FDA Zyprexa Olanzapine Tablet Instructions

: July 6, 2024
: FDA

Table of Contents

FDA Zyprexa Olanzapine Tablet
Product Information
What is ZYPREXA?
General information about ZYPREXA
What are the ingredients in ZYPREXA?
FAQ
References
Read User Manual Online (PDF format)
Download This Manual (PDF format)

FDA Zyprexa Olanzapine Tablet

Product Information

Specifications:

Product Name : ZYPREXA
Generic Name : Olanzapine
Form: Tablet, Orally Disintegrating

Product Usage Instructions:
Before starting ZYPREXA, read the Medication Guide provided with the medication and review it each time you get a refill. It is essential to consult your doctor or pharmacist if there are any aspects of the medication that you do not understand.

Important Information:
It is crucial to be aware of the following important information about ZYPREXA:

ZYPREXA is not approved for treating psychosis in elderly patients with dementia.
If you have diabetes, monitor your blood sugar levels regularly as instructed by your doctor.
High cholesterol and triglyceride levels may occur, especially in teenagers. Regular blood tests are necessary to monitor these levels.
Weight gain is common with ZYPREXA, particularly in teenagers. Regular weight checks and discussions with your doctor about weight management strategies are recommended.
Discuss with your doctor the risks associated with ZYPREXA treatment in teenagers before starting the medication.

Conditions ZYPREXA is used to treat:

Schizophrenia symptoms
Bipolar I disorder symptoms
Treatment-resistant depression symptoms

This label may not be the latest approved by the FDA.

For current labeling information, please visit https://www.fda.gov/drugsatfda

Read the Medication Guide that comes with ZYPREXA before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment. Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about ZYPREXA.

What is the most important information I should know about ZYPREXA?
Serious side effects may happen when you take ZYPREXA, including:
Increased risk of death in elderly patients with dementia-related psychosis: Medicines like ZYPREXA can raise the risk of death in elderly people who have lost touch with reality (psychosis) due to confusion and memory loss (dementia). ZYPREXA is not approved for treating psychosis in the elderly with dementia. High blood sugar (hyperglycemia): High blood sugar can happen if you have diabetes already or even if you have never had diabetes. In rare cases, this could lead to ketoacidosis (build up of acid in the blood due to ketones), coma, or death. Your doctor should do lab tests to check your blood sugar before you start taking ZYPREXA and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when ZYPREXA is stopped. People with diabetes and some people who did not have diabetes before taking ZYPREXA need to take medicine for high blood sugar even after they stop taking ZYPREXA. If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking ZYPREXA.

Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking ZYPREXA:

feel very thirsty
need to urinate more than usual
feel very hungry
feel weak or tired
feel sick to your stomach
feel confused, or your breath smells fruity.

High cholesterol and triglyceride levels in the blood (fat in the blood) may happen in people treated with ZYPREXA, especially in teenagers (13-17 years old). You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking ZYPREXA and during treatment.

Increase in weight (weight gain): Weight gain is very common in people who take ZYPREXA. Teenagers (13-17 years old) are more likely to gain weight and to gain more weight than adults. Some people may gain a lot of weight while taking ZYPREXA, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

Increased risk in teenagers (13-17 years old) : Possible serious risks of weight gain and increases in cholesterol and triglycerides are more common in teenagers than in adults. You and your doctor should decide if other available treatments should be used first. Before your teenager takes ZYPREXA, talk with your doctor about the possible long-term risks of teenagers taking ZYPREXA.

What is ZYPREXA?

ZYPREXA is a prescription medicine used to treat:

schizophrenia in people age 13 or older.
bipolar disorder, including:
manic or mixed episodes that happen with bipolar I disorder in people age 13 or older.
manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate, in adults.
long-term treatment of bipolar I disorder in adults.
episodes of depression that happen with bipolar I disorder, when used with the medicine fluoxetine (Prozac®), in adults.
episodes of depression that do not get better after 2 other medicines, also called treatment-resistant depression, when used with the medicine fluoxetine (Prozac), in adults.

ZYPREXA has not been approved for use in children under 13 years of age. The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn. The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness, racing thoughts, talking fast, impulsive behavior, and a decreased need for sleep. The symptoms of treatment resistant depression include decreased mood, decreased interest, increased guilty feelings, decreased energy, decreased concentration, changes in appetite, and suicidal thoughts or behavior. Some of your symptoms may improve with treatment. If you do not think you are getting better, call your doctor.

What should I tell my doctor before taking ZYPREXA?
ZYPREXA may not be right for you. Before starting ZYPREXA, tell your doctor if you have or had:

heart problems
seizures
diabetes or high blood sugar levels (hyperglycemia)
high cholesterol or triglyceride levels in your blood
liver problems
low or high blood pressure
strokes or “mini-strokes” also called transient ischemic attacks (TIAs)
Alzheimer’s disease
narrow-angle glaucoma
enlarged prostate in men
bowel obstruction
phenylketonuria, because ZYPREXA ZYDIS contains phenylalanine
breast cancer
thoughts of suicide or hurting yourself
any other medical condition
are pregnant or plan to become pregnant. It is not known if ZYPREXA will harm your unborn baby.
are breast-feeding or plan to breast-feed. ZYPREXA can pass into your breast milk and may harm your baby. You should not breast-feed while taking ZYPREXA. Talk to your doctor about the best way to feed your baby if you take ZYPREXA.

Tell your doctor if you exercise a lot or are in hot places often.
The symptoms of bipolar I disorder, treatment resistant depression, or schizophrenia may include thoughts of suicide or of hurting yourself or others. If you have these thoughts at any time, tell your doctor or go to an emergency room right away. Tell your doctor about all the medicines that you take, including prescription and nonprescription medicines, vitamins, and herbal supplements. ZYPREXA and some medicines may interact with each other and may not work as well, or cause possible serious side effects. Your doctor can tell you if it is safe to take ZYPREXA with your other medicines. Do not start or stop any medicine while taking ZYPREXA without talking to your doctor first.

How should I take ZYPREXA?

Take ZYPREXA exactly as prescribed. Your doctor may need to change (adjust) the dose of ZYPREXA until it is right for you.
If you miss a dose of ZYPREXA, take the missed dose as soon as you remember. If it is almost time for the next dose, just skip the missed dose and take your next dose at the regular time. Do not take two doses of ZYPREXA at the same time.
To prevent serious side effects, do not stop taking ZYPREXA suddenly. If you need to stop taking ZYPREXA, your doctor can tell you how to safely stop taking it.
If you take too much ZYPREXA, call your doctor or poison control center at 1-800-222-1212 right away, or get emergency treatment.
ZYPREXA can be taken with or without food.
ZYPREXA is usually taken one time each day.
Take ZYPREXA ZYDIS as follows:
Be sure that your hands are dry.
Open the sachet and peel back the foil on the blister. Do not push the tablet through the foil.
As soon as you open the blister, remove the tablet and put it into your mouth.
The tablet will disintegrate quickly in your saliva so that you can easily swallow it with or without drinking liquid.
Call your doctor if you do not think you are getting better or have any concerns about your condition while taking ZYPREXA.

What should I avoid while taking ZYPREXA?

ZYPREXA can cause sleepiness and may affect your ability to make decisions, think clearly, or react quickly. You should not drive, operate heavy machinery, or do other dangerous activities until you know how ZYPREXA affects you.
Avoid drinking alcohol while taking ZYPREXA. Drinking alcohol while you take ZYPREXA may make you sleepier than if you take ZYPREXA alone.
See “What is the most important information I should know about ZYPREXA?”, which describes the increased risk of death in elderly people with dementia-related psychosis and the risks of high blood sugar, high cholesterol and triglyceride levels, and weight gain.
Increased incidence of stroke or “mini-strokes” called transient ischemic attacks (TIAs) in elderly people with dementia-related psychosis (elderly people who have lost touch with reality due to confusion and memory loss). ZYPREXA is not approved for these patients.
Neuroleptic Malignant Syndrome (NMS): NMS is a rare but very serious condition that can happen in people who take antipsychotic medicines, including ZYPREXA. NMS can cause death and must be treated in a hospital. Call your doctor right away if you become severely ill and have any of these symptoms:
high fever
excessive sweating
rigid muscles
confusion
changes in your breathing, heartbeat, and blood pressure.
Tardive Dyskinesia: This condition causes body movements that keep happening and that you can not control. These movements usually affect the face and tongue. Tardive dyskinesia may not go away, even if you stop taking ZYPREXA. It may also start after you stop taking ZYPREXA. Tell your doctor if you get any body movements that you can not control.
Decreased blood pressure when you change positions, with symptoms of dizziness, fast or slow heartbeat, or fainting.
Difficulty swallowing, that can cause food or liquid to get into your lungs.
Seizures: Tell your doctor if you have a seizure during treatment with ZYPREXA.
Problems with control of body temperature: You could become very hot, for instance when you exercise a lot or stay in an area that is very hot. It is important for you to drink water to avoid dehydration. Call your doctor right away if you become severely ill and have any of these symptoms of dehydration:
sweating too much or not at all
dry mouth
feeling very hot
feeling thirsty
not able to produce urine.

Common side effects of ZYPREXA include: lack of energy, dry mouth, increased appetite, sleepiness, tremor (shakes), having hard or infrequent stools, dizziness, changes in behavior, or restlessness.
Other common side effects in teenagers (13-17 years old) include: headache, stomach-area (abdominal) pain, pain in your arms or legs, or tiredness. Teenagers experienced greater increases in prolactin, liver enzymes, and sleepiness, as compared with adults.
Tell your doctor about any side effect that bothers you or that does not go away.
These are not all the possible side effects with ZYPREXA. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

How should I store ZYPREXA?

Keep ZYPREXA away from light.
Keep ZYPREXA dry and away from moisture.

Keep ZYPREXA and all medicines out of the reach of children.

General information about ZYPREXA

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use ZYPREXA for a condition for which it was not prescribed. Do not give ZYPREXA to other people, even if they have the same condition. It may harm them.
This Medication Guide summarizes the most important information about ZYPREXA. If you would like more information, talk with your doctor. You can ask your doctor or pharmacist for information about ZYPREXA that was written
for healthcare professionals. For more information about ZYPREXA call 1-800-Lilly-Rx (1-800-545-5979) or visit www.zyprexa.com.

What are the ingredients in ZYPREXA?

Active ingredient : olanzapine

Inactive ingredients:

Tablets — c arnauba wax, crospovidone, hydroxypropyl cellulose, hypromellose, lactose, magnesium stearate, microcrystalline cellulose, and other inactive ingredients. The color coating contains Titanium Dioxide, FD&C Blue No. 2 Aluminum Lake, or Synthetic Red Iron Oxide.
ZYDIS — gelatin, mannitol, aspartame, sodium methyl paraben, and sodium propylparaben.

This Medication Guide has been approved by the U.S. Food and Drug Administration.

Medication Guide revised Month dd, 2009

Eli Lilly and Company

Indianapolis, IN 46285, USA
www.zyprexa.com

FAQ

Q: What are the serious side effects of taking ZYPREXA?
A: Serious side effects may include an increased risk of death in elderly patients with dementia-related psychosis, high blood sugar, high cholesterol and triglyceride levels, and weight gain.

Q: Who should not take ZYPREXA?
A: ZYPREXA is not approved for treating psychosis in elderly patients with dementia and should be used with caution in teenagers due to the increased risks of weight gain and metabolic issues.

Q: How should I monitor my health while taking ZYPREXA?
A: Regular monitoring of blood sugar levels, cholesterol, triglycerides, and weight is essential. Consult your doctor for guidance on managing these aspects of your health.