This medication is used to treat severe agitation associated with certain mental/mood conditions (schizophrenia, bipolar mania). Olanzapine belongs to a class of drugs known as atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.

Talk to the doctor about the risks and benefits of treatment (especially when used in teenagers). See also Precautions section.

Read the Medication Guide provided by your pharmacist before you start using olanzapine and each time you get an injection. If you have any questions, ask your doctor or pharmacist.

This medication is given by a slow injection into a muscle by a healthcare professional. The dosage is based on your medical condition and response to treatment.

This medication is intended for short-term control of acute agitation symptoms. If you require continuous treatment for your condition, your doctor may switch you to an oral medication.

Dry mouth, constipation, nausea, dizziness, lightheadedness, stomach pain, weight gain, drowsiness, back pain, or redness/pain/swelling at the injection site may occur. If any of these effects last or get worse, notify your doctor or pharmacist promptly.

Dizziness and lightheadedness can increase the risk of falling. Get up slowly when rising from a sitting or lying position.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including:

• agitation
• confusion
• slow heartbeat
• restlessness
• weakness
• numbness or tingling of hands or feet
• tremor
• yellowing of the eyes or skin
• severe stomach/abdominal pain
• difficulty swallowing
• trouble urinating
• interrupted breathing during sleep

Get medical help right away if you have any very serious side effects, including:

• seizures

This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Tell your doctor right away if you have symptoms of high blood sugar such as increased thirst/urination. If you already have diabetes, check your blood sugar regularly as directed and share the results with your doctor. Your doctor may need to adjust your diabetes medication, exercise program, or diet.

This drug may also cause significant weight gain and a rise in your blood cholesterol (or triglyceride) levels, especially in teenagers. These effects, along with diabetes, may increase your risk for developing heart disease. Discuss the risks and benefits of treatment with your doctor. (See also Notes section.)

This medication may rarely cause a very serious condition called neuroleptic malignant syndrome (NMS). Get medical help right away if you have any of the following symptoms:

• fever
• muscle stiffness/pain/tenderness/weakness
• severe tiredness
• severe confusion
• sweating
• fast/irregular heartbeat
• dark urine
• signs of kidney problems (such as change in the amount of urine)

Olanzapine may rarely cause a condition known as tardive dyskinesia. In some cases, this condition may be permanent. Tell your doctor right away if you develop any unusual/uncontrolled movements (especially of the face or tongue).

In rare instances, this medication may increase your blood level of a certain hormone (prolactin). For females, this rare increase in prolactin levels may result in unwanted breast milk, the menstrual period stopping, or difficulty becoming pregnant. For males, it may result in decreased sexual ability, inability to produce sperm, or enlarged breasts. If you develop any of these symptoms, tell your doctor right away.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including:

• fever
• swollen lymph nodes
• rash
• itching/swelling (especially of the face/tongue/throat)
• severe dizziness
• trouble breathing

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Before using olanzapine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of:

• liver problems
• dementia
• seizures
• difficulty urinating (for example, due to enlarged prostate)
• glaucoma (narrow angle)
• stomach/intestinal problems (such as blockage, chronic constipation, paralytic ileus)
• difficulty swallowing
• smoking
• low white blood cell count
• personal or family history of diabetes
• heart disease
• high cholesterol/triglyceride levels
• breathing trouble during sleep (sleep apnea)

This drug may make you dizzy or drowsy. Alcohol or marijuana (cannabis) can make you more dizzy or drowsy. Do not drive, use machinery, or do anything that needs alertness until you can do it safely. Avoid alcoholic beverages. Talk to your doctor if you are using marijuana (cannabis).

This medication may make you sweat less, making you more likely to get heat stroke. Avoid doing things that may cause you to overheat, such as hard work or exercise in hot weather, or using hot tubs. When the weather is hot, drink a lot of fluids and dress lightly. If you overheat, quickly look for a place to cool down and rest. Get medical help right away if you have a fever that does not go away, mental/mood changes, headache, or dizziness.

Teenagers may be more sensitive to the side effects of this drug, especially weight gain, and also increased amounts of cholesterol, triglycerides and prolactin. See also Side Effects section for more details.

Older adults may be more sensitive to the side effects of this drug, especially drowsiness, constipation, trouble urinating, confusion, dizziness, and lightheadedness. Drowsiness, confusion, dizziness, and lightheadedness can increase the risk of falling.

During pregnancy, this medication should be used only when clearly needed. Babies born to mothers who have used this drug during the last 3 months of pregnancy may rarely develop symptoms including muscle stiffness or shakiness, drowsiness, feeding/breathing difficulties, or constant crying. If you notice any of these symptoms in your newborn especially during their first month, tell the doctor right away.

Since untreated mental/mood problems (such as schizophrenia, bipolar mania) can be a serious condition, do not stop taking this medication unless directed by your doctor. If you are planning pregnancy, become pregnant, or think you may be pregnant, immediately discuss with your doctor the benefits and risks of using this medication during pregnancy.

This drug passes into breast milk and may have undesirable effects on a nursing infant. Tell the doctor right away if your baby develops symptoms such as muscle stiffness or shakiness, unusual sleepiness, or difficulty feeding. Consult your doctor before breastfeeding.

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

A product that may interact with this drug is:

• metoclopramide

Tell your doctor or pharmacist if you are taking other products that cause drowsiness such as opioid pain or cough relievers (such as codeine, hydrocodone), alcohol, marijuana (cannabis), drugs for sleep or anxiety (such as alprazolam, lorazepam, zolpidem), muscle relaxants (such as carisoprodol, cyclobenzaprine), or antihistamines (such as cetirizine, diphenhydramine).

Check the labels on all your medicines (such as allergy or cough-and-cold products) because they may contain ingredients that cause drowsiness. Ask your pharmacist about using those products safely.

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call 1-800-222-1222. Canada residents can call 1-844-764-7669. Symptoms of overdose may include: severe drowsiness, trouble speaking, slowed breathing, or seizures.

Lab and/or medical tests (such as fasting blood sugar, weight, blood pressure, blood cholesterol/triglyceride levels, liver function) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details

Not applicable.

Not applicable. This medication is given in a hospital and will not be stored at home.