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Olanzapine

Pronunciation

Class: Atypical Antipsychotics
Chemical Name: 2-Methyl-4-(4-methyl-1-piperazinyl)-10H-thieno[2,3-b][1,5]benzodiazepine
Molecular Formula: C17H20N4SC23H16O6 • C17H20N4S • H20
CAS Number: 132539-06-1
Brands: Symbyax, Zyprexa, Zyprexa Zydis

Warning(s)

Special Alerts:

[Posted 03/23/2015] ISSUE: FDA has concluded a review of a study undertaken to determine the cause of elevated levels of the injectable schizophrenia drug olanzapine pamoate (Zyprexa Relprevv) in two patients who died. The study results were inconclusive. FDA is unable to exclude the possibility that the deaths were caused by rapid, but delayed, entry of the drug into the bloodstream following intramuscular injection. The study suggested that much of the drug level increase could have occurred after death, a finding that could explain the extremely high blood levels found in the two patients who died 3 to 4 days after receiving injections of appropriate doses of olanzapine pamoate. On the basis of all of the information reviewed (refer to the Drug Safety Communication for a full data summary at: ), FDA is not recommending any changes to the current prescribing or use of olanzapine pamoate injection at this time. Patients should not stop receiving treatment without first talking to their health care professionals.

BACKGROUND: Treatment with olanzapine pamoate may help improve the symptoms of schizophrenia, which include hearing voices, seeing things that are not there, and being suspicious or withdrawn. The labeling for olanzapine pamoate carries a boxed warning, FDA’s most serious type of warning, for post-injection delirium sedation (PDSS). This is an update to the MedWatch safety alert issued on June 18, 2013 located at: .

RECOMMENDATION: Patients should read the Medication Guide that comes with the olanzapine pamoate prescription each time before they get an intramuscular injection, as there may be new information. Patients receiving olanzapine pamoate or their caregivers should immediately report symptoms of PDSS to a health care professional.

Health care professionals should continue to follow the Zyprexa Relprevv Patient Care Program Risk Evaluation and Mitigation Strategy (REMS) requirements and current label recommendations. Notable requirements of the REMS include:

  • For a patient to receive treatment, the prescriber, health care facility, patient, and pharmacy must all be enrolled in the Zyprexa Relprevv Patient Care Program.

  • Zyprexa Relprevv injections must be administered at a REMS-certified health care facility with ready access to emergency response services.

  • Patients must be continuously monitored at the REMS-certified health care facility for at least 3 hours following an intramuscular injection.

  • Patients receiving Zyprexa Relprevv must be accompanied to their destination from the health care facility.

For more information visit the FDA website at: and .

REMS:

FDA approved a REMS for olanzapine to ensure that the benefits outweigh the risks. The REMS may apply to one or more preparations of olanzapine and consists of the following: medication guide, elements to assure safe use, communication plan, and implementation system. See the FDA REMS page () or the ASHP REMS Resource Center ().

Warning(s)

  • Increased Mortality in Geriatric Patients
  • Substantially higher mortality rate (4.5%) in geriatric patients with dementia-related psychosis receiving atypical antipsychotic agents (e.g., olanzapine, aripiprazole, quetiapine, risperidone) compared with those receiving placebo (2.6%).1 101

  • Most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia.)1 101

  • Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.1 101 (See Increased Mortality in Geriatric Patients with Dementia-related Psychosis under Cautions.)

Introduction

Atypical or second-generation antipsychotic agent.2 4 7 14 16 17 18 19 20 22 26

Uses for Olanzapine

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Schizophrenia

Symptomatic management of schizophrenia.1

IM for management of acute agitation in patients with schizophrenia for whom treatment with olanzapine is appropriate and who require an IM antipsychotic agent for rapid control of behaviors that interfere with diagnosis and care.1 98 102

Slideshow: View Frightful (But Dead Serious) Drug Side Effects

Bipolar Disorder

Short-term management (alone or in combination with lithium or divalproex sodium [e.g., valproate sodium, valproic acid]) of acute mixed or manic episodes and maintenance of treatment response in patients with bipolar I disorder.1 36 37

Management (in fixed-combination with fluoxetine) of acute depressive episodes in patients with bipolar depression (bipolar disorder, depressed).c

IM for management of acute agitation in patients with bipolar I disorder for whom treatment with olanzapine is appropriate and who require an IM antipsychotic agent for rapid control of behaviors that interfere with diagnosis and care.1 99

Olanzapine Dosage and Administration

Administration

Administer orally or by deep IM injection.1 (See Possible Prescribing and Dispensing Errors under Cautions.)

Oral Administration

Administer orally as conventional tablets, orally disintegrating tablets, or capsules (in fixed combination with fluoxetine) once daily without regard to meals.1 c Administer fixed-combination olanzapine and fluoxetine capsules in the evening.c

Just prior to administration, gently remove orally disintegrating tablet from blister packet; do not push tablet through foil.1 With dry hands, peel open blister package, place tablet on tongue to dissolve, and swallow with or without liquid.1

IM Administration

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Administer by IM injection slowly and deeply into the muscle mass.1 Do not administer IV or sub-Q.1

Reconstitution

Reconstitute by adding 2.1 mL of sterile water for injection to vial containing 10 mg of olanzapine to provide a solution containing approximately 5 mg/mL.1

Following reconstitution, use immediately (within 1 hour).1 Discard any unused portion.1

Dosage

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Adults

Schizophrenia
Oral

Initially, 5–10 mg, usually as a single daily dose.1 20 26 Within several days, may increase by 5 mg daily, to a target dosage of 10 mg daily.1 20

Make subsequent dosage adjustments at intervals of not less than 7 days, usually in increments or decrements of 5 mg once daily.1 20

Increasing dosage beyond 10 mg daily usually does not result in greater efficacy; such increases generally should occur only after assessment of the patient’s clinical status.1

Optimum duration of therapy currently is not known, but maintenance therapy with antipsychotic agents is well established.1 23 25 In responsive patients, continue as long as clinically necessary and tolerated, but at lowest possible effective dosage; reassess need for continued therapy periodically.1 20

Bipolar Disorder
Acute Mania: Monotherapy
Oral

Initially, 10–15 mg once daily.1 Make dosage adjustments in increments or decrements of 5 mg daily, at intervals of not less than 24 hours.1

Effective dosage in clinical studies generally ranged from 5–20 mg daily.1 36 37

If elect to use olanzapine for extended periods, periodically reevaluate the long-term usefulness for the individual patient.1

Acute Mania: Combination Therapy
Oral

Initially, 10 mg once daily when administered with lithium or divalproex sodium.1

Effective dosage of olanzapine in clinical studies generally ranged from 5–20 mg daily.1

No dosage adjustment for lithium or divalproex sodium is required when used in combination with olanzapine.1

Acute Depression: Combination Therapy

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Oral

Initially, 6 mg in fixed combination with 25 mg of fluoxetine (Symbyax 6/25) once daily in the evening.c

Increase dosage according to patient response and tolerance as indicated.c

In clinical trials, antidepressive efficacy was demonstrated at olanzapine dosages ranging from 6–12 mg daily and fluoxetine dosages ranging from 25–50 mg daily.c

If elect to use combined olanzapine and fluoxetine for extended periods, periodically reevaluate the long-term risks and benefits for the individual patient.c

Acute Agitation in Schizophrenia and Bipolar Mania
IM

Initially, 10 mg.1 Consider lower doses (2.5, 5, or 7.5 mg) when clinically warranted.1

In clinical trials, efficacy of IM olanzapine for controlling agitation in patients with schizophrenia or bipolar mania was demonstrated in a dosage range of 2.5–10 mg.1 98 99 102

If agitation persists, may administer subsequent single doses of up to 10 mg.1 However, efficacy of repeated doses was not systematically evaluated in controlled trials.1

Assess patients for orthostatic hypotension prior to administration of any subsequent IM doses.1 (See Cardiovascular Effects under Cautions.)

Oral therapy should replace IM therapy as soon as possible.1

Prescribing Limits

Adults

Schizophrenia
Oral

Safety of dosages >20 mg daily not established.1 20

Bipolar Disorder
Oral

Safety of dosages >20 mg daily not established.1

Dosages >18 mg of olanzapine and 75 mg of fluoxetine in fixed-combination for acute depressive episodes not evaluated in clinical studies.c

Acute Agitation in Schizophrenia and Bipolar Mania
IM

Safety of dosages >30 mg daily or of 10-mg IM doses given more frequently than 2 hours after the initial dose and 4 hours after the second dose not established.1

Special Populations

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Initially, 5 mg orally daily or 2.5 mg IM in debilitated patients, in those predisposed to hypotension, in those who may be particularly sensitive to the effects of olanzapine, or in those who might metabolize olanzapine slowly (e.g., nonsmoking women ≥65 years of age); when indicated, adjust dosage with caution.1

In fixed combination with fluoxetine for acute depressive episodes in bipolar disorder, an oral dosage of 6 mg of olanzapine and 25 mg of fluoxetine (Symbyax 6/25) is recommended for initial and maintenance therapy in patients predisposed to hypotension, in those with hepatic impairment, or those who might metabolize the drugs(s) slowly (e.g., female gender, geriatric age, nonsmoking status); when indicated, adjust dosage with caution.c

Geriatric Patients

Careful dosage titration of oral olanzapine recommended in patients >65 years of age; initiate therapy at low end of dosage range.1 26

Consider a lower initial IM dose of 5 mg.1

Cautions for Olanzapine

Contraindications

  • Known hypersensitivity to olanzapine or any ingredient in the formulation.1

Warnings/Precautions

Warnings

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Increased Mortality in Geriatric Patients with Dementia-related Psychosis

Possible increased risk of death with use of atypical antipsychotics in geriatric patients with dementia-related psychosis.1 101 (See Boxed Warning and see Geriatric Use under Cautions.)

Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.1 101

Hyperglycemia and Diabetes Mellitus

Severe hyperglycemia, sometimes associated with ketoacidosis, hyperosmolar coma, or death, reported in patients receiving atypical antipsychotic agents, including olanzapine.1 43 44 45 46 47 48 49 50 51 52 53 54 55 56 70 71 72 73 77 95 Closely monitor patients with preexisting diabetes mellitus for worsening of glucose control and perform fasting glucose tests at baseline and periodically for patients with risk factors for diabetes (e.g., obesity, family history of diabetes).1 44 45 46 47 48 49 50 51 52 53 54 55 If manifestations of hyperglycemia occur, test for diabetes mellitus.1 44 45 46 47 48 49 50 51 52 53 54 55

Cerebrovascular Effects

Adverse cerebrovascular effects (e.g., stroke, transient ischemic attack), sometimes fatal, reported in geriatric patients with dementia-related psychosis receiving olanzapine.1 (See Geriatric Use under Cautions.)

Neuroleptic Malignant Syndrome

Neuroleptic malignant syndrome (NMS), a potentially fatal syndrome requiring immediate discontinuance of the drug and intensive symptomatic treatment, has been reported.1

Tardive Dyskinesia

Tardive dyskinesia, a syndrome of potenially irreversible, involuntary dyskinetic movements, may occur in patients receiving antipsychotic agents.1 Consider discontinuance of olanzapine if signs and symptoms of tardive dyskinesia occur.1

Sensitivity Reactions

Allergic reactions (e.g., anaphylactoid reaction, angioedema, pruritus, urticaria, rash) reported.1 c Discontinue olanzapine if alternative etiology of rash or other allergic manifestation cannot be identified.c

General Precautions

Possible Prescribing and Dispensing Errors

Ensure accuracy of prescription; similarities in spelling, dosage intervals, and tablet strengths of Zyprexa and Zyrtec (cetirizine hydrochloride, an antihistamine) may result in errors.97

Cardiovascular Effects

Orthostatic hypotension reported with oral olanzapine, particularly during initial dosage titration period.1

Hypotension, bradycardia with or without hypotension, tachycardia, and syncope reported with IM olanzapine.1

Use oral or IM olanzapine with caution in patients with known cardiovascular or cerebrovascular disease and/or conditions that would predispose patients to hypotension (e.g., dehydration, hypovolemia, concomitant antihypertensive therapy).1

Risk of clinically important orthostatic hypotension associated with use of maximum recommended IM dosages of olanzapine (i.e., three 10-mg IM doses given 2–4 hours apart).1 If drowsiness or dizziness occurs, patients should remain recumbent until examination indicates that they are not experiencing orthostatic hypotension, bradycardia, and/or hypoventilation.1 Assess patients for orthostatic hypotension prior to administration of any subsequent IM doses.1 Administration of additional IM doses to patients with clinically significant postural change in BP is not recommended.1

Use oral or IM olanzapine with caution in patients receiving other drugs that can induce hypotension, bradycardia, or respiratory and CNS depression (e.g., benzodiazepines).1 (See Specific Drugs under Interactions.)

Nervous System Effects

Possible risk of seizures; use with caution in patients with a history of seizures or conditions known to lower the seizure threshold (e.g., dementia of the Alzheimer’s type, geriatric patients).1

Disruption of the body’s ability to reduce core body temperature possible; use caution in patients exposed to conditions that may contribute to an elevation in core body temperature (e.g., dehydration, extreme heat, strenuous exercise, concomitant use of anticholinergic agents).1

Somnolence reported.1 Potential impairment of judgment, thinking, or motor skills.1

Endocrine Effects

Elevated prolactin concentrations reported; modest elevation persists during chronic administration.1

Metabolic Effects

Weight gain possible; patients with low body mass index (BMI) may be more susceptible than normal or overweight patients.1

Hepatic Effects

Clinically important ALT increases (≥3 times the ULN) possible; use with caution in patients with manifestations of hepatic impairment, those with preexisting conditions associated with limited hepatic functional reserve, and those treated with potentially hepatotoxic drugs.1 Periodically assess transaminases in patients with hepatic disease.1

GI Effects

Esophageal dysmotility and aspiration possible;1 use with caution in patients at risk for aspiration pneumonia (e.g., geriatric patients, those with advanced Alzheimer’s dementia).1

Suicide

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Attendant risk with psychotic illnesses; closely supervise high-risk patients.1 Prescribe in the smallest quantity consistent with good patient management to reduce the risk of overdosage.1

Anticholinergic Effects

Constipation, dry mouth, and tachycardia may occur, possibly related to the drug’s anticholinergic effects; use with caution in patients with clinically important prostatic hypertrophy, angle-closure glaucoma, or history of paralytic ileus.1

Phenylketonuria

Each 5, 10, 15, or 20 mg Zyprexa Zydis orally disintegrating tablet contains aspartame (e.g., Nutrasweet), which is metabolized in the GI tract to provide 0.34, 0.45, 0.67, or 0.9 mg of phenylalanine per tablet, respectively.1 30 31 32 33 34

Combination Therapy with Lithium, Divalproex Sodium, or Fluoxetine

Consider cautions, precautions, and contraindications associated with lithium, divalproex sodium, or fluoxetine when olanzapine is used in conjunction with these drugs.1 c

Specific Populations

Pregnancy

Category C.1

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Lactation

Distributed into milk in humans.1 Women receiving olanzapine should not breast-feed.1

Pediatric Use

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Safety and efficacy not established in children <18 years of age.1 35

Geriatric Use

Safety in patients ≥65 years of age with schizophrenia does not appear to differ from that in younger adults with schizophrenia; however, tolerability profile of olanzapine in geriatric patients with dementia-related psychosis may differ from that in younger patients with schizophrenia.1

Lower initial dosages and slower titration during the initial dosing period may be advisable in some geriatric patients. (See Special Populations under Dosage and Administration.)1

Possible increased risk of death in geriatric patients with dementia-related psychosis.1 101 Substantial (1.6- to 1.7-fold) increase in mortality rate reported in geriatric patients with dementia who received atypical antipsychotic agents (e.g., olanzapine, aripiprazole, quetiapine, risperidone) fortreatment of behavioral disorders; most fatalities resulted from cardiac-related events (e.g., heart failure, sudden death) or infections (mostly pneumonia).1 101 In addition, adverse cerebrovascular effects, sometimes fatal, reported in geriatric patients with dementia-related psychosis receiving olanzapine.1 (See Cerebrovascular Effects under Cautions.)

Atypical antipsychotics are not approved for the treatment of dementia-related psychosis.1 101 (See Boxed Warning.)

Common Adverse Effects

With oral therapy, somnolence, dry mouth, dizziness, asthenia, constipation, dyspepsia, personality disorder (i.e., non-aggressive objectionable behavior), weight gain, increased appetite, tremor, postural hypotension, akathisia.1

With parenteral therapy, somnolence.1

Interactions for Olanzapine

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Metabolized by CYP1A2 and CYP2D6; CYP2D6 appears to be a minor pathway. Also metabolized by direct glucuronidation.1 Appears to have little potential to inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, and CYP3A.1

Drugs Affecting Hepatic Microsomal Enzymes

CYP1A2 or glucuronyl transferase enzyme inhibitors and inducers; pharmacokinetic interaction (altered olanzapine metabolism).1

Specific Drugs

Drug

Interaction

Comment

Alcohol

Potential additive CNS effects; concomitant use with alcohol potentiates orthostatic hypotension observed with olanzapine1

Advise patients to avoid alcohol 1

Antacids (aluminum- and magnesium-containing)

Pharmacokinetic interaction unlikely1

Biperiden

Pharmacokinetic interaction unlikely1

Benzodiazepines (parenteral) (e.g., lorazepam)

Potential additive CNS and cardiovascular effects (excessive sedation and cardiorespiratory depression) during concurrent parenteral administration1

Increased somnolence during concurrent parenteral administration of olanzapine and lorazepam; no effect on pharmacokinetics of either drug1

Concurrent use of IM olanzapine with parenteral benzodiazepines not recommended1

If administered concurrently, carefully evaluate for excessive sedation and cardiorespiratory depression1

Charcoal

Decreased peak plasma concentrations and AUC of oral olanzapine1

Charcoal may be useful in treatment for olanzapine overdose1

Cimetidine

Pharmacokinetic interaction unlikely1

CNS agents

Additive CNS effects1

Use with caution1

Desipramine

Pharmacokinetic interaction unlikely1

Diazepam (oral)

Potential additive CNS and orthostatic hypotension effects; no effect on diazepam pharmacokinetics1

Use with caution1

Dopamine agonists

Potential antagonistic effects1

Fluoxetine

Small increase in maximum plasma olanzapine concentrations and decrease in olanzapine clearance1

Not considered clinically important;c dosage modification not routinely recommended1

Fluvoxamine

Decreased clearance and increased maximum plasma concentrations of olanzapine 1

Consider lower olanzapine dosage 1

Hypotensive agents

Additive hypotensive effects1

Use with caution1

Imipramine

Pharmacokinetic interaction unlikely1

Levodopa

Potential antagonistic effects1

Lithium

Pharmacokinetic interaction unlikely1

No dosage adjustment of lithium necessary during concomitant administration1

Omeprazole

Possible increase in olanzapine clearance1

Increase in olanzapine dosage may need to be considered1

Rifampin

Possible increase in olanzapine clearance1

Increase in olanzapine dosage may need to be considered1

Theophylline

Pharmacokinetic interaction unlikely1

Valproate

Clinically important pharmacokinetic interaction unlikely1

No dosage adjustment of valproate necessary during concomitant administration1

Warfarin

Pharmacokinetic interaction unlikely1

Olanzapine Pharmacokinetics

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

Absorption

Bioavailability

Well absorbed after oral administration, with peak plasma concentrations attained in approximately 6 hours.1 Rapidly absorbed following IM administration, with peak plasma concentrations generally attained within 15–45 minutes.1

About 40% of oral dose is metabolized before reaching systemic circulation.1

Conventional and orally disintegrating olanzapine tablets are bioequivalent.1

IM administration of a 5-mg dose results in a maximum plasma olanzapine concentration that is an average of about fivefold higher than that resulting from a 5-mg oral dose.1 AUCs are similar following oral and IM administration.1

Food

Food does not affect rate or extent of oral absorption.1

Distribution

Extent

Extensively distributed throughout the body.1

Olanzapine crosses the placenta.b Distributed into milk in humans; mean infant dose at steady state estimated to be about 1.8% of maternal dose.1

Plasma Protein Binding

93% (mainly albumin and α1-acid glycoprotein).1

Elimination

Metabolism

Metabolized to inactive metabolites, principally via direct glucuronidation and oxidation by CYP1A2 and the flavin-containing monooxygenase system, with minor contribution of CYP2D6.1 a

Elimination Route

Excreted in urine (57%) and feces (30%); 7% of dose is excreted in urine as unchanged drug.1

Half-life

21–54 hours.1

Special Populations

In patients with severe renal impairment, pharmacokinetics were similar to healthy individuals.1

Although hepatic impairment may be expected to reduce clearance, a study in patients with clinically important cirrhosis (Child-Pugh class A and B) revealed little effect on the pharmacokinetics of olanzapine.1

In geriatric patients, the mean elimination half-life was about 1.5 times that of younger patients.1

In women, clearance of olanzapine is approximately 30% lower than in men; there were no apparent differences between men and women in efficacy or adverse effects.1

In smokers, olanzapine clearance is about 40% higher than in nonsmokers, although dosage adjustment is not recommended.1

Combined effects of age, smoking and gender may contribute to substantial pharmacokinetic differences in populations.1

Stability

Storage

Oral

Tablets and Orally Disintegrating Tablets

20–25°C (may be exposed to 15–30°C).1 Protect from light and moisture.1

Fixed-combination (with Fluoxetine) Capsules

Tight containers at 25°C (may be exposed to 15–30°C).c Protect from moisture.c

Parenteral

Powder for Injection

20–25°C (may be exposed to 15–30°C).1 Protect from light and avoid freezing.1

The reconstituted solution may be stored for up to 1 hour at 20–25°C, if necessary; after 1 hour, discard any unused portion.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral

Drug Compatibility
Admixture Compatibility1

Incompatible

Diazepam

Haloperidol

Actions

  • Exact mechanism of antipsychotic action has not been fully elucidated; may involve antagonism at serotonin type 2 (5-hydroxytryptamine [5-HT2A, 5-HT2C]), type 3 (5-HT3),16 type 6 (5-HT6),4 18 19 20 21 and dopamine receptors.1 4 6 7 16 17 18 19 20 21 22

  • Antagonism at other receptors (e.g., α1-adrenergic receptors, muscarinic receptors, histamine H1 receptors) may contribute to other therapeutic and adverse effects (e.g., orthostatic hypotension, anticholinergic effects, sedative effects) observed with olanzapine.1 2 6 7 16 17 20

  • Possesses little or no affinity for β-adrenergic, γ-aminobutyric acid (GABA), or benzodiazepine receptors.1 16 20

Advice to Patients

Pending revision, the material in this section should be considered in light of more recently available information in the MedWatch notification at the beginning of this monograph.

  • Risk of excessive weight gain, orthostatic hypotension, disruption of regulation of body temperature, and somnolence.1

  • Importance of avoiding overheating or dehydration.1

  • Importance of informing patients with phenylketonuria that olanzapine orally disintegrating tablets contain aspartame.1 30 31 32 33 34

  • Importance of avoiding driving, operating machinery, or performing hazardous tasks until the patient gains experience with drug’s effects.1

  • Importance of informing clinicians of existing or contemplated concomitant therapy, including prescription and OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g., diabetes mellitus, seizures, dementia).1 c

  • Importance of avoiding alcohol during olanzapine therapy.1

  • Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-feed.1

  • Importance of informing patients of other important precautionary information.1 c (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some individuals; consult specific product labeling for details.

Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations.

Olanzapine

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Tablets, film-coated

2.5 mg

Zyprexa

Lilly

5 mg

Zyprexa

Lilly

7.5 mg

Zyprexa

Lilly

10 mg

Zyprexa

Lilly

15 mg

Zyprexa

Lilly

20 mg

Zyprexa

Lilly

Tablets, orally disintegrating

5 mg

Zyprexa Zydis (with aspartame and parabens)

Lilly

10 mg

Zyprexa Zydis (with aspartame and parabens)

Lilly

15 mg

Zyprexa Zydis (with aspartame and parabens)

Lilly

20 mg

Zyprexa Zydis (with aspartame and parabens)

Lilly

Parenteral

For injection

10 mg

Zyprexa Intramuscular

Lilly

Olanzapine Combinations

Routes

Dosage Forms

Strengths

Brand Names

Manufacturer

Oral

Capsules

6 mg with Fluoxetine Hydrochloride 25 mg (of fluoxetine)

Symbyax

Lilly

6 mg with Fluoxetine Hydrochloride 50 mg (of fluoxetine)

Symbyax

Lilly

12 mg with Fluoxetine Hydrochloride 25 mg (of fluoxetine)

Symbyax

Lilly

12 mg with Fluoxetine Hydrochloride 50 mg (of fluoxetine)

Symbyax

Lilly

Comparative Pricing

This pricing information is subject to change at the sole discretion of DS Pharmacy. This pricing information was updated 05/2015. Actual costs to patients will vary depending on the use of specific retail or mail-order locations and health insurance copays.

OLANZapine 10MG Tablets (PRASCO LABORATORIES): 30/$379.98 or 90/$1,120.06

OLANZapine 15MG Tablets (PRASCO LABORATORIES): 30/$490.03 or 90/$1,430.07

Symbyax 12-25MG Capsules (LILLY): 30/$719.99 or 90/$2,110.00

Symbyax 12-50MG Capsules (LILLY): 30/$651.97 or 90/$1,864.88

Symbyax 3-25MG Capsules (LILLY): 30/$345.99 or 90/$1,003.96

Symbyax 6-25MG Capsules (LILLY): 30/$453.99 or 90/$1,342.99

Symbyax 6-50MG Capsules (LILLY): 30/$480.97 or 90/$1,390.93

ZyPREXA 10MG Tablets (LILLY): 30/$624.01 or 90/$1,788.98

ZyPREXA 15MG Tablets (LILLY): 30/$908.03 or 90/$2,701.99

ZyPREXA 2.5MG Tablets (LILLY): 30/$331.00 or 90/$960.97

ZyPREXA 20MG Tablets (LILLY): 30/$1,285.99 or 90/$3,791.06

ZyPREXA 5MG Tablets (LILLY): 30/$431.98 or 90/$1,215.99

ZyPREXA 7.5MG Tablets (LILLY): 30/$476.98 or 90/$1,397.97

ZyPREXA Zydis 10MG Dispersible Tablets (LILLY): 30/$659.97 or 90/$1,927.89

ZyPREXA Zydis 5MG Dispersible Tablets (LILLY): 30/$470.01 or 90/$1,319.94

AHFS DI Essentials. © Copyright, 2004-2015, Selected Revisions May 1, 2015. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.

† Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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3. Borison RL. Clinical efficacy of serotonin-dopamine antagonists relative to classic neuroleptics. J Clin Psychopharmacol. 1995; 15(Suppl 1):S24-29.

4. Meltzer HY. Clozapine and other atypical neuroleptics: efficacy, side effects, optimal utilization. J Clin Psychiatry. 1994; 12:38-42.

5. Lilly, Indianapolis, IN: Personal communication.

6. Baldwin DS, Montgomery SA. First clinical experience with olanzapine (LY170053): results of an open-label safety and dose-ranging study in patients with schizophrenia. Int Clin Psychopharmacol. 1995; 10:239-44. [PubMed 8748045]

7. Chapleo CB, Roberts DA. New therapies for schizophrenia. Pharm Med. 1995; 9:55-61.

8. Cohen S, Chiles J, MacNaughton A. Weight gain associated with clozapine. Am J Psychiatry. 1990; 147:503-4. [IDIS 264701] [PubMed 2316740]

9. Sandoz Pharmaceuticals. Clozaril (clozapine) prescribing information. East Hanover, NJ; 1991 Apr 15.

10. Reviewers’ comments (personal observations) on clozapine 28:16.08.

11. Lipsitz L. Orthostatic hypotension in the elderly. N Engl J Med. 1989; 321:952-7. [IDIS 259578] [PubMed 2674714]

12. Montamat SC, Cusack BJ, Vestal RE. Management of drug therapy in the elderly. N Engl J Med. 1989; 321:303-9. [IDIS 257650] [PubMed 2664519]

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