英文商品名: PAROXETINE ER TABLET SR

英文药品名: PAROXETINE HCL

英文化合物名称: Piperidine, 3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-, (3S,4R)-, hydrochloride, hemihydrate

中文商品名: 帕罗西汀ER

中文药品名:盐酸帕罗西汀

中文参考化合物名称:

(-)-反式-4R-(4-氟苯基)-3S-{[3',4'-(亚甲二氧基)苯氧基]甲基}-哌啶盐酸盐半水合物;盐酸帕罗西汀半水合物

【中文品名】盐酸帕罗西汀

【药效类别】抗精神失常药>氟西汀类抗抑郁药

【中文别名】(-)-反式-4R-(4-氟苯基)-3S-{[3',4'-(亚甲二氧基)苯氧基]甲基}-哌啶盐酸盐半水合物;盐酸帕罗西汀半水合物

【英文别名】Piperidine, 3-[(1,3-Benzodioxol-5-yloxy)methyl]-4-(4-fluorophenyl)-, (3S,4R)-, hydrochloride, hemihydrate

【用途】本品为选择性中枢神经5-羟色胺再摄取抑制剂，可使突触间隙中5-羟色胺浓度增高，发挥抗抑郁作用。对其它递质作用较弱，对植物神经系统和心血管系统的影响较小。本品用于治疗抑郁症。亦可治疗强迫症、惊恐障碍或社交焦虑障碍。

【适应症】适用于治疗各种忧郁症。包括伴有焦虑的抑郁症及反应性抑郁症，伴有或不伴有广场恐怖的惊恐障碍。

【注意事项】

抗胆碱作用及对心脏功能影响较小。帕罗西汀与匹莫齐特不能同时用， 帕罗西汀可增加血浆中匹莫齐特的浓度，而匹莫齐特血药浓度升高会导致QT间期延长和严重心律失常。

葛兰素史克公司最近宣布，ＦＤＡ批准了缓释型帕罗西汀（Paxil CR）用于治疗月经前焦虑障碍（PMDD），这是本病的第一种缓释型药。另外，Paxil CR还适用于抑郁和恐慌症病人。

PDMM影响美国500多万育龄女性，它不仅是经前综合征（PMS）的新命名，也是一种更严重的PMS，可以显著损害女性进行日常个人和职业活动的能力。本病通常见于月经周期的下半期，月经开始或之后不久消失，每月或几乎每月都有症状。

了解其症状是正确诊断和治疗的关键，符合以下几条的5点（头4条至少要有一条）即可诊断PMDD：
1、情绪抑郁
2、焦虑、紧张 
3、心境不稳（突然感到悲伤，对拒绝的敏感性增加）
4、持续、明显的兴奋，愤怒，冲突增多
5、缺乏日常活动的兴趣（工作、上学、社交等）
6、注意力集中困难
7、疲劳、没有精力
8、食欲显著改变，过食或渴望进食
9、失眠或睡得太多
10、感到失去控制和有被击倒感
11、身体症状如体重增加、气胀、乳房压痛或肿胀、头痛、肌肉或关节痛。

安慰剂对照试验确定了Paxil C治疗PMDD的耐受性和有效性。在这些研究中，最低剂量的Paxil C（12.5 mg/天）减少PMDD的身心症状显著好于安慰剂，25mg剂量也有同样的结果。病人报告社会功能显著改善，与安慰剂组相比，用药组影响日常活动的症状更少。

研究中重度抑郁、恐慌症和PMDD病人治疗时常见的副作用（发病率大于5%，至少是安慰剂组的两倍）有感染、创伤、恶心、腹泻、口干、便秘、食欲下降、失眠、眩晕、性欲降低、震颤、打呵欠、出汗、视觉异常、衰弱、嗜睡、异常射精、女性生殖道疾病和阳萎.

葛兰素史克公司宣布，FDA已经批准了盐酸帕罗西汀(Paxil CR ，paroxetine HCl)控释片剂的补充新药申请，用于间歇性治疗经前焦虑障碍(PMDD)。与以往的整月连续服用不同，患者在月经周期前2周一日1次服用Paxil即可。Paxil CR是唯一用于PMDD间歇性疗法的选择性5-羟色胺再吸收抑制剂（SSRI），Paxil CR还可用于抑郁症、社交焦虑障碍和惊恐障碍的治疗。

PMDD是一种严重的经前综合征（PMS），严重影响患者的日常生活质量。本病通常见于月经周期的下半期，月经开始或之后不久消失，患病后几乎每月都有症状。
符合以下几条中的5条（前4条至少要有一条）即可诊断为PMDD：
（1）情绪抑郁；
（2）焦虑、紧张；
（3）心境不稳；
（4）持续、明显的兴奋，愤怒、冲突增多 ；
（5）缺乏日常活动的兴趣；
（6）注意力集中困难；
（7）疲劳、精神不振；
（8）食欲显著改变，过食或渴望进食；
（9）失眠或嗜睡；
（10）感到失去控制或有被击倒感；
（11）体征表现，如体重增加、气胀、乳房压痛感、肿胀、头痛、肌肉或关节痛。

一项纳入366例患者的安慰剂对照临床研究评估了帕罗西汀的间断治疗的有效性和耐受性，在月经前两周，患者服用帕罗西汀（最低剂量为12.5mg）或安慰剂。研究结果显示，帕罗西汀（12.5mg）组在改善PMDD患者的体征和情绪方面，比安慰剂组更有效，疗效与帕罗西汀（25mg）组持平。帕罗西汀组较安慰剂组，对患者日常活动的干扰更少。

Paxil CR共有3种剂量：12.5 mg、25 mg 和 37.5 mg。帕罗西汀控释片采用SkyePharma公司的Geomatrix口服药物输送专利技术。多层制剂技术可控制有效成分在体内的溶解和吸收。

本品最常见的不良反应有感染、创伤、恶心、痢疾、口干、便秘、食欲下降、嗜睡、眩晕、性欲降低、震颤、打哈欠、出汗、视觉异常、衰弱、失眠、射精异常、女性生殖器官疾病和阳痿。服Paxil CR期间不宜突然停药。接受帕罗西汀治疗的患者，不应同时服用单胺氧化酶抑制剂或硫利达嗪。

Generic Name: paroxetine (pa ROX a teen)

Brand Names: Paxil, Paxil CR, Pexeva

IMPORTANT: HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.

PAROXETINE CONTROLLED-RELEASE - ORAL

(pair-OX-eh-teen)

COMMON BRAND NAME(S): Paxil CR

WARNING:

Antidepressant medications are used to treat a variety of conditions, including depression and other mental/mood disorders. These medications can help prevent suicidal thoughts/attempts and provide other important benefits. However, studies have shown that a small number of people (especially people younger than 25) who take antidepressants for any condition may experience worsening depression, other mental/mood symptoms, or suicidal thoughts/attempts. Therefore, it is very important to talk with the doctor about the risks and benefits of antidepressant medication (especially for people younger than 25), even if treatment is not for a mental/mood condition.

Tell the doctor immediately if you notice worsening depression/other psychiatric conditions, unusual behavior changes (including possible suicidal thoughts/attempts), or other mental/mood changes (including new/worsening anxiety, panic attacks, trouble sleeping, irritability, hostile/angry feelings, impulsive actions, severe restlessness, very rapid speech). Be especially watchful for these symptoms when a new antidepressant is started or when the dose is changed.

USES:

Paroxetine is a selective serotonin reuptake inhibitor (SSRI) used to treat depression, panic attacks, obsessive-compulsive disorder (OCD), anxiety disorders, post-traumatic stress disorder, and a severe form of premenstrual syndrome (premenstrual dysphoric disorder).

SSRIs work by helping to restore the balance of certain natural substances in the brain (neurotransmitters such as serotonin). Paroxetine may improve your mood, sleep, appetite, and energy level and may help restore your interest in daily living. It may decrease anxiety/unreasonable fears, persistent/troubling thoughts (obsessions), and unwanted urges that keep returning (compulsions). It may decrease the number and severity of panic attacks. Paroxetine may lessen premenstrual symptoms such as irritability, increased appetite, and depression.

HOW TO USE:

Read the Medication Guide provided by your pharmacist before you start using paroxetine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.

Take this medication by mouth with or without food, usually once daily or as directed by your doctor. This medication may make you either sleepy or wakeful. Therefore, depending on how this medication affects you, your doctor may direct you to take the entire dose once daily in either the morning or evening. Do not crush or chew this medication. Doing so can release all of the drug at once, increasing the risk of side effects. Also, do not split the tablets unless they have a score line and your doctor or pharmacist tells you to do so. Swallow the whole or split tablet without crushing or chewing.

The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may start you at a low dose and gradually increase your dose. Follow your doctor's instructions carefully. Do not take more or less medication or take it more frequently than prescribed. Your condition will not improve any faster and your risk of side effects will increase. Use this medication regularly in order to get the most benefit from it. To help you remember, use it at the same time each day.

If you are taking paroxetine for premenstrual problems, your doctor may direct you to take it every day of the month or just for the 2 weeks before your period through the first full day of your period.

It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without first consulting your doctor.

This medication may cause withdrawal reactions, especially if it has been used regularly for a long time or in high doses. In such cases, withdrawal symptoms (such as mood swings, headache, tiredness, sleep changes, "shock-like" feelings) may occur if you suddenly stop using this medication. To prevent withdrawal reactions, your doctor may reduce your dose gradually. Consult your doctor or pharmacist for more details and report any withdrawal reactions immediately.

You should see some improvement in 1 to 2 weeks. It may take several weeks before you feel the full benefit.

Tell your doctor if your condition does not improve or if it worsens.