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Olanzapine 2.5 mg Tablet, Film Coated, 30-count — NDC 63187-0453-30 package photo

Olanzapine 2.5 mg Tablet, Film Coated, 30-count

by Proficient Rx LP · 30 TABLET, FILM COATED in 1 BOTTLE (63187-453-30)
NDC 63187-0453-30
🏷️ FDA NDC (as labeled) 63187-453-30 billing pads the product segment with a zero
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

⚠️
Other active recalls for Olanzapine (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 25, 2024 — Failed Impurities/Degradation Specifications (Macleods Pharmaceuticals Ltd) · FDA recall D-0154-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

🆔 Identity & classification

FDA NDC (as labeled) 63187-453-30
Product NDC 63187-453
11-digit billing NDC 63187045330
RxCUI 200034, 314154
UNII N7U69T4SZR
Application # ANDA090798
SPL Set ID e40d54bf-7334-4418-8a87-ff85941adec1
Established class (EPC) Atypical Antipsychotic
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2012-04-23
Route ORAL
Dosage form TABLET, FILM COATED
Substance OLANZAPINE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 63187-453-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 63187-0453-30. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

🏷️ RxNorm drug class

This medicine belongs to the Atypical Antipsychotic class.

Pharmacologic class Atypical Antipsychotic
Drug family (ATC) Diazepines, oxazepines, thiazepines and oxepines
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

🏭 Manufacturer & labeler

LabelerProficient Rx LP
Application holderAPOTEX INC
FDA applicationANDA090798 (ANDA)
Labeler code63187
First marketedApr 2012
Product typeHuman Prescription Drug
Portfolio1,729 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📗 Our plain-language guide HelloPharmacist
  • Olanzapine helps bring certain brain chemicals — mainly dopamine and serotonin — back into balance. Depending on what it's prescribed for, it can reduce symptoms of psychosis like...
  • What exactly is olanzapine supposed to do for me?
  • Honestly, yes — weight gain and changes in blood sugar and cholesterol are real and well-documented with olanzapine. Some people gain a significant amount of weight. Blood sugar ca...
  • Will olanzapine make me gain weight or affect my blood sugar?
📖 Read our full Olanzapine guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

💊 What it looks like

Color White
ShapeRound
ImprintAPO;OLA;10
Size1 mm
ScoringNot scored
One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.
Where does this data come from?
Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

🧪 Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

Loading inactive ingredients from the official FDA label in the background. No external source is being called by this page request.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

💲 Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3407 $10.22 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Olanzapine 2.5 mg 00832-6078-03 Upsher-Smith 30 tablets $0.081 AB Discontinued —
Olanzapine 2.5 mg 33342-0067-07 Macleods 30 tablets $0.081 AB Availability likely —
Olanzapine 2.5 mg 60505-3110-00 Apotex 10 tablets $0.081 AB Availability likely —
Olanzapine 2.5 mg 68084-0525-01 American 1 tablet $0.081 AB Availability likely —
Olanzapine 2.5 mg 72241-0051-11 Modavar 1000 tablets $0.081 AB Availability likely —
Olanzapine 2.5 mg 72303-0835-01 HEC 30 tablets $0.081 AB Availability likely —
Olanzapine 2.5 mg 72603-0154-01 NorthStar 30 tablets $0.081 AB Availability likely —
Olanzapine 2.5 mg 00615-8243-39 NCS 30 tablets — AB FDA listed —
Olanzapine 2.5 mg 13668-0166-01 Torrent 100 tablets — AB FDA listed —
Olanzapine 2.5 mg 55111-0163-01 Dr. 100 tablets — AB FDA listed —
Olanzapine 2.5 mg 60429-0620-10 Golden 1000 tablets — AB FDA listed —
Zyprexa 2.5 mg 61269-0630-30 H2-Pharma 30 tablets — AB FDA listed —
Olanzapine 2.5 mgthis 63187-0453-30 Proficient 30 tablets — AB FDA listed —
Olanzapine 2.5 mg 65862-0561-01 Aurobindo 100 tablets — AB FDA listed —
Olanzapine 2.5 mg 67046-0539-03 Coupler 30 tablets — AB FDA listed —
Olanzapine 2.5 mg 67046-1611-03 Coupler 30 tablets — AB FDA listed —
Olanzapine 2.5 mg 67877-0172-01 Ascend 100 tablets — AB FDA listed —
Olanzapine 2.5 mg 68788-4012-03 Preferred 30 tablets — AB FDA listed —
Olanzapine 2.5 mg 70518-3568-00 REMEDYREPACK 30 tablets — AB FDA listed —
Olanzapine 2.5 mg 71209-0073-01 Cadila 30 tablets — AB FDA listed —
Olanzapine 2.5 mg 71335-1760-01 Bryant 30 tablets — AB FDA listed —
Olanzapine 2.5 mg 72189-0478-30 Direct_Rx 30 tablets — AB FDA listed —
Olanzapine 2.5 mg 55154-6693-00 Cardinal 10 tablets — AB FDA listed —
Olanzapine 2.5 mg 70518-4729-00 REMEDYREPACK 30 tablets — AB FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

⏳ Availability & generic status

🏛️
2012
On the market since
Apr 2012
📍
2026
Currently FDA-listed
14 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

📊 Medicare Part D spend CMS · PART D · 2026 (Q1)

Medicare Part D (outpatient prescription) spending for Olanzapine — the program that covers self-administered drugs. 17 manufacturers.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Olanzapine. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Period
Total Part D spend
$25.57M
Claims incl. refills
939.5K
Beneficiaries
374.1K
Spend / beneficiary
$68.35
Spend / claim
$27.22
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

🔬 Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for OLANZAPINE — the ingredient across all brands.

Top reported reactions

Weight Increased6,931
Diabetes Mellitus5,413
Drug Interaction4,208
Toxicity To Various Agents4,207
Nausea4,139
Somnolence4,133
Fatigue3,686

Age at onset

Neonate318
Infant80
Child287
Adolescent577
Adult8,691
Elderly2,698

Reporter sex

109,181 reports

Serious outcomes

Death13,289
Life-threatening8,732
Disabling3,572
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 7,289 0
Most recent year is provisional (FAERS lags ~3 months).
Where does this data come from?
Adverse-event reports from the FDA Adverse Event Reporting System (FAERS) via openFDA. FAERS reports are voluntary and unverified — counts are not incidence and don’t establish causation.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
63187-0453-30 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (63187-453-30) 2015-02-02 Active

🧭 About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 63187-453-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 63187-0453-30, written without dashes as 63187045330. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 63187-0453-30, the first segment (63187) is the labeler code FDA assigned to Proficient Rx LP; the middle segment (0453) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Proficient Rx LP. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Proficient Rx LP is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🚨 Boxed Warning 🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS 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.

Olanzapine tablets are not approved for the treatment of patients with dementia-related psychosis [see Warnings and Precautions ( 5.1 , 5.14 ) and Patient Counseling Information ( 17.2 )] . When using olanzapine tablets and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax ® . WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS See full prescribing information for complete boxed warning. • Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death.

Olanzapine tablets are not approved for the treatment of patients with dementia-related psychosis. ( 5.1 , 5.14 , 17.2 ) When using olanzapine tablets and fluoxetine in combination, also refer to the Boxed Warning section of the package insert for Symbyax ® .

🎯 Indications and Usage ~3 min read ▾

1 INDICATIONS AND USAGE Olanzapine Tablets, USP are an atypical antipsychotic indicated: As oral formulation for the: • Treatment of schizophrenia. ( 1.1 ) • Adults: Efficacy was established in three clinical trials in patients with schizophrenia: two 6-week trials and one maintenance trial. ( 14.1 ) • Acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder.

( 1.2 ) • Adults: Efficacy was established in three clinical trials in patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one maintenance trial. ( 14.2 ) • Adjunct to valproate or lithium in the treatment of manic or mixed episodes associated with bipolar I disorder. ( 1.2 ) • Efficacy was established in two 6-week clinical trials in adults ( 14.2 ).

Maintenance efficacy has not been systematically evaluated. As olanzapine tablets and fluoxetine in combination for the: • Treatment of depressive episodes associated with bipolar I disorder. ( 1.5 ) • Efficacy was established with Symbyax ® (olanzapine and fluoxetine in combination) in adults; refer to the product label for Symbyax ® .

1.1Schizophrenia Olanzapine Tablets, USP are indicated for the treatment of schizophrenia. Efficacy was established in three clinical trials in adult patients with schizophrenia: two 6-week trials and one maintenance trial. [see Clinical Studies ( 14.1 )] . 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 hyperlipidemia.

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 [see Warnings and Precautions ( 5.5 , 5.6 )] . Information describing the use of olanzapine tablets and olanzapine orally disintegrating tablets in pediatric patients with schizophrenia is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

1.2Bipolar I Disorder (Manic or Mixed Episodes) Monotherapy — Olanzapine Tablets, USP are indicated for the acute treatment of manic or mixed episodes associated with bipolar I disorder and maintenance treatment of bipolar I disorder. Efficacy was established in three clinical trials in adult patients with manic or mixed episodes of bipolar I disorder: two 3- to 4-week trials and one monotherapy maintenance trial. [see Clinical Studies ( 14.2 )] . 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 hyperlipidemia.

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 [see Warnings and Precautions ( 5.5 , 5.6 )] . Information describing the use of olanzapine tablets and olanzapine orally disintegrating tablets in pediatric patients with bipolar I disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

Adjunctive Therapy to Lithium or Valproate — Olanzapine Tablets, USP are indicated for the treatment of manic or mixed episodes associated with bipolar I disorder as an adjunct to lithium or valproate. 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 [see Clinical Studies ( 14.2 )] .

1.3Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder Information on treating pediatric patients with sch…

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION Schizophrenia in adults ( 2.1 ) Oral: Start at 5 to 10 mg once daily; Target: 10 mg/day within several days Bipolar I Disorder (manic or mixed episodes) in adults ( 2.2 ) Oral: Start at 10 or 15 mg once daily Bipolar I Disorder (manic or mixed episodes) with lithium or valproate in adults ( 2.2 ) Oral: Start at 10 mg once daily Depressive Episodes associated with Bipolar I Disorder in adults ( 2.5 ) Oral in combination with fluoxetine: Start at 5 mg of oral olanzapine and 20 mg of fluoxetine once daily • Lower starting dose recommended in debilitated or pharmacodynamically sensitive patients or patients with predisposition to hypotensive reactions, or with potential for slowed metabolism.

( 2.1 ) • Olanzapine may be given without regard to meals. ( 2.1 ) Olanzapine tablets and fluoxetine in combination: • Dosage adjustments, if indicated, should be made with the individual components according to efficacy and tolerability. ( 2.5 ) • Olanzapine monotherapy is not indicated for the treatment of depressive episodes associated with bipolar I disorder.

( 2.5 ) • Safety of co-administration of doses above 18 mg olanzapine with 75 mg fluoxetine has not been evaluated. ( 2.5 )

2.1Schizophrenia Adults Dose Selection — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 5 to 10 mg initially, with a target dose of 10 mg/day within several days. Further dosage adjustments, if indicated, should generally occur at intervals of not less than 1 week, since steady state for olanzapine would not be achieved for approximately 1 week in the typical patient. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

Efficacy in schizophrenia was demonstrated in a dose range of 10 to 15 mg/day in clinical trials. However, doses above 10 mg/day were not demonstrated to be more efficacious than the 10 mg/day dose. An increase to a dose greater than the target dose of 10 mg/day (i.e., to a dose of 15 mg/day or greater) is recommended only after clinical assessment.

Olanzapine is not indicated for use in doses above 20 mg/day. Dosing in Special Populations — The recommended starting dose is 5 mg in patients who are debilitated, who have a predisposition to hypotensive reactions, who otherwise exhibit a combination of factors that may result in slower metabolism of olanzapine (e.g., nonsmoking female patients ≥65 years of age), or who may be more pharmacodynamically sensitive to olanzapine [see Warnings and Precautions ( 5.14 ), Drug Interactions ( 7 ), and Clinical Pharmacology ( 12.3 )] .

When indicated, dose escalation should be performed with caution in these patients. Maintenance Treatment — The effectiveness of oral olanzapine, 10 mg/day to 20 mg/day, in maintaining treatment response in schizophrenic patients who had been stable on olanzapine for approximately 8 weeks and were then followed for relapse has been demonstrated in a placebo-controlled trial [see Clinical Studies ( 14.1 )] . The physician who elects to use olanzapine tablets for extended periods should periodically reevaluate the long-term usefulness of the drug for the individual patient.

Adolescents Pediatric dosing information in pediatric patients with schizophrenia is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

2.2Bipolar I Disorder (Manic or Mixed Episodes) Adults Dose Selection for Monotherapy — Oral olanzapine should be administered on a once-a-day schedule without regard to meals, generally beginning with 10 or 15 mg. Dosage adjustments, if indicated, should generally occur at intervals of not less than 24 hours, reflecting the procedures in the placebo-controlled trials. When dosage adjustments are necessary, dose increments/decrements of 5 mg QD are recommended.

Short-term (3 to 4 weeks) a…

💊 Dosage Forms and Strengths 164 words ▾

3 DOSAGE FORMS AND STRENGTHS Olanzapine Tablets, USP are available as follows: Olanzapine Tablets, USP 2.5 mg are white, round, biconvex film-coated tablets, engraved "APO" on one side, "OLA" over "2.5" on the other side. Olanzapine Tablets, USP 5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “5” on the other side. Olanzapine Tablets, USP 7.5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “7.5” on the other side.

Olanzapine Tablets, USP 10 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “10” on the other side. Olanzapine Tablets, USP 15 mg are light blue, elliptical, biconvex film-coated tablets, engraved “APO” on one side, “OLA 15” on the other side. Olanzapine Tablets, USP 20 mg are light pink, elliptical, biconvex film-coated tablets, engraved “APO” on one side, “OLA 20” on the other side. • Tablets (not scored): 2.5, 5, 7.5, 10, 15, 20 mg ( 3 )

⛔ Contraindications 113 words ▾

4 CONTRAINDICATIONS • None with olanzapine tablets monotherapy. • When using olanzapine tablets and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax ® . • For specific information about the contraindications of lithium or valproate, refer to the Contraindications section of the package inserts for these other products. • None with olanzapine tablets monotherapy. • When using olanzapine tablets and fluoxetine in combination, also refer to the Contraindications section of the package insert for Symbyax ® .

( 4 ) • When using olanzapine tablets in combination with lithium or valproate, refer to the Contraindications section of the package inserts for those products. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS When using olanzapine tablets and fluoxetine in combination, also refer to the Warnings and Precautions section of the package insert for Symbyax ® . • Elderly Patients with Dementia-Related Psychosis: Increased risk of death and increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack). ( 5.1 ) • Suicide: 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; when using in combination with fluoxetine, also refer to the Boxed Warning and Warnings and Precautions sections of the package insert for Symbyax ® .

( 5.2 ) • Neuroleptic Malignant Syndrome: Manage with immediate discontinuation and close monitoring. ( 5.3 ) • Hyperglycemia: In some cases extreme and associated with ketoacidosis or hyperosmolar coma or death, has been reported in patients taking olanzapine. Patients taking olanzapine should be monitored for symptoms of hyperglycemia and undergo fasting blood glucose testing at the beginning of, and periodically during, treatment.

( 5.4 ) • Hyperlipidemia: Undesirable alterations in lipids have been observed. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically during, treatment. ( 5.5 ) • Weight Gain: Potential consequences of weight gain should be considered.

Patients should receive regular monitoring of weight. ( 5.6 ) • Tardive Dyskinesia: Discontinue if clinically appropriate. ( 5.7 ) • Orthostatic Hypotension: Orthostatic hypotension associated with dizziness, tachycardia, bradycardia and, in some patients, syncope, may occur especially during initial dose titration.

Use caution in patients with cardiovascular disease, cerebrovascular disease, and those conditions that could affect hemodynamic responses. ( 5.8 ) • Leukopenia, Neutropenia, and Agranulocytosis: Has been reported with antipsychotics, including olanzapine. Patients with a history of a clinically significant low white blood cell count (WBC) or drug induced leukopenia/neutropenia should have their complete blood count (CBC) monitored frequently during the first few months of therapy and discontinuation of olanzapine tablets should be considered at the first sign of a clinically significant decline in WBC in the absence of other causative factors.

( 5.9 ) • Seizures: Use cautiously in patients with a history of seizures or with conditions that potentially lower the seizure threshold. ( 5.11 ) • Potential for Cognitive and Motor Impairment: Has potential to impair judgment, thinking, and motor skills. Use caution when operating machinery.

( 5.12 ) • Hyperprolactinemia: May elevate prolactin levels. ( 5.15 ) • Use in Combination with Fluoxetine, Lithium or Valproate: Also refer to the package inserts for Symbyax ® , lithium, or valproate. ( 5.16 ) • Laboratory Tests: Monitor fasting blood glucose and lipid profiles at the beginning of, and periodically during, treatment.

( 5.17 )

5.1Elderly Patients with Dementia-Related Psychosis Increased Mortality — Elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Olanzapine tablets are not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning , Warnings and Precautions ( 5.14 ), and Patient Counseling Information ( 17.2 )] . In placebo-controlled clinical trials of elderly patients with dementia-related psychosis, the incidence of death in olanzapine-treated patients was significantly greater than placebo-treated patients (3.5% vs 1.5%, respectively).

Cerebrovascular Adverse Events (CVAE), Including Stroke — 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 incide…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS When using olanzapine tablets and fluoxetine in combination, also refer to the Adverse Reactions section of the package insert for Symbyax ® . Most common adverse reactions (≥5% and at least twice that for placebo) associated with: Oral Olanzapine Monotherapy: • Schizophrenia (Adults) – postural hypotension, constipation, weight gain, dizziness, personality disorder, akathisia ( 6.1 ) • Schizophrenia (Adolescents) – sedation, weight increased, headache, increased appetite, dizziness, abdominal pain, pain in extremity, fatigue, dry mouth ( 6.1 ) • Manic or Mixed Episodes, Bipolar I Disorder (Adults) – asthenia, dry mouth, constipation, increased appetite, somnolence, dizziness, tremor ( 6.1 ) • Manic or Mixed Episodes, Bipolar I Disorder (Adolescents) – sedation, weight increased, increased appetite, headache, fatigue, dizziness, dry mouth, abdominal pain, pain in extremity ( 6.1 ) Combination of Olanzapine Tablets and Lithium or Valproate: • Manic or Mixed Episodes, Bipolar I Disorder (Adults) – dry mouth, weight gain, increased appetite, dizziness, back pain, constipation, speech disorder, increased salivation, amnesia, paresthesia ( 6.1 ) Olanzapine tablets and Fluoxetine in Combination: Also refer to the Adverse Reactions section of the package insert for Symbyax ® .

( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Apotex Corp. at 1-800-667-4708 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect or predict the rates observed in practice. Clinical Trials in Adults The information below for olanzapine is derived from a clinical trial database for olanzapine consisting of 8661 adult patients with approximately 4165 patient-years of exposure to oral olanzapine and 722 patients with exposure to intramuscular olanzapine for injection.

This database includes: (1) 2500 patients who participated in multiple-dose oral olanzapine premarketing trials in schizophrenia and Alzheimer's disease representing approximately 1122 patient-years of exposure as of February 14, 1995; (2) 182 patients who participated in oral olanzapine premarketing bipolar I disorder (manic or mixed episodes) trials representing approximately 66 patient-years of exposure; (3) 191 patients who participated in an oral olanzapine trial of patients having various psychiatric symptoms in association with Alzheimer's disease representing approximately 29 patient-years of exposure; (4) 5788 patients from 88 additional oral olanzapine clinical trials as of December 31, 2001; and (5) 722 patients who participated in intramuscular olanzapine for injection premarketing trials in agitated patients with schizophrenia, bipolar I disorder (manic or mixed episodes), or dementia.

In addition, information from the premarketing 6-week clinical study database for olanzapine in combination with lithium or valproate, consisting of 224 patients who participated in bipolar I disorder (manic or mixed episodes) trials with approximately 22 patient-years of exposure, is included below. The conditions and duration of treatment with olanzapine varied greatly and included (in overlapping categories) open-label and double-blind phases of studies, inpatients and outpatients, fixed-dose and dose-titration studies, and short-term or longer-term exposure.

Adverse reactions were assessed by collecting adverse reactions, results of physical examinations, vital signs, weights, laboratory analytes, ECGs, chest x-rays, and results of ophthalmologic examinations. Certain portions of the discussion below relating to objective or numeric safety parameters, namely, dose-dependent adverse reactions, vital sign changes, weight gain, laboratory changes, and ECG changes are derived from studies in patients with schizophrenia and ha…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS The risks of using olanzapine in combination with other drugs have not been extensively evaluated in systematic studies. • Diazepam: May potentiate orthostatic hypotension. ( 7.1 , 7.2 ) • Alcohol: May potentiate orthostatic hypotension. ( 7.1 ) • Carbamazepine: Increased clearance of olanzapine.

( 7.1 ) • Fluvoxamine: May increase olanzapine levels. ( 7.1 ) • Olanzapine tablets and Fluoxetine in Combination: Also refer to the Drug Interactions section of the package insert for Symbyax ® . ( 7.1 ) • CNS Acting Drugs: Caution should be used when taken in combination with other centrally acting drugs and alcohol.

( 7.2 ) • Antihypertensive Agents: Enhanced antihypertensive effect. ( 7.2 ) • Levodopa and Dopamine Agonists: May antagonize levodopa/dopamine agonists. ( 7.2 ) • Lorazepam (IM): Increased somnolence with IM olanzapine.

(7.2) • Other Concomitant Drug Therapy: When using olanzapine in combination with lithium or valproate, refer to the Drug Interactions sections of the package insert for those products. ( 7.2 )

7.1Potential for Other Drugs to Affect Olanzapine Diazepam — The co-administration of diazepam with olanzapine potentiated the orthostatic hypotension observed with olanzapine [see Drug Interactions ( 7.2 )] . Cimetidine and Antacids — Single doses of cimetidine (800 mg) or aluminum- and magnesium-containing antacids did not affect the oral bioavailability of olanzapine. Inducers of CYP1A2 — Carbamazepine therapy (200 mg bid) causes an approximately 50% increase in the clearance of olanzapine.

This increase is likely due to the fact that carbamazepine is a potent inducer of CYP1A2 activity. Higher daily doses of carbamazepine may cause an even greater increase in olanzapine clearance. Alcohol — Ethanol (45 mg/70 kg single dose) did not have an effect on olanzapine pharmacokinetics.

The co-administration of alcohol (i.e., ethanol) with olanzapine potentiated the orthostatic hypotension observed with olanzapine [see Drug Interactions ( 7.2 )] . Inhibitors of CYP1A2 Fluvoxamine: Fluvoxamine, a CYP1A2 inhibitor, decreases the clearance of olanzapine. This results in a mean increase in olanzapine Cmax following fluvoxamine of 54% in female nonsmokers and 77% in male smokers.

The mean increase in olanzapine AUC is 52% and 108%, respectively. Lower doses of olanzapine should be considered in patients receiving concomitant treatment with fluvoxamine. Inhibitors of CYP2D6 Fluoxetine: Fluoxetine (60 mg single dose or 60 mg daily dose for 8 days) causes a small (mean 16%) increase in the maximum concentration of olanzapine and a small (mean 16%) decrease in olanzapine clearance.

The magnitude of the impact of this factor is small in comparison to the overall variability between individuals, and therefore dose modification is not routinely recommended. When using olanzapine tablets and fluoxetine in combination, also refer to the Drug Interactions section of the package insert for Symbyax ® . Warfarin — Warfarin (20 mg single dose) did not affect olanzapine pharmacokinetics [see Drug Interactions ( 7.2 )] .

Inducers of CYP1A2 or Glucuronyl Transferase — Omeprazole and rifampin may cause an increase in olanzapine clearance. Charcoal — The administration of activated charcoal (1 g) reduced the Cmax and AUC of oral olanzapine by about 60%. As peak olanzapine levels are not typically obtained until about 6 hours after dosing, charcoal may be a useful treatment for olanzapine overdose.

7.2Potential for Olanzapine to Affect Other Drugs CNS Acting Drugs — Given the primary CNS effects of olanzapine, caution should be used when olanzapine is taken in combination with other centrally acting drugs and alcohol. Antihypertensive Agents — Olanzapine, because of its potential for inducing hypotension, may enhance the effects of certain antihypertensive agents. Levodopa and Dopamine Agonists — Olanzapine may antagonize the effects of levodopa and dopamine agonists.

Lithium — Multiple doses of olanzapine (10 mg for 8 d…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS When using olanzapine tablets and fluoxetine in combination, also refer to the Use in Specific Populations section of the package insert for Symbyax ® . • Pregnancy: Olanzapine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. ( 8.1 ) • Nursing Mothers: Breast-feeding is not recommended. ( 8.3 ) • Pediatric Use: Safety and effectiveness of olanzapine tablets in children <13 years of age have not been established.

( 8.4 ) Information describing the use of olanzapine tablets and olanzapine orally disintegrating tablets in pediatric patients with schizophrenia and bipolar I disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling. However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

8.1Pregnancy Teratogenic Effects, Pregnancy Category C — In oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to 30 mg/kg/day (9 and 30 times the maximum recommended human daily oral dose on a mg/m 2 basis, respectively) no evidence of teratogenicity was observed. In an oral rat teratology study, early resorptions and increased numbers of nonviable fetuses were observed at a dose of 18 mg/kg/day (9 times the maximum recommended human daily oral dose on a mg/m 2 basis). Gestation was prolonged at 10 mg/kg/day (5 times the maximum recommended human daily oral dose on a mg/m 2 basis).

In an oral rabbit teratology study, fetal toxicity (manifested as increased resorptions and decreased fetal weight) occurred at a maternally toxic dose of 30 mg/kg/day (30 times the maximum recommended human daily oral dose on a mg/m 2 basis). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Placental transfer of olanzapine occurs in rat pups.

There are no adequate and well-controlled trials with olanzapine in pregnant females. Seven pregnancies were observed during clinical trials with olanzapine, including 2 resulting in normal births, 1 resulting in neonatal death due to a cardiovascular defect, 3 therapeutic abortions, and 1 spontaneous abortion. Nonteratogenic Effects, Class Effect - Extrapyramidal and/or withdrawal symptoms have been reported following delivery in neonates exposed to antipsychotic drugs (including olanzapine), during the third trimester of pregnancy.

These reports include: agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Olanzapine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.2Labor and Delivery The effect of olanzapine on labor and delivery in humans is unknown. Parturition in rats was not affected by olanzapine.

8.3Nursing Mothers In a study in lactating, healthy women, olanzapine was excreted in breast milk. Mean infant dose at steady state was estimated to be 1.8% of the maternal olanzapine dose. It is recommended that women receiving olanzapine should not breast-feed.

8.4Pediatric Use Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels [see Warnings and Precautions ( 5.5 , 5.6 , 5.15 , 5.17 ) and Adverse Reactions ( 6.2 )] . 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 hyperlipidemia.

Safety and effectivenes…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Teratogenic Effects, Pregnancy Category C — In oral reproduction studies in rats at doses up to 18 mg/kg/day and in rabbits at doses up to 30 mg/kg/day (9 and 30 times the maximum recommended human daily oral dose on a mg/m 2 basis, respectively) no evidence of teratogenicity was observed. In an oral rat teratology study, early resorptions and increased numbers of nonviable fetuses were observed at a dose of 18 mg/kg/day (9 times the maximum recommended human daily oral dose on a mg/m 2 basis). Gestation was prolonged at 10 mg/kg/day (5 times the maximum recommended human daily oral dose on a mg/m 2 basis).

In an oral rabbit teratology study, fetal toxicity (manifested as increased resorptions and decreased fetal weight) occurred at a maternally toxic dose of 30 mg/kg/day (30 times the maximum recommended human daily oral dose on a mg/m 2 basis). Because animal reproduction studies are not always predictive of human response, this drug should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Placental transfer of olanzapine occurs in rat pups.

There are no adequate and well-controlled trials with olanzapine in pregnant females. Seven pregnancies were observed during clinical trials with olanzapine, including 2 resulting in normal births, 1 resulting in neonatal death due to a cardiovascular defect, 3 therapeutic abortions, and 1 spontaneous abortion. Nonteratogenic Effects, Class Effect - Extrapyramidal and/or withdrawal symptoms have been reported following delivery in neonates exposed to antipsychotic drugs (including olanzapine), during the third trimester of pregnancy.

These reports include: agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. These complications have varied in severity; while in some cases symptoms have been self-limited, in other cases neonates have required intensive care unit support and prolonged hospitalization. Olanzapine tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 168 words ▾

8.4Pediatric Use Compared to patients from adult clinical trials, adolescents were likely to gain more weight, experience increased sedation, and have greater increases in total cholesterol, triglycerides, LDL cholesterol, prolactin and hepatic transaminase levels [see Warnings and Precautions ( 5.5 , 5.6 , 5.15 , 5.17 ) and Adverse Reactions ( 6.2 )] . 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 hyperlipidemia.

Safety and effectiveness of olanzapine in children <13 years of age have not been established [see Patient Counseling Information ( 17.13 )] . Safety and effectiveness of olanzapine and fluoxetine in combination in children and adolescents <18 years of age have not been established. Pediatric use information in pediatric patients with schizophrenia and bipolar I disorder is approved for Eli Lilly and Company’s olanzapine drug product labeling.

However, due to Eli Lilly and Company’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.

🧓 Geriatric Use 212 words ▾

8.5Geriatric Use Of the 2500 patients in premarketing clinical studies with oral olanzapine, 11% (263) were 65 years of age or over. In patients with schizophrenia, there was no indication of any different tolerability of olanzapine in the elderly compared to younger patients. Studies in elderly patients with dementia-related psychosis have suggested that there may be a different tolerability profile in this population compared to younger patients with schizophrenia.

Elderly patients with dementia-related psychosis treated with olanzapine are at an increased risk of death compared to placebo. In placebo-controlled studies of olanzapine in elderly patients with dementia-related psychosis, there was a higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) in patients treated with olanzapine compared to patients treated with placebo. Olanzapine is not approved for the treatment of patients with dementia-related psychosis.

Also, the presence of factors that might decrease pharmacokinetic clearance or increase the pharmacodynamic response to olanzapine should lead to consideration of a lower starting dose for any geriatric patient [see Boxed Warning , Dosage and Administration ( 2.1 ), and Warnings and Precautions ( 5.1 )] . Clinical studies of olanzapine and fluoxetine in combination did not include sufficient numbers of patients ≥65 years of age to determine whether they respond differently from younger patients.

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE

10.1Human Experience In premarketing trials involving more than 3100 patients and/or normal subjects, accidental or intentional acute overdosage of olanzapine was identified in 67 patients. In the patient taking the largest identified amount, 300 mg, the only symptoms reported were drowsiness and slurred speech. In the limited number of patients who were evaluated in hospitals, including the patient taking 300 mg, there were no observations indicating an adverse change in laboratory analytes or ECG.

Vital signs were usually within normal limits following overdoses. In postmarketing reports of overdose with olanzapine alone, symptoms have been reported in the majority of cases. In symptomatic patients, symptoms with ≥10% incidence included agitation/aggressiveness, dysarthria, tachycardia, various extrapyramidal symptoms, and reduced level of consciousness ranging from sedation to coma.

Among less commonly reported symptoms were the following potentially medically serious reactions: aspiration, cardiopulmonary arrest, cardiac arrhythmias (such as supraventricular tachycardia and 1 patient experiencing sinus pause with spontaneous resumption of normal rhythm), delirium, possible neuroleptic malignant syndrome, respiratory depression/arrest, convulsion, hypertension, and hypotension. Reports have been received of fatality in association with overdose of olanzapine alone. In 1 case of death, the amount of acutely ingested olanzapine was reported to be possibly as low as 450 mg of oral olanzapine; however, in another case, a patient was reported to survive an acute olanzapine ingestion of approximately 2 g of oral olanzapine.

10.2Management of Overdose The possibility of multiple drug involvement should be considered. In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation, which may include intubation. Gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered.

The administration of activated charcoal (1 g) reduced the Cmax and AUC of oral olanzapine by about 60%. As peak olanzapine levels are not typically obtained until about 6 hours after dosing, charcoal may be a useful treatment for olanzapine overdose. The possibility of obtundation, seizures, or dystonic reaction of the head and neck following overdose may create a risk of aspiration with induced emesis.

Cardiovascular monitoring should commence immediately and should include continuous electrocardiographic monitoring to detect possible arrhythmias. There is no specific antidote to olanzapine. Therefore, appropriate supportive measures should be initiated.

Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents. (Do not use epinephrine, dopamine, or other sympathomimetics with beta-agonist activity, since beta stimulation may worsen hypotension in the setting of olanzapine-induced alpha blockade.) Close medical supervision and monitoring should continue until the patient recovers. For specific information about overdosage with lithium or valproate, refer to the Overdosage section of the package inserts for these products.

For specific information about overdosage with olanzapine and fluoxetine in combination, refer to the Overdosage section of the Symbyax ® package insert.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. The mechanism of action of olanzapine in the treatment of acute manic or mixed episodes associated with bipolar I disorder is unknown.

12.2Pharmacodynamics Olanzapine binds with high affinity to the following receptors: serotonin 5HT 2A/2C , 5HT 6 (K i =4, 11, and 5 nM, respectively), dopamine D 1-4 (K i =11 to 31 nM), histamine H 1 (K i =7 nM), and adrenergic α 1 receptors (K i =19 nM). Olanzapine is an antagonist with moderate affinity binding for serotonin 5HT 3 (K i =57 nM) and muscarinic M 1-5 (K i =73, 96, 132, 32, and 48 nM, respectively). Olanzapine binds weakly to GABA A , BZD, and β-adrenergic receptors (K i >10 μM).

Antagonism at receptors other than dopamine and 5HT 2 may explain some of the other therapeutic and side effects of olanzapine. Olanzapine's antagonism of muscarinic M 1-5 receptors may explain its anticholinergic-like effects. Olanzapine's antagonism of histamine H 1 receptors may explain the somnolence observed with this drug.

Olanzapine's antagonism of adrenergic α 1 receptors may explain the orthostatic hypotension observed with this drug.

12.3Pharmacokinetics Oral Administration, Monotherapy — Olanzapine is well absorbed and reaches peak concentrations in approximately 6 hours following an oral dose. It is eliminated extensively by first pass metabolism, with approximately 40% of the dose metabolized before reaching the systemic circulation. Food does not affect the rate or extent of olanzapine absorption.

Pharmacokinetic studies showed that olanzapine tablets and olanzapine orally disintegrating tablets dosage forms of olanzapine are bioequivalent. Olanzapine displays linear kinetics over the clinical dosing range. Its half-life ranges from 21 to 54 hours (5th to 95th percentile; mean of 30 hr), and apparent plasma clearance ranges from 12 to 47 L/hr (5th to 95th percentile; mean of 25 L/hr).

Administration of olanzapine once daily leads to steady-state concentrations in about 1 week that are approximately twice the concentrations after single doses. Plasma concentrations, half-life, and clearance of olanzapine may vary between individuals on the basis of smoking status, gender, and age. Olanzapine is extensively distributed throughout the body, with a volume of distribution of approximately 1000 L.

It is 93% bound to plasma proteins over the concentration range of 7 to 1100 ng/mL, binding primarily to albumin and α 1 -acid glycoprotein. Metabolism and Elimination — Following a single oral dose of 14 C labeled olanzapine, 7% of the dose of olanzapine was recovered in the urine as unchanged drug, indicating that olanzapine is highly metabolized. Approximately 57% and 30% of the dose was recovered in the urine and feces, respectively.

In the plasma, olanzapine accounted for only 12% of the AUC for total radioactivity, indicating significant exposure to metabolites. After multiple dosing, the major circulating metabolites were the 10-N-glucuronide, present at steady state at 44% of the concentration of olanzapine, and 4′-N-desmethyl olanzapine, present at steady state at 31% of the concentration of olanzapine. Both metabolites lack pharmacological activity at the concentrations observed.

Direct glucuronidation and cytochrome P450 (CYP) mediated oxidation are the primary metabolic pathways for olanzapine. In vitro studies suggest that CYPs 1A2 and 2D6, and the flavin-containing monooxygenase system are involved in olanzapine oxidation. CYP2D6 mediated oxidation appears to be a minor metabolic pathway in vivo, because the clearance of olanzapine is not reduced in subjects who are deficient in this enzyme.

Specific Populations Renal Impairment — Because olanzapine is highly metabolized before e…

🧬 Mechanism of Action 66 words ▾

12.1Mechanism of Action The mechanism of action of olanzapine, as with other drugs having efficacy in schizophrenia, is unknown. However, it has been proposed that this drug's efficacy in schizophrenia is mediated through a combination of dopamine and serotonin type 2 (5HT2) antagonism. The mechanism of action of olanzapine in the treatment of acute manic or mixed episodes associated with bipolar I disorder is unknown.

📦 How Supplied / Storage and Handling 178 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1How Supplied Olanzapine Tablets, USP 2.5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “2.5” on the other side. They are supplied as follows: Bottles of 30s (NDC 63187-453-30) Olanzapine Tablets, USP 10 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “10” on the other side. They are supplied as follows: Bottles of 30s (NDC 63187-429-30)

16.2Storage and Handling Store olanzapine tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect olanzapine tablets from light and moisture.

16.1How Supplied Olanzapine Tablets, USP 2.5 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “2.5” on the other side. They are supplied as follows: Bottles of 30s (NDC 63187-453-30) Olanzapine Tablets, USP 10 mg are white, round, biconvex film-coated tablets, engraved “APO” on one side, “OLA” over “10” on the other side. They are supplied as follows: Bottles of 30s (NDC 63187-429-30)

📦 Storage and Handling 35 words ▾

16.2Storage and Handling Store olanzapine tablets at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Protect olanzapine tablets from light and moisture.

📋 Description 131 words ▾

11 DESCRIPTION Olanzapine is an atypical antipsychotic that belongs to the thienobenzodiazepine class. The chemical designation is 2-methyl-4-(4-methyl-1-piperazinyl)-10 H -thieno[2,3- b ] [1,5]benzodiazepine. The molecular formula is C 17 H 20 N 4 S, which corresponds to a molecular weight of 312.43.

The chemical structure is: Olanzapine is a yellow powder. Olanzapine Tablets, USP are intended for oral administration only. Each tablet contains olanzapine equivalent to 2.5 mg (8 μmol), 5 mg (16 μmol), 7.5 mg (24 μmol), 10 mg (32 μmol), 15 mg (48 μmol), or 20 mg (64 μmol).

Inactive ingredients are lactose, microcrystalline cellulose, starch, magnesium stearate. The color coating contains hypromellose, hydroxypropyl cellulose, polyethylene glycol, titanium dioxide (all strengths), FD&C Blue No.2 Aluminum Lake (15 mg), or red ferric oxide and yellow iron oxide (20 mg). structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved Medication Guide . Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking olanzapine tablets as monotherapy or in combination with fluoxetine. If you do not think you are getting better or have any concerns about your condition while taking olanzapine tablets, call your doctor.

When using olanzapine tablets and fluoxetine in combination, also refer to the Patient Counseling Information section of the package insert for Symbyax ® .

17.1Information on Medication Guide Prescribers or other health professionals should inform patients, their families, and their caregivers about the potential benefits and potential risks associated with treatment with olanzapine tablets, and should counsel them in its appropriate use. A patient Medication Guide is available for olanzapine tablets. Prescribers or other health professionals should instruct patients, their families, and their caregivers to read the Medication Guide and should assist them in understanding its contents.

Patients should be given the opportunity to discuss the contents of the Medication Guide and to obtain answers to any questions they may have. When using olanzapine tablets and fluoxetine in combination, also refer to the Medication Guide for Symbyax ® .

17.2Elderly Patients with Dementia-Related Psychosis: Increased Mortality and Cerebrovascular Adverse Events (CVAE), Including Stroke Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with antipsychotic drugs are at an increased risk of death. Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with olanzapine had a significantly higher incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) compared with placebo.

Olanzapine tablets are not approved for elderly patients with dementia-related psychosis [see Boxed Warning and Warnings and Precautions ( 5.1 )] .

17.3Neuroleptic Malignant Syndrome (NMS) Patients and caregivers should be counseled that a potentially fatal symptom complex sometimes referred to as NMS has been reported in association with administration of antipsychotic drugs, including olanzapine. Signs and symptoms of NMS include hyperpyrexia, muscle rigidity, altered mental status, and evidence of autonomic instability (irregular pulse or blood pressure, tachycardia, diaphoresis, and cardiac dysrhythmia) [see Warnings and Precautions ( 5.3 )] .

17.4Hyperglycemia Patients should be advised of the potential risk of hyperglycemia-related adverse reactions. Patients should be monitored regularly for worsening of glucose control. Patients who have diabetes should follow their doctor's instructions about how often to check their blood sugar while taking olanzapine tablets [see Warnings and Precautions ( 5.4 )] .

17.5Hyperlipidemia Patients should be counseled that hyperlipidemia has occurred during treatment with olanzapine. Patients should have their lipid profile monitored regularly [see Warnings and Precautions ( 5.5 )] .

17.6Weight Gain Patients should be counseled that weight gain has occurred during treatment with olanzapine. Patients should have their weight monitored regularly [see Warnings and Precautions ( 5.6 )] .

17.7Orthostatic Hypotension Patients should be advised of the risk of orthostatic hypotension, especially during the period of initial dose titration and in association with the use of concomitant drugs that may potentiate the orthostatic effect of olanzapine tablets, e.g., diazepam or alcohol [see Warnings and Precautions ( 5.8 ) and Drug Interactions ( 7 )] . Patients should be advised to change positions carefully to help prevent orthostatic hypotension, and to lie down if they feel dizzy or faint, until they feel better.

Patients should be advised to call their doctor if they experience any of the following signs and symptoms associated with…

💬 Medication Guide ~3 min read ▾

Medication Guide Olanzapine Tablets, USP 2.5 mg, 5 mg, 7.5 mg, 10 mg, 15 mg and 20 mg Read the Medication Guide that comes with olanzapine tablets before you start taking it and each time you get a refill. There may be new information. This Medication Guide does not take the place of talking to your doctor about your medical condition or treatment.

Talk with your doctor or pharmacist if there is something you do not understand or you want to learn more about olanzapine tablets. What is the most important information I should know about olanzapine tablets? Olanzapine tablets may cause serious side effects, including: • Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). • High blood sugar (hyperglycemia) . • High fat levels in your blood (increased cholesterol and triglycerides), especially in teenagers age 13 to 17. • Weight gain, especially in teenagers age 13 to 17.

These serious side effects are described below. • Increased risk of death in elderly people who are confused, have memory loss and have lost touch with reality (dementia-related psychosis). Olanzapine tablets are not approved for treating psychosis in elderly people with dementia. • High blood sugar (hyperglycemia). High blood sugar can happen if you have diabetes already or if you have never had diabetes.

High blood sugar could lead to: Your doctor should do tests to check your blood sugar before you start taking olanzapine tablets and during treatment. In people who do not have diabetes, sometimes high blood sugar goes away when olanzapine tablets are stopped. People with diabetes and some people who did not have diabetes before taking olanzapine tablets need to take medicine for high blood sugar even after they stop taking olanzapine tablets.

If you have diabetes, follow your doctor’s instructions about how often to check your blood sugar while taking olanzapine tablets. Call your doctor if you have any of these symptoms of high blood sugar (hyperglycemia) while taking olanzapine tablets: • a build up of acid in your blood due to ketones (ketoacidosis) • coma • death • feel very thirsty • need to urinate more than usual • feel very hungry • feel weak or tired • feel sick to your stomach • feel confused, or your breath smells fruity • High fat level in your blood (cholesterol and triglycerides).

High fat levels may happen in people treated with olanzapine tablets, especially in teenagers (13 to 17 years old). You may not have any symptoms, so your doctor should do blood tests to check your cholesterol and triglyceride levels before you start taking olanzapine tablets and during treatment. • Weight gain. Weight gain is very common in people who take olanzapine tablets.

Teenagers (13 to 17 years old) are more likely to gain weight and to gain more weight than adults. Some people may gain a lot of weight while taking olanzapine tablets, so you and your doctor should check your weight regularly. Talk to your doctor about ways to control weight gain, such as eating a healthy, balanced diet, and exercising.

What are olanzapine tablets? Olanzapine tablets are a prescription medicine used to treat: • schizophrenia. • bipolar disorder, including: • manic or mixed episodes that happen with bipolar I disorder. • manic or mixed episodes that happen with bipolar I disorder, when used with the medicine lithium or valproate, in adults. • long-term treatment of bipolar I disorder in adults. • episodes of depression that happen with bipolar I disorder, when used with the medicine fluoxetine (Prozac ® ), in adults. Olanzapine tablets have not been approved for use in children under 13 years of age.

The symptoms of schizophrenia include hearing voices, seeing things that are not there, having beliefs that are not true, and being suspicious or withdrawn. The symptoms of bipolar I disorder include alternating periods of depression and high or irritable mood, increased activity and restlessness,…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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