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olanzapine

Pronunciation

Generic Name: olanzapine (oral) (oh LANZ a peen)
Brand Name: ZyPREXA, ZyPREXA Zydis

What is olanzapine?

Olanzapine is an antipsychotic medication that affects chemicals in the brain.

Olanzapine is used to treat the symptoms of psychotic conditions such as schizophrenia and bipolar disorder (manic depression) in adults and children who are at least 13 years old.

Olanzapine is sometimes used together with other antipsychotic medications or antidepressants.

Olanzapine may also be used for purposes not listed in this medication guide.

What is the most important information I should know about olanzapine?

Olanzapine is not approved for use in psychotic conditions related to dementia. Olanzapine may increase the risk of death in older adults with dementia-related conditions.

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

What should I discuss with my healthcare provider before taking olanzapine?

You should not take olanzapine if you are allergic to it.

Olanzapine is not approved for use in psychotic conditions related to dementia. Olanzapine may increase the risk of death in older adults with dementia-related conditions.

Long-term use of olanzapine can cause a serious movement disorder that may not be reversible. Symptoms of this disorder include uncontrollable muscle movements of your lips, tongue, eyes, face, arms, or legs. The longer you take olanzapine, the more likely you are to develop this movement disorder. The risk of this side effect is higher in women and older adults.

To make sure olanzapine is safe for you, tell your doctor if you have:

  • liver disease;

  • heart disease, high or low blood pressure;

  • a history of low white blood cell (WBC) counts;

  • high cholesterol or triglycerides;

  • a history of heart failure, heart attack, or stroke;

  • a history of breast cancer;

  • seizures or epilepsy;

  • diabetes;

  • an enlarged prostate or difficulty urinating;

  • bowel problems; or

  • narrow-angle glaucoma.

FDA pregnancy category C. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Taking antipsychotic medication during the last 3 months of pregnancy may cause problems in the newborn, such as withdrawal symptoms, breathing problems, feeding problems, fussiness, tremors, and limp or stiff muscles. However, you may have withdrawal symptoms or other problems if you stop taking your medicine during pregnancy. If you become pregnant while taking olanzapine, do not stop taking it without your doctor's advice.

Olanzapine can pass into breast milk and may harm a nursing baby. You should not breast-feed while using olanzapine.

The olanzapine orally disintegrating tablet (Zyprexa Zydis) may contain phenylalanine. Talk to your doctor before using this form of olanzapine if you have phenylketonuria (PKU).

How should I take olanzapine?

Follow all directions on your prescription label. Your doctor may occasionally change your dose to make sure you get the best results. Do not take this medicine in larger or smaller amounts or for longer than recommended.

Olanzapine can be taken with or without food.

Olanzapine is usually taken once a day. Olanzapine may be only part of a complete program of treatment that also includes counseling and other psychological support programs. Follow your doctor's instructions.

To take olanzapine orally disintegrating tablet (Zyprexa Zydis):

  • 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.

  • Using dry hands, remove the tablet and place it in your mouth. It will begin to dissolve right away.

  • Do not swallow the tablet whole. Allow it to dissolve in your mouth without chewing.

  • Swallow several times as the tablet dissolves. If desired, you may drink liquid to help swallow the dissolved tablet.

Call your doctor if your symptoms do not improve, or if they get worse while using olanzapine.

Do not stop using olanzapine suddenly, even if you feel fine. Stopping suddenly may cause serious side effects.

Olanzapine can cause high blood sugar (hyperglycemia). If you are diabetic, check your blood sugar levels on a regular basis while you are taking olanzapine.

You may gain weight or have high cholesterol and triglycerides (types of fat) while taking this medicine, especially if you are a teenager. Your blood may need to be tested often. Visit your doctor regularly.

If you are taking a combination of drugs, use all medications as directed by your doctor. Read the medication guide or patient instructions provided with each medication. Do not change your doses or medication schedule without your doctor's advice.

Store at room temperature away from moisture, heat, and light.

What happens if I miss a dose?

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include drowsiness, agitation, aggression, slurred speech, confusion, increased heart rate, jerky or uncontrolled muscle movements, trouble breathing, or fainting.

What should I avoid while taking olanzapine?

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

Avoid getting up too fast from a sitting or lying position, or you may feel dizzy. Get up slowly and steady yourself to prevent a fall.

Drinking alcohol can increase sleepiness caused by olanzapine.

Avoid becoming overheated or dehydrated. Drink plenty of fluids, especially in hot weather and during exercise. It is easier to become dangerously overheated and dehydrated while you are taking olanzapine.

Olanzapine side effects

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

Call your doctor at once if you have:

  • uncontrolled muscle movements in your face (chewing, lip smacking, frowning, tongue movement, blinking or eye movement);

  • trouble speaking or swallowing;

  • swelling in your hands or feet;

  • confusion, unusual thoughts or behavior, hallucinations, or thoughts about hurting yourself;

  • sudden weakness or ill feeling, fever, chills, sore throat, swollen gums, painful mouth sores, pain when swallowing, skin sores, cold or flu symptoms, cough;

  • signs of dehydration--feeling very thirsty or hot, being unable to urinate, heavy sweating, or hot and dry skin;

  • liver problems--upper stomach pain, itching, loss of appetite, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes);

  • high blood sugar--increased thirst, increased urination, hunger, dry mouth, fruity breath odor, drowsiness, dry skin, blurred vision, weight loss; or

  • severe nervous system reaction--very stiff (rigid) muscles, high fever, sweating, confusion, fast or uneven heartbeats, tremors, feeling like you might pass out.

Common side effects may include:

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

  • headache, dizziness, drowsiness, feeling tired or restless;

  • problems with speech or memory;

  • tremors or shaking, numbness or tingly feeling;

  • changes in personality;

  • dry mouth, or increased salivation;

  • stomach pain, constipation; or

  • pain in your arms or legs.

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.

See also: Side effects (in more detail)

Olanzapine dosing information

Usual Adult Dose for Bipolar Disorder:

Monotherapy:
Initial dose: 10 or 15 mg orally once a day
Dose adjustments: If indicated, dose adjustments should occur at intervals of at least 24 hours in 5 mg increments/decrements
Maintenance dose: 5 to 20 mg orally once a day
Maximum dose: 20 mg orally once a day

Adjunctive Treatment with Lithium or Valproate:
-Initial dose: 10 mg orally once a day

For the Treatment of Depressive Episodes Associated with Bipolar I Disorder when used in Combination with Fluoxetine:
Initial dose: 5 mg orally once a day (with fluoxetine 20 mg)
Dose adjustments: Should be made with the individual components within the dose range of 5 to 12.5 mg as indicated according to efficacy and tolerability
Maximum dose: 12.5 mg per day (with fluoxetine 50 mg per day)

Uses:
-Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.
-Treatment of depressive episodes associated with bipolar I disorder when used in combination with fluoxetine.

Usual Adult Dose for Schizophrenia:

Initial dose: 5 to 10 mg orally once a day
Target dose: 10 mg orally once a day within the first several days; further dose adjustments, if needed, should occur at intervals of not less than 1 week in 5 mg increments/decrements
Maximum dose: 20 mg orally once a day

Comments:
-Efficacy has been demonstrated in doses of 10 to 15 mg per day; doses above 10 mg per day were not demonstrated as more efficacious.
-Dose increases above 10 mg per day should occur only after a clinical assessment.

Parenteral: Extended Release IM Suspension
-Establish tolerability with oral olanzapine prior to initiating IM extended-release therapy.

Dosing for Extended Release Injectable Suspension Based on Corresponding Oral Doses:
-If the target oral olanzapine dose is 10 mg/day, then dosing during the first 8 weeks is 210 mg/2 weeks or 405 mg/4 weeks; after 8 weeks, the maintenance dose is 150 mg/2 weeks or 300 mg/4 weeks
-If the target oral olanzapine dose is 15 mg/day, then the dosing during the first 8 weeks is 300 mg/2 weeks; after 8 weeks, the maintenance dose is 210 mg/2 weeks or 405 mg/4 weeks
-If the target oral olanzapine dose is 20 mg/day, then the dosing during the first 8 weeks is 300 mg/2 weeks; after 8 weeks the maintenance dose is 300 mg/2 weeks

Comments: Efficacy has been demonstrated with doses from 150 mg to 300 mg IM every 2 weeks and 405 mg IM every 4 weeks.

Use: Treatment of schizophrenia

Usual Adult Dose for Depression:

Initial dose: 5 mg orally once a day (with fluoxetine 20 mg)
Dose adjustments: Should be made with the individual components within the dose range of 5 to 20 mg as indicated according to efficacy and tolerability
Maximum dose: 18 mg per day (with fluoxetine 50 mg per day)

Comments:
-The safety of co-administration of doses above olanzapine 18 mg-fluoxetine 75 mg has not been evaluated in clinical studies.
-Monotherapy is not indicated for treatment resistant depression.

Uses:
-For the treatment of patients with treatment resistant depression defined as those with major depressive disorder who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode.

Usual Adult Dose for Agitated State:

Immediate-Release Injection:
-Initial dose: 10 mg IM once; dose range 2.5 to 10 mg IM
-Subsequent doses up to 10 mg may be given every 2 hours for agitation that persists following the initial dose
-Maximum number of doses: 3 doses in 24 hours; additional doses in patients with clinically significant postural hypotension are not recommended

Comments:
-The efficacy of repeated doses in agitated patients has not been systematically evaluated in controlled clinical trials.
-The safety of total daily dose greater than 30 mg (or 10 mg injections given more frequently than 2 hours after the initial dose and 4 hours after the second dose) has not been evaluated in clinical trials; maximal dosing may be associated with significant orthostatic hypotension.
-If ongoing therapy is clinically indicated, oral olanzapine may be initiated in a range of 5 to 20 mg per day as soon as clinically appropriate.

Use: For the treatment of acute agitation associated with schizophrenia and bipolar I mania.

Usual Geriatric Dose for Agitated State:

Immediate-Release Injection:
-Initial dose: 5 mg IM once
-Subsequent doses may be given for agitation that persists following the initial dose
-Maximum dose: 10 mg IM 2 to 4 hours apart; additional doses in patients with clinically significant postural hypotension are not recommended

Comments:
-The efficacy of repeated doses in agitated patients has not been systematically evaluated in controlled clinical trials.
-The safety of total daily dose greater than 30 mg (or 10 mg injections given more frequently than 2 hours after the initial dose and 4 hours after the second dose) has not been evaluated in clinical trials; maximal dosing may be associated with significant orthostatic hypotension.
-If ongoing therapy is clinically indicated, oral olanzapine may be initiated in a range of 5 to 20 mg per day as soon as clinically appropriate.

Use: For the treatment of acute agitation associated with schizophrenia and bipolar I mania.

Usual Pediatric Dose for Schizophrenia:

Age 13 years or older:
Initial dose: 2.5 to 5 mg orally once a day
Target dose: 10 mg orally once a day; further dose adjustments, if needed, should occur at intervals of not less than 1 week in 2.5 to 5 mg increments/decrements.
Maximum dose: 20 mg orally once a day

Comments:
-Efficacy has been demonstrated in the range of 2.5 to 20 mg per day; a mean modal dose of 12.5 mg per day (mean dose 11.1 mg per day) was demonstrated in adolescent schizophrenia efficacy trials.
-Medication therapy for adolescents should be initiated only after a thorough diagnostic evaluation and careful consideration given to the risks associated with treatment; medication treatment should be part of a total treatment program that includes psychological, educational, and social interventions.
-When deciding among the alternative treatments, clinicians should consider the increased potential for weight gain and dyslipidemia in this population compared to adults.

Use: Treatment of schizophrenia

Usual Pediatric Dose for Bipolar Disorder:

For the Treatment of Manic or Mixed Episodes Associated with Bipolar I Disorder:
Age: 13 years or older:
Initial dose: 2.5 to 5 mg orally once a day
Target dose: 10 mg orally once a day; dose adjustments, if needed, should occur at intervals of not less than 1 week in 2.5 to 5 mg increments/decrements.
Maximum dose: 20 mg orally once a day

Comment: Efficacy has been demonstrated in the range of 2.5 to 20 mg per day; a mean modal dose of 10.7 mg per day (mean dose 8.9 mg per day) was demonstrated in adolescent clinical trials.

For the Treatment of Depressive Episodes Associated with Bipolar I Disorder when used in Combination with Fluoxetine:
Age: 10 years or older:
Initial dose: 2.5 mg orally once a day (with fluoxetine 20 mg)
Dose adjustments: Should be made with the individual components within the dose range of 5 to 12.5 mg as indicated according to efficacy and tolerability
Maximum dose: 12.5 mg per day (with fluoxetine 50 mg per day)

Comments:
-Medication therapy for adolescents should be initiated only after a thorough diagnostic evaluation and careful consideration given to the risks associated with treatment; medication treatment should be part of a total treatment program that includes psychological, educational, and social interventions.
-When deciding among the alternative treatments, clinicians should consider the increased potential for weight gain and dyslipidemia in this population compared to adults.

Uses:
-Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.
-Treatment of depressive episodes associated with bipolar I disorder when used in combination with fluoxetine.

What other drugs will affect olanzapine?

Taking this medicine with other drugs that make you sleepy can worsen this effect. Ask your doctor before taking olanzapine with a sleeping pill, narcotic pain medicine, muscle relaxer, or medicine for anxiety, depression, or seizures.

Other drugs may interact with olanzapine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Where can I get more information?

  • Your pharmacist can provide more information about olanzapine.
  • Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
  • Disclaimer: Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 14.01. Revision Date: 2014-07-14, 1:16:58 PM.

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