Olanzapine (patient information)

IMPORTANT WARNING:

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

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

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

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

What special precautions should I follow

Before taking olanzapine

• tell your doctor and pharmacist if you are allergic to olanzapine or any other medications.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take. Be sure to mention any of the following: antidepressants; antihistamines; carbamazepine (Tegretol); dopamine agonists such as bromocriptine (Parlodel), cabergoline (Dostinex), levodopa (Dopar, Larodopa), pergolide (Permax), and ropinirole (Requip); fluoroquinolone antibiotics including ciprofloxacin (Cipro), gatifloxacin (Tequin) (not available in the United States), levofloxacin (Levaquin), norfloxacin (Noroxin), ofloxacin (Floxin), others; fluvoxamine (Luvox); ipratropium (Atrovent); medications for anxiety, hypertension, irritable bowel disease, mental illness, motion sickness, Parkinson's disease, seizures, ulcers, or urinary problems; omeprazole (Prilosec); rifampin (Rifadin); sedatives; sleeping pills; ticlopidine (Ticlid); and tranquilizers. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you use or have ever used street drugs or have overused prescription medications and if you have or have ever had a stroke, a mini-stroke, heart disease or a heart attack, an irregular heartbeat, seizures, breast cancer, any condition that makes it difficult for you to swallow, high or low blood pressure, liver or prostate disease, paralytic ileus (condition in which food cannot move through the intestine); or glaucoma (an eye condition), or if you or anyone in your family has or has ever had diabetes. Also tell your doctor if you have ever had to stop taking a medication for mental illness because of severe side effects.
• tell your doctor if you are pregnant or plan to become pregnant. If you become pregnant while taking olanzapine, call your doctor. Do not breast-feed if you are taking olanzapine.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are taking olanzapine.
• you should know that olanzapine may make you drowsy. Do not drive a car or operate machinery until you know how this medication affects you.
• you should know that alcohol can add to the drowsiness caused by this medication. Do not drink alcohol while taking olanzapine.
• tell your doctor if you use tobacco products. Cigarette smoking may decrease the effectiveness of this medication.
• you should know that you may experience hyperglycemia (increases in your blood sugar) while you are taking this medication, even if you do not already have diabetes. If you have schizophrenia, you are more likely to develop diabetes than people who do not have schizophrenia, and taking olanzapine or similar medications may increase this risk. Tell your doctor immediately if you have any of the following symptoms while you are taking olanzapine: extreme thirst, frequent urination, extreme hunger, blurred vision, or weakness. It is very important to call your doctor as soon as you have any of these symptoms, because high blood sugar can cause a serious condition called ketoacidosis. Ketoacidosis may become life-threatening if it is not treated at an early stage. Symptoms of ketoacidosis include: dry mouth, nausea and vomiting, shortness of breath, breath that smells fruity, and decreased consciousness.
• you should know that olanzapine may cause dizziness, lightheadedness, and fainting when you get up too quickly from a lying position. This is more common when you first start taking olanzapine. To avoid this problem, get out of bed slowly, resting your feet on the floor for a few minutes before standing up.
• you should know that olanzapine may make it harder for your body to cool down when it gets very hot. Tell your doctor if you plan to do vigorous exercise or be exposed to extreme heat.
• if you have phenylketonuria (PKU, an inherited condition in which a special diet must be followed to prevent mental retardation), you should know that the orally disintegrating tablets contain phenylalanine.

What special dietary instructions should I follow

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

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.

Side effects

Mild side effects

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

• drowsiness
• dizziness
• restlessness
• unusual behavior
• depression
• difficulty falling asleep or staying asleep
• weakness
• difficulty walking
• constipation
• weight gain
• dry mouth
• pain in arms, legs, back, or joints

Severe side effects

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:

• seizures
• changes in vision
• swelling of the arms, hands, feet, ankles, or lower legs
• unusual movements of your face or body that you cannot control
• fever
• very stiff muscles
• excess sweating
• fast or irregular heartbeat
• rash
• hives
• difficulty breathing or swallowing

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/report.htm] or by phone [1-800-332-1088].

What storage conditions are needed for this medicine

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

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:

• drowsiness
• slurred speech
• agitation
• fast heartbeat
• sudden movements that you cannot control
• coma (loss of consciousness for a period of time)

What other information should I know

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.

Brand names

• Zyprexa®
• Zydis®

Brand names of combination products

• Symbyax® containing Olanzapine and Fluoxetine Hydrochloride