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olanzapine

Pronunciation

Generic Name: olanzapine (injection) (oh LAN za peen)
Brand Name: ZyPREXA, ZyPREXA Relprevv

What is olanzapine injection?

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

Olanzapine injection is used to treat adults who are in an agitated state due to schizophrenia or bipolar disorder (manic depression). Olanzapine injection is not for daily use to treat any psychotic condition.

Olanzapine injection is available only under a special program. You must be registered in the program and understand the risks and benefits of taking this medication.

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

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

Olanzapine injection can cause symptoms of delirium (sudden severe confusion, disorientation, agitation, problems with speech or walking), or drowsiness severe enough for you to lapse into a coma. You will be watched closely for at least 3 hours after your injection, and you should not drive for the rest of the day.

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

What should I discuss with my healthcare provider before receiving olanzapine injection?

You should not receive this medication if you are allergic to 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.

If possible before you receive olanzapine injection, tell your doctor if you have:

  • diabetes;

  • high cholesterol;

  • heart disease;

  • seizures or epilepsy;

  • a history of heart attack or stroke;

  • if you are also using a sedative such as Valium.

FDA pregnancy category C. It is not known whether olanzapine injection will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

Olanzapine can pass into breast milk and may harm a nursing baby. You may need to stop breast-feeding for a short time after receiving an olanzapine injection. Follow your doctor's instructions.

In an emergency situation, it may not be possible before you are treated with olanzapine to tell your caregivers if you are pregnant or breast feeding. Make sure any doctor caring for your pregnancy or your baby knows you have received this medicine.

How is olanzapine injection given?

Olanzapine is injected into a muscle. You will receive this injection in a clinic or hospital setting.

An olanzapine injection is usually given only once. If you still have symptoms after 2 hours, your caregivers may use a second or third dose.

Olanzapine injection can cause symptoms of delirium (sudden severe confusion, disorientation, agitation, problems with speech or walking), or drowsiness severe enough for you to lapse into a coma. You will be watched closely for at least 3 hours after your injection.

What happens if I miss a dose?

Since olanzapine injection is given by a healthcare professional in an emergency setting, you are not likely to miss a dose.

What happens if I overdose?

Since this medication is given by a healthcare professional in a medical setting, an overdose is unlikely to occur.

What should I avoid after receiving olanzapine injection?

Avoid drinking alcohol.

Olanzapine can cause severe drowsiness and may impair your thinking or reactions. You must remain at the healthcare facility for at least 3 hours after your injection, and you should not drive for the rest of the day.

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.

Olanzapine injection 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.

Olanzapine injection can cause serious symptoms if the medicine gets into your bloodstream too fast. During the first 3 hours after your injection you will be watched for the following signs:

  • severe dizziness, drowsiness, or weakness;

  • confusion, anxiety, feeling angry or hostile;

  • feeling nervous or shaky;

  • trouble walking or talking;

  • seizure (convulsions); or

  • a light-headed feeling, like you might pass out.

Call your doctor at once if you have:

  • twitching or uncontrollable movements of your eyes, lips, tongue, face, arms, or legs;

  • trouble swallowing;

  • signs of dehydration--if you feel very thirsty or hot, are unable to urinate, and have heavy sweating or hot and dry skin;

  • weak immune system--sudden weakness or ill feeling, fever, chills, swollen gums, painful mouth sores, sore throat, trouble swallowing, skin sores, cold or flu symptoms, cough, trouble breathing;

  • 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.

Common side effects may include:

  • headache, back pain;

  • weight gain, increased appetite;

  • mild drowsiness;

  • dry mouth, nausea, vomiting, diarrhea;

  • sinus pain, runny or stuffy nose, cough; or

  • pain, bruising, swelling, or other irritation where the injection was given.

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:

Oral (monotherapy):
Initial dose: 10 to 15 mg orally once a day.
Maintenance dose: 5 to 20 mg orally once a day.
Maximum dose: 20 mg orally once a day.

Oral (combination therapy with lithium or valproate):
Initial dose: 10 mg orally once a day.
Maintenance dose: 5 to 20 mg orally once a day.
Maximum dose: 20 mg orally once a day.

Injection:
Initial dose: 10 mg IM once.
Recommended dose: 10 mg IM once. A lower dose of 5 mg or 7.5 mg may be considered when clinical factors warrant. If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. The efficacy of repeated doses of IM olanzapine 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 four hours after the second dose) has not been evaluated in clinical trials.

Dosage range: 2.5 mg to 10 mg IM once.

If ongoing olanzapine therapy is clinically indicated, oral olanzapine may be initiated in a range of 5 to 20 mg per day as soon as clinically appropriate.

Usual Adult Dose for Schizophrenia:

Oral:
Initial dose: 5 to 10 mg orally once a day.
Maintenance dose: 10 mg orally once a day.
Maximum dose: 20 mg orally once a day.

There are two olanzapine intramuscular formulations with different dosing schedules. Olanzapine intramuscular (10 mg/vial) is a short-acting formulation and should not be confused with olanzapine extended release injectable suspension (Brand Name: RELPREVV).

Short-acting Injection:
Initial dose: 10 mg IM once.
Recommended dose: 10 mg IM once. A lower dose of 5 mg or 7.5 mg may be considered when clinical factors warrant. If agitation warranting additional intramuscular doses persists following the initial dose, subsequent doses up to 10 mg may be given. The efficacy of repeated doses of IM olanzapine 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 four hours after the second dose) has not been evaluated in clinical trials.

Dosage range: 2.5 mg to 10 mg IM once.

If ongoing olanzapine therapy is clinically indicated, oral olanzapine may be initiated in a range of 5 to 20 mg per day as soon as clinically appropriate.

Extended Release Injectable Suspension:

The extended release injectable suspension is intended for deep intramuscular gluteal injection only and should not be administered intravenously or subcutaneously.

Tolerability should be established with oral olanzapine prior to initiating treatment with the extended release injectable suspension.

The efficacy of olanzapine extended release injectable suspension has been demonstrated within the range of 150 mg to 300 mg administered every 2 weeks and with 405 mg administered every 4 weeks.

Recommended Dosing for Olanzapine Extended Release Injectable Suspension Based on Correspondence to Oral Olanzapine Doses:

1) If the target oral olanzapine dose is 10 mg/day, then the dosing during the first 8 weeks is 210 mg/2 weeks or 405 mg/4 weeks, and the maintenance dose after 8 weeks is 150 mg/2 weeks or 300 mg/4 weeks.

2) If the target oral olanzapine dose is 15 mg/day, then the dosing during the first 8 weeks is 300 mg/2 weeks, and the maintenance dose after 8 weeks is 210 mg/2 weeks or 405 mg/4 weeks.

3) If the target oral olanzapine dose is 20 mg/day, then the dosing during the first 8 weeks is 300 mg/2 weeks, and the maintenance dose after 8 weeks is 300 mg/2 weeks.

Olanzapine extended release injectable suspension doses greater than 405 mg every 4 weeks or 300 mg every 2 weeks have not been evaluated in clinical trials.

For patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients 65 years of age or older), or who may be more pharmacodynamically sensitive to olanzapine:
Recommended starting dose: 150 mg/4 weeks
When indicated, dose escalation should be undertaken with caution in these patients.

Maintenance: Although no controlled studies have been conducted to determine how long patients should be treated with olanzapine extended release injectable suspension, efficacy has been demonstrated over a period of 24 weeks in patients with stabilized schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment.

Usual Geriatric Dose for Bipolar Disorder:

Oral:
Initial dose: 5 mg orally once a day if debilitated or predisposed to hypotension.
Maintenance dose: May increase cautiously.

Injection:
Initial Dose: 5 mg IM once. A lower dose of 2.5 mg per injection should be considered for patients who otherwise may be debilitated, predisposed to hypotensive reactions, or who are more pharmacodynamically sensitive to olanzapine.

Usual Geriatric Dose for Schizophrenia:

Oral:
Initial dose: 5 mg orally once a day if debilitated or predisposed to hypotension.
Maintenance dose: May increase cautiously.

There are two olanzapine intramuscular formulations with different dosing schedules. Olanzapine intramuscular (10 mg/vial) is a short-acting formulation and should not be confused with olanzapine extended release injectable suspension (Brand Name: RELPREVV).

Short-acting Injection:
Initial Dose: 5 mg IM once. A lower dose of 2.5 mg per injection should be considered for patients who otherwise may be debilitated, predisposed to hypotensive reactions, or who are more pharmacodynamically sensitive to olanzapine.

Extended Release Injectable Suspension:

For patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients 65 years of age or older), or who may be more pharmacodynamically sensitive to olanzapine:
Recommended starting dose: 150 mg/4 weeks
When indicated, dose escalation should be undertaken with caution.

Maintenance: Although no controlled studies have been conducted to determine how long patients should be treated with olanzapine extended release injectable suspension, efficacy has been demonstrated over a period of 24 weeks in patients with stabilized schizophrenia. Patients should be periodically reassessed to determine the need for continued treatment.

Usual Pediatric Dose for Schizophrenia:

8 to 12 years (Limited data available):
Initial: 2.5 to 5 mg once daily; increase dose in 2.5 or 5 mg increments at weekly intervals to target dose of 10 mg once daily; maximum dose: 20 mg/day.

13 to 17 years old:
Initial dose: 2.5 to 5 mg orally once a day
Maintenance dose: 10 mg orally once a day
Efficacy in adolescents with schizophrenia has been demonstrated based on a flexible dose range of 2.5 mg to 20 mg/day in clinical trials. When dosage adjustments are necessary, dose increments/decrements of 2.5 mg or 5 mg are recommended.

The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials.

Maintenance: The efficacy of olanzapine for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated. However, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. It is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

Usual Pediatric Dose for Bipolar Disorder:

4 to 5 years: Limited data available: Initial: 1.25 mg orally once daily; increase at weekly intervals according to response and tolerability to target dose: 10 mg/day.
6 to 12 years: Limited data available: Initial: 2.5 mg orally once daily; increase dose in 2.5 or 5 mg increments at weekly intervals to target dose of 10 mg once daily; maximum dose: 20 mg/day.

13 to 17 years old:
Initial dose: 2.5 mg to 5 mg orally once a day
Maintenance dose: 10 mg orally once a day
Efficacy in adolescents with bipolar I disorder (manic or mixed episodes) was demonstrated based on a flexible dose range of 2.5 to 20 mg/day in clinical trials. When dosage adjustments are necessary, dose increments/decrements of 2.5 or 5 mg are recommended.

The safety and effectiveness of doses above 20 mg/day have not been evaluated in clinical trials.

Maintenance: The efficacy of olanzapine for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated. However, maintenance efficacy can be extrapolated from adult data along with comparisons of olanzapine pharmacokinetic parameters in adult and adolescent patients. It is generally recommended that responding patients be continued beyond the acute response, but at the lowest dose needed to maintain remission. Patients should be periodically reassessed to determine the need for maintenance treatment.

Usual Pediatric Dose for Anorexia Nervosa:

9 years and older: (Limited data available): 1.25 to 2.5 mg orally once daily has been shown in one small trial and several case reports to improve BMI and other disease related symptoms (e.g., eating attitudes, anxiety); another case series used initial doses of 2.5 mg once daily and final doses of 5 mg to 10 mg once daily; reported range: 1.25 to 12.5 mg/day; however, it has been suggested that higher doses (greater than 2.5 mg once daily) may not be associated with greater efficacy. Further studies are needed.

Usual Pediatric Dose for Tourette's Syndrome:

Tourette syndrome, tic disorder:
7 years and older: Limited data available:
Patient weight less than 40 kg: Initial: 2.5 mg orally every other day for 3 days, increase to 2.5 mg every day for remainder of week; increase to 5 mg/day by second week if needed; then increase in 5 mg increments at weekly intervals as tolerated; maximum dose: 20 mg/day
Patient weight greater than 40 kg: Initial: 2.5 mg every day for 3 days; increase to 5 mg every day for remainder of week if needed, then increase in 5 mg increments at weekly intervals as tolerated; maximum dose: 20 mg/day
An open-label study of 10 pediatric patients (7 to 13 years of age) reported significant reductions in tic severity [Yale Global Tic Severity Scale (YGTSS)] from baseline at a mean final dose of 14.5 mg/day after 8 weeks of treatment. An open-label trial of 12 children and adolescents (7 to 14 years of age) reported a significant reduction (30%) in total tic severity (YGTSS) at a final mean dose of 11.3 mg/day (range: 2.5 to 20 mg/day).

What other drugs will affect olanzapine injection?

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

Other drugs may interact with olanzapine injection, 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 doctor or pharmacist can provide more information about olanzapine injection.
  • 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: 2.02. Revision Date: 2014-06-13, 1:10:47 PM.

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