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 详细处方信息以本药内容附件PDF文件（20108321554319.pdf）的“原文Priscribing Information”为准
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部分中文SYMBYAX处方资料（仅供参考）

【商品名称】SYMBYAX
【有效成份】FLUOXETINE HYDROCHLORIDE; OLANZAPINE
【申请机构】LILLY AND CO
【剂型】CAPSULE;
【批准日期】Dec 24, 2003
    美国监管部门批准了礼来扩展其再普乐与百忧解复方制剂Symbyax的标签，这使得该药成为第一个获得批准用于治疗难治性抑郁症（TRD）的药物。
    Symbyax（奥氮平与氟西汀）于2003年获得美国食品药品管理局（FDA）批准用于治疗双相抑郁症。此次新增加的适应症是专门治疗对于两项不同抗抑郁药物单独试验无反应的成人抑郁障碍。
    在批准Symbyax扩展标签的同时，FDA还批准精神分裂症药物再普乐（奥氮平）与百忧解（氟西汀）联用，治疗双相抑郁症及难治性抑郁症。
    鉴于百忧解的专利已过期了一段时间，而仍为礼来带来巨大收入的再普乐目前也面临着海外仿制药的竞争，因此，此次获批扩展标签对礼来来说是一个很好的消息。
    此外，再普乐还受到了人们对其会导致体重增加并增加患糖尿病风险的担忧。为此，礼来指出，其还根据FDA对其于2007年8月和2008年7月提交的临床数据的审查结果，修改了Symbyax和再普乐的标签，增加了有关增加体重，可能导致高血糖和高血脂的信息。

Symbyax
Generic Name: fluoxetine and olanzapine (floo OX eh teen and oh LAN za peen)
Brand Names: Symbyax

What is Symbyax?
Symbyax (fluoxetine and olanzapine) contains a combination of fluoxetine and olanzapine. Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).

Olanzapine is an antipsychotic medication. These drugs affect chemicals in the brain.

Symbyax is used to treat depression caused by bipolar disorder (manic depression). Symbyax is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

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

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Important information about Symbyax
Symbyax is not for use in psychotic conditions related to dementia. Symbyax may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not take Symbyax together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), rasagiline (Azilect), phenelzine (Nardil), 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.

Olanzapine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking Symbyax.

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 Symbyax, do not stop taking the medication without first talking to your doctor.

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Before taking Symbyax
Symbyax is not for use in psychotic conditions related to dementia. Olanzapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions. Do not use Symbyax 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 Symbyax. You must wait at least 14 days after stopping an MAO inhibitor before you can take Symbyax. You must wait 5 weeks after stopping Symbyax before you can take thioridazine (Mellaril) or an MAO inhibitor.

If you have any of these other conditions, you may need a Symbyax dose adjustment or special tests:
liver disease;
heart disease, high or low blood pressure, or a history of heart attack or stroke;
diabetes;
high cholesterol or triglycerides;
seizures or epilepsy;
narrow-angle glaucoma;
paralytic ileus (a stomach disorder);
breast cancer;
enlarged prostate; or
a history of drug abuse or suicidal thoughts.

You may have thoughts about suicide when you first start taking an antidepressant such as Symbyax, especially if you are younger than 24 years old.

Tell your doctor if you have worsening symptoms of 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. An SSRI antidepressant may cause serious lung problems in a newborn if you take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you become pregnant while taking Symbyax, do not stop taking the medication without first talking to your doctor. Fluoxetine and olanzapine can pass into breast milk and may harm a nursing baby. You should not breast-feed while you are taking Symbyax. Do not give Symbyax to anyone younger than 18 years old without the advice of a doctor.

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How should I take Symbyax?
Take Symbyax 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.

Symbyax can be taken with or without food. Try to take the medicine at the same time each day.

It may take up to 4 weeks before your symptoms improve. Keep using the medication as directed and tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Olanzapine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking Symbyax.

Store Symbyax 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. 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.

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What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. Overdose symptoms may include nausea, vomiting, tremor, problems with speech or vision, seizure (convulsions), and coma.

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What should I avoid while taking Symbyax?
Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking Symbyax. Drinking alcohol can increase certain side effects of fluoxetine and olanzapine. Symbyax may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

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Symbyax side effects
Get emergency medical help if you have any of these signs of an allergic reaction to Symbyax: 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 a serious side effect such as:
sudden and severe headache, chest pain, numbness, and problems with vision, speech, or balance;
increased thirst, frequent urination, excessive hunger, or weakness;
agitation, hallucinations, fever, fast heart rate, overactive reflexes, vomiting, diarrhea, loss of coordination;
very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;
jerky muscle movements you cannot control;
seizure (convulsions);
feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;
flu symptoms, easy bruising, sores in your mouth and throat; or
nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious Symbyax side effects may include:
trouble swallowing, runny nose, sore throat;
weight gain, swelling in your hands of feet;
drowsiness, trouble concentrating, sleep problems (insomnia);
dry mouth, mild diarrhea, increased appetite;
breast swelling or discharge (in women or men);
missed menstrual periods; or
decreased sex drive, impotence, or difficulty having an orgasm.

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 Symbyax?
Ask your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with Symbyax may cause you to bruise or bleed easily.

Before using Symbyax, 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 Symbyax.

Tell your doctor about all other medicines you use, especially:
vinblastine (Velban);
heart rhythm or blood pressure medication;
tryptophan (sometimes called L-tryptophan);
lithium, clozapine (Clozaril, Fazaclo), haloperidol (Haldol);
phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol);
a blood thinner such as warfarin (Coumadin);
another form of fluoxetine or olanzapine such as Prozac, Prozac Weekly, Sarafem, or Zyprexa;
theophylline (Theo-Dur, TheoBid, Uniphyl, Slo-Bid, Elixophyllin, and others);
medicine to treat Parkinson's disease, such as bromocriptine (Parlodel), pergolide (Permax), pramipexole (Mirapex), ropinorole (Requip), or cabergoline (Cabaser);
almotriptan (Axert), frovatriptan (Frova), sumatriptan (Imitrex), naratriptan (Amerge), rizatriptan (Maxalt), or zolmitriptan (Zomig); or
any other antidepressants.

This list is not complete and other drugs may interact with Symbyax. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.

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

Every effort has been made to ensure that the information provided is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. 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. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

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 详细处方信息以本药内容附件PDF文件（20108321554319.pdf）的“原文Priscribing Information”为准
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