olanzapine pamoate 300 mg IM suspension

Generic name:
Olanzapine extended release - injection

Pronunciation
(oh-LAN-za-peen)

Brand name(s)
Zyprexa Relprevv

This long-acting form of olanzapine injection may cause serious side effects, including severe drowsiness, inability to wake up (coma), and confusion (delirium) after injection. Your doctor/healthcare professional will monitor you closely at the healthcare facility for at least 3 hours after each injection. Have someone drive you home after your injection.

To receive the long acting form of olanzapine injection in the United States, you must understand, agree to, and carefully follow the requirements of the REMS Program for this medication. If you live in Canada or any other country, consult your doctor and pharmacist for your country's regulations.

There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.

This medication is used to treat a certain mental/mood disorder (schizophrenia). Extended-release olanzapine injection is a long-acting form of olanzapine. 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 Warning and Precautions sections.

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

There are 2 types of olanzapine injection (short- and long-acting). These 2 forms have different uses and dosing and the 2 products are not interchangeable. There is also a form that can be taken by mouth. The extended-release injection should only be used if you have already taken olanzapine by mouth without any serious side effects.

This medication is given by injection into the buttock muscle by a health care professional. It is given as directed by your doctor, usually every 2 to 4 weeks. The dosage is based on your medical condition and response to treatment.

Use this medication regularly to get the most benefit from it. To help you remember, mark your calendar with a reminder.

Tell your doctor if your condition lasts or gets worse.

Drowsiness, dizziness, lightheadedness, nausea, constipation, increased appetite, weight gain, dry mouth, headache, 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.

Olanzapine extended-release injection is designed to release medication slowly over 2 to 4 weeks. If the medication releases too quickly, your drug levels may be too high. Get medical help right away if any of these symptoms of high olanzapine levels occur:

• very drowsy/hard to wake up
• severe dizziness
• slowed breathing
• new or worsening mental/mood changes (such as confusion, agitation, nervousness, aggression)
• restlessness
• muscle stiffness/spasm
• shaking (tremor)
• unusual weakness
• difficulty walking or speaking
• balance problems
• seizure

This drug may rarely make your blood sugar rise, which can cause or worsen diabetes. Weight gain from this drug may increase the risk of this side effect. 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 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.)

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

• yellowing of the eyes/skin
• difficulty swallowing
• severe stomach/abdominal pain
• trouble urinating
• interrupted breathing during sleep

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 cases, olanzapine may increase your level of a certain substance made by the body (prolactin). For females, this increase in prolactin may result in unwanted breast milk, missed/stopped periods, 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
• 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). Do not drive for the rest of the day after receiving your injection.

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, diabetes, and 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) 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 blood sugar, complete blood count, weight, blood fats/triglyceride levels, liver function, blood pressure) should be done while you are using this medication. Keep all medical and lab appointments. Consult your doctor for more details.

Talk with your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

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

HOW TO USE THIS INFORMATION: This is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate for you. This information is not individual medical advice and does not substitute for the advice of your health care professional. Always ask your health care professional for complete information about this product and your specific health needs.