Symbyax contains a combination of fluoxetine and olanzapine.

Fluoxetine is selective serotonin reuptake inhibitor (SSRI) antidepressant. Olanzapine is an antipsychotic medication.

Symbyax is used to treat depression caused by bipolar disorder (manic depression).

Symbyax is sometimes used after at least 2 other medications have been tried without success.

You should not use Symbyax if you also take pimozide or thioridazine, or if you take other medicines that contain fluoxetine or olanzapine in a non-combination form.

Do not use Symbyax if you have used an MAO inhibitor in the past 14 days, such as isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, or tranylcypromine.

Symbyax is not approved for use in older adults with dementia-related psychosis.

Symbyax is not approved for use by anyone younger than 10 years old.

Some young people have thoughts about suicide when first taking an antidepressant. Stay alert to changes in your mood or symptoms. Report any new or worsening symptoms to your doctor.

Take Symbyax exactly as prescribed by your doctor. Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose.

You should not stop using Symbyax suddenly. Follow your doctor's instructions about tapering your dose.

Take Symbyax at the same time each day, with or without food.

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.

Store Symbyax at room temperature away from moisture and heat.

Usual Adult Dose of Symbyax for Depression:

Initial Dose: Fluoxetine 25 mg-olanzapine 6 mg orally once a day
Maintenance dose: Adjust as clinically necessary to within a range of:
-Fluoxetine: 25 to 50 mg orally once a day
-Olanzapine: 3 to 12 mg orally once a day
Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally once a day
Duration: It is generally accepted that treatment-resistant depression and Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, are chronic illnesses requiring chronic treatment.

Use: Acute treatment of treatment-resistant depression and depressive episodes associated with Bipolar I Disorder

Usual Adult Dose for Bipolar Disorder:

Initial Dose: Fluoxetine 25 mg-olanzapine 6 mg orally once a day
Maintenance dose: Adjust as clinically necessary to within a range of:
-Fluoxetine: 25 to 50 mg orally once a day
-Olanzapine: 3 to 12 mg orally once a day
Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally once a day
Duration: It is generally accepted that treatment-resistant depression and Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, are chronic illnesses requiring chronic treatment.

Use: Acute treatment of treatment-resistant depression and depressive episodes associated with Bipolar I Disorder

Usual Geriatric Dose for Depression:

Initial Dose: Fluoxetine 25 mg-olanzapine 3 mg to fluoxetine 25 mg-olanzapine 6 mg orally once a day
Maintenance dose: Adjust with caution as clinically necessary to within a range of:
-Fluoxetine: 25 to 50 mg orally once a day
-Olanzapine: 6 to 12 mg orally once a day
Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally once a day
Duration: It is generally accepted that treatment-resistant depression and Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, are chronic illnesses requiring chronic treatment.

Use: Acute treatment of treatment-resistant depression and depressive episodes associated with Bipolar I Disorder

Usual Geriatric Dose for Bipolar Disorder:

Initial Dose: Fluoxetine 25 mg-olanzapine 3 mg to fluoxetine 25 mg-olanzapine 6 mg orally once a day
Maintenance dose: Adjust with caution as clinically necessary to within a range of:
-Fluoxetine: 25 to 50 mg orally once a day
-Olanzapine: 6 to 12 mg orally once a day
Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally once a day
Duration: It is generally accepted that treatment-resistant depression and Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, are chronic illnesses requiring chronic treatment.

Use: Acute treatment of treatment-resistant depression and depressive episodes associated with Bipolar I Disorder

Usual Pediatric Dose for Depression:

10 to 17 years of age:
Initial Dose: Fluoxetine 25 mg-olanzapine 3 mg orally once a day
Maintenance dose: Adjust as clinically necessary to within a range of:
-Fluoxetine: 25 to 50 mg orally per day
-Olanzapine: 6 to 12 mg orally per day
Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally per day
Duration: It is generally accepted that Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, is a chronic illness requiring chronic treatment.

Use: Acute treatment of depressive episodes associated with Bipolar I Disorder

Usual Pediatric Dose for Bipolar Disorder:

10 to 17 years of age:
Initial Dose: Fluoxetine 25 mg-olanzapine 3 mg orally once a day
Maintenance dose: Adjust as clinically necessary to within a range of:
-Fluoxetine: 25 to 50 mg orally per day
-Olanzapine: 6 to 12 mg orally per day
Maximum dose: Fluoxetine 50 mg-olanzapine 12 mg orally per day
Duration: It is generally accepted that Bipolar I disorder, including the depressive episodes associated with Bipolar I disorder, is a chronic illness requiring chronic treatment.

Use: Acute treatment of depressive episodes associated with Bipolar I Disorder

You should not use Symbyax if you also take pimozide or thioridazine, or if you take other forms of fluoxetine or olanzapine (such as Prozac, Rapiflux, Sarafem, Selfemra, or Zyprexa).

Do not use Symbyax if you have taken an MAO inhibitor in the past 14 days. A dangerous drug interaction could occur. MAO inhibitors include isocarboxazid, linezolid, methylene blue injection, phenelzine, rasagiline, selegiline, and tranylcypromine. Do not take an MAO inhibitor within 5 weeks after you stop taking Symbyax.

Symbyax may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

To make sure Symbyax is safe for you, tell your doctor if you have:

• Alzheimer's disease:

• liver disease;

• narrow-angle glaucoma;

• heart problems;

• high or low blood pressure;

• low white blood cell (WBC) counts;

• a seizure;

• bleeding problems;

• breast cancer;

• a stroke, including "mini-stroke" or "TIA";

• diabetes, high cholesterol or triglycerides;

• bowel obstruction, or severe constipation;

• electroconvulsive therapy (ECT);

• an enlarged prostate; or

• trouble swallowing.

Be sure your doctor knows if you also take stimulant medicine, opioid medicine, herbal products, or medicine for depression, mental illness, Parkinson's disease, migraine headaches, serious infections, or prevention of nausea and vomiting. These medicines may interact with fluoxetine and olanzapine and cause a serious condition called serotonin syndrome.

Some young people have thoughts about suicide when first taking an antidepressant. Your doctor should check your progress at regular visits. Your family or other caregivers should also be alert to changes in your mood or symptoms.

Ask your doctor about taking Symbyax if you are pregnant. Taking an SSRI antidepressant during late pregnancy may cause serious medical complications in the baby. However, you may have a relapse of depression if you stop taking your antidepressant. Tell your doctor right away if you become pregnant. Do not start or stop taking Symbyax without your doctor's advice.

If you are pregnant, your name may be listed on a pregnancy registry to track the effects of fluoxetine and olanzapine on the baby.

It may be harder for you to get pregnant while you are using Symbyax.

If you are breastfeeding, tell your doctor if you notice fussiness, drowsiness, feeding problems, weight loss, or unusual muscle movements in the nursing baby.

Symbyax is not approved for use by anyone younger than 10 years old.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Drinking alcohol can increase certain side effects of Symbyax.

Avoid driving or operating machinery until you know how Symbyax will affect you. Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

Get emergency medical help if you have signs of an allergic reaction to Symbyax: skin rash or hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Seek medical treatment if you have symptoms of a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, unusual bruising, or jaundice (yellowing of your skin or eyes).

High doses or long-term use of Symbyax can cause a serious movement disorder that may not be reversible, especially in women and older adults. Tell your doctor right away if you have uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs.

Report any new or worsening symptoms to your doctor, 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:

• unusual bleeding or bruising;

• vision changes;

• fast or pounding heartbeats, fluttering in your chest, shortness of breath, and sudden dizziness (like you might pass out);

• dehydration symptoms - feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out;

• high blood sugar - increased thirst, increased urination, hunger, fruity breath odor, confusion, upset stomach;

• low sodium level - headache, confusion, slurred speech, severe weakness, vomiting, loss of coordination, feeling unsteady; or

• low white blood cell counts - fever, chills, mouth sores, skin sores, sore throat, cough, trouble breathing.

Seek medical attention right away if you have symptoms of serotonin syndrome, such as: agitation, hallucinations, fever, sweating, shivering, fast heart rate, muscle stiffness, twitching, loss of coordination, nausea, vomiting, or diarrhea.

Common Symbyax side effects may include:

• drowsiness, blurred vision, dry mouth;

• increased appetite, weight gain;

• trouble concentrating, feeling tired;

• swelling in your hands or feet;

• tremor; or

• abnormal liver function or cholesterol tests.

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.

Symbyax can cause a serious heart problem. Your risk may be higher if you also use certain other medicines for infections, asthma, heart problems, high blood pressure, depression, mental illness, cancer, malaria, or HIV.

Using Symbyax with other drugs that make you drowsy or slow your breathing can worsen these effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, cold or allergy medicine, or medicine for anxiety or seizures.

Ask your doctor before taking a nonsteroidal anti-inflammatory drug (NSAID) such as aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve), celecoxib (Celebrex), diclofenac, indomethacin, meloxicam, and others. Using an NSAID with Symbyax may cause you to bruise or bleed easily.

Many drugs can interact with fluoxetine and olanzapine. This includes prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible interactions are listed here. Tell your doctor about all your current medicines and any medicine you start or stop using.