Zyprexa Zydis

Zyprexa Zydis is a prescription medication used to treat schizophrenia. It is also used to treat bipolar disorder. Zyprexa Zydis belongs to a group of drugs called atypical antipsychotics, which work by altering the activity and levels of certain natural chemicals in the brain.

This medication comes in an orally disintegrating tablet and is is taken once a day, with or without food.

Zyprexa Zydis is placed on the tongue. The tablet will disintegrate quickly in your saliva so that you can easily swallow it with or without drinking liquid. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Common side effects of Zyprexa Zydis include lack of energy, dry mouth, increased appetite, somnolence, and tremor (shakes).

Zyprexa Zydis is a prescription medicine used to treat schizophrenia and bipolar disorder. When Zyprexa Zydis (olanzapine) is combined with Prozac (fluoxetine) it is also used to treat:

• depression that happens with bipolar I (one) disorder
• depression that did not get better after 2 other medications

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

• Lilly, Eli & Company

Serious side effects may happen when you take Zyprexa Zydis, including:

• See "Drug Precautions", 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 Zydis 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 Zydis. 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 Zydis. It may also start after you stop taking Zyprexa Zydis. 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 Zydis.
• 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 Zydis 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 Zydis. For more information, ask your doctor or pharmacist.

Tell your doctor about all the medicines you take including prescription and non-prescription medicines, vitamins, and herbal supplements. Especially tell your doctor if you take:

• diazepam (Valium)
• alcohol
• carbamazepine (Tegretol)
• fluvoxamine (Luvox)
• fluoxetine (Prozac, Symbax)
• levodopa
• lorazepam
• antidepressants
• antihistamines
• medicines for anxiety
• medicines for high blood pressure

This is not a complete list of Zyprexa Zydis drug interactions. Ask your doctor or pharmacist for more information.

Zyprexa Zydis may cause serious side effects, including:

1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis).
2. High blood sugar (hyperglycemia).
3. High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17.
4. Weight gain, especially in teenagers age 13 to 17.

These serious side effects are described below.

1. Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Zyprexa Zydis is not approved for treating psychosis in elderly people with dementia.

2. High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes. High blood sugar could lead to:

• a build up of acid in your blood due to ketones (ketoacidosis)
• coma
• death

Your doctor should do tests to check your blood sugar before you start taking Zyprexa Zydis and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when Zyprexa Zydis is stopped. People with diabetes and some people who did not have diabetes before taking Zyprexa Zydis need to take medicine for high blood sugar even after they stop taking Zyprexa Zydis.

If you have diabetes, follow your doctor's instructions about how often to check your blood sugar while taking Zyprexa Zydis.

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

• 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

3. High fat levels in your blood (cholesterol and triglycerides). High fat levels may happen in people treated with Zyprexa Zydis, especially in teenagers (13 to 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 Zydis and during treatment.

4. Weight gain. Weight gain is very common in people who take Zyprexa Zydis. Teenagers (13 to 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 Zydis, 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.

• Zyprexa Zydis 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 Zydis affects you.
• Avoid drinking alcohol while taking Zyprexa Zydis. Drinking alcohol while you take Zyprexa Zydis may make you sleepier than if you take Zyprexa Zydis alone.

Grapefruit and grapefruit juice may interact with Zyprexa Zydis and lead to potentially dangerous effects. Discuss the use of grapefruit products with your doctor.

Before starting Zyprexa Zydis, 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

Tell your doctor if you are pregnant or breastfeeding

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 Zydis 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 Zydis with your other medicines. Do not start or stop any medicine while taking Zyprexa Zydis without talking to your doctor first.

Tell your doctor if you are pregnant or plan to become pregnant. It is not known if Zyprexa Zydis will harm your unborn baby.

Tell your doctor if you are breastfeeding or plan to breastfeed. Zyprexa Zydis may be excreted in human breast milk. It may harm your nursing baby.

• Take Zyprexa Zydis exactly as prescribed. Your doctor may need to change (adjust) the dose of Zyprexa Zydis until it is right for you.
• If you miss a dose of Zyprexa Zydis, 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 Zydis at the same time.
• To prevent serious side effects, do not stop taking Zyprexa Zydis suddenly. If you need to stop taking Zyprexa Zydis, your doctor can tell you how to safely stop taking it.
• If you take too much Zyprexa Zydis, call your doctor or poison control center at 1-800-222-1222 right away, or get emergency treatment.
• Zyprexa Zydis can be taken with or without food.
• Zyprexa Zydis is usually taken one time each day.

Zyprexa Zydis:

• Be sure that your hands are dry.
• Keep the tablet in its blister pack until you are ready to take it. Open the package and peel back the foil from the tablet blister. Do not push a tablet through the foil or you may damage the tablet.
• 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. Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

Call your doctor if you do not think you are getting better or have any concerns about your condition while taking Zyprexa Zydis.

Take Zyprexa Zydis exactly as prescribed by your doctor. Follow the directions on your prescription label carefully. Your doctor will determine the best dose for you, after weighing a number of factors including:

• condition, and severity of condition being treated
• your age
• your other medical conditions
• other medicines you currently take.

For the treatment of schizophrenia, the recommended starting dose of Zyprexa Zydis (olanzapine) in adults is 5 mg to 10 mg taken once daily. The maximum recommended daily dose is 20 mg. 

For the treatment of bipolar disorder, the recommended starting dose of Zyprexa Zydis (olanzapine) in adults is 10 mg to 15 mg taken once daily. The maximum recommended daily dose is 20 mg.

If you take too much Zyprexa Zydis, call your local Poison Control Center or seek emergency medical attention right away.

• Store Zyprexa Zydis at room temperature, between 68°F to 77°F (20°C to 25°C).
• Keep Zyprexa Zydis away from light.
• Keep Zyprexa Zydis dry and away from moisture.

Keep Zyprexa Zydis and all medicines out of the reach of children.

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature. Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear. Zyprexa Zydis is not approved for the treatment of patients with dementia-related psychosis.

When using Zyprexa Zydis (olanzapine) and Prozac (fluoxetine) in combination, also refer to the Boxed Warning section of the package insert for Symbyax.