英文药名: Celexa(Citalopram Hydrobromide Oral Solution)

中文药名: 氢溴酸西酞普兰口服液

生产厂家: Forest pharmaceuticals Inc.

药品名称

通用名称：氢溴酸西酞普兰
英文名称：Citalopram Hydrobromide
成份: 本品主要成份：氢溴酸西酞普兰
化学名称：1-(3-二甲氨丙基)-1-(4-氟代苯基)-1,3-二氢异苯并呋喃-5-腈,氢溴酸盐
药品类别: 抗抑郁药物
市场情况

精神障碍是人类常见的病症，其患病率甚高。进入现代社会，抑郁症成为相当普遍的疾病。据统计在美国有1500万成年人患有抑郁症，三分之一的人一生中会患抑郁症;有估计认为，终生患有抑郁症的病人占人口总数的3%～5%。另据世界卫生组织不久前公布的年度报告揭示，抑郁症目前已位居世界十大疾病之第四，预计到2020年，将跃至第二，紧随于心肌梗死之后，甚至排在癌症之前；随着社会的发展，我国的抑郁症患者比例也有明显上升。这从各种统计数字中可以得到佐证，但由于抑郁症少有严重的行为失常，仅表现为心境恶劣、兴趣丧失、脑力迟缓伴有消化、循环系统等生理功能障碍，因此既往诊断率较低，其中15%患者在发病中有自杀举动。现代医学的发展提高了抑郁症的诊断率，就要求药物研究工作者能开发出不同类别的抗抑郁药对其进行治疗。在这种前提下，对新型抗抑郁药左旋西酞普兰的研制开发，将会创造良好的社会效益和经济效益。
西酞普兰于1989年在丹麦首次批准上市，1990年～1996年依次在芬兰（1990）、瑞士（1991）、瑞典（1992）、英国（1995）、德国（1996）等63个国家上市，1998年7月17日美国FDA批准西酞普兰（Celexa）在美国上市，自上市至2000年，西酞普兰成为美国市场销售增长最快的抗抑郁药，1998年销售额为4000万美元，1999年上升为3.34亿美元，2000年达到7.37亿美元，列畅销药的第32位。 西酞普兰在美国的生产商为Forest Laboratories。
药理毒理

氢溴酸西酞普兰是一种很强的、具有选择性的5-羟色胺摄取抑制剂，具有抗抑郁作用。
这种药物对胆碱能毒蕈碱受体、组织胺受体和α-肾上腺素能受体无抑制作用。若这些受体被抑制，则会产生很多抗抑郁药物引起的副作用，如口干，镇静，体位性低血压等。
氢溴酸西酞普兰对内源性和非内源性抑郁的病人同样有效。其抗抑郁作用通常在2～4周后建立。氢溴酸西酞普兰不影响心脏传导系统和血压。这一点对于老年病人尤为重要。另外，氢溴酸西酞普兰也不影响血液、肝、及肾等系统。氢溴酸西酞普兰的少见的副作用和最轻度镇静的特性使它特别适用于长期治疗。而且，氢溴酸西酞普兰既不会导致体重增加，也不会强化酒精的作用。
药代动力学　

氢溴酸西酞普兰的口服生物利用度大约为80%。服用每日剂量后，可在2～4小时内达到氢溴酸西酞普兰的最高血浆水平。蛋白结合率低于80%。药物和代谢产物可穿过胎盘屏障，而在胎儿的分布则与母体相似。哺乳期妇女服用本药会有少量药物及其代谢产物通过母乳进入婴儿体内。生物半衰期大约为1至1.5天。经尿及粪便排泄。
适应症

抑郁性精神障碍(内源性及非内源性抑郁)、抑郁症及焦虑症的常规治疗。
用法用量

成人：氢溴酸西酞普兰片剂每日服用1次。
开始剂量每日1片(20mg)，如临床需要，可增加至每日2片(40mg)或最高剂量每日3片(60mg)。
超过65岁的病人，剂量减半，即每日0.5片～1.5片(10～30mg)。
抗抑郁剂治疗属于对症治疗，必须持续适当长的时间，一般来说对躁狂性-抑郁精神障碍需4～6个月。
若出现失眠或严重的静坐不能，在急性期建议辅予镇静剂治疗。
儿童：临床经验不详。
任何疑问,请遵医嘱。
不良反应

所观察到氢溴酸西酞普兰的副作用通常很少，很轻微且短暂。最常见的不良反应有：恶心、出汗增多、流涎减少、头痛和睡眠时间缩短。通常在治疗开始的第一或第二周时比较明显，随着抑郁状态的改善一般都逐渐消失。在稀有个案中曾观察到癫痫发作。在已存心搏缓慢病人中，心搏过缓可使治疗更复杂。
禁忌

禁忌与单胺氧化酶抑制剂联合使用；对本品和/或本品中任何成份过敏者禁用。
注意事项

服用单胺氧化酶抑制剂的病人不可同时使用氢溴酸西酞普兰。停用单胺氧化酶抑制剂十四天后方可使用氢溴酸西酞普兰。但如使用半衰期短的可逆单胺氧化酶抑制剂，如吗氯贝胺，则可于停药一天后使用氢溴酸西酞普兰。
肝功能不全的病人应以低剂量开始治疗，并仔细监测。
因本品解除抑制的作用可先于抗抑郁作用，所以病人在出现明显抑郁缓解之前仍可能持续存在自杀的可能性。如病人进入躁狂期，应停用氢溴酸西酞普兰，并给予精神抑制药(如珠氯噻醇(【中文商品名】高抗素))以作适当治疗。
对驾驶及操作机械能力的影响：氢溴酸西酞普兰对认知性及精神运动性行为甚少或无影响。
孕妇及哺乳期妇女用药

氢溴酸西酞普兰对孕妇的安全性尚未确定。因此，除非对于病人来说服药的好处远超理论上可能对胎儿或婴儿带来的风险，否则怀孕期及授乳期内不应服用。
动物试验未显示任何可能致畸的证据。并且，氢溴酸西酞普兰也不影响生殖或产期状态。很少量的氢溴酸西酞普兰可通过母乳到达哺乳的新生动物体内。
儿童用药

儿童：临床经验不详。
老年患者用药

超过65岁的病人，剂量减半，即每日0.5片～1.5片(10～30mg)。
药物相互作用

同时服用单胺氧化酶抑制剂可导致高血压危象。
药物过量

症状：
服药达600mg：疲乏、无力、嗜睡、头晕、手颤、恶心。最高服用量记录约为2000mg。病人在木僵及呼吸困难状态下住院，但无心脏中毒迹象。病人很快康复。
治疗：
对症治疗和支持疗法。口服过量药物后尽快洗胃。插管以保持呼吸道通畅，缺氧时给予吸氧，出现惊厥时给予安定。建议给予24小时医疗监护。
规格

氢溴酸西酞普兰片 10mg;20mg; 40mg.
氢溴酸西酞普兰口服液 10mg/5ml （按西酞普兰计）

Important note
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.

Monograph title
CITALOPRAM - ORAL

Phonetic pronunciation
(sye-TAL-oh-pram)

Common brand name(s)
Celexa

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
Citalopram is an antidepressant (selective serotonin reuptake inhibitor-SSRI) used to treat depression. It works by restoring the balance of certain natural substances (neurotransmitters such as serotonin) in the brain. Citalopram may improve your feelings of well-being and energy level.

Other uses
This section contains uses of this drug that are not listed in the approved professional labeling for the drug but that may be prescribed by your health care professional. Use this drug for a condition that is listed in this section only if it has been so prescribed by your health care professional.This drug is also used to treat other mental conditions (obsessive-compulsive disorder, panic disorder).

How to use
Read the Medication Guide provided by your pharmacist before you start using citalopram and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication once daily in the morning or evening, with or without food or as directed by your doctor. The dosage is based on your medical condition and response to treatment. If you are using the liquid form of this medication, measure the dose carefully using a special measuring device/spoon. Do not use a household spoon because you may not get the correct dose.To reduce your risk of side effects, your doctor may direct you to start taking this drug 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.It is important to continue taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is suddenly stopped. Your dose may need to be gradually decreased.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 nervousness, headache, numbness, tingling, trouble sleeping, nightmares) 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.It may take 1 to 2 weeks to feel a benefit from this drug and 4 weeks to feel the full benefit of this medication. Tell your doctor if your condition persists or worsens.

Missed dose
If you miss a dose, take it as soon as you remember. If it is near the time of the next dose, skip the missed dose and resume your usual dosing schedule. Do not double the dose to catch up.

Precautions
Before taking citalopram, tell your doctor or pharmacist if you are allergic to it; or to escitalopram; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.Before using this medication, tell your doctor or pharmacist your medical history, especially of: personal or family history of psychiatric disorders (e.g., bipolar/manic-depressive disorder), personal or family history of suicide attempts, bleeding problems, liver disease, seizures, severe kidney disease, stomach bleeding, severe loss of body water (dehydration), low sodium in the blood (hyponatremia).Citalopram may cause a condition that affects the heart rhythm (QT prolongation). QT prolongation can infrequently result in serious (rarely fatal) fast/irregular heartbeat and other symptoms (such as severe dizziness, fainting) that need medical attention right away. The risk of QT prolongation may be increased if you have certain medical conditions or are taking other drugs that may affect the heart rhythm. Before using citalopram, tell your doctor or pharmacist of all the drugs you take and if you have any of the following conditions: certain heart problems (heart failure, slow heartbeat, QT prolongation in the EKG), family history of certain heart problems (QT prolongation in the EKG, sudden cardiac death).Low levels of potassium or magnesium in the blood may also increase your risk of QT prolongation. This risk may increase if you use certain drugs (such as diuretics/"water pills") or if you have conditions such as severe sweating, diarrhea, or vomiting. Talk to your doctor about using citalopram safely.This drug may make you dizzy or drowsy. Do not drive, use machinery, or do any activity that requires alertness until you are sure you can perform such activities safely. Avoid alcoholic beverages.Caution is advised when using this drug in the elderly because they may be more sensitive to its effects. The elderly are more likely to lose too much salt (hyponatremia), especially if they are also taking "water pills" (diuretics) with this medication.Use this medication only when clearly needed during pregnancy. It may harm an unborn baby. Also, babies born to mothers who have used this drug during the last 3 months of pregnancy may infrequently develop withdrawal symptoms such as feeding/breathing difficulties, seizures, muscle stiffness, or constant crying. If you notice any of these symptoms in your newborn, tell the doctor promptly.Since untreated depression can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss the benefits and risks of using this medication during pregnancy with your doctor.This drug passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.

Side effects
See also Warning section.Nausea, dry mouth, trouble sleeping, loss of appetite, weakness, tiredness, drowsiness, dizziness, increased sweating, blurred vision, or yawning may occur. If any of these effects persist or worsen, tell your doctor promptly.Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.Tell your doctor immediately if any of these unlikely but serious side effects occur: unusual or severe mental/mood changes (e.g., nervousness, unusual high energy/excitement, rare thoughts of suicide), shakiness (tremor), decreased interest in sex, changes in sexual ability.Tell your doctor immediately if any of these rare but very serious side effects occur: stomach pain, fainting, bloody/black/tarry stools, vomit that looks like coffee grounds, easy bruising/bleeding, muscle weakness/cramps, seizures, fast/irregular/pounding heartbeat, difficulty urinating, change in the amount of urine.This medication may rarely cause a very serious condition called serotonin syndrome. The risk increases when this medication is used with certain other drugs such as "triptans" used to treat migraine headaches (e.g., sumatriptan, eletriptan), certain antidepressants including other SSRIs (e.g., fluoxetine, paroxetine) and SNRIs (e.g., venlafaxine), lithium, tramadol, tryptophan, or a certain drug to treat obesity (sibutramine). See also Drug Interactions section. Before taking this drug, tell your doctor if you take any of these medications. Serotonin syndrome may be more likely when you start or increase the dose of any of these medications. Seek immediate medical attention if you develop some of the following symptoms: hallucinations, restlessness, loss of coordination, fast heartbeat, severe dizziness, unexplained fever, severe nausea/vomiting/diarrhea, twitchy muscles.For males, in the very unlikely event you have a painful or prolonged erection lasting 4 or more hours, stop using this drug and seek immediate medical attention, or permanent problems could occur.A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.In the US -Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Drug interactions
Your doctor or pharmacist may already be aware of any possible drug interactions and may be monitoring you for them. Do not start, stop, or change the dosage of any medicine before checking with your doctor or pharmacist first.Taking certain medications with this product could result in serious (rarely fatal) drug interactions. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) with citalopram for 2 weeks before treatment, during treatment, or for 2 weeks after your last dose of citalopram.This drug should not be used with the following medications because very serious interactions may occur: pimozide, tryptophan, weight loss drugs (e.g., sibutramine, phentermine).If you are currently using any of these medications, tell your doctor or pharmacist before starting citalopram.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: cimetidine, metoprolol, "water pills" (diuretics such as furosemide), drugs that can cause bleeding/bruising (e.g., aspirin, antiplatelet drugs such as clopidogrel, NSAIDs such as ibuprofen, "blood thinners" such as heparin/warfarin).Aspirin can increase the risk of bleeding when used with this medication (see above). If your doctor has directed you to take low-dose aspirin for heart attack or stroke prevention (usually at dosages of 81-325 milligrams a day), you should continue taking it unless your doctor instructs you otherwise. Discuss the risks and benefits with your doctor.Also tell your doctor if you take any other drugs that increase serotonin, such as buspirone, dextromethorphan, lithium, meperidine, propoxyphene, phentermine, other SSRIs (e.g., paroxetine), SNRIs (e.g., duloxetine), tryptophan, St. John's wort, drugs used to treat migraines such as "triptans" and dihydroergotamine, street drugs such as MDMA/"ecstasy," amphetamine. (See also Side Effects section.)Tell your doctor or pharmacist if you also take drugs that cause drowsiness, such as certain antihistamines (e.g., diphenhydramine), anti-seizure drugs (e.g., carbamazepine), medicine for sleep or anxiety (e.g., lorazepam, zolpidem), muscle relaxants, narcotic pain relievers (e.g., codeine), psychiatric medicines (e.g., chlorpromazine, quetiapine, nortriptyline, trazodone). Check the labels on all your medicines (e.g., cough-and-cold products) because they may contain ingredients that cause drowsiness.Cimetidine is a nonprescription drug that is commonly used to treat extra stomach acid. Because it may cause undesirable interactions when used with citalopram, ask your pharmacist about other products to treat stomach acid.This document does not contain all possible interactions. Therefore, before using this product, tell your doctor or pharmacist of all the products you use. Keep a list of all your medications with you, and share the list with your doctor and pharmacist.

Overdose
If overdose is suspected, contact your local poison control center or emergency room immediately. US residents can call the US National Poison Hotline at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes
Do not share this medication with others.Psychiatric/medical check-ups and possibly lab tests (such as EKG) should be done periodically to monitor your progress or check for side effects. Consult your doctor for more details.

Storage
Store at room temperature at 77 degrees F (25 degrees C) away from light and moisture. Brief storage between 59-86 degrees F (15-30 degrees C) is permitted. Do not store in the bathroom. Keep all medicines away from children and pets.Do not flush medications down the toilet or pour them into a drain unless instructed to do so. Properly discard this product when it is expired or no longer needed. Consult your pharmacist or local waste disposal company for more details about how to safely discard your prod