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  药店国别: 新西兰药房
产地国家: 新西兰
所属类别: 神经系统药物->抗抑郁药
处方药:处方药
包装规格: 20毫克/胶囊 28胶囊/盒
计价单位:
   
生产厂家中文参考译名:
Pacific Pharmaceuticals Ltd
生产厂家英文名:
Pacific Pharmaceuticals Ltd
该药品相关信息网址1:
http://www.prozac.com/
该药品相关信息网址2:
http://www.drugs.com/prozac.html
该药品相关信息网址3:
http://www.rxlist.com/prozac-drug.htm
原产地英文商品名:
FLUOX(New Zealand PROZAC) 20mg/cap 28caps/box
原产地英文药品名:
FLUOXETINE
中文参考商品译名:
FLUOX(新西兰百优解) 20毫克/胶囊 28胶囊/盒
中文参考药品译名:
氟西汀
原产地国家批准上市年份:
0000/00/00
英文适应病症1:
Depression
英文适应病症2:
Obsessive-compulsive disorder
英文适应病症3:
Bulimia
临床试验期:
完成
中文适应病症参考翻译1:
抑郁症
中文适应病症参考翻译2:
强迫症
中文适应病症参考翻译3:
暴食症
药品信息:

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 详细处方信息以本药内容附件PDF文件(2010101423424525.pdf)的“原文Priscribing Information”为准
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部分中文氟西汀处方资料(仅供参考)

【商品名】百优解Prozac

【原名】百忧解

【通用名】盐酸氟西汀

【药理作用】
氟西汀是神经元摄取5-羟色胺的选择性抑制剂,它的抗抑郁活性证实是与抑制神经元摄取5-羟色胺的能力有直接关系。
病人如有肝损伤可影响百优解的消除。
严重肾损伤病人可导致百优解或其所有代谢物的进一步蓄积。

【药代动力学】
口服氟西汀单次剂量后6-8小时血药浓度达峰。饭后服用百优解不影响药物的吸收量。

【适应症】
百优解适用于抑郁症及其伴发之焦虑的治疗。也可用于治疗神经性贪食症和强迫性障碍。

【用法用量】
抑郁症:建议起始剂量为晨服20mg。如果经数周治疗后,临床症状没有改善,可考虑增加剂量,逐渐增加剂量,比如改为1天2次,早、午各服20mg。
神经性贪食症:建议治疗剂量为每天60mg。
强迫性障碍:建议治疗剂量为每天20-60mg。
以上任何状况下治疗剂量均不能超过每天80mg。
老年患者:建议治疗剂量为每天20mg。
肝功能损伤患者-用量和频度均应减少。
肾功能损伤患者-用量和频度均应减少。氟西汀为口服用药。片剂可溶于一杯水中或直接吞服。

【药物过量】
征兆或症状:主要为恶心和呕吐。可能出现其它中枢神经兴奋的征兆如激动或抽搐。自上市以来,由于单独服用氟西汀过量所致的死亡病例极端罕见。
治疗:建议进行对症治疗和支持治疗。服用活性炭与催吐或洗胃一样有效甚至更有效。因氟西汀导致的惊厥发作如不能自行缓解,可用地西泮进行治疗。
在氟西汀与其它抗抑郁药共同服用过量时,应格外小心。

【不良反应】
与使用氟西汀有关的最常见的不良反应为:焦虑、紧张、失眠、困倦、疲劳、震颤、多汗、厌食、恶心、腹泻、头晕。
不太常见的反应为:头痛、口干、消化不良、呕吐。
其它严重的不良反应偶见报道,例如晕厥、心律失常、非正常肝反应、甲状腺功能减退或亢进、出血时间延长、急性脑部综合征和惊厥。|

【禁忌症】禁用于对百优解和/或百优解中任何成分过敏的病人。

【警告】
某些患有与氟西汀有关的皮疹的病人,曾经发展为严重的认为与脉管炎有关的全身反应。与此有关的非常偶然的致命事件也有报道。如发生皮疹或其它任何明显的未知病因的过敏症状均应立即停药。

【注意事项】
据报道,部分病人应用氟西汀后可出现躁狂/轻躁狂。
对驾驶的影响:对操作危险机械包括机动车的病人应予以警告,直至他们确认药物对他们不产生有害的影响为止。

【孕妇及哺乳期妇女用药】使用氟西汀的安全性还未研究。因此,妊娠期妇女除非必要,否则禁用此药。百优解可从母乳中分泌,因此授乳期妇女慎用百优解。

【儿童用药】由于缺乏百优解应用于儿童的经验资料,故不宜用于儿童。

【老年患者用药】临床研究未发现与年龄有关的不良现象产生。

【药物相互作用】
百优解偶尔可增加其它抗抑郁药的血药水平。
据报道,糖尿病人在应用百优解治疗期间有可能出现低血糖症,中断治疗后有可能出现高血糖症。应适当调整胰岛素用量和/或口服降血糖药。
百优解与单胺氧化酶抑制剂(MAOI)不能同时服用,也不能在中断MAOI治疗后14日内使用。中断氟西汀治疗和应用MAOI治疗的间隔期限应严格遵守5周的时间。

【贮藏】室温15-25°C保存,

【有效期】3年。

Generic Name: fluoxetine (floo OX e teen)
Brand Names: Prozac, Prozac Weekly, Rapiflux, Sarafem, Selfemra
Manufacturer: Pacific manufactures Fluox ( Prozac, sarafem, Symbyox, Generic Fluoxetine ).

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What is Sarafem (fluoxetine)?
Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs). Fluoxetine affects chemicals in the brain that may become unbalanced and cause depression, panic, anxiety, or obsessive-compulsive symptoms.

Fluoxetine is used to treat major depressive disorder, bulimia nervosa (an eating disorder) obsessive-compulsive disorder, panic disorder, and premenstrual dysphoric disorder (PMDD).

Fluoxetine is sometimes used together with another medication called olanzapine (Zyprexa) to treat depression caused by bipolar disorder (manic depression). This combination is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Fluoxetine may also be used for other purposes not listed in this medication guide.

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What is the most important information I should know about Sarafem (fluoxetine)?
Do not take fluoxetine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), rasagiline (Azilect), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).
You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor.

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What should I discuss with my healthcare provider before taking Sarafem (fluoxetine)?
Do not use fluoxetine if you are using any of the following drugs:
pimozide (Orap);
thioridazine (Mellaril); or
an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).

Serious and sometimes fatal reactions can occur when these medicines are taken with fluoxetine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine. You must wait 5 weeks after stopping fluoxetine before you can take thioridazine (Mellaril) or an MAOI.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely fluoxetine:
cirrhosis of the liver;
kidney disease;
diabetes;
seizures or epilepsy;
bipolar disorder (manic depression); or
a history of drug abuse or suicidal thoughts.

You may have thoughts about suicide while taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine, do not stop taking the medication without first talking to your doctor. Fluoxetine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby. Do not give fluoxetine to anyone younger than 18 years old without a doctor's advice.

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How should I take Sarafem (fluoxetine)?
Take this medication exactly as it was prescribed for you. Do not take the medication in larger amounts, or take it for longer than recommended by your doctor. Follow the directions on your prescription label.

Your doctor may occasionally change your dose to make sure you get the best results from the medication.

Do not break, chew, or open an extended-release capsule. Swallow the pill whole. It is specially made to release medicine slowly in the body. Breaking the pill would cause too much of the drug to be released at one time.
Measure the liquid form of fluoxetine with a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

It may take 4 weeks or longer before you start feeling better. Do not stop using fluoxetine without first talking to your doctor. You may have unpleasant side effects if you stop taking this medication suddenly.
To treat premenstrual dysphoric disorder, the usual dose of fluoxetine is once daily while you are having your period, or 14 days before you expect your period to start. Follow your doctor's instructions.

Store fluoxetine at room temperature away from moisture and heat.

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What happens if I miss a dose?
Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

If you miss a dose of Prozac Weekly, take the missed dose as soon as you remember and take the next dose 7 days later. However, if it is almost time for the next regularly scheduled weekly dose, skip the missed dose and take the next one as directed.Do not take extra medicine to make up the missed dose.

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What happens if I overdose?
Seek emergency medical attention if you think you have taken too much of this medication. Overdose may cause nausea, vomiting, fever, sleepiness, rapid or uneven heartbeat, confusion, fainting, seizures, or coma.

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What should I avoid while taking Sarafem (fluoxetine)?
Avoid drinking alcohol, which can increase some of the side effects of fluoxetine. Fluoxetine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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Sarafem (fluoxetine) side effects
Get emergency medical help if you have any of these signs of an allergic reaction: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic attacks, trouble sleeping, or if you feel impulsive, irritable, agitated, hostile, aggressive, restless, hyperactive (mentally or physically), more depressed, or have thoughts about suicide or hurting yourself.

Call your doctor at once if you have any of these serious side effects:
severe blistering, peeling, and red skin rash;
very stiff (rigid) muscles, high fever, sweating, fast or uneven heartbeats, tremors, overactive reflexes;
nausea, vomiting, diarrhea, loss of appetite, feeling unsteady, loss of coordination; or
headache, trouble concentrating, memory problems, weakness, confusion, hallucinations, fainting, seizure, shallow breathing or breathing that stops.

Less serious side effects may include:
cold symptoms such as stuffy nose, sneezing, sore throat;
drowsiness, dizziness, feeling nervous;
mild nausea, upset stomach, constipation;
increased appetite, weight changes;
sleep problems (insomnia);
decreased sex drive, impotence, or difficulty having an orgasm; or
dry mouth.

This is not a complete list of side effects and others may occur. 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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What other drugs will affect Sarafem (fluoxetine)?
Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin and NSAIDs (non-steroidal anti-inflammatory drugs) such as ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with fluoxetine may cause you to bruise or bleed easily.

Tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety). They can add to sleepiness caused by fluoxetine.

Tell your doctor about all other medications you are using, especially:
alprazolam (Xanax);
clopidogrel (Plavix);
clozapine (Clozaril, Fazaclo);
flecainide (Tambocor);
haloperidol (Haldol);
seizure medication such as phenytoin (Dilantin) or carbamazepine (Tegretol);
tryptophan (also called L-tryptophan);
vinblastine (Velban);
a blood thinner such as warfarin (Coumadin);
almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
any other antidepressants such as amitriptyline (Elavil), escitalopram (Lexapro), imipramine (Tofranil), sertraline (Zoloft), and others.

This list is not complete and there may be other drugs that can interact with fluoxetine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Where can I get more information?
Your pharmacist can provide more information about fluoxetine.

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

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 详细处方信息以本药内容附件PDF文件(2010101423424525.pdf)的“原文Priscribing Information”为准
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更新日期: 2012-5-7
附件:




2010101423424525.pdf    

 
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