Xerostomia (9-22%) Weakness (2-20%) Dizziness (4-18%) Accidental injury (12%) Insomnia (12%) Elevated alanine aminotransferase (ALT) level (5-12%) Constipation (9-11%) Dyspepsia (7-11%) Hyperprolactinemia (30%) Hyperglycemia (12.8%) 1-10% Hypotension (2%) Postural hypotension (1%) Tremor (1%) Asthenia (2%) Akathisia reactions (2%) Parkinsonism reactions (4%) <1% Syncope Sudden cardiac death Hyperglycemia Diabetic coma with ketoacidosis Diabetic ketoacidosis Acute hemorrhagic pancreatitis Venous thromboembolism Immune hypersensitivity reaction Cerebrovascular disease Seizure, status epilepticus Suicidal intent Pulmonary embolism Death Neuroleptic malignant syndrome (NMS) Tardive dyskinesia Postmarketing Reports Eosinophilia and Systemic Symptoms (DRESS) Falls Restless legs syndrome Salivary hypersecretion Black Box Warnings Not approved for dementia-related psychosis; elderly patients with dementia-related psychosis who are treated with antipsychotic drugs are at increased risk of death, as shown in short-term controlled trials; in these trials, deaths appeared to be either cardiovascular (eg, heart failure, sudden death) or infectious (eg, pneumonia) in nature Patients are at risk for severe sedation (including coma) or delirium after each injection and must be observed for at least 3 hours in registered facility with ready access to emergency response services Because of this risk, olanzapine is available only through restricted distribution programContraindications Documented hypersensitivity Refer to the package insert for Symbyax contraindications, when using PO olanzapine and fluoxetine in combination Cautions Possibility of suicide attempt is inherent in schizophrenia and bipolar I disorder, and close supervision of high-risk patients should accompany drug therapy; when using in combination with fluoxetine, also refer to Boxed Warning and Precautions sections of package insert for Symbyax Irreversible, involuntary, dyskinetic movements may develop with antipsychotic drugs; prevalence appears to be highest among elderly individuals, especially elderly women; discontinue if clinically appropriate Tardive dyskinesia may remit, partially or completely, if antipsychotic treatment withdrawn; however, antipsychotic treatment, itself, may suppress (or partially suppress) signs and symptoms of syndrome and possibly mask underlying process; effect symptomatic suppression has upon long-term course of syndrome unknown Neutropenia, leukopenia, and agranulocytosis reported; discontinue therapy at first sign of blood dyscrasias or if absolute neutrophil count <1000/mm³ Cerebrovascular effects including, stroke and transient ischemic attack resulting in death reported FDA warning regarding off-label use for dementia in elderly (see Black Box Warnings) Use caution in patients with history of seizures or with conditions that potentially lower seizure threshold Changes from normal to high prolactin levels observed in controlled studies (incidence, 30%) Use caution with strenuous exercise, dehydration, heat exposure, and medications with anticholinergic effects; impaired core body temperature regulation may occur Use with caution in patients with current diagnosis or prior history of urinary retention Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) reported with olanzapine exposure; DRESS may present with a cutaneous reaction (such as rash or exfoliative dermatitis), eosinophilia, fever, and/or lymphadenopathy with systemic complications such as hepatitis, nephritis, pneumonitis, myocarditis, and/or pericarditis; DRESS is sometimes fatal; discontinue olanzapine if DRESS suspected May cause somnolence, postural hypotension, motor and sensory instability, which may lead to falls and, consequently, fractures or other injuries; for patients with diseases, conditions, or medications that could exacerbate these effects, complete fall risk assessments when initiating antipsychotic treatment and recurrently for patients on long-term antipsychotic therapy Has potential to impair judgment, thinking, and motor skills; use caution when operating machinery Olanzapine indicated as integral part of comprehensive treatment program for pediatric patients with schizophrenia and bipolar disorder, which may include other measures (eg, psychological, educational, social) as well IM, extended-release: Risk of postinjection delirium/sedation syndrome, availability is restricted and requires registration (call 877-772-9390) Use in patients with concomitant illnesses Use caution in patients with clinically significant prostatic hypertrophy, narrow angle glaucoma, or a history of paralytic ileus or related conditions; olanzapine exhibits in vitro muscarinic activity May induce orthostatic hypotension associated with dizziness, tachycardia, bradycardia and, in some patients, syncope, especially during initial dose-titration period, probably as consequence of alpha1-adrenergic antagonistic propertie Metabolic changes Weight gain Increased potential (in adolescents as compared with adults) for weight gain and hyperlipidemia; clinicians prescribing to adolescents should consider potential long-term risks, which in many cases may lead them to prescription of other drugs first in this population Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically during, treatment Hyperglycemia and diabetes mellitus Consider risks and benefits when prescribing olanzapine to patients with diabetes mellitus, or borderline increased blood glucose level (fasting 100-126 mg/dL, nonfasting 140-200 mg/dL); monitor regularly for worsening of glucose control; hyperglycemia, in some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients treated with atypical antipsychotics including olanzapine Neuroleptic malignant syndrome NMS have been reported in association with atypical antipsychotic administration (eg, olanzapine) Symptoms includes hyperpyrexia, muscle rigidity; altered mental status and evidence of autonomic instability Management of NMS should include immediate discontinuation of antipsychotic drugs and other drugs not essential to concurrent therapy; intensive symptomatic treatment and medical monitoring; and treatment of any concomitant serious medical problems for which specific treatments are available If a patient requires antipsychotic drug treatment after recovery from NMS, the potential reintroduction of drug therapy should be carefully considered and monitored Pregnancy category: C Neonates exposed to antipsychotic drugs during 3rd trimester of pregnancy are at risk for EPS or withdrawal symptoms after delivery; these complications vary in severity, with some being self-limited and others requiring ICU support and prolonged hospitalization Lactation: Drug enters breast milk; not recommendedPregnancy Categories A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk. B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available. Mechanism of Action May act through combination of dopamine and serotonin type 2 receptor site antagonism Absorption Peak plasma time: 6 hr (PO); 15-45 min (short-acting IM); 7 days (extended-release IM) Distribution Protein bound: 93% Vd: 1000 L Metabolism Extensively metabolized through direct glucuronidation and CYP450 oxidation Metabolites: Inactive Elimination Half-life: 21-54 hr (immediate release); 30 days (extended release) Excretion: Urine (57%), feces (30%) Oral administration May take with or without food Oral disintegrating tablets After opening sachet, peel back foil on blister; do not push tablet through foil Immediately upon opening the blister, using dry hands, remove tablet and place entire tablet in the mouth Tablet disintegration occurs rapidly in saliva so it can be easily swallowed with or without liquid IM Administration Short-acting and extended-release IM preparations are not interchangeable Short-acting: Dissolve in 2.1 mL SWI to yield 5 mg/mL solution; inject deep and slow within 1 hr of reconstitution Extended-release: Reconstitute with supplied diluent (210-mg vial in 1.3 mL; 300-mg vial in 1.8 mL; 405-mg vial in 2.3 mL); inject deep in gluteal muscle Do not use lorazepam injection for reconstitution, and do not mix with haloperidol or diazepam in syringe Storage tablets and oral disintegrating tablets Store at room temperature, 68-77°F (20-25°C) Protect from light and moisture IM, short-acting Before reconstitution: Store at room temperature, 68-77°F (20-25°C) Reconstituted vial: Store at room temperature, 68-77°F (20-25°C) for up to 1 hr if necessary Discard any unused portion of reconstituted vial Protect from light, do not freeze. IM, extended-release Before reconstitution: Store at room temperature not to exceed 30°C (86°F) Suspended solution: Store at room temperature for up to 24 hr if necessary Immediately agitate prior to product withdrawal; administer immediately once suspension is withdrawn into syringe BRAND FORM. UNIT PRICE PILL IMAGE Zyprexa oral- 2.5 mg tabletZyprexa oral- 15 mg tabletZyprexa oral- 10 mg tabletZyprexa oral- 7.5 mg tabletZyprexa oral- 5 mg tabletZyprexa oral- 20 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 7.5 mg tabletolanzapine oral- 7.5 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 2.5 mg tabletolanzapine oral- 2.5 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 2.5 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 7.5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 7.5 mg tabletolanzapine oral- 2.5 mg tabletolanzapine oral- 2.5 mg tabletolanzapine oral- 7.5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 7.5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 2.5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 7.5 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 2.5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 7.5 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 2.5 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 7.5 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 20 mg tabletolanzapine oral- 15 mg tabletolanzapine oral- 10 mg tabletolanzapine oral- 5 mg tabletolanzapine oral- 15 mg tabletZyprexa Zydis oral- 20 mg tabletZyprexa Zydis oral- 15 mg tabletZyprexa Zydis oral- 15 mg tabletZyprexa Zydis oral- 10 mg tabletZyprexa Zydis oral- 5 mg tabletZyprexa Zydis oral- 20 mg tabletZyprexa intramuscular- 10 mg vialolanzapine intramuscular- 10 mg vialolanzapine intramuscular- 10 mg vialCopyright © 2010 First DataBank, Inc.Select a drug:olanzapine oralolanzapine intramuscularPrint Patient Educationolanzapine oral OLANZAPINE - ORAL (oh-LAN-za-peen) COMMON BRAND NAME(S): Zyprexa WARNING: There may be a slightly increased risk of serious, possibly fatal side effects (such as stroke, heart failure, fast/irregular heartbeat, pneumonia) when this medication is used by older adults with dementia. This medication is not approved for the treatment of dementia-related behavior problems. Discuss the risks and benefits of this medication, as well as other effective and possibly safer treatments for dementia-related behavior problems, with the doctor.If you are using olanzapine in combination with other medication to treat depression, also carefully read the drug information for the other medication. USES: Olanzapine is used to treat certain mental/mood conditions (such as schizophrenia, bipolar disorder). It may also be used in combination with other medication to treat depression. This medication can help to decrease hallucinations and help you to think more clearly and positively about yourself, feel less agitated, and take a more active part in everyday life.Olanzapine belongs to a class of drugs called atypical antipsychotics. It works by helping to restore the balance of certain natural substances in the brain.Talk to the doctor about the risks and benefits of treatment (especially when used by teenagers). See also Precautions section. HOW TO USE: Read the Medication Guide provided by your pharmacist before you start taking olanzapine and each time you get a refill. If you have any questions, ask your doctor or pharmacist.Take this medication by mouth with or without food as directed by your doctor, usually once daily.The dosage is based on your medical condition and response to treatment. To reduce your risk of side effects, your doctor may direct you to start this medication at a low dose and gradually increase your dose. Follow your doctor's instructions carefully.Take this medication regularly to get the most benefit from it. To help you remember, take it at the same time each day. Keep taking this medication even if you feel well. Do not stop taking this medication without consulting your doctor.Tell your doctor if your condition