英文药名: Symbyax (Olanzapine/Fluoxetine Capsules)

中文药名: 奥氮平氟西汀胶囊

生产厂家: Eli Lilly

【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 (Ox ah fly way we peen LAN adolescents and OH)
Brand Name: Symbyax

What is Symbyax?
Symbyax (fluoxetine and olanzapine) containing fluoxetine and olanzapine combination. Fluoxetine is a known as selective serotonin reuptake inhibitors (SSRIs) antidepressants group.

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

Symbyax is used to treat bipolar disorder (manic depression) caused by depression. Symbyax also used to treat depression, at least 2 courses of treatment, the symptoms have not been successful treatment attempt.

Symbyax can also be used not listed in this guide purposes other drugs.

Important information Symbyax
Symbyax is not suitable for dementia-related psychotic state. Symbyax can cause dementia-related diseases of the elderly heart failure, sudden death, or pneumonia. Do not Symbyax and pimozide (Orap), thioridazine (Mellaril), or with monoamine oxidase inhibitors (monoamine oxidase), such as isocarboxazid (Marplan), rasagiline (brand name Azilect), phenelzine ( Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

You may have suicidal thoughts when you first start taking antidepressants, especially if you are under 24 years of age. Need to check with your doctor regular visits, at least in the first 12 weeks of treatment you.

Once you have called the doctor, if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic, insomnia, or if you feel impulsive, irritable, anxiety, hostility, aggressiveness, irritability, hyperactivity (mentally or physically), more depressed, or suicidal thoughts or hurt themselves.

Olanzapine can cause high blood sugar (glucose). If you are diabetic, check your blood sugar levels regularly while you are taking Symbyax.

SSRI antidepressants could lead to medication during pregnancy or neonatal severe life-threatening lung problems. However, you may have a depression relapse during pregnancy if you stop taking antidepressants. If you are planning a pregnancy, or pregnancy, and if you take Symbyax, Do not stop taking medications without first consulting a doctor.

Taking Symbyax
Symbyax is not suitable for dementia-related psychotic state. Olanzapine may result in dementia-related diseases of the elderly heart failure, sudden death, or pneumonia. Do not use Symbyax if you use one of the following drugs:
Pimozide (Orap);
Thioridazine (Mellaril); or
One, such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (brand name Azilect), or selegiline (Eldepryl, Emsam) hair inhibitors.

Serious and sometimes fatal reactions can occur when taking these drugs and Symbyax. You have to wait after stopping an MAO inhibitor at least 14 days before taking Symbyax. You must wait 5 weeks after stopping Symbyax, before taking thioridazine (Mellaril), or MAO inhibitors.

If you have any of these other conditions, you may need to adjust the dose of Symbyax or special tests:
Liver disease;
Heart disease, high or low blood pressure, or heart attack or stroke history;
Diabetes;
High cholesterol or triglycerides;
Or seizures;
Narrow-angle glaucoma;
(A stomach) paralytic ileus;
Breast cancer;
Prostatic hypertrophy; or
A history of drug abuse or suicidal thoughts.

You may have suicidal thoughts when you first start taking antidepressants, such as Symbyax, especially if you are under 24 years of age.

Tell your doctor if you have a deterioration in the treatment of the first few weeks of the symptoms of depression or suicidal thoughts, as long as your dose or change.

Your family or other caregivers should also be vigilant in your mood or symptoms change. Need to check with your doctor regular visits, at least in the first 12 weeks of treatment you.

A U.S. FDA pregnancy category C SSRI antidepressants may cause neonatal severe lung problem, if you are taking during pregnancy. However, you may have a depression relapse during pregnancy if you stop taking antidepressants. If you are pregnant while taking Symbyax, Do not stop taking medications without first consulting a 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 anyone under the age of 18 years old without a doctor's advice.

How should I take Symbyax?
To Symbyax exactly as prescribed by your doctor. Do not use larger or smaller amounts or for longer than recommended. In accordance with the instructions of your prescription label.

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

May take up to 4 weeks before the symptoms improved. Instructions to continue to use drugs, tell your doctor if your symptoms do not improve after 4 weeks of treatment.

Olanzapine can cause high blood sugar (glucose). If you are diabetic, check your blood sugar levels regularly while you are taking Symbyax.

Symbyax store away from moisture and heat to room temperature.

If I miss doses?
Missed dose as soon as possible you remember. Skip the missed dose if it is almost time for your next dose. Do not put extra medicine to make up for lost dose.

If I overdose?
Seek emergency medical care, or call the poison hotline 1-800-222-1222. Overdose symptoms include nausea, vomiting, tremor, speech or vision, seizure (convulsions), coma problem.

What should I avoid while taking Symbyax?
Drink plenty of water, especially in hot weather and during exercise. It is easier to become a dangerous overheating and dehydration, and you are taking Symbyax. Fluoxetine and alcohol consumption can increase the side effects of olanzapine. Symbyax may impair your thinking or reactions. Be careful if you drive or do anything you need to be alert.

Symbyax side effects
Access to emergency medical help if you are allergic to any of these signs Symbyax: rash or hives, difficulty breathing; your face, lips, tongue or throat swelling.

Once you have called the doctor, if you have any new or worsening symptoms such as: mood or behavior changes, anxiety, panic, insomnia, or if you feel impulsive, irritable, anxiety, hostility, aggressiveness, irritability, hyperactivity (mentally or physically), more depressed, or suicidal thoughts or hurt themselves.

Once you call the doctor, if you have serious side effects, such as:
Sudden severe headache, chest pain, numbness, vision, speech, or balance;
Increased thirst, frequent urination, excessive hunger, or weakness;
Restlessness, hallucinations, fever, rapid heart rate, excessive reaction, vomiting, diarrhea, loss of coordination;
Very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeat, tremor, feeling like you might pass out;
Jerky muscle movements you can not control;
Convulsions (seizures);
Feeling very thirsty, hot, not urinating, sweating, or hot and dry skin;
Flu symptoms, easy bruising, in your mouth and throat pain; or
Nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stool, jaundice (yellowing of skin or eyes).

Symbyax less serious side effects may include:
Difficulty swallowing, runny nose, sore throat;
Weight gain, swelling of the feet of your hands;
Drowsiness, trouble concentrating, sleep problems (insomnia);
Dry mouth, mild diarrhea, increased appetite;
Breast swelling or discharge (female or male);
Missed menstrual cycle; or
Decreased libido, impotence, or difficulty climax.

This is not a side effect and a complete list of other possible. Call your doctor the side effects of medical care. You may report side effects to the FDA 1 - 800 - U.S. FDA - 1088.

What other drugs will affect Symbyax?
Required to take any pain, arthritis, fever, or swelling of the medical doctor. This includes aspirin, ibuprofen (Advil, ibuprofen), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone ( Relafen), etodolac (Iodine) and so on. And Symbyax to these drugs may cause you any bruising or easy bleeding.

In the use of Symbyax, tell your doctor if you regularly use other drugs, so you sleepy (such as cold or allergy medicine, narcotic painkillers, sleep seizures or anxiety medicines, muscle relaxants, medicine, etc.). They can be added by the Symbyax cause drowsiness.

Tell you all of your other drug use, especially doctors:
Vinblastine (Velban);
Heart rate and blood pressure medications;
Tryptophan (sometimes called L - tryptophan);
Lithium, clozapine (Clozaril, Fazaclo), haloperidol (Haldol);
Phenytoin (PHT), carbamazepine (Carbatrol, Tegretol);
A blood thinner such as warfarin (Coumadin);
Another, such as fluoxetine or Prozac, Prozac Weekly, Sarafem, olanzapine or Zyprexa form;
Theophylline (Theo Toure TheoBid, Uniphyl, Slovakia's bid, Elixophyllin, etc.);
Drug treatment of Parkinson's disease, such as bromocriptine (Parlodel), pergolide (Permax), pramipexole (brand name Mirapex), ropinorole (Requip, etc.), 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 be Symbyax. Tell your doctor all medications used. This includes prescription, over-the counter, vitamins and herbal products. Do not start without telling your doctor a new drug.

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

We have done our utmost to ensure that the information provided is accurate, current and complete, but no guarantee to this effect. Drug information contained therein may be time sensitive. Multum's drug information is information resources designed to help them take care of patients of health care practitioners licensed and / or services to consumers of the service as a supplement, not a professional knowledge, skills, knowledge and health care practitioners to judge instead. A given drug or combination of warning there is no way the case can not be interpreted as indicating that the drug or drug combination is safe, effective, or any appropriate patients. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects.

【原产地英文商品名】:SYMBYAX (12/50)mg/cap 30caps/bottle
【原产地英文药品名】:OLANZAPINE/FLUOXETINE HCL
【中文参考商品译名】:SYMBYAX (12/50)毫克/胶囊 30胶囊/瓶
【中文参考药品译名】:奥氮平/盐酸氟西汀
【生产厂家中文参考译名】:礼来
【生产厂家英文名】:LILLY