Zyprexa Relprevv is a long-acting injection containing olanzapine, an antipsychotic medication that affects chemicals in the brain.

Zyprexa Relprevv is used to treat adults who are in an agitated state due to schizophrenia or bipolar disorder (manic depression). This injection is not for daily use to treat any psychotic condition.

Zyprexa Relprevv is available only under a special program. You must be registered in the program and understand the risks and benefits of taking this medication.

Zyprexa Relprevv can cause symptoms of delirium (sudden severe confusion, disorientation, agitation, problems with speech or walking), or drowsiness severe enough for you to lapse into a coma. You will be watched closely for at least 3 hours after your injection, and you should not drive for the rest of the day.

Before you receive Zyprexa Relprevv, tell your doctor if you have heart disease, congestive heart failure, a heart rhythm disorder, a history of heart attack or stroke, or if you are also using a sedative such as Valium.

In an emergency situation it may not be possible before you are treated to tell your caregivers about your health conditions or if you are pregnant or breast feeding. Make sure any doctor caring for you afterward knows that you have received this medicine.

Olanzapine may impair your thinking or reactions. Be careful if you drive or do anything that requires you to be alert.

Zyprexa Relprevv is not approved for use in older adults with dementia-related psychosis.

Before taking this medicine

You should not receive Zyprexa if you are allergic to olanzapine.

Zyprexa may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

If possible before you receive Zyprexa Relprevv, tell your doctor if you have ever had:

• suicidal thoughts or actions;

• liver disease;

• heart disease, high or low blood pressure;

• high cholesterol or triglycerides;

• a stroke, including "mini-stroke";

• breast cancer;

• a seizure;

• Alzheimer's disease;

• diabetes or high blood sugar;

• an enlarged prostate;

• bowel problems; or

• narrow-angle glaucoma.

Tell your doctor if you are pregnant. Using antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn.

Tell your doctor if you are breastfeeding. Olanzapine can pass into breast milk and may cause side effects in the nursing baby.

In an emergency, you may not be able to tell caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you received this medicine.

Zyprexa Relprevv is not approved for use by anyone younger than 18 years old.

Zyprexa Relprevv is injected into a muscle. You will receive this injection in a clinic or hospital setting.

Zyprexa Relprevv is usually given only once. If you still have symptoms after 2 hours, your caregivers may use a second or third dose.

Zyprexa Relprevv can cause symptoms of delirium (sudden severe confusion, disorientation, agitation, problems with speech or walking), or drowsiness severe enough for you to lapse into a coma. You will be watched closely for at least 3 hours after your injection.

You should not receive Zyprexa if you are allergic to olanzapine.

Zyprexa may increase the risk of death in older adults with dementia-related psychosis and is not approved for this use.

If possible before you receive Zyprexa Relprevv, tell your doctor if you have ever had:

• suicidal thoughts or actions;

• liver disease;

• heart disease, high or low blood pressure;

• high cholesterol or triglycerides;

• a stroke, including "mini-stroke";

• breast cancer;

• a seizure;

• Alzheimer's disease;

• diabetes or high blood sugar;

• an enlarged prostate;

• bowel problems; or

• narrow-angle glaucoma.

Tell your doctor if you are pregnant. Using antipsychotic medicine in the last 3 months of pregnancy may cause breathing problems, feeding problems, or withdrawal symptoms in the newborn.

Tell your doctor if you are breastfeeding. Olanzapine can pass into breast milk and may cause side effects in the nursing baby.

In an emergency, you may not be able to tell caregivers if you are pregnant or breastfeeding. Make sure any doctor caring for your pregnancy or your baby knows you received this medicine.

Zyprexa Relprevv is not approved for use by anyone younger than 18 years old.

Since Zyprexa Relprevv is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

Avoid drinking alcohol. Dangerous side effects could occur.

Olanzapine can cause severe drowsiness and may impair your thinking or reactions. You must remain at the healthcare facility for at least 3 hours after your injection, and you should not drive for the rest of the day.

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Dizziness or severe drowsiness can cause falls, fractures, or other injuries.

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

Seek medical treatment if you have a serious drug reaction that can affect many parts of your body. Symptoms may include: skin rash, fever, swollen glands, flu-like symptoms, muscle aches, severe weakness, unusual bruising, or yellowing of your skin or eyes.

Zyprexa Relprevv can cause serious symptoms if the medicine gets into your bloodstream too fast. During the first 3 hours after your injection you will be watched for the following signs:

• severe dizziness, drowsiness, or weakness;

• confusion, anxiety, feeling angry or hostile;

• feeling nervous or shaky;

• trouble walking or talking;

• seizure (convulsions); or

• a light-headed feeling, like you might pass out.

Call your doctor at once if you have:

• twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

• trouble speaking or swallowing;

• signs of dehydration - if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin;

• high blood sugar - increased thirst, increased urination, hunger, dry mouth, fruity breath odor; or

• severe nervous system reaction - very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors.

Common Zyprexa side effects may include:

• headache, back pain;

• weight gain (more likely in teenagers), increased appetite;

• drowsiness;

• dry mouth, nausea, vomiting, diarrhea;

• sinus pain, runny or stuffy nose, cough; or

• pain where the injection was given.

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.

Using Zyprexa with other drugs that make you sleepy or slow your breathing can cause dangerous or life-threatening side effects. Ask your doctor before using opioid medication, a sleeping pill, a muscle relaxer, or medicine for anxiety or seizures.

Other drugs may interact with olanzapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.