双语说明书(氟西汀)

双语说明书(氟西汀)

         
      通用名称：氟西汀
      英文名称：Fluoxetine
      中文别名：氟苯氧苯胺、氟苯氧丙胺、氟烷苯胺丙醚
      英文别名：Adofen、Fluctin、Prozac 20 Pulvules

      【药理】
      本品高度选择性抑制突触前膜对5-HT的再摄取，对去甲肾上腺素的再摄取影响很小。易通过血脑屏障进入中枢神经系统。其抗抑郁疗效与三环类相似，而抗胆碱能及心血管副反应则比三环类小得多。
      药动学
      口服吸收好，进食不影响药物吸收，生物利用度接近100％。血浆蛋白结合率为 94％，达峰时间为 6～8h、半减期为 1～3日，代谢物去甲氟西汀半减期为
      7～15日。表观分布容积为 25.9L/kg，80％由尿排泄，15％由粪便排出。

      【适应症】
      适用于各型抑郁症，尤宜用于老年抑郁症。还可用于强迫症、恐怖症以及抑郁症的焦虑症状。国外曾用本药与丙咪嗪、阿米替林、多塞平作双盲对照研究，发现本品明显优于丙咪嗪，也不像阿米替林久服后体重会增加。由于不良反应少，中途退出治疗的也少。

      【用法用量】
      抑郁症:最初治疗建议20mg/天,4周后才能显效.暴食症:建议60mg/天.强迫症:建议初始剂量为每日晨20mg,20-60mg/天.
      [用法及用量]口服，每日 20～40mg，最大剂量每日 80mg。对患者服药后可能出现的自杀意图应高度重视。
      [剂型与规格]胶囊剂：20mg/粒。

      【禁用慎用】
      孕妇及儿童的安全与效果试验尚未确立,除非必需,请勿使用。临床试验未发现与年龄有关的不良反应,但老年人的结果尚未作系统分析。服药过量时除维持空气流通,充足供氧和换气外,活性碳与山梨醇一起服用可能比催吐剂和灌肠有效.对此药过敏者禁用。
      有癫痫发作病史的患者应谨慎使用此药。

      【给药说明】
      对患者服药后可能出现的自杀意图应高度重视。

      【不良反应】
      常有胃肠不适:厌食,恶心,腹泻;神经失调:头痛,焦虑,神经质,失眠,昏昏欲睡,倦怠或虚弱,流汗,颤抖,目旋,头重脚轻.发疹或出现荨麻疹应立即停药.约1%病人发生狂躁或轻躁症.有自杀意图的高危险病人,初期用药应予严密监视.服用本品病人接受电休克治疗时,罕有发作延期的报告.
      早期常见为恶心、头痛、口干、出汗、视物模糊等。皮疹发生率为
      3％，大剂量可诱发癫痫。有时可能诱发轻躁狂，未发现潜在心脏毒性作用。近年报告，使用本药初期，可能出现性功能障碍及毛发脱落。长期使用后个别患者出现认知功能障碍，停药后可恢复。
      常见的不良反应有：胃肠道不适，包括厌食、恶心、腹泻；神经失调，包括头痛、焦虑、神经质及失眠、昏昏欲睡及倦怠或虚弱、流汗、颤抖及目眩或头重脚轻。另外，约有4％的病人会发生皮疹或荨麻疹，这已在该药上市前对5600名美国病人给予Fluoxetine的治疗中得到证实，其中1/3的病人终止试验。临床上的报告包括发烧、白血球增多、关节痛、水肿、腕管征候群、呼吸急促、淋巴腺病变、蛋白尿、转胺酶轻度上升。大多数病人在停药后或给予抗组织胺类或类固醇类药物会迅速改善。而且，所有出现上述现象的病人都能完全康复。

      【相互作用】
      虽血浆蛋白结合率较高，但不能被华法林及地高辛所取代。本品能抑制地西泮的脱甲基的代谢过程，使其半减期延长。与卡马西平、三环类抗抑郁药同，可提高它们的血药浓度，因此应减量并定期监测血药浓度。能明显延长阿普唑仑半减期。
      本品和其它抗抑郁药，使后者的血中浓度超过2倍以上；与锂并用，可能增加或降低锂的血中浓度，必须对锂的血中浓度进行监测；与安定并用可能会延长安定的半衰期。

       通用名称：氟西汀
      英文名称：Fluoxetine
      中文别名：氟苯氧苯胺、氟苯氧丙胺、氟烷苯胺丙醚
      英文别名：Adofen、Fluctin、Prozac 20 Pulvules

      【适应症】
      1.Fluoxetine is in a class of drugs called selective serotonin reuptake
      inhibitors. Fluoxetine affects chemicals in your brain that may become
      unbalanced and cause depression or mood disturbances, eating disorders, or
      obsessive or compulsive symptoms.
      2.Fluoxetine is used to treat depression, obsessive-compulsive disorders,
      and bulimia (binge eating and purging). Fluoxetine is also used to treat
      premenstrual dysphoric disorder (PMDD) symptoms of which occur in the week
      or two before a womans menstrual period and commonly include
      irritability, mood swings, and tension as well as the physical symptoms of
      bloating and breast tenderness.
      3.Fluoxetine may also be used for purposes other than those listed in this
      medication guide.

      【用法用量】
      1.Take fluoxetine exactly as directed by your doctor. If you do not
      understand these instructions, ask your pharmacist, nurse, or doctor to
      explain them to you.
      2.Take each dose with water.
      3.To ensure that you get the correct dose, measure the oral solution with
      a dose-measuring cup or spoon, not with a regular table spoon. If you do
      not have a dose-measuring device, ask your pharmacist for one.
      4.Fluoxetine may be taken with or without food.
      5.Try to take fluoxetine at the same time each day.
      6.Do not stop taking fluoxetine without first talking to your doctor. It
      may take 4 weeks or more for you to start feeling better.
      7.Store fluoxetine at room temperature away from moisture and heat.

      【注意事项】
      1.Do not stop taking fluoxetine without first talking to your doctor. It
      may take 4 weeks or more for you to start feeling better.
      If Miss a Dose: 1.Take the missed dose as soon as you remember. However,
      if it is almost time for your next regularly scheduled dose, skip the
      missed dose and take the next one as directed. Do not take a double dose
      of this medication unless otherwise directed by your doctor.
      Contraindications: 1.Do not take fluoxetine if you have taken a monoamine
      oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), phenelzine
      (Nardil), or tranylcypromine (Parnate) during the last 2 weeks. Serious,
      and sometimes fatal, reactions have occurred when these medicines have
      been used together. Also, do not take fluoxetine if you are taking
      thioridazine (Mellaril). Dangerous, even fatal irregular heartbeats may
      occur if these medicines are taken together. You must wait 5 weeks after
      stopping fluoxetine before taking thioridazine (Mellaril).
      2.Before taking fluoxetine, tell your doctor if you
      *have liver disease,
      *have kidney disease,
      *have diabetes,
      *suffer from seizures, or
      *suffer from mania or have suicidal thoughts.
      3.You may not be able to take fluoxetine, or you may need a dosage
      adjustment or special monitoring during treatment if you have any of the
      conditions listed above.
      4.Fluoxetine is in the FDA pregnancy category C. This means that it is not
      known whether fluoxetine will harm an unborn baby. Do not take fluoxetine
      without first talking to your doctor if you are pregnant.
      5.Fluoxetine passes into breast milk and may affect a nursing infant. Do
      not take fluoxetine without first talking to your doctor if you are
      breast-feeding a baby.
      Special Concerns: 1.Use caution when driving, operating machinery, or
      performing other hazardous activities. Fluoxetine may cause dizziness or
      drowsiness. If you experience dizziness or drowsiness, avoid these
      activities.
      2.Use alcohol cautiously. Alcohol may increase drowsiness or dizziness
      while you are taking fluoxetine.

      【不良反应】
      1.If you experience any of the following serious side effects, stop taking
      fluoxetine and call your doctor immediately or seek emergency medical
      treatment:
      *an allergic reaction (difficulty breathing; closing of your throat;
      swelling of your lips, tongue, or face; or hives);
      *an irregular heartbeat or pulse;
      *low blood pressure (dizziness, weakness);
      *high blood pressure (severe headache, blurred vision);
      *chills or fever;
      *unusual bleeding or bruising;
      *a rash or hives.
      2.If you experience any of the following less serious side effects,
      continue taking fluoxetine and talk to your doctor:
      *headache, tremor, nervousness, or anxiety;
      *difficulty concentrating;
      *nausea, diarrhea, dry mouth, or changes in appetite or weight;
      *weakness;
      *increased sweating;
      *sleepiness or insomnia; or
      *decreased sex drive, impotence, or difficulty having an orgasm.
      3.Side effects other than those listed here may also occur. Talk to your
      doctor about any side effect that seems unusual or that is especially
      bothersome.

      【相互作用】
      1.Do not take fluoxetine if you have taken a monoamine oxidase inhibitor
      (MAOI) such as isocarboxazid (Marplan), phenelzine (Nardil), or
      tranylcypromine (Parnate) during the last 2 weeks. Serious, and sometimes
      fatal, reactions have occurred when these medicines have been used
      together. Also, do not take fluoxetine if you are taking thioridazine
      (Mellaril). Dangerous, even fatal irregular heartbeats may occur if these
      medicines are taken together. You must wait 5 weeks after stopping
      fluoxetine before taking thioridazine (Mellaril).
      2.Before taking fluoxetine, tell your doctor if you are taking any of the
      following medicines:
      *a benzodiazepine including diazepam (Valium), alprazolam (Xanax),
      chlordiazepoxide (Librium), clorazepate (Tranxene), temazepam (Restoril),
      triazolam (Halcion), and others;
      *a tricyclic antidepressant including amitriptyline (Elavil), imipramine
      (Tofranil), doxepin (Sinequan), nortriptyline (Pamelor), and others;
      *a phenothiazine including chlorpromazine (Thorazine), fluphenazine
      (Prolixin), mesoridazine (Serentil), perphenazine (Trilafon),
      prochlorperazine (Compazine), and others;
      *lithium (Lithobid, Eskalith, others) or haloperidol (Haldol);
      *sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or
      zolmitriptan (Zomig);
      *carbamazepine (Tegretol) or phenytoin (Dilantin);
      *warfarin (Coumadin); or
      *digoxin (Lanoxin).
      3.You may not be able to take fluoxetine, or you may require a dosage
      adjustment or special monitoring during treatment if you are taking any of
      the medicines listed above.
      4.Drugs other than those listed here may also interact with fluoxetine.
      Talk to your doctor and pharmacist before taking any prescription or
      over-the-counter medicines.

      【药物过量】
      1.Seek emergency medical attention.
      2.Symptoms of a fluoxetine overdose include nausea, vomiting, tremor,
      agitation, seizures, drowsiness, hyperactivity, and enlarged pupils.