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What is the most important information I should know about fluoxetine-olanzapine?

This medication is not for use in psychotic conditions related to dementia. Olanzapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not take fluoxetine and olanzapine together with pimozide (Orap), thioridazine (Mellaril), or a monoamine oxidase inhibitor (MAOI) such as isocarboxazid (Marplan), rasagiline (Azilect), phenelzine (Nardil), selegiline (Eldepryl, Emsam), or tranylcypromine (Parnate).

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

Call your doctor at once if you have any new or worsening symptoms 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.

Olanzapine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking olanzapine.

SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine and olanzapine, do not stop taking the medication without first talking to your doctor.

Warning

Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

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What is fluoxetine-olanzapine?

Fluoxetine is an antidepressant in a group of drugs called selective serotonin reuptake inhibitors (SSRIs).

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

The combination of fluoxetine and olanzapine is used to treat depression caused by bipolar disorder (manic depression). Fluoxetine and olanzapine is also used to treat depression after at least 2 other medications have been tried without successful treatment of symptoms.

Fluoxetine and olanzapine may also be used for other purposes not listed in this medication guide.

Precautions

This medication is not for use in psychotic conditions related to dementia. Olanzapine may cause heart failure, sudden death, or pneumonia in older adults with dementia-related conditions.

Do not use fluoxetine and olanzapine if you are using any of the following drugs:

  • pimozide (Orap);
  • thioridazine (Mellaril); or
  • an MAO inhibitor such as isocarboxazid (Marplan), tranylcypromine (Parnate), phenelzine (Nardil), rasagiline (Azilect), or selegiline (Eldepryl, Emsam).

Serious and sometimes fatal reactions can occur when these medicines are taken with fluoxetine and olanzapine. You must wait at least 14 days after stopping an MAO inhibitor before you can take fluoxetine and olanzapine. You must wait 5 weeks after stopping fluoxetine and olanzapine before you can take thioridazine (Mellaril) or an MAO inhibitor.

If you have any of these other conditions, you may need a dose adjustment or special tests to safely take this medication:

  • liver disease;
  • heart disease, high or low blood pressure, or a history of heart attack or stroke;
  • diabetes;
  • high cholesterol or triglycerides;
  • seizures or epilepsy;
  • glaucoma;
  • paralytic ileus (a stomach disorder);
  • enlarged prostate; or
  • a history of drug abuse or suicidal thoughts.

You may have thoughts about suicide when you first start taking an antidepressant, especially if you are younger than 24 years old. Tell your doctor if you have worsening symptoms of depression or suicidal thoughts during the first several weeks of treatment, or whenever your dose is changed.

Your family or other caregivers should also be alert to changes in your mood or symptoms. Your doctor will need to check you at regular visits for at least the first 12 weeks of treatment.

FDA pregnancy category C. SSRI antidepressants may cause serious or life-threatening lung problems in newborn babies whose mothers take the medication during pregnancy. However, you may have a relapse of depression if you stop taking your antidepressant during pregnancy. If you are planning a pregnancy, or if you become pregnant while taking fluoxetine and olanzapine, do not stop taking the medication without first talking to your doctor.

Fluoxetine and olanzapine can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Do not give fluoxetine and olanzapine to anyone younger than 18 years old without the advice of a doctor.

Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking fluoxetine and olanzapine.

Avoid drinking alcohol, which can increase some of the side effects of fluoxetine and olanzapine.

Fluoxetine and olanzapine can cause side effects that may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be awake and alert.

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Instructions

Seek emergency medical attention if you think you have taken too much of this medication. Overdose symptoms may include nausea, vomiting, tremor, problems with speech or vision, seizure (convulsions), and coma.

Take the missed dose as soon as you remember. However, if it is almost time for the next regularly scheduled dose, skip the missed dose and take the next one as directed. Do not take extra medicine to make up the missed dose.

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Side Effects

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

Call your doctor at once if you have any new or worsening symptoms 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 any of these serious side effects:

  • sudden and severe headache, blurred vision, confusion, chest pain, numbness, and problems with vision, speech, or balance;
  • increased thirst, frequent urination, excessive hunger, or weakness;
  • fever, stiff muscles, confusion, sweating, fast or uneven heartbeats, trouble breathing;
  • jerky muscle movements you cannot control;
  • seizure (convulsions);
  • feeling like you might pass out;
  • easy bruising or bleeding; or
  • nausea, stomach pain, low fever, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).

Less serious side effects may include:

  • trouble swallowing, runny nose, sore throat;
  • weight gain, swelling in your hands of feet;
  • drowsiness, trouble concentrating, sleep problems (insomnia);
  • dry mouth, diarrhea, changes in appetite; or
  • decreased sex drive, impotence, or difficulty having an orgasm.

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.

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Interactions

Talk to your doctor before taking any medicine for pain, arthritis, fever, or swelling. This includes aspirin, ibuprofen (Advil, Motrin), naproxen (Aleve, Naprosyn), diclofenac (Voltaren), indomethacin, piroxicam (Feldene), nabumetone (Relafen), etodolac (Lodine), and others. Taking any of these drugs with fluoxetine and olanzapine may cause you to bruise or bleed easily.

Before using fluoxetine and olanzapine, tell your doctor if you regularly use other medicines that make you sleepy (such as cold or allergy medicine, narcotic pain medicine, sleeping pills, muscle relaxers, and medicine for seizures or anxiety). They can add to sleepiness caused by fluoxetine and olanzapine.

The following drugs can interact with fluoxetine and olanzapine. Tell your doctor if you are using any of these:

  • vinblastine (Velban);
  • heart rhythm or blood pressure medication;
  • tryptophan (sometimes called L-tryptophan);
  • lithium, clozapine (Clozaril, Fazaclo), haloperidol (Haldol);
  • phenytoin (Dilantin), carbamazepine (Carbatrol, Tegretol);
  • a blood thinner such as warfarin (Coumadin);
  • another form of fluoxetine or olanzapine such as Prozac, Prozac Weekly, Sarafem, or Zyprexa;
  • theophylline (Theo-Dur, TheoBid, Uniphyl, Slo-Bid, Elixophyllin, and others);
  • medicine to treat Parkinson's disease, such as bromocriptine (Parlodel), pergolide (Permax), pramipexole (Mirapex), ropinorole (Requip), 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 there may be other drugs that can interact with fluoxetine and olanzapine. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

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Disclaimer

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2004 Cerner Multum, Inc. Version 2.05. Revision date 8/23/04