×
Min. Age:
Max. Age:
Gender:
Reason:
Duration:

Zyprexa

Generic Name: Olanzapine
Drug Category: Atypical Antipsychotic
Litigation Alert Level: High
This drug has been approved for use by males and females over the age of 10 years old and under the age of 65 years old for a maximum duration of 1 year.

Approved Uses

Oral ZYPREXA Indicated for:

Schizophrenia: (Oral ZYPREXA)

•Treatment of Schizophrenia in adult patients and adolescents (ages 13-17). The efficacy of ZYPREXA for the maintenance treatment of schizophrenia in the adolescent population has not been systematically evaluated.

When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.

Bipolar I Disorder (Manic or Mixed Episodes): (Oral ZYPREXA)

Monotherapy:

• Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder in adult patients and manic or mixed episodes associated with bipolar I disorder in adolescent patients (ages 13-17). The efficacy of ZYPREXA for the maintenance treatment of bipolar I disorder in the adolescent population has not been evaluated.

When deciding among the alternative treatments available for adolescents, clinicians should consider the increased potential (in adolescents as compared with adults) for weight gain and dyslipidemia. Clinicians should consider the potential long-term risks when prescribing to adolescents, and in many cases this may lead them to consider prescribing other drugs first in adolescents.

Adjunctive Therapy to Lithium or Valproate:

• Treatment of manic or mixed episodes associated with bipolar I disorder as an adjunct to lithium or valproate in adult patients. Efficacy was established in two 6-week clinical trials in adults. The effectiveness of adjunctive therapy for longer-term use has not been systematically evaluated in controlled trials.

ZYPREXA and Fluoxetine in Combination: Depressive Episodes Associated with Bipolar I Disorder: (Oral ZYPREXA)

• Oral ZYPREXA and fluoxetine in combination for treatment of depressive episodes associated with bipolar I disorder in adults and children and adolescents (ages 10-17). ZYPREXA monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.

ZYPREXA and Fluoxetine in Combination: Treatment Resistant Depression: (Oral ZYPREXA)

• Oral ZYPREXA and fluoxetine in combination for the treatment of treatment-resistant depression (major depressive disorder in patients who do not respond to 2 separate trials of different antidepressants of adequate dose and duration in the current episode) in adult patients. ZYPREXA monotherapy is not indicated for the treatment of treatment-resistant depression.

ZYPREXA and fluoxetine in combination have not been systematically studied in patients over 65 years of age or in patients under 10 years of age.

ZYPREXA IntraMuscular is indicated for:

Agitation Associated with Schizophrenia and Bipolar I Mania: (ZYPREXA IntraMuscular)

• The treatment of acute agitation associated with schizophrenia and bipolar I mania in adult patients. ZYPREXA IntraMuscular is intended for intramuscular use only. Do not administer intravenously or subcutaneously. 

Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Analyses of seventeen placebo-controlled trials (modal duration of 10 weeks), largely in patients taking atypical antipsychotic drugs, revealed a risk of death in drug-treated patients of between 1.6 to 1.7 times the risk of death in placebo-treated patients. Over the course of a typical 10-week controlled trial, the rate of death in drug-treated patients was about 4.5%, compared to a rate of about 2.6% in the placebo group. Although the causes of death were varied, most of the deaths appeared to be either cardiovascular (e.g., heart failure, sudden death) or infectious (e.g., pneumonia) in nature.

Observational studies suggest that, similar to atypical antipsychotic drugs, treatment with conventional antipsychotic drugs may increase mortality. The extent to which the findings of increased mortality in observational studies may be attributed to the antipsychotic drug as opposed to some characteristic(s) of the patients is not clear.

ZYPREXA (olanzapine) is not approved for the treatment of patients with dementia-related psychosis.

Cerebrovascular adverse events (e.g., stroke, transient ischemic attack), including fatalities, were reported in patients in trials of olanzapine in elderly patients with dementia-related psychosis. In placebo-controlled trials, there was a significantly higher incidence of cerebrovascular adverse events in patients treated with olanzapine compared to patients treated with placebo.

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. Prescriptions for olanzapine should be written for the smallest quantity of tablets consistent with good patient management, in order to reduce the risk of overdose.

Olanzapine is not approved for the treatment of patients with Alzheimer’s disease.

Potential consequences of weight gain should be considered prior to starting olanzapine. Patients receiving olanzapine should receive regular monitoring of weight.

ZYPREXA 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.

Because of the risk of orthostatic hypotension with olanzapine, caution should be observed in cardiac patients. Olanzapine has not been evaluated or used to any appreciable extent in patients with a recent history of myocardial infarction or unstable heart disease.

A potentially fatal symptom complex sometimes referred to as Neuroleptic Malignant Syndrome (NMS) has been reported in association with administration of antipsychotic drugs, including olanzapine.

Drug Reaction with Eosinophilia and Systemic Symptoms (DRESS) has been reported with olanzapine exposure.

Any patient treated with atypical antipsychotics should be monitored for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness. 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.

Undesirable alterations in lipids have been observed with olanzapine use. Clinically significant, and sometimes very high (>500 mg/dL), elevations in triglyceride levels have been observed with olanzapine use. Modest mean increases in total cholesterol have also been seen with olanzapine use.

A syndrome of potentially irreversible, involuntary, dyskinetic movements may develop in patients treated with antipsychotic drugs.

Events of leukopenia/neutropenia have been reported temporally related to antipsychotic agents, including ZYPREXA.

Olanzapine should be used cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold, e.g., Alzheimer’s dementia.

Disruption of the body’s ability to reduce core body temperature has been attributed to antipsychotic agents.

Olanzapine exhibits in vitro muscarinic receptor affinity. In premarketing clinical trials, Zyprexa was associated with constipation, dry mouth, and tachycardia, all adverse reactions possibly related to cholinergic antagonism. Such adverse reactions were not often the basis for discontinuations, but Zyprexa should be used with caution in patients with a current diagnosis or prior history of urinary retention, clinically significant prostatic hypertrophy, constipation, or a history of paralytic ileus or related conditions. In post marketing experience, the risk for severe adverse reactions (including fatalities) was increased with concomitant use of anticholinergic medications.

As with other drugs that antagonize dopamine D2 receptors, olanzapine elevates prolactin levels, and the elevation persists during chronic administration. Hyperprolactinemia may suppress hypothalamic GnRH, resulting in reduced pituitary gonadotropin secretion. This, in turn, may inhibit reproductive function by impairing gonadal steroidogenesis in both female and male patients.

Galactorrhea, amenorrhea, gynecomastia, and impotence have been reported in patients receiving prolactin-elevating compounds. Long-standing hyperprolactinemia when associated with hypogonadism may lead to decreased bone density in both female and male subjects.

Co-administration of diazepam with olanzapine potentiated the orthostatic hypotension observed with olanzapine.

Olanzapine, because of its potential for inducing hypotension, may enhance the effects of certain antihypertensive agents.

Carbamazepine therapy (200 mg bid) causes an approximately 50% increase in the clearance of olanzapine.

Fluvoxamine, a CYP1A2 inhibitor, decreases the clearance of olanzapine.

Olanzapine may antagonize the effects of levodopa and dopamine agonists.

Omeprazole and rifampin may cause an increase in olanzapine clearance.

Neonates exposed to antipsychotic drugs (including ZYPREXA), during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery. There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates.

Breastfeeding is not recommended.

GoToSource

Off-label Uses

• Anxiety disorder, attention deficit hyperactivity disorder, dementia, eating disorders, insomnia, obsessive compulsive disorder, post-traumatic stress disorder, personality disorders, substance abuse and tourette syndrome. GoToSource

• Monotherapy in patients under 13 years of age or patients older than 65 years of age. GoToSource

• Combination therapy with fluoxetine in patients under 10 years of age. GoToSource 

• Chemotherapy-induced nausea and vomiting. GoToSource

• Burning mouth syndrome. GoToSource

• Adjunctive use with antidepressants to treat sleep paralysis. GoToSource

Adverse Events

Hyperglycemia (high blood sugar), diabetes mellitus, weight gain and hyperlipidaemia (elevated lipid (fat) levels in the blood). GoToSource

Neuroleptic malignant syndrome (life-threatening drug reaction). GoToSource

Sudden cardiac death. GoToSource

A 1.7-fold increase in risk of death in elderly patients taking Zyprexa over short periods of time (approx.10 weeks). GoToSource

Tardive dyskinesia (involuntary movements). GoToSource

Diabetic ketoacidosis (life-threatening complication of diabetes). GoToSource

Strokes. GoToSource

Somnolence, mydriasis (excess pupil dilation), blurred vision, respiratory depression, hypotension (low blood pressure), hyperpyrexia (abnormally high fever), leukocytosis (elevated white blood count) and elevated creatine phosphokinase levels. GoToSource

Suicidal ideation and behavior. GoToSource 

Hypothermia. GoToSource 

Post-injection delirium/sedation syndrome. GoToSource 

Acute kidney injury. GoToSource 

Hyperprolactinemia (high levels of prolactin in the blood), metabolic syndrome and sexual dysfunction. GoToSource 

Restless legs syndrome. GoToSource 

Drug reaction with eosinophilia and systemic symptoms ( life-threatening drug reaction). GoToSource

Seizures. GoToSource

Litigation

Lawsuits filed for diabetes, pancreatitis, cardiac arrest, stroke and death. 

The material contained in GoToPills is for informational purposes only and not intended to replace the judgment, evaluation and treatment of physicians, pharmacists and other healthcare providers. GoToPills does not provide medical advice, diagnoses or treatment. Always seek the advice of your physician or other qualified health provider regarding a medical condition or treatment.

 

 iOSAndroidAppOrchard - EPIC EHR

Site Last Updated March 28, 2024