Generic Name: Olanzapine and fluoxetine hydrochloride

  • What is Symbyax?

    Symbyax contains two medicines, olanzapine and fluoxetine. Symbyax is used to treat adults who have depressive episodes associated with bipolar disorder.
  • What is the most important information I should know about Symbyax?

    Symbyax is not for use in dementia-related psychosis (decreased mental functioning complicated by seeing or hearing things or having irrational thoughts or fears). There is an increased risk of death in elderly patients with dementia-related psychosis who are treated with Symbyax.

    A life-threatening condition called serotonin syndrome (serious changes in how your brain, muscles, and digestive system work) can happen when you take Symbyax with medicines known as triptans, which are used to treat migraine headaches. Signs and symptoms of serotonin syndrome include restlessness, diarrhea, hallucinations, coma, loss of coordination, nausea, fast heartbeat, vomiting, increased body temperature, rapid changes in blood pressure, and overactive reflexes. Serotonin syndrome may be more likely to occur when starting or increasing the dose of Symbyax or a triptan.

    Antidepressants can increase the risk of suicidal thinking and behavior in children and teenagers. Adult and pediatric patients taking antidepressants should be watched closely for changes in moods or actions, especially when they first start therapy or when their dose is increased or decreased. Patients and their families should contact the doctor immediately if new symptoms develop or seem to get worse. Signs to watch for include anxiety, hostility, insomnia, restlessness, impulsive or dangerous behavior, and thoughts about suicide or dying.

    Symbyax may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Take Symbyax with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.

    Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Symbyax; it may add to their effects.

    Symbyax may cause dizziness, lightheadedness, or fainting; alcohol, hot weather, exercise, or fever may increase these effects. To prevent them, sit up or stand slowly, especially in the morning. Sit or lie down at the first sign of any of these effects.

    Do not become overheated in hot weather or while you are being active; heatstroke may occur.

    Several weeks may pass before your symptoms improve. Do NOT take more than the recommended dose, change your dose, or take Symbyax for longer than prescribed without checking with your doctor.

    Symbyax may rarely cause a prolonged, painful erection. This could happen even when you are not having sex. If this is not treated right away, it could lead to permanent sexual problems such as impotence. Contact your doctor right away if this happens.

    Symbyax may raise your blood sugar. High blood sugar may make you feel confused, drowsy, or thirsty. It can also make you flush, breathe faster, or have a fruit-like breath odor. If these symptoms occur, tell your doctor right away.

    Neuroleptic malignant syndrome (NMS) is a potentially fatal syndrome that can be caused by Symbyax. Symptoms may include fever, stiff muscles, confusion, abnormal thinking, fast or irregular heartbeat, and sweating. Contact your doctor at once if you have any of these symptoms.

    Some patients who take Symbyax may develop tardive dyskinesia, a potentially irreversible disorder characterized by involuntary muscle movements and twitches. Older people, especially women, appear to be at greater risk. The chance that this will happen or that it will become permanent is greater in those who take Symbyax in higher doses or for a long time. Tell your doctor at once if you have muscle problems with your arms, legs, tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Symbyax.

  • Who should not take Symbyax?

    Never take Symbyax if you are taking antidepressant drugs called monoamine oxidase inhibitors (MAOIs), or if you have stopped taking an MAOI in the last 14 days. Taking Symbyax close in time to an MAOI can result in serious—sometimes fatal—reactions, including high body temperature, coma, or seizures. Do not take an MAOI within 5 weeks of stopping Symbyax. MAOI drugs include isocarboxazid, phenelzine, and tranylcypromine.

    Never take Symbyax while you are taking thioridazine and do not take thioridazine within 5 weeks of stopping Symbyax. Simultaneously taking these drugs can result in serious heart rhythm problems.

    Do not take Symbyax if you are taking pimozide or if you are sensitive to any component of the drug.

  • What should I tell my doctor before I take the first dose of Symbyax?

    Tell your doctor about all prescription, over-the-counter, and herbal medications you are taking before beginning treatment with Symbyax. Also talk to your doctor about your complete medical history, especially if you have any of the following: a history of certain cancers (breast, pancrease, pituitary) or if you are at risk for breast cancer; high blood sugar or diabetes or a family history of diabetes; a stomach problem called paralytic ileus; an enlarged prostate; narrow-angle glaucoma; history of heart attack; high or low blood pressure; liver, kidney, or heart problems; seizures; and strokes or mini-strokes.

    Caregivers should tell the doctor if the patient has Alzheimer's disease or is older than 65 and has dementia.

    Let the doctor know if you currently smoke, drink alcohol, exercise a lot, or are often in hot places.

    You should especially tell your doctor if you are taking or plan to take Prozac, Prozac Weekly, Sarafem, olanzapine, Zyprexa, or Zyprexa Zydis. These medicines each contain an ingredient that is also found in Symbyax.

  • What is the usual dosage?

    The information below is based on the dosage guidelines your doctor uses. Depending on your condition and medical history, your doctor may prescribe a different regimen. Do not change the dosage or stop taking your medication without your doctor's approval.

    Adults: The usual starting dose is 1 capsule containing 6 milligrams (mg) of olanzapine and 25 mg of fluoxetine, taken once a day in the evening. If needed, your doctor may gradually increase the dose. The usual dose range is 6 to 12 mg of olanzapine and 25-50 mg of fluoxetine. The efficacy of Symbyax was demonstrated in a dose range of 6 mg to 12 mg of olanzapine and 25 mg to 50 mg of fluoxetine. The safety of doses above 18 mg olanzapine and 75 mg fluoxetine has not been evaluated in clinical studies.

    Your doctor may adjust your dose if you have liver problems, a high risk of low blood pressure, or a combination of factors that may slow your body's processing of Symbyax (female, older age, nonsmoker).

  • How should I take Symbyax?

    Take Symbyax exactly as instructed by your doctor. Your doctor will usually start you on a low dose of Symbyax. Your dose may be adjusted depending on your body's response to Symbyax. Do not stop taking Symbyax or change your dose even if you feel better. Do not suddenly stop taking Symbyax without checking with your doctor.

    Symbyax is usually taken once a day in the evening. Take Symbyax at the same time each day.

    You can take Symbyax with or without food.

  • What should I avoid while taking Symbyax?

    Avoid driving, operating machinery, or performing other hazardous activities until you know how this medication affects you. If you experience dizziness or drowsiness, avoid these activities. Dizziness may be more likely to occur when you rise from a sitting or lying position. Rise slowly to prevent dizziness and a possible fall.

    Do not drink alcohol while taking Symbyax. The combination can cause a sudden drop in blood pressure.

    Avoid becoming overheated while taking Symbyax. Drink plenty of fluid and use caution in hot weather and during exercise.

  • What are possible food and drug interactions associated with Symbyax?

    If Symbyax is taken with certain other drugs, the effects of either could be increased, decreased, or altered. It is especially important to check with your doctor before combining Symbyax with the following: alprazolam, antidepressants known as MAOIs or tricyclics, blood pressure drugs, carbamazepine, clozapine, diazepam, dopamine, fluvoxamine, haloperidol, levodopa, lithium, omeprazole, phenytoin, pimozide, rifampin, St. John's wort, thioridazine, tramadol, triptans such as sumatriptan or eletriptan, tryptophan, and warfarin.

    Be careful about combining Symbyax with aspirin or nonsteroidal anti-inflammatory drugs (NSAIDs) such as ibuprofen, or with other drugs that affect blood clotting. The combination may increase the risk of bleeding

  • What are the possible side effects of Symbyax?

    Side effects cannot be anticipated. If any develop or change in intensity, tell your doctor as soon as possible. Only your doctor can determine if it is safe for you to continue taking this drug.

    Side effects may include: diarrhea, constipation, decreased sexual desire or ability, dizziness, dry mouth, feeling weak, increased appetite, problems keeping your body temperature regulated, sleepiness, black or tarry stools, confusion, anxiety, memory problems, irritability, sore through, swelling of your hands and feet, tremors, trouble concentrating, weight gain, or allergic reactions

    Seek immediate medical attention if you experience symptoms of an allergic reaction such as hives, rash, itching, difficulty breathing, or swelling of the lips, face, mouth, or tongue.

  • Can I receive Symbyax if I am pregnant or breastfeeding?

    The effects of Symbyax during pregnancy and breastfeeding are unknown. Tell your doctor immediately if you are pregnant, plan to become pregnant, or are breastfeeding. Do not breastfeed while you are taking Symbyax.

    Neonates exposed to fluoxetine, a component of Symbyax, late in the third trimester have developed complications requiring prolonged hospitalizations, respiratory support, and tube feeding. The risks and benefits of treatment should be carefully considered when using Symbyax during pregnancy.

  • What should I do if I miss a dose of Symbyax?

    Take it as soon as you remember. However, if it is almost time for your next dose, skip the missed dose and take only your regularly scheduled dose. Do not take two doses at once.
  • How should I store Symbyax?

    Store at room temperature away from heat, moisture, and light. Do not store in the bathroom.