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.

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.

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.

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?

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.