Olanzapine (ZYPREXA®)

• Olanzapine

• ZYPREXA®

• SSRI
• ANTIDEPRESSANT

• Treatment of schizophrenia
• Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder
• Medication therapy for pediatric patients with schizophrenia or bipolar I disorder should be undertaken only after a thorough diagnostic evaluation and with careful consideration of the potential risks.
• Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder.

• Tablets (not scored): 2.5, 5, 7.5, 10, 15, 20 mg
• Orally Disintegrating Tablets (not scored): 5, 10, 15, 20 mg
• Intramuscular Injection: 10 mg vial

Schizophrenia in adults:

• Oral: Start at 5-10 mg once daily;
• Target: 10 mg/day within several days

Schizophrenia in adolescents

• Oral: Start at 2.5-5 mg once daily;
• Target: 10 mg/day

Bipolar I Disorder (manic or mixed episodes) in adults

• Oral: Start at 10 or 15 mg once daily

Bipolar I Disorder (manic or mixed episodes) in adolescents

• Oral: Start at 2.5-5 mg once daily;
• Target: 10 mg/day

Bipolar I Disorder (manic or mixed episodes) with lithium or valproate in adults

• Oral: Start at 10 mg once daily

Agitation associated with Schizophrenia and Bipolar I Mania in adults

• IM: 10 mg (5 mg or 7.5 mg when clinically warranted)
• Assess for orthostatic hypotension prior to subsequent dosing (max. 3 doses 2-4 hrs apart)

Depressive Episodes associated with Bipolar I Disorder in adults

• Oral in combination with fluoxetine:  Start at 5 mg of oral olanzapine and 20 mg of fluoxetine once daily

Depressive Episodes associated with Bipolar I Disorder in children and adolescents

Oral in combination with fluoxetine:

• Start at 2.5 mg of oral olanzapine and 20 mg of fluoxetine once daily

Treatment Resistant Depression in adults

• Oral in combination with fluoxetine: Start at 5 mg of oral olanzapine and 20 mg of fluoxetine once daily

• Diazepam: May potentiate orthostatic hypotension.
• Alcohol: May potentiate orthostatic hypotension.
• Carbamazepine: Increased clearance of olanzapine.
• Fluvoxamine: May increase olanzapine levels.
• ZYPREXA and Fluoxetine in Combination: Also refer to the Drug Interactions section of the package insert for Symbyax.
• CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs and alcohol.
• Antihypertensive Agents: Enhanced antihypertensive effect.
• Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists.
• Lorazepam (IM): Increased somnolence with IM olanzapine.

• Most common adverse reactions (≥5% and at least twice that for placebo) associated with:
• Oral Olanzapine Monotherapy:
  • Schizophrenia (Adults) – postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia (6.1)
  • Schizophrenia (Adolescents) – sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth (6.3)
  • Manic or Mixed Episodes, Bipolar I Disorder (Adults) – asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor (6.1)
  • Manic or Mixed Episodes, Bipolar I Disorder (Adolescents) –sedation, weight increased, increased appetite, headache, fatigue, dizziness, dry mouth, abdominal pain, pain in extremity
• Combination with Lithium or Valproate:
  • Manic or Mixed Episodes, Bipolar I Disorder (Adults) – dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia

• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. (5.3)
• Metabolic Changes: Atypical antipsychotic drugs have been associated with metabolic changes including hyperglycemia, dyslipidemia, and weight gain.
• Hyperglycemia and Diabetes Mellitus: In some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients taking olanzapine. Patients taking olanzapine should be monitored for symptoms of hyperglycemia and undergo fasting blood glucose testing at the beginning of, and periodically during, treatment.
• Dyslipidemia: Undesirable alterations in lipids have been observed. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically during, treatment.
• Weight Gain: Potential consequences of weight gain should be considered. Patients should receive regular monitoring of weight.
• Tardive Dyskinesia: Discontinue if clinically appropriate.
• Orthostatic Hypotension: Orthostatic hypotension associated with dizziness, tachycardia, bradycardia and, in some patients, syncope, may occur especially during initial dose titration. Use caution in patients with cardiovascular disease, cerebrovascular disease, and those conditions that could affect hemodynamic responses.
• Leukopenia, Neutropenia, and Agranulocytosis: Has been reported with antipsychotics, including ZYPREXA. Patients with a
• history of a clinically significant low white blood cell count (WBC) or drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of ZYPREXA should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.
• Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold.
• Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery.
• Hyperprolactinemia: May elevate prolactin levels.
• Use in Combination with Fluoxetine, Lithium or Valproate: Also refer to the package inserts for Symbyax, lithium, or valproate.
• Laboratory Tests: Monitor fasting blood glucose and lipid profiles at the beginning of, and periodically during, treatment.

1. Olanzapine is used to treat schizophrenia and related psychotic disorders. It helps to relieve hallucinations (hearing or seeing things that are not there), delusions, suspiciousness, emotional withdrawal, depression, anxiety and tension. It may also be used to treat other disorders as determined by your physician.
2. Take the medication exactly as prescribed by your physician. Do not stop taking the drug unless you first discuss this with your physician. Symptoms usually relapse if medication is stopped.
3. This medication may be taken with or without food.
4. The oral disintegrating tablets (Zyprexa Zydis) dissolve immediately in the mouth. They may also be pre-dissolved in a glass of water, milk, coffee, orange juice or apple juice and ingested immediately. Tablets must be handled with dry hands.
5. If you miss a dose by a few hours, take it as soon as you remember. However, if most of the day has passed, wait until your next scheduled dose and try not to miss any more. Do not take two doses at once to make up for a missed one.
6. Dizziness, lightheadedness or fainting may occur when you first start taking this medication, especially when you get up from a sitting or lying position. Getting up slowly may help. Check with your physician if the problem continues or gets worse.
7. If this medication makes you feel drowsy, dizzy, confused, lightheaded, or causes blurred vision, do not drive a vehicle or operate hazardous machinery.

1. Other possible side effects include increased appetite, weight gain, ankle swelling, constipation, and dry mouth.
2. Check with your physician if any of the following side effects occur: muscle spasms, restlessness, shuffling walk, jerky movements of the head, face, neck and mouth, or trembling of hands and fingers. Also tell your physician if you have increased thirst and increased urination.
3. Tranquilizers, sleeping pills, medicines for seizures, some painkillers, and some cold and allergy medications may add to drowsiness. Check with your physician or pharmacist before taking any of these.
4. The effects of alcohol can be made worse while taking olanzapine. Drowsiness and dizziness may be increased; it is recommended that you not take alcohol while on this medication.
5. Tell your physician if you are pregnant, or plan to become pregnant, or if you wish to breast-feed your baby.
6. Store this medication in a tightly closed container, protected from light and in a dry place. Do not let anyone else use this medication. Keep it out of the reach of children.