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Olanzapine

(oh lan' za peen)

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IMPORTANT WARNING:   Return to top

[Posted 05/02/2007] FDA notified healthcare professionals that the Agency proposed that makers of all antidepressant medications update the existing black box warning on the prescribing information for their products to include warnings about the increased risks of suicidal thinking and behavior in young adults ages 18 to 24 years old during the first one to two months of treatment. The proposed labeling changes also state that scientific data did not show this increased risk in adults older than 24 years of age and that adults 65 years of age and older taking antidepressants have a decreased risk of suicidality. The proposed updates apply to the entire category of antidepressants. Individuals currently taking prescribed antidepressant medications should not stop taking them and should notify their healthcare professional if they have concerns. Manufacturers of antidepressant medications will have 30 days to submit their revised product labeling and revised Medication Guides to FDA for review. See the FDA press release for the list of products affected by the proposed antidepressant product labeling changes. For more information visit the FDA website at: http://www.fda.gov/medwatch/safety/2007/safety07.htm#Antidepressant, http://www.fda.gov/bbs/topics/NEWS/2007/NEW01624.html and http://www.fda.gov/cder/drug/antidepressants/default.htm.

IMPORTANT WARNING:   Return to top

Studies have shown that older adults with dementia (a brain disorder that affects the ability to remember, think clearly, communicate, and perform daily activities and that may cause changes in mood and personality) who take antipsychotics (medications for mental illness) such as olanzapine have an increased chance of death during treatment. Older adults with dementia may also have a greater chance of having a stroke or mini-stroke during treatment. If you experience any of the following symptoms, call your doctor immediately: slow or difficult speech, sudden dizziness or faintness, or weakness or numbness of an arm or leg.

Olanzapine is not approved by the Food and Drug Administration (FDA) for the treatment of behavior disorders in older adults with dementia. Talk to the doctor who prescribed this medication if you, a family member, or someone you care for has dementia and is taking olanzapine. For more information visit the FDA website: http://www.fda.gov/cder

Why is this medication prescribed?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Olanzapine is used to treat the symptoms of schizophrenia (a mental illness that causes disturbed or unusual thinking, loss of interest in life, and strong or inappropriate emotions). It is also used to treat bipolar disorder (manic depressive disorder; a disease that causes episodes of depression, episodes of mania, and other abnormal moods). Olanzapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

How should this medicine be used?   Return to top

Olanzapine comes as a tablet and an orally disintegrating tablet (tablet that dissolves quickly in the mouth) to take by mouth. It is usually taken once a day with or without food. Take olanzapine at around the same time every day. Follow the directions on your prescription label carefully, and ask your doctor or pharmacist to explain any part you do not understand. Take olanzapine exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Do not try to push the orally disintegrating tablet through the foil. Instead ,use dry hands to peel back the foil packaging. Immediately take out the tablet and place it in your mouth. The tablet will quickly dissolve and can be swallowed with or without liquid.

Your doctor may start you on a low dose of olanzapine and gradually increase your dose.

Olanzapine may help control your symptoms, but it will not cure your condition. It may take several weeks or longer before you feel the full benefit of olanzapine. Continue to take olanzapine even if you feel well. Do not stop taking olanzapine without talking to your doctor. Your doctor will probably want to decrease your dose gradually.

Other uses for this medicine   Return to top

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What special precautions should I follow?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Before taking olanzapine,

What special dietary instructions should I follow?   Return to top

Talk to your doctor about eating grapefruit and drinking grapefruit juice while taking this medicine.

Be sure to drink plenty of water every day while you are taking this medication.

What should I do if I forget a dose?   Return to top

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

What side effects can this medication cause?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Olanzapine may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

Some side effects can be serious. If you experience any of the following symptoms or those listed in the IMPORTANT WARNING section or the SPECIAL PRECAUTIONS section, call your doctor immediately:

Olanzapine may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online [at http://www.fda.gov/MedWatch/index.html] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine?   Return to top

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom). Always store the orally disintegrating tablets in their sealed package, and use them immediately after opening the package. Throw away any medication that is outdated or no longer needed. Talk to your pharmacist about the proper disposal of your medication.

In case of emergency/overdose   Return to top

In case of overdose, call your local poison control center at 1-800-222-1222. If the victim has collapsed or is not breathing, call local emergency services at 911.

Symptoms of overdose may include:

What other information should I know?   Return to top

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to olanzapine.

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

Brand names   Return to top

  • Zyprexa®
  • Zydis®

Brand names of combination products   Return to top

  • Symbyax® containing Olanzapine and Fluoxetine Hydrochloride

Last Revised - 07/01/2007
Last Reviewed - 08/01/2007


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