文药名: Mirapex(pramipexole tablets)
中文药名: 米拉帕（普拉克索片）
生产厂家: Boehringer Ingelheim
药品名称
药品名：盐酸普拉克索片
英文名：Pramipexole Dihydrochloride Tablets
性状: 本品为白色片。
药理毒性
药理作用
普拉克索是一种非麦角类多巴胺激动剂。体外研究显示，普拉克索对D2受体的特异性较高并具有完全的内在活性，对D3受体的亲和力高于D2和D4受体。普拉克索与D3受体的这种结合作用与帕金森氏病的相关性不明确。普拉克索治疗帕金森氏病的确切机制尚不清楚，目前认为与激活纹状体的多巴胺受体有关。动物电生理试验显示，普拉克索可通过激活纹状体与黑质的多巴胺受体而影响纹状体神经元放电频率。
毒理研究
-遗传毒性 普拉克索Ames实验、HGRRT V79基因突变试验、CHO细胞染色体畸变试验、小鼠微核试验结果均为阴性。
-生殖毒性
生育力实验中，大鼠给予普拉克索2.5mg/kg/天（按mg/m2推算，相当于人最大推荐剂量（1.5mg,tid）的5.4倍），可见动情周期延长，着床率降低，这可能与普拉克索导致的血清催乳素水平降低有关（在大鼠早期妊娠中，胚胎的着床和维持需要催乳素，而家兔和人则不需要）。妊娠大鼠于致畸敏感期给予普拉克索1.5mg/kg天（按血浆AUC推算，相当于人最大推荐剂量时AUC的4.3倍），可总吸收胎发生率增加，这可能与普拉克索导致的血清催乳素水平降低有关。妊娠家兔于致畸敏感期给予普拉克索10mg/kg/天（血浆AUC为人给予最大推荐剂量时AUC的71倍），未见异常。妊娠大鼠围产期给予普拉克索0.5mg/kg/天（按mg/m2推算相当于人的最高临床推荐剂量）或更高剂量，子代大鼠出生后生长未受不良影响。
-致癌性
小鼠与大鼠掺食法分别给予普拉克索0.3、2、10mg/kg/天（按mg/m2推算，分别相当于人最大推荐剂量的0.3、2.2和11倍）或0.3、2、8mg/kg/天（按血浆AUC推算，分别相当于人最大推荐剂时AUC的0.3、2.5和12.5倍），未见肿瘤发生率增加。
药代动力学
普拉克索口服吸收迅速完全。绝对生物利用度高于90%，最大血浆浓度在服药后1-3小时之间出现。与食物一起服用不会降低普拉克索吸收的程度，但会降低其吸收速率。普拉克索显示出线性动力学特点，患者间血浆水平差异很小。在人体内，普拉克索的血浆蛋白结合度很低（小于20%），分布容积很大（400普拉克索在男性体内的代谢程度很低。
以原形从肾脏排泄是普拉克索的主要清除途径。14C标记的药物大约有90%是通过肾排泄的，粪便中的药物少于2%。普拉克索的总清除率大约为500ml/分钟，肾脏清除率大约为400ml/分钟。年轻人和老年人的普拉克索清除半衰期（t1/2）从8?12小时不等。
适应症
本品被用来治疗特发性帕金森病的体征和症状，单独（无左旋多巴）或与左旋多巴联用。例如，在疾病后期左旋多巴的疗效逐渐减弱或者出现变化和波动时（剂末现象或开关波动），需要应用本品。
用法用量
*初始治疗：
起始剂量为每日0.375mg，然后每5-7天增加一次剂量。如果患者可以耐受，应增加剂量以达到最大疗效。
如果需要进一步增加剂量，应该以周为单位，每周加量一次，每次日剂量增加0.75mg，每日最大剂量为4.5mg。
然而，应该注意的是，每日剂量高于1.5mg时，嗜睡发生率增加（见【不良反应】）。
*维持治疗：
个体剂量应该在每天0.375mg至4.5mg之间。在剂量逐渐增加的三项重要研究中，从每日剂量为1.5mg开始可以观察到药物疗效。作进一步剂量调整应根据临床反应和耐受性进行。在临床试验中有大约5%的患者每天服用剂量低于1.5mg。当计划减少左旋多巴治疗时，每天服用剂量大于1.5mg对晚期帕金森病患者可能是有效的。在本品加量和维持治疗阶段，建议根据患者的个体反应减少左旋多巴用量。治疗中止：
突然中止多巴胺能治疗会导致非神经阻断性恶性综合症发生。因此，应该以每天减少0.75mg的速度逐渐停止应用普拉克索，直到日剂量降至0.75mg。此后，应每天减少0.375mg（见【注意事项】）。
*肾功能损害患者的用药： 普拉克索的清除依靠肾功能。
对于初始治疗建议应用如下剂量方案：
肌酐清除率高于50ml/min的患者无需降低日剂量。
肌酐清除率介于20-50ml/min之间的患者，本品的初始日剂量应分两次服用，每次0.125mg，每日两次。
肌酐清除率低于20ml/min的患者，本品的日剂量应一次服用，从每天0.125mg开始。
如果在维持治疗阶段肾功能降低，则以与肌酐清除率下降相同的百分比降低本品的日剂量，例如，当肌酐清除率下降30%，则本品的日剂量也减少30%。如果肌酐清除率介于20-50ml/min之间，日剂量应分两次服用；如果肌酐清除率低于20ml/min，日剂量应一次服用。
*肝功能损害患者的用药：
对肝功能衰竭的患者可能不需要进行剂量调整，因为所吸收的药物中大约90%是通过肾脏排泄的。然而，肝功能不全对本品药代动力学的潜在影响还未被阐明。
任何疑问，请遵医嘱！
不良反应
基于汇总的安慰剂对照试验，其中包括1351名服用本品的患者和1131名服用安慰剂的患者，分析显示两组都经常发生不良事件。88%服用本品的患者和83.6%服用安慰剂的患者至少报告过一起不良事件。当本品日剂量高于1.5mg（见【用法用量】）时嗜睡的发生率增加。与左旋多巴联用时最常见的不良反应是运动障碍。便秘、恶心和运动障碍往往随治疗进行逐渐消失。治疗初期可能发生低血压，尤其本品药量增加过快时。
下面是安慰剂对照试验中服用本品所发生的药物不良反应（数字为高于安慰剂的发生率）：
*精神障碍：常见（1%-10%）：失眠、幻觉、精神错乱
*神经系统异常：常见（1%-10%）：眩晕、运动障碍、嗜睡
*血管异常：不常见（0.1-1%）：低血压
*胃肠道异常：常见（1%-10%）：恶心、便秘
*全身异常：常见（1%-10%）：外周水肿 本品与嗜睡有关，与偶发的白天过度嗜睡及突然睡眠发作也有关。
*本品可能与性欲异常有关（增加或降低）。 另见【注意事项】
禁忌
对普拉克索或产品中任何其它成份过敏者。
注意事项
当肾功能损害的患者服用本品时，建议参照【用法用量】减少剂量。幻觉为多巴胺能受体激动剂和左旋多巴治疗的副反应。应告知患者可能会发生幻觉（多为视觉上的）。对于晚期帕金森病，联合应用左旋多巴，可能会在本品的初始加量阶段发生运动障碍。如果发生上述副反应，应该减少左旋多巴用量。
本品与嗜睡和突然睡眠发作有关，尤其对于帕金森病患者。在日常活动中的突然睡眠发作，有时没有意识或预兆，但是这种情况很少被报导。必须告知患者这种副反应，建议其在应用本品治疗的过程中要谨慎驾驶车辆或操作机器。已经发生过嗜睡和/或突然睡眠发作副反应的患者，必须避免驾驶或操作机器，而且应该考虑降低剂量或终止治疗。由于可能的累加效应，当患者在服用普拉克索时应慎用其它镇静类药物或酒精（见【对驾驶和操作机器能力的影响】和【不良反应】）。
有精神障碍的患者，如果潜在的益处大于风险，应仅用多巴胺能受体激动剂进行治疗。
普拉克索应避免与抗精神病药物同时应用（见【药物相互作用】）。
应定期或在发生视觉异常时进行眼科检查。
应注意伴随严重心血管疾病的患者。由于多巴胺能治疗与体位性低血压发生有关，建议监测血压，尤其在治疗初期。
已报道突然终止多巴胺能治疗时会发生非神经阻断性恶性综合症的症状（见【用法用量】）。
孕妇和哺乳期妇女用药
普拉克索对人妊娠期和哺乳期的影响还未被研究。它对大鼠和家兔没有致畸作用，但是，其在母体毒性剂量下对大鼠胚胎有毒性（见毒理研究）。本品禁用于妊娠期，除非确实需要，例如，对胎儿潜在的益处大于风险时。由于本品抑制人催乳素的分泌，因此其抑制泌乳。本品是否可分泌到妇女乳汁中还未作研究。大鼠乳汁中药物相关的放射性强度高于血浆。由于缺乏人体数据，应尽可能不在哺乳期内应用本品。然而，如果其应用不可避免的话，应中止哺乳。
Details
What is pramipexole?
Pramipexole has some of the same effects as a chemical called dopamine, which occurs naturally in your body. Low levels of dopamine in the brain are associated with Parkinson's disease.

Pramipexole or equivalent buy Mirapex is used to treat symptoms of Parkinson's disease, such as stiffness, tremors, muscle spasms, and poor muscle control. Pramipexole is also used to treat restless legs syndrome (RLS).

As a Mirapex buyer, you must know that Pramipexole may also be used for purposes not listed in this medication guide.

What is the most important information I should know about pramipexole?
Some people taking pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking this medication. Talk with your doctor if you believe you have any intense or unusual urges while taking pramipexole.

If you are taking this medication for rest leg syndrome (RLS), tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Do not stop using pramipexole without first talking to your doctor. You may need to use less and less before you stop the medication completely.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pramipexole. Tell your doctor if you regularly use any of these other medicines. Drinking alcohol can increase certain side effects of pramipexole. Pramipexole may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.
What should I discuss with my healthcare provider before taking pramipexole?
You should not use pramipexole if you are allergic to it. Some people taking pramipexole have fallen asleep during normal daytime activities such as working, talking, eating, or driving. You may fall asleep suddenly, even after feeling alert. Tell your doctor if you have any problems with daytime sleepiness or drowsiness. If you are unsure of how this medicine will affect you, be careful if you drive or do anything that requires you to be awake and alert.

To make sure you can safely take cheap pramipexole, tell your doctor if you have any of these other conditions:

low blood pressure;

kidney disease; or

tremors (dyskinesia) or uncontrolled muscle movements.

You may have increased sexual urges, unusual urges to gamble, or other intense urges while taking pramipexole. It is not known whether the medicine actually causes this effect. Talk with your doctor if you believe you have any intense or unusual urges while taking pramipexole.

Some people taking Parkinson's disease medications have developed skin cancer (melanoma). However, people with Parkinson's disease may have a higher risk of melanoma. Talk to your doctor about this risk and what skin symptoms to watch for. You may need to have regular skin exams.

FDA pregnancy category C. It is not known whether pramipexole will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication. It is not known whether pramipexole passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Pramipexole may cause hallucinations (the sensation of hearing or seeing something that is not there), most commonly among elderly people. Call your doctor if you have hallucinations.

How should I take pramipexole?
Buy pramipexole online and take exactly as prescribed by your doctor. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results.

The dose and timing of pramipexole in treating Parkinson's disease is different from the dose and timing in treating RLS. Follow the directions on your prescription label.

Pramipexole can be taken with or without food. Take the Cheap Mirapex or equivalent medication with food if it upsets your stomach. Do not crush, chew, or break an extended-release tablet. Swallow it whole. Breaking the pill may cause too much of the drug to be released at one time.

If you are taking this medication for RLS, tell your doctor if your symptoms get worse, if they occur in the morning or earlier than usual in the evening, or if you feel restless symptoms in your hands or arms.

Do not stop using pramipexole without first talking to your doctor. You may need to use less and less before you stop the medication completely. Store at room temperature away from moisture and heat.

What happens if I miss a dose?
Take the missed dose of prescription buying Mirapex as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

What should I avoid while taking pramipexole?
Pramipexole may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert. Drinking alcohol can increase certain side effects of pramipexole.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Pramipexole side effects
Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat. Stop taking pramipexole and call your doctor at once if you have any of these serious side effects:

extreme drowsiness, falling asleep suddenly, even after feeling alert;

nausea, sweating, feeling light-headed, fainting;

hallucinations;

muscle pain, tenderness, or weakness with fever or flu symptoms and dark colored urine;

chest discomfort, dry cough, feeling short of breath;

feeling weak or tired, loss of appetite, rapid weight loss;

fast or uneven heartbeats; or

tremors, twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs.

Less serious side effects may include:

dry mouth, stomach pain, vomiting, constipation;

headache, dizziness, spinning sensation;

mild drowsiness;

swelling in your hands or feet;

appetite or weight changes;

blurred vision;

sleep problems (insomnia), unusual dreams;

amnesia, forgetfulness, thinking problems; or

impotence, loss of interest in sex, or trouble having an orgasm.

This is not a complete list of Mirapex side effects and others may occur that is useful to know before placing order of Mirapex. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Pramipexole Dosing Information
Usual Adult Dose for Parkinson's Disease:

Pramipexole immediate-release:
Initial dose: 0.125 mg orally three times a day with or without food.
Maintenance dose: The dosage should be titrated gradually to the desired clinical effect. Generally, the dosage may be increased every 5 to 7 days based on efficacy and tolerability, up to a maximum of 4.5 mg/day (given as 1.5 mg three times a day). The efficacy of dosages beyond 4.5 mg/day has not been established.

Pramipexole extended-release:
Initial dose: 0.375 mg once daily with or without food.
Maintenance dose: The dosage should be titrated gradually to the desired clinical effect. Generally, the dosage may be increased every 5 to 7 days based on efficacy and tolerability, first to 0.75 mg per day and then by 0.75 mg increments up to a maximum recommended dose of 4.5 mg per day. The efficacy of dosages beyond 4.5 mg/day has not been established.

Usual Adult Dose for Restless Legs Syndrome:

Pramipexole immediate-release:
Initial dose: 0.125 mg orally once a day 2 to 3 hours before bedtime. If needed, dose may be titrated upwards by increments of 0.125 mg every 4 to 7 days.
Maintenance dose: 0.5 mg orally once a day 2 to 3 hours before bedtime.

Pramipexole extended-release is not indicated for Restless Legs Syndrome.

What other drugs will affect pramipexole?
Cold or allergy medicine, sedatives, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures, depression or anxiety can add to sleepiness caused by pramipexole. Tell your doctor if you regularly use any of these medicines, or any other medicines for Parkinson's disease.

Tell your doctor about all other medicines you use, especially:

amantadine (Symmetrel);

cimetidine (Tagamet);

diltiazem (Cardizem, Cartia, Dilacor, Tiazac);

ranitidine (Zantac);

quinidine (Quin-G);

quinine (Qualaquin);

triamterene (Dyrenium);

verapamil (Calan, Covera, Isoptin);

medicine to prevent or treat nausea and vomiting, such as metoclopramide (Reglan, Metozolv) or promethazine (Pentazine, Phenergan, Anergan, Antinaus); or

medicine to treat psychiatric disorders, such as chlorpromazine (Thorazine), fluphenazine (Permitil, Prolixin), haloperidol (Haldol), thiothixene (Navane), thioridazine (Mellaril), and others.

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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！
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产地国家：加拿大
原产地英文商品名:
MIRAPEX 1.5mg/tab 90Tabs/bottle
原产地英文药品名:
PRAMIPEXOLE DIHYDROCHLORIDE
中文参考商品译名:
米拉帕 1.5毫克/片 90片/瓶
中文参考药品译名:
盐酸普拉克索
中文参考化合物名称:
一水合二盐酸（S）-2-氨基-4，5，6，7-四氢-6-丙胺-苯并噻唑=盐酸普拉克索一水合物
生产厂家中文参考译名:
德国勃林格殷格翰
生产厂家英文名:
BOEHRINGER INGELHEIM
---------------------------------------------------------------
产地国家：加拿大
原产地英文商品名:
MIRAPEX 1mg/tab 100Tabs/bottle
原产地英文药品名:
PRAMIPEXOLE DIHYDROCHLORIDE
中文参考商品译名:
米拉帕 1毫克/片 100片/瓶
中文参考药品译名:
盐酸普拉克索
中文参考化合物名称:
一水合二盐酸（S）-2-氨基-4，5，6，7-四氢-6-丙胺-苯并噻唑=盐酸普拉克索一水合物
生产厂家中文参考译名:
德国勃林格殷格翰
生产厂家英文名:
BOEHRINGER INGELHEIM
---------------------------------------------------------------
产地国家：加拿大
原产地英文商品名:
MIRAPEX 0.125mg/tab30Tabs/bottle
原产地英文药品名:
PRAMIPEXOLE DIHYDROCHLORIDE
中文参考商品译名:
米拉帕 0.125毫克/片 90片/瓶
中文参考药品译名:
盐酸普拉克索
中文参考化合物名称:
一水合二盐酸（S）-2-氨基-4，5，6，7-四氢-6-丙胺-苯并噻唑=盐酸普拉克索一水合物
生产厂家中文参考译名:
德国勃林格殷格翰
生产厂家英文名:
BOEHRINGER INGELHEIM
---------------------------------------------------------------
产地国家：加拿大
原产地英文商品名:
MIRAPEX 0.125mg/tab 90Tabs/bottle
原产地英文药品名:
PRAMIPEXOLE DIHYDROCHLORIDE
中文参考商品译名:
米拉帕 0.125毫克/片 90片/瓶
中文参考药品译名:
盐酸普拉克索
中文参考化合物名称:
一水合二盐酸（S）-2-氨基-4，5，6，7-四氢-6-丙胺-苯并噻唑=盐酸普拉克索一水合物
生产厂家中文参考译名:
德国勃林格殷格翰
生产厂家英文名:
BOEHRINGER INGELHEIM