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Quetiapine Fumarate 25 mg Tablet, Film Coated, 30-count — NDC 46708-0134-30 package photo

Quetiapine Fumarate 25 mg Tablet, Film Coated, 30-count

by Alembic Pharmaceuticals Limited · 30 TABLET, FILM COATED in 1 BOTTLE (46708-134-30)
NDC 46708-0134-30
🏷️ FDA NDC (as labeled) 46708-134-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.1085/unit — full pricing hub ↓
Also comes in: 100 tablets 46708-0134-10 100 tablets 46708-0134-31 1000 tablets 46708-0134-91
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

🆔 Identity & classification

FDA NDC (as labeled) 46708-134-30
Product NDC 46708-134
11-digit billing NDC 46708013430
RxCUI 312743, 312744, 312745, 317174, 616483, 616487
UNII 2S3PL1B6UJ
UPC 0346708138301
Application # ANDA203390
SPL Set ID 93ab6237-321e-4a2c-b0ca-3fc9acb31f9a
Established class (EPC) Atypical Antipsychotic
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2017-02-21
Route ORAL
Dosage form TABLET, FILM COATED
Substance QUETIAPINE FUMARATE
Why two NDCs? The FDA registers this code as 46708-134-30 — 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 → 46708-0134-30. 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

LabelerAlembic Pharmaceuticals Limited
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA203390 (ANDA)
Labeler code46708
First marketedFeb 2017
Product typeHuman Prescription Drug
Portfolio502 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

📖 What it is MedlinePlus · NLM

Quetiapine is used to treat schizophrenia (a mental illness that affects how a person thinks, feels and behaves), bipolar disorder (a disease that causes depression, mania, and other abnormal moods) and major depressive disorder. Quetiapine is in a class of medications called atypical antipsychotics. It works by changing the activity of certain natural substances in the brain.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Quetiapine is approved to treat schizophrenia, bipolar disorder (both manic episodes and depressive episodes), and — in the extended-release form only — as an add-on to an antidepr...
  • It depends on the form. If you're taking the regular tablet, you can take it with or without food — no restrictions. But if you're on the extended-release tablet, you should take i...
  • Does it matter if I take quetiapine with food?
  • Sleepiness is actually one of the most common side effects — in some studies, more than half of patients reported it. Quetiapine blocks histamine receptors in the brain, which has...
📖 Read our full Quetiapine guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
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
ShapeCapsule
ImprintL229
Size19 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.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII L11K75P92J
    A mineral salt made from calcium and phosphate. It acts as a filler and binder in tablets to add bulk and help hold the medicine together in solid form.
  • UNII RFW2ET671P
    Hydroxypropyl cellulose is a plant-derived thickening agent made from cellulose. It acts as a binder to hold tablet ingredients together and as a film-former to coat tablets or control how fast the medicine releases.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII OP1R32D61U
    Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
  • UNII U725QWY32X
    Povidone K30 is a synthetic polymer made from petroleum. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the stomach so the medicine can be absorbed.
  • UNII 5856J3G2A2
    A starch-based powder made from potatoes and processed with sodium. It acts as a disintegrant, helping the tablet or capsule break apart quickly in the stomach so the medicine can be absorbed.
  • UNII 15FIX9V2JP
    Titanium dioxide is a bright white mineral powder commonly used as a colorant and opacifying agent. It makes pills and tablets white or lighter in color and helps make coatings non-transparent.

9 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

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 $0.1085 $3.26 / 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
Quetiapine 25 mg 00093-2063-01 Teva 100 tablets $0.023 AB Availability likely —
Quetiapine 25 mg 00904-6638-61 Major 100 tablets $0.023 AB Availability likely —
Quetiapine Fumarate 25 mg 16571-0717-01 Rising 100 tablets $0.023 AB Availability likely —
Quetiapine Fumarate 25 mg 16714-0375-01 NorthStar 100 tablets $0.023 AB Availability likely —
Quetiapine Fumarate 25 mg 29300-0147-01 Unichem 100 tablets $0.023 AB Availability likely —
Quetiapine Fumarate 25 mg 31722-0764-01 Camber 100 tablets $0.023 AB Availability likely —
Quetiapine 25 mg 43547-0518-10 Solco 100 tablets $0.023 AB Availability likely —
Quetiapine fumarate 25 mg 47335-0902-18 Sun 1000 tablets $0.023 — Discontinued —
Quetiapine Fumarate 25 mg 50268-0630-15 AvPAK 50 tablets $0.023 AB Availability likely —
Quetiapine fumarate 25 mg 60687-0327-01 American 100 tablets $0.023 AB Availability likely —
Quetiapine Fumarate 25 mg 65862-0489-01 Aurobindo 100 tablets $0.023 — Availability likely —
Quetiapine 25 mg 67877-0242-01 Ascend 100 tablets $0.023 AB Availability likely —
Quetiapine fumarate 25 mg 68001-0185-00 BluePoint 100 tablets $0.023 AB Availability likely —
Quetiapine fumarate 25 mg 68180-0445-01 Lupin 100 tablets $0.023 AB Availability likely —
Quetiapine fumarate 25 mg 82009-0095-01 Quallent 100 tablets $0.023 AB Availability likely —
Quetiapine 25 mg 16729-0145-01 Accord 100 tablets $0.028 — Availability likely —
Quetiapine fumarate 25 mg 33342-0099-11 Macleods 100 tablets $0.036 AB FDA listed —
Seroquel 25 mg 00310-0275-10 AstraZeneca 100 tablets $3.711 AB Availability likely —
Quetiapine Fumarate 25 mg 00054-0220-20 Hikma 100 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 00615-8470-05 NCS 15 tablets — AB FDA listed —
Quetiapine 25 mg 42291-0695-10 AvKARE 1000 tablets — AB Discontinued —
Quetiapine Fumarate 25 mgthis 46708-0134-30 Alembic 30 tablets — — FDA listed —
Quetiapine Fumarate 25 mg 50090-3333-00 A-S 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 51407-0066-01 Golden 100 tablets — AB FDA listed —
Quetiapine 25 mg 55154-7881-00 Cardinal 10 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 60760-0764-30 ST. 30 tablets — AB FDA listed —
Seroquel 25 mg 61269-0250-10 H2-Pharma, 100 tablets — AB FDA listed —
Quetiapine fumarate 25 mg 63187-0452-03 Proficient 3 tablets — AB FDA listed —
Quetiapine fumarate 25 mg 67046-1440-03 Coupler 30 tablets — — FDA listed —
Quetiapine fumarate 25 mg 68071-3676-09 NuCare 90 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 68071-3931-09 NuCare 90 tablets — AB FDA listed —
Quetiapine fumarate 25 mg 68788-8764-01 : 100 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 68788-8823-01 Preferred 100 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 70518-3747-00 REMEDYREPACK 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 71205-0826-30 Proficient 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 71335-1562-01 Bryant 30 tablets — AB Discontinued —
Quetiapine Fumarate 25 mg 71335-2679-01 Bryant 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 71610-0140-30 Aphena 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 72189-0446-30 Direct_Rx 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 72865-0264-01 XLCare 100 tablets — AB FDA listed —
Quetiapine 25 mg 76420-0512-01 ASCLEMED 100 tablets — AB FDA listed —
Quetiapine fumarate 25 mg 87441-0074-01 Unit 30 tablets — AB FDA listed —
Quetiapine Fumarate 25 mg 70518-4705-00 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

🏛️
2017
On the market since
Feb 2017
📍
2026
Currently FDA-listed
9 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 Quetiapine Fumarate — the program that covers self-administered drugs. 15 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 Quetiapine Fumarate. 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
$46.34M
Claims incl. refills
2.4M
Beneficiaries
1M
Spend / beneficiary
$45.82
Spend / claim
$19.65
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 Quetiapine Fumarate — the ingredient across all brands.

Top reported reactions

Fatigue2,746
Pain2,705
Condition Aggravated2,177
Headache2,153
Rheumatoid Arthritis2,114
Nausea2,109
Weight Increased2,075

Age at onset

Neonate111
Infant21
Child20
Adolescent129
Adult3,532
Elderly966

Reporter sex

29,339 reports
Male · 37%
Female · 62%
Unknown · 0%

Serious outcomes

Hospitalization11,739
Life-threatening3,991
Disabling2,891
Reports over time (by year) — tap or hover for the count & year
2022 2023 2024 2026 3,404 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
46708-0134-10 100 TABLET, FILM COATED in 1 CARTON (46708-134-10) 2017-02-21 Active
46708-0134-30 You're viewing this 30 TABLET, FILM COATED in 1 BOTTLE (46708-134-30) 2017-02-21 Active
46708-0134-31 100 TABLET, FILM COATED in 1 BOTTLE (46708-134-31) 2017-02-21 Active
46708-0134-91 1000 TABLET, FILM COATED in 1 BOTTLE (46708-134-91) 2017-02-21 Active

Pack size FAQ

What quantity is in NDC 46708-0134-30?
NDC 46708-0134-30 is a 30-count package — 30 tablet, film coated in 1 bottle.
What is the difference between NDC 46708-0134-30 and NDC 46708-0134-10?
Both are Quetiapine Fumarate 25 mg Tablet, Film Coated — the drug itself is identical. NDC 46708-0134-30 is the 30-count package, while NDC 46708-0134-10 is the 100 tablets package.
What NDC number is used to bill for this package of Quetiapine Fumarate 25 mg Tablet, Film Coated?
Bill NDC 46708-0134-30 — the 11-digit billing format is 46708013430. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 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) ✓ 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 — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope.
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 46708-134-30, 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: 46708-0134-30, written without dashes as 46708013430. 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 46708-0134-30, the first segment (46708) is the labeler code FDA assigned to Alembic Pharmaceuticals Limited; the middle segment (0134) 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 Alembic Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 100 tablets (46708-0134-10), 100 tablets (46708-0134-31), 1000 tablets (46708-0134-91). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Alembic Pharmaceuticals Limited 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 📋 Description 💬 Information for Patients 💬 Medication Guide
🚨 Boxed Warning ~1 min read ▾

WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS 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 [ see Warnings and Precautions (5.1)]. Quetiapine fumarate is not approved for the treatment of patients with dementia-related psychosis [ see Warnings and Precautions (5.1) ]. Suicidal Thoughts and Behaviors Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term studies.

These studies did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in patients over age 24; there was a reduction in risk with antidepressant use in patients aged 65 and older [ see Warnings and Precautions (5.2) ]. In patients of all ages who are started on antidepressant therapy, monitor closely for worsening, and for emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber [ see Warnings and Precautions (5.2) ].

Quetiapine fumarate is not approved for use in pediatric patients under ten years of age [ see Use in Specific Populations (8.4) ]. WARNING: INCREASED MORTALITY IN ELDERLY PATIENTS WITH DEMENTIA-RELATED PSYCHOSIS; and SUICIDAL THOUGHTS AND BEHAVIORS See full prescribing information for complete boxed 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.

Quetiapine fumarate is not approved for elderly patients with dementia-related psychosis (5.1) Suicidal Thoughts and Behaviors · Increased risk of suicidal thoughts and behavior in children, adolescents and young adults taking antidepressants (5.2) Monitor for worsening and emergence of suicidal thoughts and behaviors (5.2)

🎯 Indications and Usage ~2 min read ▾

1 INDICATIONS AND USAGE Quetiapine fumarate is an atypical antipsychotic indicated for the treatment of: · Schizophrenia (1.1) · Bipolar I disorder manic episodes (1.2) · Bipolar disorder, depressive episodes (1.2)

1.1Schizophrenia Quetiapine fumarate is indicated for the treatment of schizophrenia. The efficacy of quetiapine fumarate in schizophrenia was established in three 6-week trials in adults and one 6-week trial in adolescents (13 to 17 years). The effectiveness of quetiapine fumarate for the maintenance treatment of schizophrenia has not been systematically evaluated in controlled clinical trials [ see Clinical Studies (14.1) ].

1.2Bipolar Disorder Quetiapine fumarate is indicated for the acute treatment of manic episodes associated with bipolar I disorder, both as monotherapy and as an adjunct to lithium or divalproex. Efficacy was established in two 12-week monotherapy trials in adults, in one 3-week adjunctive trial in adults, and in one 3-week monotherapy trial in pediatric patients (10 to 17 years) [ see Clinical Studies (14.2)]. Quetiapine fumarate is indicated as monotherapy for the acute treatment of depressive episodes associated with bipolar disorder.

Efficacy was established in two 8-week monotherapy trials in adult patients with bipolar I and bipolar II disorder [ see Clinical Studies (14.2)]. Quetiapine fumarate is indicated for the maintenance treatment of bipolar I disorder, as an adjunct to lithium or divalproex. Efficacy was established in two maintenance trials in adults.

The effectiveness of quetiapine fumarate as monotherapy for the maintenance treatment of bipolar disorder has not been systematically evaluated in controlled clinical trials [ see Clinical Studies (14.2)].

1.3Special Considerations in Treating Pediatric Schizophrenia and Bipolar I Disorder Pediatric schizophrenia and bipolar I disorder are serious mental disorders, however, diagnosis can be challenging. For pediatric schizophrenia, symptom profiles can be variable, and for bipolar I disorder, patients may have variable patterns of periodicity of manic or mixed symptoms. It is recommended that medication therapy for pediatric schizophrenia and bipolar I disorder be initiated only after a thorough diagnostic evaluation has been performed and careful consideration given to the risks associated with medication treatment.

Medication treatment for both pediatric schizophrenia and bipolar I disorder is indicated as part of a total treatment program that often includes psychological, educational and social interventions.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Quetiapine fumarate can be taken with or without food (2.1). Indication Initial Dose Recommended Dose Maximum Dose Schizophrenia-Adults (2.2) 25 mg twice daily 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) (2.2) 25 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex (2.2) 50 mg twice daily 400 to 800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy (2.2) 25 mg twice daily 400 to 600 mg/day 600 mg/day Bipolar Depression-Adults (2.2) 50 mg once daily at bedtime 300 mg/day 300 mg/day · Geriatric Use: Consider a lower starting dose (50 mg/day), slower titration and careful monitoring during the initial dosing period in the elderly (2.3, 8.5) · Hepatic Impairment: Lower starting dose (25 mg/day) and slower titration may be needed (2.4, 8.7, 12.3)

2.1Important Administration Instructions Quetiapine fumarate can be taken with or without food.

2.2Recommended Dosing The recommended initial dose, titration, dose range and maximum quetiapine fumarate dose for each approved indication is displayed in Table 1. After initial dosing, adjustments can be made upwards or downwards, if necessary, depending upon the clinical response and tolerability of the patient [ see Clinical Studies (14.1 and 14.2) ]. Table 1: Recommended Dosing for Quetiapine Fumarate Indication Initial Dose and Titration Recommended Dose Maximum Dose Schizophrenia-Adults Day 1: 25 mg twice daily.

Increase in increments of 25 mg to 50 mg divided two or three times on Days 2 and 3 to range of 300 to 400 mg by Day 4. Further adjustments can be made in increments of 25 to 50 mg twice a day, in intervals of not less than 2 days. 150 to 750 mg/day 750 mg/day Schizophrenia-Adolescents (13 to 17 years) Day 1: 25 mg twice daily.

Day 2: Twice daily dosing totaling 100 mg. Day 3: Twice daily dosing totaling 200 mg. Day 4: Twice daily dosing totaling 300 mg.

Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 800 mg/day. Based on response and tolerability, may be administered three times daily.

400 to 800 mg/day 800 mg/day Schizophrenia-Maintenance N/A 1 400 to 800 mg/day 800 mg/day Bipolar Mania-Adults Monotherapy or as an adjunct to lithium or divalproex Day 1: Twice daily dosing totaling 100 mg. Day 2: Twice daily dosing totaling 200 mg. Day 3: Twice daily dosing totaling300 mg.

Day 4: Twice daily dosing totaling 400 mg. Further dosage adjustments up to 800 mg/day by Day 6 should be in increments of no greater than 200 mg/day. 400 to 800 mg/day 800 mg/day Bipolar Mania-Children and Adolescents (10 to 17 years), Monotherapy Day 1: 25 mg twice daily.

Day 2: Twice daily dosing totaling 100 mg. Day 3: Twice daily dosing totaling 200 mg. Day 4: Twice daily dosing totaling 300 mg.

Day 5: Twice daily dosing totaling 400 mg. Further adjustments should be in increments no greater than 100 mg/day within the recommended dose range of 400 to 600 mg/day. Based on response and tolerability, may be administered three times daily.

400 to 600 mg/day 600 mg/day Bipolar Depression-Adults Administer once daily at bedtime. Day 1: 50 mg Day 2: 100 mg Day 3: 200 mg Day 4: 300 mg 300 mg/day 300 mg/day Bipolar I Disorder Maintenance Therapy-Adults Administer twice daily totaling 400 to 800 mg/day as adjunct to lithium or divalproex. Generally, in the maintenance phase, patients continued on the same dose on which they were stabilized.

400 to 800 mg/day 800 mg/day 1 N/A Not applicable Maintenance Treatment for Schizophrenia and Bipolar I Disorder Maintenance Treatment – Patients should be periodically reassessed to determine the need for maintenance treatment and the appropriate dose for such treatment [see Clinical Studies (14.2)] .

2.3Dose Modifications in Elderly Patients Consideration should be given to a slower rate of dose titration and…

💊 Dosage Forms and Strengths 171 words ▾

3 DOSAGE FORMS AND STRENGTHS 25 mg tablets are white to off white, round, biconvex, film coated tablets debossed with ‘224’ on one side and ‘L’ on the other side. 50 mg tablets are white to off white, round, biconvex, film coated tablets debossed with ‘225’ on one side and ‘L’ on the other side. 100 mg tablets are white to off white, round, biconvex, film coated tablets debossed with ‘226’ on one side and ‘L’ on the other side.

200 mg tablets are white to off white, round, biconvex, film coated tablets, debossed with ‘L227’ on one side and plain on the other side. 300 mg tablets are white to off white, capsule shaped, biconvex, film coated tablets, debossed with ‘L228’ on one side and plain on the other side. 400 mg tablets are white to off white, capsule shaped, biconvex, film coated tablets, debossed with ‘L229’ on one side and plain on the other side.

25 mg, 50 mg, 100 mg, 200 mg, 300 mg, and 400 mg (3)

⛔ Contraindications 37 words ▾

4 CONTRAINDICATIONS Hypersensitivity to quetiapine or to any excipients in the quetiapine fumarate formulation. Anaphylactic reactions have been reported in patients treated with quetiapine fumarate. Known hypersensitivity to quetiapine fumarate or any components in the formulation. (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS · Cerebrovascular Adverse Reactions: Increased incidence of cerebrovascular adverse events (e.g., stroke, transient ischemic attack) hasbeen seen in elderly patients with dementia-related psychoses treated with atypical antipsychotic drugs (5.3) · Neuroleptic Malignant Syndrome (NMS): Manage with immediate discontinuation and close monitoring (5.4) · Metabolic Changes: Atypical antipsychotics have been associated with metabolic changes. These metabolic changes include hyperglycemia, dyslipidemia, and weight gain (5.5) · Hyperglycemia and Diabetes Mellitus: Monitor patients for symptoms of hyperglycemia including polydipsia, polyuria, polyphagia, and weakness.

Monitor glucose regularly in patients with diabetes or at risk for diabetes · Dyslipidemia: Undesirable alterations have been observed in patients treated with atypical antipsychotics. Appropriate clinical monitoring is recommended, including fasting blood lipid testing at the beginning of, and periodically, during treatment · Weight Gain: Gain in body weight has been observed; clinical monitoring of weight is recommended · Tardive Dyskinesia: Discontinue if clinically appropriate (5.6) · Hypotension: Use with caution in patients with known cardiovascular or cerebrovascular disease (5.7) · Increased Blood Pressure in Children and Adolescents: Monitor blood pressure at the beginning of, and periodically during treatment in children and adolescents (5.9) · Leukopenia, Neutropenia and Agranulocytosis: Monitor complete blood count frequently during the first few months of treatment in patients with a pre-existing low white cell count or a history of leukopenia/neutropenia and discontinue quetiapine fumarate at the first sign of a decline in WBC in absence of other causative factors (5.10) · Cataracts: Lens changes have been observed in patients during long-term quetiapine treatment.

Lens examination is recommended when starting treatment and at 6-month intervals during chronic treatment (5.11)

5.1Increased 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. Analysis of 17 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.

Quetiapine fumarate is not approved for the treatment of patients with dementia-related psychosis [see Boxed Warning] .

5.2Suicidal Thoughts and Behaviors in Adolescents and Young Adults Patients with major depressive disorder (MDD), both adult and pediatric, may experience worsening of their depression and/or the emergence of suicidal ideation and behavior (suicidality) or unusual changes in behavior, whether or not they are taking antidepressant medications, and this risk may persist until significant remission occurs. Suicide is a known risk of depression and certain other psychiatric disorders, and these disorders themselves are the strongest predictors of suicide.

There has been a long-standing concern, however, that antidepressants may have a role in inducing worsening of depression and the emergence of suicidality in certain patients during…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following adverse reactions are discussed in more detail in other sections of the labeling: · Increased mortality in elderly patients with dementia-related psychosis [see Warning and Precautins (5.1)] · Suicidal thoughts and behaviors in adolescents and young adults [see Warning and Precautins (5.2)] · Cerebrovascular adverse reactions, including stroke in elderly patients with dementia-related psychosis [see Warning and Precautins (5.3)] · Neuroleptic Malignant Syndrome (NMS) [ see Warning and Precautins (5.4) ] · Metabolic changes (hyperglycemia, dyslipidemia, weight gain) [ see Warning and Precautins (5.5) ] · Tardive dyskinesia [ see Warning and Precautins (5.6) ] · Hypotension [ see Warning and Precautins (5.7) ] • Falls [see Warnings and Precautions 5.8] · Increases in blood pressure (children and adolescents) [ see Warning and Precautins (5.9) ] · Leukopenia, neutropenia and agranulocytosis [ see Warning and Precautins (5.10) ] · Cataracts [ see Warning and Precautins (5.11) ] · QT Prolongation [ see Warning and Precautins (5.12) ] · Seizures [ see Warning and Precautins (5.13) ] · Hypothyroidism [ see Warning and Precautins (5.14) ] · Hyperprolactinemia[ see Warning and Precautins (5.15) ] · Potential for cognitive and motor impairment [ see Warning and Precautins (5.16) ] · Body temperature regulation[ see Warning and Precautins (5.17) ] · Dysphagia [ see Warning and Precautins (5.18) ] · Discontinuation Syndrome [ see Warning and Precautins (5.19) ] • Most common adverse reactions (incidence ≥5% and twice placebo): Adults: somnolence, dry mouth, dizziness, constipation, asthenia, abdominal pain, postural hypotension, pharyngitis, weight gain, lethargy, ALT increased, dyspepsia (6.1) • Children and Adolescents: somnolence, dizziness, fatigue, increased appetite, nausea, vomiting, dry mouth, tachycardia, weight increased (6.1) To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .

6.1Clinical Study Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical studies of another drug and may not reflect the rates observed in practice. Adults: The information below is derived from a clinical trial database for quetiapine fumarate consisting of over 4300 patients. This database includes 698 patients exposed to quetiapine fumarate for the treatment of bipolar depression, 405 patients exposed to quetiapine fumarate for the treatment of acute bipolar mania (monotherapy and adjunct therapy), 646 patients exposed to quetiapine fumarate for the maintenance treatment of bipolar I disorder as adjunct therapy, and approximately 2600 patients and/or normal subjects exposed to 1 or more doses of quetiapine fumarate for the treatment of schizophrenia.

Of these approximately 4300 subjects, approximately 4000 (2300 in schizophrenia, 405 in acute bipolar mania, 698 in bipolar depression, and 646 for the maintenance treatment of bipolar I disorder) were patients who participated in multiple dose effectiveness trials, and their experience corresponded to approximately 2400 patient-years. The conditions and duration of treatment with quetiapine fumarate 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 events, results of physical examinations, vital signs, weights, laboratory analyses, ECGs, and results of ophthalmologic examinations. The stated frequencies of adverse reactions represent the proportion of individuals who experienced, at least once, a treatment-emergent adverse reaction of the type listed. Adverse Reactions Associated with Discontinuation of Treatment in Short-Term, Placebo-Controlled Trials Schizophrenia: Overal…

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS · Concomitant use of strong CYP3A4 inhibitors: Reduce quetiapine dose to one sixth when coadministered with strong CYP3A4 inhibitors (e.g., ketoconazole, ritonavir) (2.5, 7.1, 12.3) · Concomitant use of strong CYP3A4 inducers: Increase quetiapine dose up to 5 fold when used in combination with a chronic treatment (more than 7 to 14 days) of potent CYP3A4 inducers (e.g., phenytoin, rifampin, St. John’s wort) (2.6, 7.1, 12.3) · Discontinuation of strong CYP3A4 inducers: Reduce quetiapine dose by 5 fold within 7 to 14 days of discontinuation of CYP3A4 inducers (2.6, 7.1, 12.3)

7.1Effect of Other Drugs on Quetiapine The risks of using quetiapine fumarate in combination with other drugs have not been extensively evaluated in systematic studies. Given the primary CNS effects of quetiapine fumarate, caution should be used when it is taken in combination with other centrally acting drugs. Qetiapine fumarate potentiated the cognitive and motor effects of alcohol in a clinical trial in subjects with selected psychotic disorders, and alcoholic beverages should be limited while taking quetiapine.

Quetiapine exposure is increased by the prototype CYP3A4 inhibitors (e.g., ketoconazole, itraconazole, indinavir, ritonavir, nefazodone, etc.) and decreased by the prototype CYP3A4 inducers (e.g., phenytoin, carbamazepine, rifampin, avasimibe, St. John’s wort etc.). Dose adjustment of quetiapine will be necessary if it is co-administered with potent CYP3A4 inducers or inhibitors.

CYP3A4 inhibitors: Coadministration of ketoconazole, a potent inhibitor of cytochrome CYP3A4, resulted in significant increase in quetiapine exposure. The dose of quetiapine fumarate should be reduced to one sixth of the original dose if co-administered with a strong CYP3A4 inhibitor [see Dosage and Administration (2.5) and Clinical Pharmacology (12.3)] . CYP3A4 inducers: Coadministration of quetiapine and phenytoin, a CYP3A4 inducer increased the mean oral clearance of quetiapine by 5fold.

Increased doses of quetiapine fumarate up to 5 fold may be required to maintain control of symptoms of schizophrenia in patients receiving quetiapine and phenytoin, or other known potent CYP3A4 inducers [see Dosage and Administration (2.6) and Clinical Pharmacology (12.3)] . When the CYP3A4 inducer is discontinued, the dose of quetiapine fumarate should be reduced to the original level within 7 to 14 days [see Dosage and Administration (2.6)] . The potential effects of several concomitant medications on quetiapine pharmacokinetics were studied [see Clinical Pharmacology (12.3)] .

7.2Effect of Quetiapine on Other Drugs Because of its potential for inducing hypotension, quetiapine fumarate may enhance the effects of certain antihypertensive agents. Qetiapine fumarate may antagonize the effects of levodopa and dopamine agonists. There are no clinically relevant pharmacokinetic interactions of Quetiapine fumarate on other drugs based on the CYP pathway.

Quetiapine fumarate and its metabolites are non-inhibitors of major metabolizing CYP’s (1A2, 2C9, 2C19, 2D6 and 3A4).

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS · Pregnancy: Limited human data. Based on animal data, may cause fetal harm. Quetiapine should be used only if the potential benefit justifies the potential risk (8.1) · Nursing Mothers: Discontinue drug or nursing, taking into consideration importance of drug to mother’s health (8.3)

8.1Pregnancy Pregnancy Category C: Risk Summary There are no adequate and well-controlled studies of quetiapine fumarate use in pregnant women. In limited published literature, there were no major malformations associated with quetiapine exposure during pregnancy. In animal studies, embryo-fetal toxicity occurred.

Quetiapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Human Data There are limited published data on the use of quetiapine for treatment of schizophrenia and other psychiatric disorders during pregnancy. In a prospective observational study, 21 women exposed to quetiapine and other psychoactive medications during pregnancy delivered infants with no major malformations.

Among 42 other infants born to pregnant women who used quetiapine during pregnancy, there were no major malformations reported (one study of 36 women, 6 case reports). Due to the limited number of exposed pregnancies, these postmarketing data do not reliably estimate the frequency or absence of adverse outcomes. Neonates exposed to antipsychotic drugs (including quetiapine fumarate), during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. 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. Animal Data When pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect at doses up to 2.4 times the maximum recommended human dose (MRHD) for schizophrenia of 800 mg/day based on mg/m 2 body surface area.

However, there was evidence of embryo-fetal toxicity, which included delays in skeletal ossification occurring at approximately 1 and 2 times the MRHD of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1 to 2 times the MRHD (all doses tested) in rabbits.

In a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.12, and 0.24 times the MRHD of 800 mg/day based on mg/m 2 body surface area. However, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the MRHD.

8.2Labor & Delivery The effect of quetiapine fumarate on labor and delivery in humans is unknown.

8.3Nursing Mothers Quetiapine fumarate was excreted into human milk. Because of the potential for serious adverse reactions in nursing infants from quetiapine fumarate, a decision should be made whether to discontinue nursing or to discontinue the drug, taking into account the importance of the drug to the mother’s health. In published case reports, the level of quetiapine in breast milk ranged from undetectable to 170 μg/L.

The estimated infant dose ranged from 0.09% to 0.43% of the weight-adjusted maternal dose. Based on a limited number (N=8) of mother/infant pairs, calculated infant daily doses range from less than 0.01 mg/kg (at a maternal daily dose up to 100 mg quetiapine) to 0.1 mg/kg (at a maternal daily dose of 400 mg).

8.4 Pediatric Use In general, the adverse reactions obse…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Pregnancy Category C: Risk Summary There are no adequate and well-controlled studies of quetiapine fumarate use in pregnant women. In limited published literature, there were no major malformations associated with quetiapine exposure during pregnancy. In animal studies, embryo-fetal toxicity occurred.

Quetiapine should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus. Human Data There are limited published data on the use of quetiapine for treatment of schizophrenia and other psychiatric disorders during pregnancy. In a prospective observational study, 21 women exposed to quetiapine and other psychoactive medications during pregnancy delivered infants with no major malformations.

Among 42 other infants born to pregnant women who used quetiapine during pregnancy, there were no major malformations reported (one study of 36 women, 6 case reports). Due to the limited number of exposed pregnancies, these postmarketing data do not reliably estimate the frequency or absence of adverse outcomes. Neonates exposed to antipsychotic drugs (including quetiapine fumarate), during the third trimester of pregnancy are at risk for extrapyramidal and/or withdrawal symptoms following delivery.

There have been reports of agitation, hypertonia, hypotonia, tremor, somnolence, respiratory distress and feeding disorder in these neonates. 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. Animal Data When pregnant rats and rabbits were exposed to quetiapine during organogenesis, there was no teratogenic effect at doses up to 2.4 times the maximum recommended human dose (MRHD) for schizophrenia of 800 mg/day based on mg/m 2 body surface area.

However, there was evidence of embryo-fetal toxicity, which included delays in skeletal ossification occurring at approximately 1 and 2 times the MRHD of 800 mg/day in both rats and rabbits, and an increased incidence of carpal/tarsal flexure (minor soft tissue anomaly) in rabbit fetuses at approximately 2 times the MRHD. In addition, fetal weights were decreased in both species. Maternal toxicity (observed as decreased body weights and/or death) occurred at 2 times the MRHD in rats and approximately 1 to 2 times the MRHD (all doses tested) in rabbits.

In a peri/postnatal reproductive study in rats, no drug-related effects were observed when pregnant dams were treated with quetiapine at doses 0.01, 0.12, and 0.24 times the MRHD of 800 mg/day based on mg/m 2 body surface area. However, in a preliminary peri/postnatal study, there were increases in fetal and pup death, and decreases in mean litter weight at 3 times the MRHD.

🧒 Pediatric Use ~2 min read ▾

8.4Pediatric Use In general, the adverse reactions observed in children and adolescents during the clinical trials were similar to those in the adult population with few exceptions. Increases in systolic and diastolic blood pressure occurred in children and adolescents and did not occur in adults. Orthostatic hypotension occurred more frequently in adults (4 to 7%) compared to children and adolescents (< 1%) [see Warnings and Precautions (5.7) and Adverse Reactions (6.1)].

Schizophrenia The efficacy and safety of quetiapine fumarate in the treatment of schizophrenia in adolescents aged 13 to 17 years were demonstrated in one 6-week, double-blind, placebo-controlled trial [see Indications and Usage (1.1), Dosage and Administration (2.2), Adverse Reactions (6.1), and Clinical Studies (14.1)]. Safety and effectiveness of quetiapine fumarate in pediatric patients less than 13 years of age with schizophrenia have not been established. Maintenance The safety and effectiveness of quetiapine fumarate in the maintenance treatment of bipolar disorder has not been established in pediatric patients less than 18 years of age.

The safety and effectiveness of quetiapine fumarate in the maintenance treatment of schizophrenia has not been established in any patient population, including pediatric patients. Bipolar Mania The efficacy and safety of quetiapine fumarate in the treatment of mania in children and adolescents ages 10 to 17 years with Bipolar I disorder was demonstrated in a 3-week, double-blind, placebo controlled, multicenter trial [see Indications and Usage (1.2), Dosage and Administration (2.3), Adverse Reactions (6.1), and Clinical Studies (14.2)] .

Safety and effectiveness of quetiapine fumarate in pediatric patients less than 10 years of age with bipolar mania have not been established. Bipolar Depression Safety and effectiveness of quetiapine fumarate in pediatric patients less than 18 years of age with bipolar depression have not been established. A clinical trial with quetiapine fumarate extended-release tablets was conducted in children and adolescents (10 to 17 years of age) with bipolar depression, efficacy was not established.

Some differences in the pharmacokinetics of quetiapine were noted between children/adolescents (10 to 17 years of age) and adults. When adjusted for weight, the AUC and Cmax of quetiapine were 41% and 39% lower, respectively, in children and adolescents compared to adults. The pharmacokinetics of the active metabolite, norquetiapine, were similar between children/adolescents and adults after adjusting for weight [see Clinical Pharmacology (12.3)] .

🧓 Geriatric Use 120 words ▾

8.5Geriatric Use Of the approximately 3700 patients in clinical studies with quetiapine fumarate, 7% (232) were 65 years of age or over. In general, there was no indication of any different tolerability of quetiapine fumarate in the elderly compared to younger adults. Nevertheless, the presence of factors that might decrease pharmacokinetic clearance, increase the pharmacodynamic response to quetiapine fumarate, or cause poorer tolerance or orthostasis, should lead to consideration of a lower starting dose, slower titration, and careful monitoring during the initial dosing period in the elderly.

The mean plasma clearance of quetiapine fumarate was reduced by 30% to 50% in elderly patients when compared to younger patients [ see Clinical Pharmacology (12.3) and Dosage and Administration (2.3) ].

🆘 Overdosage ~2 min read ▾

10 OVERDOSAGE

10.1Human Experience In clinical trials, survival has been reported in acute overdoses of up to 30 grams of quetiapine. Most patients who overdosed experienced no adverse reactions or recovered fully from the reported reactions. Death has been reported in a clinical trial following an overdose of 13.6 grams of quetiapine alone.

In general, reported signs and symptoms were those resulting from an exaggeration of the drug’s known pharmacological effects, i.e., drowsiness and sedation, tachycardia and hypotension. Patients with pre-existing severe cardiovascular disease may be at an increased risk of the effects of overdose [see Warnings and Precautions (5.12)]. One case, involving an estimated overdose of 9600 mg, was associated with hypokalemia and first-degree heart block.

In post-marketing experience, there were cases reported of QT prolongation with overdose. There were also very rare reports of overdose of quetiapine fumarate alone resulting in death or coma.

10.2Management of Overdosage In case of acute overdosage, establish and maintain an airway and ensure adequate oxygenation and ventilation. Gastric lavage (after intubation, if patient is unconscious) and administration of activated charcoal together with a laxative should be considered. The possibility of obtundation, seizure 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. If antiarrhythmic therapy is administered, disopyramide, procainamide and quinidine carry a theoretical hazard of additive QT-prolonging effects when administered in patients with acute overdosage of quetiapine fumarate. Similarly it is reasonable to expect that the alpha-drenergic-blocking properties of bretylium might be additive to those of quetiapine, resulting in problematic hypotension.

There is no specific antidote to quetiapine fumarate. Therefore, appropriate supportive measures should be instituted. The possibility of multiple drug involvement should be considered.

Hypotension and circulatory collapse should be treated with appropriate measures such as intravenous fluids and/or sympathomimetic agents (epinephrine and dopamine should not be used, since beta stimulation may worsen hypotension in the setting of quetiapine-induced alpha blockade). In cases of severe extrapyramidal symptoms, anticholinergic medication should be administered. Close medical supervision and monitoring should continue until the patient recovers.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action The mechanism of action of quetiapine fumarate is unknown. However, it has been proposed that the efficacy of quetiapine fumarate in schizophrenia and its mood stabilizing properties in bipolar depression and mania are mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of quetiapine fumarate.

Quetiapine fumarate’s antagonism of histamine H 1 receptors may explain the somnolence observed with this drug. Quetiapine fumarate’s antagonism of adrenergic α 1 receptors may explain the orthostatic hypotension observed with this drug.

12.2Pharmacodynamics Quetiapine fumarate is an antagonist at multiple neurotransmitter receptors in the brain: serotonin 5HT 1A and 5HT 2 (IC 50s =717 & 148nM, respectively), dopamine D 1 and D 2 (IC 50s =1268 & 329nM, respectively), histamine H 1 (IC 50 =30nM), and adrenergic α 1 and α 2 receptors (IC 50s =94 & 271nM, respectively). quetiapine fumarate has no appreciable affinity at cholinergic muscarinic and benzodiazepine receptors (IC 50s >5000 nM). Effect on QT Interval In clinical trials quetiapine was not associated with a persistent increase in QT intervals.

However, the QT effect was not systematically evaluated in a thorough QT study. In post marketing experience there were cases reported of QT prolongation in patients who overdosed on quetiapine [see Overdosage (10.1)] , in patients with concomitant illness, and in patients taking medicines known to cause electrolyte imbalance or increase QT interval.

12.3Pharmacokinetics Adults Quetiapine fumarate activity is primarily due to the parent drug. The multiple-dose pharmacokinetics of quetiapine are dose-proportional within the proposed clinical dose range, and quetiapine accumulation is predictable upon multiple dosing. Elimination of quetiapine is mainly via hepatic metabolism with a mean terminal half-life of about 6 hours within the proposed clinical dose range.

Steady-state concentrations are expected to be achieved within two days of dosing. Quetiapine is unlikely to interfere with the metabolism of drugs metabolized by cytochrome P450 enzymes. Children and Adolescents At steady state the pharmacokinetics of the parent compound, in children and adolescents (10 to 17 years of age), were similar to adults.

However, when adjusted for dose and weight, AUC and C max of the parent compound were 41% and 39% lower, respectively, in children and adolescents than in adults. For the active metabolite, norquetiapine, AUC and C max were 45% and 31% higher, respectively, in children and adolescents than in adults. When adjusted for dose and weight, the pharmacokinetics of the metabolite, norquetiapine, was similar between children and adolescents and adults [see Use in Specific Populations (8.4)] .

Absorption Quetiapine fumarate is rapidly absorbed after oral administration, reaching peak plasma concentrations in 1.5 hours. The tablet formulation is 100% bioavailable relative to solution. The bioavailability of quetiapine is marginally affected by administration with food, with C max and AUC values increased by 25% and 15%, respectively.

Distribution Quetiapine is widely distributed throughout the body with an apparent volume of distribution of 10 ± 4 L/kg. It is 83% bound to plasma proteins at therapeutic concentrations. In vitro , quetiapine did not affect the binding of warfarin or diazepam to human serum albumin.

In turn, neither warfarin nor diazepam altered the binding of quetiapine. Metabolism and Elimination Following a single oral dose of 14 C-quetiapine, less than 1% of the administered dose was excreted as unchanged drug, indicating that quetiapine is highly metabolized. Approximately 73% and 20% of the dose was recovered in the urine and feces, respectively.

Quetiapine is extensively metabolized by the liver. The major meta…

🧬 Mechanism of Action 112 words ▾

12.1Mechanism of Action The mechanism of action of quetiapine fumarate is unknown. However, it has been proposed that the efficacy of quetiapine fumarate in schizophrenia and its mood stabilizing properties in bipolar depression and mania are mediated through a combination of dopamine type 2 (D 2 ) and serotonin type 2 (5HT 2 ) antagonism. Antagonism at receptors other than dopamine and 5HT 2 with similar receptor affinities may explain some of the other effects of quetiapine fumarate.

Quetiapine fumarate’s antagonism of histamine H 1 receptors may explain the somnolence observed with this drug. Quetiapine fumarate’s antagonism of adrenergic α 1 receptors may explain the orthostatic hypotension observed with this drug.

📦 How Supplied / Storage and Handling ~2 min read ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Quetiapine Fumarate Tablets are supplied as below: 25 mg: White to off white, round, biconvex, film coated tablets debossed with ‘224’ on one side and ‘L’ on the other side. NDC 46708-134-30 bottle of 30 tablets NDC 46708-134-31 bottle of 100 tablets NDC 46708-134-91 bottle of 1000 tablets NDC 46708-134-10 100 (10 x 10) Tablets Unit dose package 50 mg: White to off white, round, biconvex, film coated tablets debossed with ‘225’ on one side and ‘L’ on the other side. NDC 46708-135-30 bottle of 30 tablets NDC 46708-135-31 bottle of 100 tablets NDC 46708-135-91 bottle of 1000 tablets NDC 46708-135-10 100 (10 x 10) Tablets Unit dose package 100 mg: White to off white, round, biconvex, film coated tablets debossed with ‘226’ on one side and ‘L’ on the other side.

NDC 46708-136-30 bottle of 30 tablets NDC 46708-136-31 bottle of 100 tablets NDC 46708-136-91 bottle of 1000 tablets NDC 46708-136-10 100 (10 x 10) Tablets Unit dose package 200 mg: White to off white, round, biconvex, film coated tablets, debossed with ‘L227’ on one side and plain on the other side. NDC 46708-137-30 bottle of 30 tablets NDC 46708-137-31 bottle of 100 tablets NDC 46708-137-91 bottle of 1000 tablets NDC 46708-137-10 100 (10 x 10) Tablets Unit dose package 300 mg: White to off white, capsule shaped, biconvex, film coated tablets, debossed with ‘L228’ on one side and plain on the other side.

NDC 46708-138-30 bottle of 30 tablets NDC 46708-138-60 bottle of 60 tablets NDC 46708-138-91 bottle of 1000 tablets NDC 46708-138-10 100 (10 x 10) Tablets Unit dose package 400 mg: White to off white, capsule shaped, biconvex, film coated tablets, debossed with ‘L229’ on one side and plain on the other side. NDC 46708-139-30 bottle of 30 tablets NDC 46708-139-31 bottle of 100 tablets NDC 46708-139-71 bottle of 500 tablets NDC 46708-139-10 100 (10 x 10) Tablets Unit dose package Store at 25ºC (77ºF); excursions permitted to 15° to 30ºC (59° to 86ºF) [see USP].

📋 Description 172 words ▾

11 DESCRIPTION Quetiapine fumarate is a psychotropic agent belonging to a chemical class, the dibenzothiazepine derivatives. The chemical designation is 2-[2-(4-dibenzo [ b,f ] [1,4]thiazepin-11-yl-1-piperazinyl)ethoxy]-ethanol fumarate (2:1) (salt). It is present in tablets as the fumarate salt.

All doses and tablet strengths are expressed as milligrams of base, not as fumarate salt. Its molecular formula is C 42 H 50 N 6 O 4 S 2 •C 4 H 4 O 4 and it has a molecular weight of 883.11 (fumarate salt). The structural formula is: Quetiapine fumarate is a white to cream colored powder which is practically insoluble in water.

Quetiapine fumarate tablets are supplied for oral administration as 25 mg (round, white to off-white), 50 mg (round, white to off-white), 100 mg (round, white to off-white), 200 mg (round, white to off-white), 300 mg (capsule-shaped, white to off-white), and 400 mg (capsule-shaped, white to off-white) tablets. Inactive ingredients are povidone, dibasic calcium phosphate anhydrous, microcrystalline cellulose, sodium starch glycolate, lactose monohydrate, magnesium stearate, hypromellose, hydroxypropyl cellulose and titanium dioxide.

Structure

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION See FDA-approved patient labeling (Medication Guide) Prescribers or other health professionals should inform patients, their families, and their caregivers about the benefits and risks associated with treatment with quetiapine fumarate and should counsel them in its appropriate use. A patient Medication Guide about “Antidepressant Medicines, Depression and other Serious Mental Illness, and Suicidal Thoughts or Actions” is available for quetiapine fumarate. The prescriber or health professional 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. The complete text of the Medication Guide is reprinted at the end of this document. Patients should be advised of the following issues and asked to alert their prescriber if these occur while taking quetiapine fumarate.

Increased Mortality in Elderly Patients with Dementia-Related Psychosis Patients and caregivers should be advised that elderly patients with dementia-related psychosis treated with atypical antipsychotic drugs are at increased risk of death compared with placebo. Quetiapine is not approved for elderly patients with dementia-related psychosis [see Warnings and Precautions (5.1)] . Suicidal Thoughts and Behaviors Patients, their families, and their caregivers should be encouraged to be alert to the emergence of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, mania, other unusual changes in behavior, worsening of depression, and suicidal ideation, especially early during antidepressant treatment and when the dose is adjusted up or down.

Families and caregivers of patients should be advised to look for the emergence of such symptoms on a day-to-day basis, since changes may be abrupt. Such symptoms should be reported to the patient's prescriber or health professional, especially if they are severe, abrupt in onset, or were not part of the patient's presenting symptoms. Symptoms such as these may be associated with an increased risk for suicidal thinking and behavior and indicate a need for very close monitoring and possibly changes in the medication [see Warnings and Precautions (5.2)].

Neuroleptic Malignant Syndrome (NMS) Patients should be advised to report to their physician any signs or symptoms that may be related to NMS. These may include muscle stiffness and high fever [see Warnings and Precautions (5.4)]. Hyperglycemia and Diabetes Mellitus Patients should be aware of the symptoms of hyperglycemia (high blood sugar) and diabetes mellitus.

Patients who are diagnosed with diabetes, those with risk factors for diabetes, or those that develop these symptoms during treatment should have their blood glucose monitored at the beginning of and periodically during treatment [see Warnings and Precautions (5.5)]. Hyperlipidemia Patients should be advised that elevations in total cholesterol, LDL-cholesterol and triglycerides and decreases in HDL-cholesterol may occur. Patients should have their lipid profile monitored at the beginning of and periodically during treatment [see Warnings and Precautions (5.5)] .

Weight Gain Patients should be advised that they may experience weight gain. Patients should have their weight monitored regularly [see Warnings and Precautions (5.5)]. Orthostatic Hypotension Patients should be advised of the risk of orthostatic hypotension (symptoms include feeling dizzy or lightheaded upon standing, which may lead to falls), especially during the period of initial dose titration, and also at times of re-initiating treatment or increases in dose [see Warnings and Precautions (5.7)] .

Increased Blood Pressure in Children and Adolescents Children and adolescent patients should have their blood…

💬 Medication Guide ~3 min read ▾

Medication Guide Quetiapine Fumarate (kwe-TYE-a-peen FUE-ma-rate) Tablets Read this Medication Guide before you start taking quetiapine fumarate and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about quetiapine fumarate? quetiapine fumarate may cause serious side effects, including: 1. risk of death in the elderly with dementia. Medicines like quetiapine fumarate can increase the risk of death in elderly people who have memory loss (dementia). Quetiapine fumarate is not for treating psychosis in the elderly with dementia.

2. risk of suicidal thoughts or actions (antidepressant medicines, depression and other serious mental illnesses, and suicidal thoughts or actions). · Talk to your or your family member’s healthcare provider about : o all risks and benefits of treatment with antidepressant medicines. o all treatment choices for depression or other serious mental illness · Antidepressant medications may increase suicidal thoughts or actions in some children, teenagers, and young adults within the first few months of treatment. · Depression and other serious mental illnesses are the most important causes of suicidal thoughts and actions.

Some people may have a particularly high risk of having suicidal thoughts or actions. These include people who have (or have a family history of) depression, bipolar illness (also called manic-depressive illness), or suicidal thoughts or actions. · How can I watch for and try to prevent suicidal thoughts and actions in myself or a family member? o Pay close attention to any changes, especially sudden changes, in mood, behaviors, thoughts, or feelings. This is very important when an antidepressant medicine is started or when the dose is changed. o Call the healthcare provider right away to report new or sudden changes in mood, behavior, thoughts, or feelings. o Keep all follow-up visits with the healthcare provider as scheduled.

Call the healthcare provider between visits as needed, especially if you have concerns about symptoms. Call a healthcare provider right away if you or your family member has any of the following symptoms, especially if they are new, worse, or worry you: · thoughts about suicide or dying · attempts to commit suicide · new or worse depression · new or worse anxiety · feeling very agitated or restless · panic attacks · trouble sleeping (insomnia) · new or worse irritability · acting aggressive, being angry, or violent · acting on dangerous impulses · an extreme increase in activity and talking (mania) · other unusual changes in behavior or mood What else do I need to know about antidepressant medicines? · Never stop an antidepressant medicine without first talking to your healthcare provider.

Stopping an antidepressant medicine suddenly can cause other symptoms. · Antidepressants are medicines used to treat depression and other illnesses. It is important to discuss all the risks of treating depression and also the risks of not treating it. Patients and their families or other caregivers should discuss all treatment choices with the healthcare provider, not just the use of antidepressants. · Antidepressant medicines have other side effects.

Talk to the healthcare provider about the side effects of the medicine prescribed for you or your family member. · Antidepressant medicines can interact with other medicines. Know all of the medicines that you or your family member take. Keep a list of all medicines to show the healthcare provider.

Do not start new medicines without first checking with your healthcare provider. · Not all antidepressant medicines prescribed for children are FDA approved for use in children. Talk to your child’s healthcare provider for more information. What is quetiapine fumarate?

Quetiapine fumarate is a prescription medicine used to treat: · schizophrenia in peopl…

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.