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All about: Olanzapine/Fluoxetine

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Generic Name: Olanzapine/Fluoxetine Capsules (oh-LAN-za-peen/floo-OX-e-teen)
Brand Name: Symbyax

Antidepressants may increase the risk of suicidal thoughts or actions in children and teenagers. The risk may be greater during the first few months that patients take Olanzapine/Fluoxetine . Be sure that the benefits of using Olanzapine/Fluoxetine outweigh the risks. Talk with the patient's doctor if you have any questions.

Family and caregivers must closely observe patients who take Olanzapine/Fluoxetine . It is important to keep in close contact with the patient's doctor. Tell the doctor right away if the patient has symptoms like worsened depression, suicidal thoughts, or changes in behavior.

Olanzapine/Fluoxetine contains an atypical antipsychotic. It may increase the risk of death when used to treat mental problems caused by dementia in elderly patients. Most of the deaths were linked to heart problems or infection. Olanzapine/Fluoxetine is not approved to treat mental problems caused by dementia.

Olanzapine/Fluoxetine is used for:

Treating depression in patients with bipolar disorder. It may also be used for other conditions as determined by your doctor.

Olanzapine/Fluoxetine is a combination of an atypical antipsychotic and a selective serotonin reuptake inhibitor (SSRI). It works by affecting certain substances in the brain, including serotonin. This helps to improve certain mood problems.

Do NOT use Olanzapine/Fluoxetine if:

  • you are allergic to any ingredient in Olanzapine/Fluoxetine
  • you are taking or have taken a monoamine oxidase inhibitor (MAOI) (eg, phenelzine), selegiline, or St. John's wort within the last 14 days
  • you are taking a fenfluramine derivative (eg, dexfenfluramine), an H1 antagonist (eg, astemizole, terfenadine), nefazodone, pimozide, a serotonin norepinephrine reuptake inhibitor (SNRI) (eg, venlafaxine), sibutramine, thioridazine, or tryptophan

Contact your doctor or health care provider right away if any of these apply to you.

Before using Olanzapine/Fluoxetine :

Some medical conditions may interact with Olanzapine/Fluoxetine . Tell your doctor or pharmacist if you have any medical conditions, especially if any of the following apply to you:

  • if you are pregnant, planning to become pregnant, or are breast-feeding
  • if you are taking any prescription or nonprescription medicine, herbal preparation, or dietary supplement
  • if you have allergies to medicines, foods, or other substances
  • if you or a family member has a history of bipolar disorder (manic-depression), other mental or mood problems, suicidal thoughts or attempts, or alcohol or substance abuse
  • if you have a history of seizures, heart problems (eg, heart failure; fast, slow, or irregular heartbeat), abnormal electrocardiogram (ECG), heart attack, stroke blood vessel problems, high blood cholesterol levels, or high or low blood pressure
  • if you have a history of liver problems, severe kidney problems, stomach or bowel problems (eg, bleeding, paralytic ileus), bleeding problems, enlarged prostate, narrow-angle glaucoma, neuroleptic malignant syndrome (NMS), prolonged painful erection, or metabolism problems
  • if you have diabetes or are very overweight, or if a family member has had diabetes
  • if you are dehydrated or have low blood volume, low blood sodium levels, Alzheimer disease, dementia, or trouble swallowing
  • if you drink alcohol, smoke, or will be exposed to high temperatures
  • if you have a history of high blood prolactin levels or a history of certain types of cancer (eg, breast, pancreas, pituitary), or if you are at risk for breast cancer
  • if you will be having electroconvulsive therapy (ECT)

Some MEDICINES MAY INTERACT with Olanzapine/Fluoxetine . Tell your health care provider if you are taking any other medicines, especially any of the following:

  • 5-HT1 receptor agonists (eg, sumatriptan), Fenfluramine derivatives (eg, dexfenfluramine), MAOIs (eg, phenelzine), nefazodone, selegiline, sibutramine, serotonin norepinephrine reuptake inhibitors (SNRIs) (eg, venlafaxine), St. John's wort, tramadol, or tryptophanbecause severe side effects, such as a reaction that may include fever, rigid muscles, blood pressure changes, mental changes, confusion, irritability, agitation, delirium, and coma, may occur
  • H1 antagonists (eg, astemizole, terfenadine), pimozide, or thioridazine because the risk of serious irregular heartbeat may be increased by Olanzapine/Fluoxetine
  • Many prescription and nonprescription medicines (eg, used for anxiety, other mental or mood problems, allergies, appetite suppression, blood thinning, cancer, cough, blood pressure, HIV, heart problems, heartburn, ulcers, infections, inflammation, irregular heartbeat, aches and pains, high blood pressure, high cholesterol, migraine headaches, muscle relaxers, Parkinson disease, seizures), multivitamin products, and herbal or dietary supplements (eg, herbal teas, coenzyme Q10, garlic, ginseng, ginkgo) may interact with Olanzapine/Fluoxetine , increasing the risk of side effects

This may not be a complete list of all interactions that may occur. Ask your health care provider if Olanzapine/Fluoxetine may interact with other medicines that you take. Check with your health care provider before you start, stop, or change the dose of any medicine.

How to use Olanzapine/Fluoxetine :

Use Olanzapine/Fluoxetine as directed by your doctor. Check the label on the medicine for exact dosing instructions.

  • Olanzapine/Fluoxetine comes with an extra patient information sheet called a Medication Guide. Read it carefully. Read it again each time you get Olanzapine/Fluoxetine refilled.
  • Take Olanzapine/Fluoxetine by mouth on an empty stomach or with food.
  • Take Olanzapine/Fluoxetine in the evening, unless your doctor tells you otherwise.
  • Continue to take Olanzapine/Fluoxetine even if you feel well. Do not miss any doses.
  • Do not suddenly stop taking Olanzapine/Fluoxetine without checking with your doctor. Side effects may occur. They may include mental or mood changes, numbness or tingling of the skin, dizziness, confusion, headache, trouble sleeping, or unusual tiredness. You will be closely monitored when you start Olanzapine/Fluoxetine and whenever a change in dose is made.
  • If you miss a dose of Olanzapine/Fluoxetine , take it as soon as possible. If it is almost time for your next dose, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

Ask your health care provider any questions you may have about how to use Olanzapine/Fluoxetine .

Important safety information:

  • Olanzapine/Fluoxetine may cause drowsiness or dizziness. These effects may be worse if you take it with alcohol or certain medicines. Take Olanzapine/Fluoxetine with caution. Do not drive or perform other possibly unsafe tasks until you know how you react to it.
  • Do not drink alcohol while you are taking Olanzapine/Fluoxetine .
  • Do not drink alcohol or use medicines that may cause drowsiness (eg, sleep aids, muscle relaxers) while you are using Olanzapine/Fluoxetine ; it may add to their effects. Ask your pharmacist if you have questions about which medicines may cause drowsiness.
  • Olanzapine/Fluoxetine 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 Olanzapine/Fluoxetine for longer than prescribed without checking with your doctor.
  • Children and teenagers who take Olanzapine/Fluoxetine may be at increased risk for suicidal thoughts or actions. Adults may also be affected. The risk may be greater in patients who have had suicidal thoughts or actions in the past. The risk may also be greater in patients who have had bipolar (manic-depressive) illness, or if their family members have had it. Watch patients who take Olanzapine/Fluoxetine closely. Contact the doctor at once if new, worsened, or sudden symptoms such as depressed mood; anxious, restless, or irritable behavior; panic attacks; or any unusual change in mood or behavior occur. Contact the doctor right away if any signs of suicidal thoughts or actions occur.
  • Olanzapine/Fluoxetine 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.
  • Olanzapine/Fluoxetine 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.
  • Diabetes patients - Olanzapine/Fluoxetine may affect your blood sugar. Check blood sugar levels closely. Ask your doctor before you change the dose of your diabetes medicine.
  • Neuroleptic malignant syndrome (NMS) is a possibly fatal syndrome that can be caused by Olanzapine/Fluoxetine . 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 Olanzapine/Fluoxetine may develop muscle movements that they cannot control. This is more likely to happen in elderly patients, especially women. The chance that this will happen or that it will become permanent is greater in those who take Olanzapine/Fluoxetine in higher doses or for a long time. Muscle problems may also occur after short-term treatment with low doses. Tell your doctor at once if you have muscle problems with your arms; legs; or your tongue, face, mouth, or jaw (eg, tongue sticking out, puffing of cheeks, mouth puckering, chewing movements) while taking Olanzapine/Fluoxetine .
  • Serotonin syndrome is a possibly fatal syndrome that can be caused by Olanzapine/Fluoxetine . Your risk may be greater if you take Olanzapine/Fluoxetine with certain other medicines (eg, "triptans," MAOIs). Symptoms may include agitation; confusion; hallucinations; coma; fever; fast or irregular heartbeat; tremor; excessive sweating; and nausea, vomiting, or diarrhea. Contact your doctor at once if you have any of these symptoms.
  • If your doctor tells you to stop taking Olanzapine/Fluoxetine , you will need to wait for several weeks before beginning to take certain other medicines (eg, MAOIs, nefazodone, thioridazine). Ask your doctor when you should start to take your new medicines after you have stopped taking Olanzapine/Fluoxetine .
  • Lab tests, including fasting blood sugar levels, may be performed while you use Olanzapine/Fluoxetine . These tests may be used to monitor your condition or check for side effects. Be sure to keep all doctor and lab appointments.
  • Use Olanzapine/Fluoxetine with caution in the ELDERLY; they may be more sensitive to its effects, especially low blood sodium levels.
  • Olanzapine/Fluoxetine should be used with extreme caution in CHILDREN; safety and effectiveness in children have not been confirmed.
  • Caution is advised when using Olanzapine/Fluoxetine in CHILDREN; they may be more sensitive to its effects, especially increased risk of suicidal thoughts or actions.
  • Olanzapine/Fluoxetine may cause weight changes. If CHILDREN or teenagers take Olanzapine/Fluoxetine , they may need regular weight and growth checks.
  • PREGNANCY and BREAST-FEEDING: Olanzapine/Fluoxetine may cause harm to the fetus if it is used during the last 3 months of pregnancy. If you become pregnant, contact your doctor. You will need to discuss the benefits and risks of using Olanzapine/Fluoxetine while you are pregnant. Olanzapine/Fluoxetine is found in breast milk. Do not breast-feed while taking Olanzapine/Fluoxetine .

Possible side effects of Olanzapine/Fluoxetine :

All medicines may cause side effects, but many people have no, or minor, side effects. Check with your doctor if any of these most COMMON side effects persist or become bothersome:

Constipation; decreased sexual desire or ability; dizziness; drowsiness; diarrhea; dry mouth; increased appetite; sore throat; weakness; weight gain.

Seek medical attention right away if any of these SEVERE side effects occur:

Severe allergic reactions (rash; hives; itching; difficulty breathing; tightness in the chest; swelling of the mouth, face, lips, or tongue); abnormal thoughts; black or bloody stools; chest pain; confusion; decreased coordination; fast, slow, or irregular heartbeat; fainting; fever; joint pain; memory loss; new or worsening agitation, anxiety, panic attacks, aggressiveness, impulsiveness, irritability, hostility, exaggerated feeling of well being, restlessness, or inability to sit still; persistent, painful erection; red, swollen, blistered, or peeling skin; rigid muscles; seizures; severe or persistent dizziness or trouble sleeping; suicidal thoughts or attempts; swelling of the hands, ankles, or feet; symptoms of high blood sugar (eg, increased thirst, hunger, or urination; unusual weakness); tremor; trouble concentrating, speaking, swallowing, or walking; uncontrolled muscle movements (eg, arm or leg movements, twitching of the face or tongue, jerking or twisting); unusual bruising or bleeding; unusual or severe mental or mood changes; unusual swelling, hoarseness, or sweating; vision changes; worsening of depression.

This is not a complete list of all side effects that may occur. If you have questions or need medical advice about side effects, contact your doctor or health care provider. You may report side effects to the FDA at 1-800-FDA-1088 (1-800-332-1088) or at http://www.fda.gov/medwatch.

If OVERDOSE is suspected:

Contact 1-800-222-1222 (the American Association of Poison Control Centers), your local poison control center (http://www.aapcc.org/findyour.htm), or emergency room immediately. Symptoms may include chest pain; coma; confusion; delirium; difficult breathing; fainting; fast, slow, or irregular heartbeat; fever; loss of coordination; seizures; severe or persistent dizziness, drowsiness, nausea, or vomiting; sluggishness; tremor; trouble speaking.

Proper storage of Olanzapine/Fluoxetine :

Store Olanzapine/Fluoxetine at 77 degrees F (25 degrees C). Brief storage at temperatures between 59 and 86 degrees F (15 and 30 degrees C) is permitted. Store away from heat, moisture, and light. Do not store in the bathroom. Keep Olanzapine/Fluoxetine out of the reach of children and away from pets.

General information:

  • If you have any questions about this medicine, please talk with your doctor, pharmacist, or other health care provider.
  • Olanzapine/Fluoxetine is to be used only by the patient for whom it is prescribed. Do not share it with other people.
  • If your symptoms do not improve or if they become worse, check with your doctor.

This information is summary only. It does not contain all information about Olanzapine/Fluoxetine . If you have questions about the medicine you are taking or would like more information, check with your doctor, pharmacist, or other health care provider.

Issue Date: September 5, 2007
Database Edition
Copyright © 2007 Wolters Kluwer Health, Inc.

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