Classes
DEA Class; Rx
Common Brand Names; Zyprexa, Zyprexa Relprevv, Zyprexa Zydis
- Antipsychotics, 2nd Generation;
- Antimanic Agents
Description
Used for the treatment of schizophrenia and for manic or mixed episodes of bipolar I disorder (as monotherapy or in combination with lithium or valproate) in both adults and adolescents; also used for maintenance treatment
Is an effective adjunct to fluoxetine for treatment-refractory depression or for depressive episodes of bipolar I disorder in adults; an IM solution formulation (Zyprexa IntraMuscular) treats acute agitation associated with schizophrenia and bipolar disorder; the extended-release IM depot (Zyprexa Relprevv) is for maintenance treatment of schizophrenia in adults
Boxed warning for an increased risk of suicidality in children, adolescents, and young adults, as well as regarding increased mortality risk in elderly patients treated for dementia-related psychosis, is noted in the product labels
Indications
Contraindications
Documented hypersensitivity
Refer to the package insert for Symbyax contraindications, when using PO olanzapine and fluoxetine in combination
Adverse Effects
- Orthostatic hypotension (≥20%)
- Weight gain, dose dependent (5-40%)
- Hypertriglyceridemia (≤39%)
- Hypercholesterolemia (≤39%)
- Somnolence, dose dependent (6-39%)
- Extrapyramidal symptoms (EPS), dose dependent (15-32%)
- 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%)
- Hypotension (2%)
- Postural hypotension (1%)
- Tremor (1%)
- Asthenia (2%)
- Akathisia reactions (2%)
- Parkinsonism reactions (4%)
- 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
Warnings
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
Pregnancy and Lactation
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 recommended
Maximum Dosage
20 mg/day PO; 30 mg/day immediate-release IM; 300 mg every 2 weeks or 405 mg every 4 weeks extended-release IM.
20 mg/day PO; 30 mg/day immediate-release IM; 300 mg every 2 weeks or 405 mg every 4 weeks extended-release IM.
20 mg/day PO for bipolar I disorder or schizophrenia; 12 mg/day PO for bipolar depression. Safety and efficacy have not been established for other indications or injectable formulations; however, doses up to 0.14 mg/kg/day (Max: 10 mg/day) PO for chemotherapy-induced nausea/vomiting and 10 to 30 mg/day PO or IM (immediate-release) for acute agitation have been used off-label. Max doses for PICU delirium are not well-defined.
10 to 12 years: 12 mg/day PO for bipolar depression. Safety and efficacy have not been established for other indications or injectable formulations; however, doses up to 20 mg/day PO for schizophrenia, 0.14 mg/kg/day (Max: 10 mg/day) PO for chemotherapy-induced nausea/vomiting, and 10 to 30 mg/day PO or IM (immediate-release) for acute agitation have been used off-label. Max doses for PICU delirium are not well-defined.
6 to 9 years: Safety and efficacy have not been established; however, doses up to 20 mg/day PO for schizophrenia, 0.14 mg/kg/day (Max: 10 mg/day) PO for chemotherapy-induced nausea/vomiting, and 10 to 30 mg/day PO or IM (immediate-release) for acute agitation have been used off-label. Max doses for PICU delirium are not well-defined.
3 to 5 years: Safety and efficacy have not been established; however, doses up 0.14 mg/kg/day (Max: 10 mg/day) PO for chemotherapy-induced nausea/vomiting have been used off-label. Max doses for PICU delirium are not well-defined.
1 to 2 years: Safety and efficacy have not been established. Max doses for PICU delirium are not well-defined (mean reported Max: 7.59 mg/day PO).
7 to 11 months: Safety and efficacy have not been established. Max doses for PICU delirium are not well-defined (mean reported Max: 7.59 mg/day PO).
1 to 6 months: Safety and efficacy have not been established.
How supplied
Olanzapine
tablet
- 2.5mg
- 5mg
- 7.5mg
- 10mg
- 15mg
- 20mg
tablet, orally disintegrating
- 5mg
- 10mg
- 15mg
- 20mg
IM injection, short-acting
- 10mg
IM injection, extended-release suspension
- 210mg/vial
- 300mg/vial
- 405mg/vial
