GENERIC NAME: OLANZAPINE/FLUOXETINE - ORAL (oh-LAN-za-peen/floo-OX-e-teen)
BRAND NAME(S): Symbyax
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.
There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.
USES: This medication is a combination of 2 drugs, olanzapine (an antipsychotic drug) and fluoxetine (a selective serotonin reuptake inhibitor-SSRI). It is used to treat a certain type of mental/mood disorder (depression associated with bipolar disorder). It is also used to treat depression that has not responded to other medications. This medication may help you sleep, improve your mood, improve your concentration, and decrease nervousness. It works by helping to restore the balance of certain natural substances in the brain (neurotransmitters).Talk to the doctor about the risks and benefits of treatment (especially when used in teenagers). See also Precautions section.
HOW TO USE: Read the Medication Guide provided by your pharmacist before you start using olanzapine/fluoxetine and each time you get a refill. If you have any questions, consult your doctor or pharmacist.Take this medication by mouth, with or without food, usually once daily in the evening or as directed by your doctor.The dosage is based on your medical condition and response to treatment.Use this medication regularly in order to get the most benefit from it. Remember to use it at the same time each day.It may take up to several weeks before the full benefit of this drug takes effect. It is important to continue taking this medication as prescribed even if you feel well. Do not stop taking this medication without consulting your doctor. Some conditions may become worse when the drug is abruptly stopped. Your dose may need to be gradually decreased.If your condition persists or worsens, contact your doctor or pharmacist.
SIDE EFFECTS: See also the Warning section.Dizziness, drowsiness, diarrhea, dry mouth, constipation, increased appetite, weight gain, or trouble sleeping may occur. If any of these effects persist or worsen, tell your doctor or pharmacist 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., confusion, nervousness, trouble concentrating, rare thoughts of suicide), swelling hands/ankles/feet, restlessness, shaking (tremor), inability to keep still, decreased interest in sex, changes in sexual ability, large pupils, trouble urinating.Tell your doctor immediately if any of these rare but very serious side effects occur: black stools, vomit that looks like coffee grounds, easy bruising/bleeding, muscle spasm, yellowing eyes/skin, severe stomach/abdominal pain, slow heartbeat, signs of infection (such as fever, persistent sore throat).Get medical help right away if any of these rare but serious side effects occur: fainting, severe headache, seizures.This drug may infrequently make your blood sugar level rise, an effect that may cause or worsen diabetes. This high blood sugar can rarely cause serious conditions such as diabetic coma. Tell your doctor immediately if you develop symptoms of high blood sugar, such as increased thirst/urination or unexplained weakness. If you already have diabetes, be sure to check your blood sugars regularly and share the results with your doctor. Your doctor may need to adjust your medication, diet, and exercise program when you start or stop this medication.This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels, especially in teenagers. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)This medication may increase serotonin and rarely cause a very serious condition called serotonin syndrome/toxicity. The risk increases if you are also taking other drugs that increase serotonin, so tell your doctor or pharmacist of all the drugs you take (see Drug Interactions section). Get medical help right away if you develop some of the following symptoms: fast heartbeat, hallucinations, loss of coordination, severe dizziness, severe nausea/vomiting/diarrhea, twitching muscles, unexplained fever, unusual agitation/restlessness.This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms: fever, muscle stiffness/pain/tenderness/weakness, severe tiredness, severe confusion, sweating, fast/irregular heartbeat, dark urine, change in the amount of urine.Olanzapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor immediately if you develop any unusual/uncontrolled movements (especially of the face/lips/tongue).In rare cases, this medication may increase your blood level of a certain hormone (prolactin). For females, this rare increase in prolactin levels may result in unwanted breast milk, irregular/stopped menstrual periods, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor immediately.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.
PRECAUTIONS: Before taking olanzapine/fluoxetine, tell your doctor or pharmacist if you are allergic to olanzapine or fluoxetine; 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 suicide attempts, breast cancer, intestinal problems (e.g., paralytic ileus, chronic constipation), kidney disease, liver problems, low blood pressure, neuroleptic malignant syndrome, narrow-angle glaucoma, prostate problems, seizures, stomach/intestinal ulcers, brain problems (e.g., dementia, stroke), severe loss of body water (dehydration), low white blood cell count.Also tell your doctor or pharmacist if either you or a family member has a history of the following: diabetes, heart disease (e.g., chest pain, heart attack, heart failure, irregular heartbeat), high blood cholesterol/triglyceride levels, high blood pressure, obesity.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.To reduce dizziness and lightheadedness, get up slowly when rising from a sitting or lying position, especially when you first start taking this medication.Fluoxetine 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 cause QT prolongation. Before using olanzapine/fluoxetine, 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 this medication safely.This medication can make it harder to control your body temperature. Avoid activities that might cause you to overheat (e.g., doing strenuous work, exercising in hot weather, or using hot tubs). Drink plenty of fluids to avoid becoming dehydrated.Teenagers may be more sensitive to the side effects of this drug, especially weight gain, and also increased amounts of cholesterol, triglycerides and prolactin. See also Side Effects section for more details.Older adults may be more sensitive to the side effects of this drug, especially QT prolongation (see above), drowsiness, constipation, trouble urinating, confusion, or dizziness upon standing. Older adults may also be more likely to develop low sodium in the blood, especially if they are taking "water pills" (diuretics). Drowsiness, confusion, and dizziness can increase the risk of falling.During pregnancy, this medication should be used only when clearly needed. 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 symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn anytime during their first month, tell the doctor right away.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 medication passes into breast milk and may have undesirable effects on a nursing infant. Consult your doctor before breast-feeding.
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DRUG INTERACTIONS: Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.Fluoxetine (one of the drugs in this medication) can stay in your body for many weeks after your last dose and may interact with many other medications. If you have taken this medication in the previous 5 weeks, consult your doctor or pharmacist before using any other medication.Before using this medication, tell your doctor or pharmacist of all prescription and nonprescription/herbal products you may use, especially of: drugs removed from your body by certain liver enzymes (e.g., carbamazepine, cimetidine, phenytoin, vinblastine, drugs for anxiety such as alprazolam and diazepam, antipsychotics such as aripiprazole/clozapine/haloperidol/perphenazine, antiarrhythmics such as propafenone/flecainide, TCA antidepressants such as desipramine/imipramine), fosamprenavir/ritonavir, 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), drugs for high blood pressure, medicines for Parkinson's disease (e.g., levodopa, cabergoline).Taking MAO inhibitors with his medication may cause a serious (possibly fatal) drug interaction. Avoid taking MAO inhibitors (isocarboxazid, linezolid, methylene blue, moclobemide, phenelzine, procarbazine, rasagiline, selegiline, tranylcypromine) during treatment with this medication. Most MAO inhibitors should also not be taken for 2 weeks before and at least 5 weeks after treatment with this medication. Ask your doctor when to start or stop taking this medication.Many drugs besides fluoxetine may affect the heart rhythm (QT prolongation), including pimozide and thioridazine, among others.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.The risk of serotonin syndrome/toxicity increases if you are also taking other drugs that increase serotonin. Examples include street drugs such as MDMA/"ecstasy" St. John's wort, certain antidepressants (including other SSRIs such as citalopram/paroxetine, SNRIs such as duloxetine/venlafaxine), tryptophan, among others. The risk of serotonin syndrome/toxicity may be more likely when you start or increase the dose of these drugs.Tell your doctor or pharmacist if you are taking other products that cause drowsiness including alcohol, antihistamines (such as cetirizine, diphenhydramine), drugs for sleep or anxiety (such as alprazolam, diazepam, zolpidem), muscle relaxants, and narcotic pain relievers (such as codeine).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 fluoxetine, ask your pharmacist about other products to treat stomach acid.Cigarette smoking may decrease blood levels of this medication. Tell your doctor if you smoke or if you have recently stopped smoking.This medication may interfere with certain medical/laboratory tests (including brain scan for Parkinson's disease), possibly causing false test results. Make sure laboratory personnel and all your doctors know you use this drug.
OVERDOSE: If overdose is suspected, contact a poison control center or emergency room immediately. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center. Symptoms of overdose may include: irregular heartbeat, seizures, loss of consciousness.
NOTES: Psychiatric/medical checkups and laboratory/medical tests (e.g., liver function tests, blood sugar, weight, blood pressure, blood cholesterol/triglyceride levels) should be done periodically to monitor your progress and check for side effects. Consult your doctor for more details.Do not share this medication with others.
MISSED DOSE: If you miss a dose, use 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.
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 product.
Information last revised November 2013. Copyright(c) 2013 First Databank, Inc.
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