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olanzapine (Rx)Brand and Other Names:Zyprexa, Zyprexa Relprevv, more...Zyprexa Zydis

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

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
more...

Schizophrenia

PO

  • 5-10 mg/day initially; if necessary, may be titrated upward in increments of 5 mg/day at intervals >1 week
  • Maintenance: 10-20 mg/day; not to exceed 20 mg/day

IM, extended-release

  • Recommended dosing based on oral dosing
  • Oral dosage 10 mg/day: 210 mg IM every 2 weeks or 405 mg IM every 4 weeks for 1st 8 weeks, then 150 mg every 2 weeks or 300 mg every 4 weeks
  • Oral dosage 15 mg/day: 300 mg IM every 2 weeks for 1st 8 weeks, then 210 mg every 2 weeks or 405 mg every 4 weeks
  • Oral dosage 20 mg/day: 300 mg IM every 2 weeks for 1st 8 weeks, then 300 mg every 2 weeks

Bipolar Mania

Used as monotherapy or in combination with lithium or valproate

Monotherapy: 10-15 mg/day PO initially

Adjunct to lithium or valproate: 10 mg/day PO initially

Maintenance: 5-20 mg/day PO; not to exceed 20 mg/day

Depression in bipolar disorder

  • Use in combination with fluoxetine
  • 5 mg in evening; adjusted to range of 5-12.5 mg/day; may be increased up to 20 mg/day in resistant depression

Dosing considerations

  • Dosage adjustments, if necessary, should be made at intervals >24 hr

Schizophrenia or Bipolar-Related Agitation

10 mg IM (short-acting); consider 5-7.5 mg for geriatric patients or if circumstances warrant; subsequent IM doses up to 10 mg may be administered 2 hours after 1st dose and 4 hours after 2nd dose; not to exceed 30 mg/day

Dosing Modifications

Renal impairment: Dose adjustment not necessary

Hepatic impairment: Dose adjustment may be necessary; use caution

Administration

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 hour 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

Dosage Forms & Strengths

tablet

  • 2.5mg
  • 5mg
  • 7.5mg
  • 10mg
  • 15mg
  • 20mg

tablet, orally disintegrating

  • 5mg
  • 10mg
  • 15mg
  • 20mg
more...

Bipolar I Disorder (Manic or Mixed Episodes)

<13 years: Safety and efficacy not established

13-17 years: 2.5-5 mg/day PO initially; target dosage, 10 mg/day; adjust by increments/decrements of 2.5-5 mg; dosage range, 2.5-20 mg/day

Schizophrenia

<13 years: Safety and efficacy not established

13-17 years: 2.5-5 mg/day PO initially; target dosage, 10 mg/day; adjust by increments/decrements of 2.5-5 mg; dosage range, 2.5-20 mg/day

Stuttering (Off-label)

≤12 years: 1.25 mg PO at bedtime for 4 weeks, then 2.5 mg at bedtime

>12 years: 2.5 mg PO at bedtime for 4 weeks, then 5 mg at bedtime

Not approved for dementia-related psychosis, because of increased risk of cardiovascular or infection-related mortality (see Black Box Warnings)

Consider lower starting dosage

Schizophrenia

2.5-5 mg/day PO initially

IM (extended-release): 150 mg every 4 weeks in patients who are debilitated or predisposed to hypotensive episodes; not studied in patients with renal or hepatic impairment; requires deep IM administration (muscle mass in elderly may be sufficient)

Schizophrenia or Bipolar-Related Agitation

IM (short-acting): 5 mg; consider 2.5 mg if patient is predisposed to hypotensive reactions

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Interactions

Interaction Checker

olanzapine and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

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            Adverse Effects

            >10%

            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%)

            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

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            Warnings

            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 program

            Contraindications

            Documented hypersensitivity

            Cautions

            Increased risk of hyperglycemia and diabetes; in some cases, hyperglycemia concomitant with use of atypical antipsychotics has been associated with ketoacidosis, hyperosmolar coma, or death

            Monitor blood glucose of high-risk patients

            Irreversible, involuntary, dyskinetic movements may develop with antipsychotic drugs; prevalence appears to be highest among elderly individuals, especially elderly women

            May cause anticholinergic effects including paralytic ileus, urinary retention, xerostomia, BPH, and visual problems

            Neutropenia, leukopenia, and agranulocytosis reported; discontinue therapy at firs sign of blood dyscrasias or if absolute neutrophil count <1000/mm³

            Cerebrovascular effects including, stroke and transient ischemic attack resulting in death reported

            NMS has been reported

            Increased potential for weight gain; patients should receive regular monitoring of weight

            Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically during, treatment

            May elevate prolactin levels

            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 properties

            Do not reconstitute with lorazepam injection; do not mix with diazepam or haloperidol in syringe

            FDA warning regarding off-label use for dementia in elderly (see Black Box Warnings)

            In narrow-angle glaucoma, cardiovascular disease, cerebrovascular disease, prostatic hypertrophy, seizure disorders, hypovolemia, and dehydration, hyperglycemia may occur and in some cases may be extreme, resulting in ketoacidosis, hyperosmolar coma, or death; IM administration of >1 injection is associated with substantial orthostatic hypotension (33%); maintain patient in recumbent position and monitor blood pressure before repeating IM doses

            Changes from normal to high prolactin levels observed in controlled studies (incidence, 30%)

            Use caution in patients at risk of pneumonia; may cause esophageal dysmotility and aspiration

            Use caution with strenuous exercise, dehydration, heat exposure, and medications with anticholinergic effects; impaired core body temperature regulation may occur

            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

            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

            • Because of risk of postinjection delirium/sedation syndrome, availability is restricted and requires registration (call 877-772-9390)
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            Pregnancy & 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

            Pregnancy 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.

            more...
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            Pharmacology

            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%)

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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