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ZYPREXA (olanzapine) is an atypical antipsychotic indicated:
As oral formulation for:
• Acute and maintenance treatment of Schizophrenia in adults
• Acute treatment of manic or mixed episodes associated with Bipolar I Disorder (monotherapy and in combination with lithium or valproate) and maintenance treatment of Bipolar I Disorder (monotherapy) in adults
As ZYPREXA IntraMuscular for:
• Acute agitation associated with Schizophrenia and Bipolar I Mania in adults
As ZYPREXA and Fluoxetine in Combination for:
• Acute treatment of Depressive Episodes associated with Bipolar I Disorder in adults
• Acute treatment of treatment resistant depression in adults (Major
Depressive Disorder in adult patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode)
Most common adverse reactions (≥5% and at least twice that for placebo) associated with:
Oral Olanzapine Monotherapy:
• Schizophrenia – postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia
• Manic or Mixed Episodes, Bipolar I Disorder – asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor
Combination of ZYPREXA and Lithium or Valproate:
• Manic or Mixed Episodes, Bipolar I Disorder – dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia
• 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
• Other Concomitant Drug Therapy: When using olanzapine in combination with lithium or valproate, refer to the Drug Interactions sections of the package insert for those products
• Elderly Patients with Dementia-Related Psychosis: Increased risk of death and increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack)
• Suicide: The possibility of a suicide attempt is inherent in Schizophrenia and in Bipolar I Disorder, and close supervision of high-risk patients should accompany drug therapy; when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax
• Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring
• Hyperglycemia: 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
• Hyperlipidemia: 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