NDC 43598-0248-30 — Fesoterodine fumarate 8 mg, 30-count

🆔 Identity & classification

FDA NDC (as labeled) 43598-248-30

Product NDC 43598-248

11-digit billing NDC 43598024830

NCPDP billing unit EA — each (per item)

RxCUI 810071, 810077

UNII EOS72165S7

UPC 0343598248301, 0343598247304

Application # ANDA204975

SPL Set ID 5c5d2a97-9029-744f-c410-a4bbbe9761a8

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2022-06-10

Route ORAL

Dosage form TABLET, EXTENDED RELEASE

Substance FESOTERODINE FUMARATE

GPI-14 54100020207530

GPI class Fesoterodine Fumarate ER

GCN Seq No 064001

GCN 99712

HICL code 035606

Ingredient (HICL) Fesoterodine Fumarate

HIC1 code R

Therapeutic class — broad (HIC1) Kidney/Urinary Tract

HIC2 code R1

Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract

HIC3 code R1A

Therapeutic class — specific (HIC3) Urinary Tract Antispasmodic/Antiincontinence Agent

AHFS code 86:12.04.00

AHFS class Antimuscarinics

FDB label name FESOTERODINE ER 8 MG TABLET

FDB brand name Fesoterodine Fumarate Er

Legend status F — Federal legend — prescription drug or device

TE code (Orange Book) AB · RLD · RS

Why two NDCs? The FDA registers this code as 43598-248-30 — 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 → 43598-0248-30. 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 Drugs for urinary frequency and incontinence class.

Drug family (ATC) Drugs for urinary frequency and incontinence

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

LabelerDr.Reddy's Laboratories Inc.,

Application holderDR REDDYS LABORATORIES LTD

FDA applicationANDA204975 (ANDA)

Labeler code43598

First marketedJun 2022

Product typeHuman Prescription Drug

Portfolio18 products on file

🔎 All NDCs from Dr.Reddy's Laboratories Inc.,

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

Label name FESOTERODINE ER 8 MG TABLET Ingredient Fesoterodine Fumarate

📖 What it is MedlinePlus · NLM

Fesoterodine is used to treat overactive bladder (a condition in which the bladder muscles contract uncontrollably and cause frequent urination, urgent need to urinate, and inability to control urination). Fesoterodine is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles to prevent urgent, frequent, or uncontrolled urination.

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It's calming down overactive signals in your bladder muscle. When your bladder squeezes too often or too urgently, it's because certain nerve receptors are overstimulated. Fesotero...
What is fesoterodine actually doing for my bladder?
No, you can take it with or without food — it works either way. The one thing that does matter is how you take the tablet: swallow it whole with a glass of liquid. Don't chew, crus...
Dry mouth is the most common side effect, and it's more noticeable at higher doses. Sipping water throughout the day, chewing sugar-free gum, or using sugar-free hard candies can h...

📖 Read our full Fesoterodine guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

Some supplements/herbs that may interact with Fesoterodine Fumarate — tap one for details:

Activated CharcoalMajor Coffee CharcoalModerate European MandrakeModerate GlucomannanModerate Guar GumModerate Gum ArabicModerate Slippery ElmModerate TragacanthModerate

🌿 Every supplement checked against Fesoterodine Fumarate (195 interactions) — ranked by severity →

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 Blue

ShapeOval

ImprintDrreddyslogo;FT

Size13 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 3SY5LH9PMK
Anhydrous lactose is a milk sugar with no water content. It acts as a filler and binder in tablets and capsules, adding bulk and helping ingredients stick together.
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 L06K8R7DQK
A synthetic blue dye approved by the FDA for use in medications and foods. It serves as a colorant to make pills and liquids visually distinct and easier to identify.
UNII 6YSS42VSEV
Fructose is a natural sugar derived from fruits and plants. It's used in medicines as a sweetener and filler to improve taste and add bulk to tablets or syrups.
UNII R8WTH25YS2
Glyceryl dibehenate is a wax-like substance made from behenate fatty acids and glycerol. It functions as a binder and release-control agent in tablets and capsules, helping hold ingredients together and regulate how quickly the medicine dissolves and releases in your body.
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 1DI56QDM62
A natural fatty substance from soybeans that helps mix oil and water-based ingredients together. It acts as an emulsifier and lubricant in medicines to improve texture and help the product break down properly in your body.
UNII 3WJQ0SDW1A
Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
UNII 532B59J990
Polyvinyl alcohol is a synthetic polymer made from plant-derived materials. It's used as a binder to hold ingredients together, a film-former in coatings, and a thickener in liquid formulations.
UNII 7SEV7J4R1U
A powder made from a naturally occurring mineral. In medicines, talc works as a glidant and anti-caking agent, helping tablets and capsules flow smoothly during manufacturing and preventing clumping.
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.

11 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 system	Per ea	Per package
Retail pharmacies payNADAC · weekly	$0.813	$24.38 / 30 tablets
Medicaid paysCMS SDUD · 12 mo	$1.29	$38.61 / 30 tablets
Medicare drug plans payPart D · Q2 2026	$1.66	$49.93 / 30 tablets

NADAC price history (per ea) — tap or hover for the price & month

▼ Down 23% over the last 14 months.

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

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Fesoterodine Fumarate 8 mg 31722-0034-30	Camber	30 tablets	$0.813	AB	Availability likely	—
Fesoterodine fumarate 8 mgthis 43598-0248-30	Dr.Reddy's	30 tablets	$0.813	AB	Availability likely	—
Fesoterodine Fumarate 8 mg 65862-0767-30	Aurobindo	30 tablets	$0.813	AB	Availability likely	—
Fesoterodine Fumarate 8 mg 67877-0068-30	Ascend	30 tablets	$0.813	AB	Availability likely	—
fesoterodine fumarate 8 mg 68382-0480-06	Zydus	30 tablets	$0.813	AB	Availability likely	—
Fesoterodine Fumarate 8 mg 72603-0414-01	NorthStar	30 tablets	$0.813	AB	Availability likely	—
Toviaz 8 mg 00069-0244-30	Pfizer	30 tablets	$9.265	AB	Availability likely	+1040%
Fesoterodine Fumarate 8 mg 46708-0176-10	Alembic	100 tablets	—	AB	FDA listed	—
Fesoterodine fumarate 8 mg 51407-0662-30	Golden	30 tablets	—	AB	FDA listed	—
Fesoterodine Fumarate 8 mg 62332-0176-10	Alembic	100 tablets	—	AB	FDA listed	—
Fesoterodine Fumarate 8 mg 65162-0370-03	Amneal	30 tablets	—	AB	FDA listed	—
fesoterodine fumarate 8 mg 70771-1169-03	Zydus	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

🏛️

2022

On the market since

Jun 2022

📍

2026

Currently FDA-listed

4 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.

🗺️ Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for 43598-0248-30, not the drug overall. Other pack sizes report separately.

💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.

📅 Q1 2025 – Q4 2025 · 4 quarters of data

ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.

Prescriptions last 4 qtrs

1.8K

Units reimbursed last 4 qtrs

78.8K

Gross reimbursed last 4 qtrs

$101.4K

Avg / prescription

$55.49

Avg / unit

$1.2871

Latest quarter Q4 2025

473Rx

Medicaid pays / ea

$1.2871

gross reimbursed

vs

NADAC / ea

$0.8127

acquisition cost

=

Spread

+$0.4744

+58% vs cost

What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.

Fee-for-service vs managed care ⓘ

46% FFS 54% MCO

Fee-for-service · 847 Rx Managed care · 980 Rx

State Medicaid map

Units reimbursed · per 100k residents

6.1331

gray = no data reported ⓘ

Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.

Tap or hover a state

…for its Medicaid breakdown

🏆 Top states by units · per 100k residents

1 West Virginia 331 /100k

2 Colorado 90.9 /100k

3 Nebraska 89.2 /100k

4 North Carolina 75.6 /100k

5 Wisconsin 69.0 /100k

6 Louisiana 63.3 /100k

7 Michigan 44.4 /100k

8 Idaho 42.8 /100k

National units — by quarter

💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

💊 Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.

30 tablets this page43598-0248-30 1,827 Rx · $101,372

90 tablets43598-0248-90 No Medicaid data

Drug total (last 4 qtrs): 1,827 Rx · 78,759 units · $101,372 gross reimbursed

Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Fesoterodine Fumarate ER (matched by generic name) — the program that covers self-administered drugs. 7 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 Fesoterodine Fumarate ER. CMS lists 2 products for this generic; we show the highest-spend one. 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

$3.07M

Claims incl. refills

31K

Beneficiaries

19.5K

Spend / beneficiary

$157.85

Spend / claim

$99.15

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 Fesoterodine fumarate — the ingredient across all brands.

Top reported reactions

Dry Mouth823

Fall534

Fatigue519

Constipation504

Urinary Retention502

Pain456

Headache431

Age at onset

Neonate4

Child2

Adolescent1

Adult314

Elderly405

Reporter sex

Male · 31%

Female · 68%

Unknown · 1%

Serious outcomes

Hospitalization2,320

Death439

Life-threatening278

Disabling196

Reports over time (by year) — tap or hover for the count & year

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 NDC	Description	Per unit	Per pack	Marketing start	Status
43598-0248-30 You're viewing this	30 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-248-30)	$0.8127 / ea	$24.38	2022-06-10	Active
43598-0248-90	90 TABLET, EXTENDED RELEASE in 1 BOTTLE (43598-248-90)	—	—	2022-06-10	Active

You're viewing the smallest of 2 pack sizes for this product.

In Medicaid, this is the most-dispensed pack of this product — about 100% of fills over the last four reported quarters. See all packs ↓

Pack size FAQ

What quantity is in NDC 43598-0248-30?

NDC 43598-0248-30 is a 30-count package — 30 tablet, extended release in 1 bottle.

What is the difference between NDC 43598-0248-30 and NDC 43598-0248-90?

Both are Fesoterodine fumarate 8 mg Tablet, Extended Release — the drug itself is identical. NDC 43598-0248-30 is the 30-count package, while NDC 43598-0248-90 is the 90 tablets package.

What NDC number is used to bill for this package of Fesoterodine fumarate 8 mg Tablet, Extended Release?

Bill NDC 43598-0248-30 — the 11-digit billing format is 43598024830. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

Prices are the latest CMS NADAC pharmacy acquisition cost per NDC; per-pack figures are per-unit × pack quantity, shown only when the pack is denominated in the same measure NADAC prices.

📄 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.

🎯 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

🎯 Indications and Usage 116 words ▾

1 INDICATIONS AND USAGE Fesoterodine fumarate extended-release are indicated for the treatment of: • Overactive bladder(OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency. ( 1.1 ) • Neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older and weighing greater than 25 kg. ( 1.2)

1.1Adult Overactive Bladder Fesoterodine fumarate extended-release tablets are indicated for the treatment of overactive bladder (OAB) in adults with symptoms of urge urinary incontinence, urgency, and frequency.

1.2Pediatric Neurogenic Detrusor Overactivity Fesoterodine fumarate extended-release tablets are indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients 6 years of age and older with a body weight greater than 25 kg.

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • OAB in Adults:The recommended starting dosage is 4 mg orally once daily. Based upon individual response and tolerability, increase the maximum dosage of 8 mg once daily. ( 2.1 ) • NDO in Pediatric Patients 6 Years and Older: Pediatric Patients Weighing Greater than 25 kg and up to 35 kg: The recommended dosage is 4 mg orally once daily.

If needed, dosage may be increased to 8 mg orally once daily. (2.2) Pediatric Patients Weighing Greater than 35 kg: The recommended starting dosage is 4 mg orally once daily. After one week, increase to 8 mg orally once daily.

(2.2) • Adult or Pediatric Patients with Renal Impairment : Refer to the full prescribing information for recommended dosage. ( 2.3 , 2.4 ) • Dosage Modifications Due to Strong CYP3A4 Inhibitors : Refer to the full prescribing information for recommended dosage. ( 2.5 ) • Administration : Swallow whole with liquid.

Do not chew, divide, or crush. Take with or without food. ( 2.6 )

2.1Recommended Dosage for Adult Patients With OAB The recommended starting dosage of fesoterodine fumarate extended-release tablets in adults is 4 mg orally once daily. Based upon individual response and tolerability, increase to the maximum dosage of fesoterodine fumarate extended-release tablets 8 mg once daily. For administration instructions, see Dosage and Administration ( 2.6 ).

2.2Recommended Dosage for Pediatric Patients Aged 6 Years and Older With NDO Pediatric Patients Weighing Greater than 25 kg and up to 35 kg The recommended dosage of fesoterodine fumarate extended-release tablets is 4 mg orally once daily. If needed, dosage may be increased to Toviaz 8 mg orally once daily. For administration instructions, see Dosage and Administration ( 2.6 ) .

Pediatric Patients Weighing Greater than 35 kg The recommended starting dosage of fesoterodine fumarate extended-release tablets is 4 mg orally once daily. After one week, increase to fesoterodine fumarate extended-release tablets 8 mg orally once daily. For administration instructions, see Dosage and Administration ( 2.6 ).

2.3Recommended Dosage in Adult Patients With Renal Impairment The recommended dosage of fesoterodine fumarate extended-release tablets in adult patients with renal impairment is described in Table 1 [see Use in Specific Populations ( 8.6 )] . For administration instructions, see Dosage and Administration ( 2.6 ) . Table 1: Fesoterodine Fumarate Extended-Release Tablets Recommended Dose in Adult Patients With Renal Impairment (Administered Orally Once Daily) Estimated Creatinine Clearance 1 Recommended Dose CLcr 30 to 89 mL/min 8 mg CLcr 15 to 29 mL/min 4 mg CLcr˂ 15 mL/min 4 mg 1 Calculate CLcr using the Cockcroft-Gault formula

2.4Recommended Dosage in Pediatric Patients With Renal Impairment Pediatric Patients Weighing Greater than 25 kg and up to 35 kg The recommended dosage of fesoterodine fumarate extended-release tablets in pediatric patients with renal impairment weighing greater than 25 kg and up to 35 kg is described in Table 2 [see Use in Specific Populations (8.6)]. For administration instructions, see Dosage and Administration (2.6). Table 2: fesoterodine fumarate extended-release tablets Recommended Dose in Pediatric Patients Aged 6 Years and Older Weighing Greater Than 25 kg and up to 35 kg With Renal Impairment (Administered Orally Once Daily) Estimated Glomerular Filtration Rate (GFR)1 Recommended Dose2 eGFR 30 to 89 mL/min/1.73m 2 4 mg eGFR 15 to 29 mL/min/1.73m 2 Use is Not Recommended eGFR <15 mL/min/1.73m 2 or requiring dialysis Use is Not Recommended 1 Estimate GFR using a validated GFR estimating equation for the pediatric age range of the approved indication.

2 Dosing was derived assuming similar proportional effects of renal impairment in adults and pediatric patients 6 years and older. Pediatric Patients weighing greater than 35 kg The recommended dosage of fesoterodine fumarate extended-release tablets in pediatric patients with renal impairment weighing greater…

💊 Dosage Forms and Strengths 117 words ▾

3 DOSAGE FORMS AND STRENGTHS Fesoterodine fumarate extended-release tablets, 4 mg are light blue colored, oval shaped, biconvex, film coated, debossed with on one side and 'FS' on the other side. Fesoterodine fumarate extended-release tablets, 8 mg are blue colored, oval shaped, biconvex, film coated, debossed with on one side and ‘FT’ on the other side. Fesoterodine fumarate extended-release tablets, 4 mg are light blue colored, oval shaped, biconvex, film coated, debossed with ‘ ’ on one side and 'FS' on the other side.

( 3 ) Fesoterodine fumarate extended-release tablets, 8 mg are blue colored, oval shaped, biconvex, film coated, debossed with ‘ ’ on one side and ‘FT’ on the other side. ( 3 )

⛔ Contraindications 141 words ▾

4 CONTRAINDICATIONS Fesoterodine fumarate extended-release tablets are contraindicated in patients with any of the following, known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients, or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules [s ee Clinical Pharmacology ( 12.1 ) ]. Reactions have included angioedema [ see Warnings and Precautions ( 5.1 ) ]. urinary retention [ see Warnings and Precautions ( 5.2 ) ] gastric retention [ see Warnings and Precautions ( 5.3 ) ] uncontrolled narrow-angle glaucoma [ see Warnings and Precautions ( 5.4 ) ] • Known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients or to tolterodine tartrate tablets or tolterodine tartrate extended-release capsules.

( 4 ) • Urinary retention ( 4 ) • Gastric retention ( 4 ) • Uncontrolled narrow-angle glaucoma. ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Angioedema : Promptly discontinue fesoterodine fumarate and provide appropriate therapy. ( 5.1 ). Urinary Retention : Fesoterodine fumarate extended-release tablets are not recommended in patients with clinically significant bladder outlet obstruction because of the risk of urinary retention.

( 5.2 ) Decreased Gastrointestinal Motility : Fesoterodine fumarate extended-release tablets are not recommended for use in patients with decreased gastrointestinal motility, such as those with severe constipation. ( 5.3 ) Worsening of Narrow Angle Glaucoma : Use fesoterodine fumarate with caution in patients being treated for narrow-angle glaucoma. ( 5.4 ) Central Nervous System Effects: Somnolence has been reported with fesoterodine fumarate extended-release tablets.

Advise patients not to drive or operate heavy machinery until they know how fesoterodine fumarate extended-release tablets affects them ( 5.5 ) Worsening of Myasthenia Gravis Symptoms: Use fesoterodine fumarate extended-release tablets with caution in patients with myasthenia gravis. ( 5.6 )

5.1Angioedema Angioedema of the face, lips, tongue, and/or larynx has been reported with fesoterodine fumarate extended-release tablets . In some cases, angioedema occurred after the first dose; however, cases have been reported to occur hours after the first dose or after multiple doses. Angioedema associated with upper airway swelling may be life-threatening.

Fesoterodine fumarate extended-release tablets are contraindicated in patients with a known or suspected hypersensitivity to fesoterodine fumarate extended-release tablets or any of its ingredients [ see Contraindications ( 4 ) ]. If involvement of the tongue, hypopharynx, or larynx occurs, fesoterodine fumarate should be promptly discontinued and appropriate therapy and/or measures to ensure a patent airway should be promptly provided.

5.2Urinary Retention in Adult Patients With Bladder Outlet Obstruction The use of fesoterodine fumarate extended-release tablets, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction, including patients with urinary retention, may result in further urinary retention and kidney injury. The use of Fesoterodine fumarate extended-release tablets are not recommended in patients with clinically significant bladder outlet obstruction, and is contraindicated in patients with urinary retention [ see Contraindications ( 4 ) and Adverse Reactions ( 6.1 ) ].

5.3Decreased Gastrointestinal Motility Fesoterodine fumarate extended-release tablets are associated with decreased gastric motility. Fesoterodine fumarate extended-release tablets are contraindicated in patients with gastric retention [see Contraindications ( 4 ) ]. The use of Fesoterodine fumarate extended-release tablets are not recommended in patients with decreased gastrointestinal motility, such as those with severe constipation.

5.4Worsening of Narrow-Angle Glaucoma Fesoterodine fumarate extended-release tablets can worsen controlled narrow-angle glaucoma. Fesoterodine fumarate extended-release tablets are contraindicated in patients with uncontrolled narrow-angle glaucoma [ see Contraindications (4) ]. Fesoterodine fumarate should be used with caution in patients being treated for narrow-angle glaucoma..

5.5Central Nervous System Effects Fesoterodine fumarate is associated with anticholinergic central nervous system (CNS) adverse reactions [ see Adverse Reactions ( 6.1 )]. A variety of CNS anticholinergic effects have been reported, including headache, dizziness, and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose.

Advise patients not to drive or operate heavy machinery until they know how fesoterodine fumarate affects them. If a patient experiences anticholinergic CNS effects, fesoterodine fumarate extended-release tablets dose reduction or discontinuation should be conside…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant adverse reactions are described elsewhere in labeling: Angioedema [ see Warnings and Precautions ( 5.1 ) ] Urinary Retention [ see Warnings and Precautions ( 5.2 ) ] Decreased Gastrointestinal Motility [ see Warnings and Precautions ( 5.3 ) ] Most frequently reported adverse events with fesoterodine fumarate extended-release tablets in adult patients with OAB (≥4%) were: dry mouth (placebo, 7%; fesoterodine fumarate extended-release tablets 4 mg, 19%; fesoterodine fumarate extended-release tablets 8 mg, 35%) and constipation (placebo, 2%; fesoterodine fumarate extended-release tablets 4 mg, 4%; fesoterodine fumarate extended-release tablets 8 mg, 6%).

( 6.1 ) Most frequently reported adverse reactions with fesoterodine fumarate extended-release tablets in pediatric patients (≥2%) with NDO were: diarrhea, urinary tract infection (UTI), dry mouth, constipation, abdominal pain, nausea, weight increased, and headache. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Dr. Reddy’s Laboratories, Inc. at 1-888-375-3784 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 the rates observed in practice. Adult Overactive Bladder (OAB) The safety of fesoterodine fumarate extended-release tablets was evaluated in Phase 2 and 3 controlled trials in a total of 2,859 patients with overactive bladder, of which 2,288 were treated with fesoterodine fumarate extended-release tablets.

Of this total, 782 received fesoterodine fumerate 4 mg/day, and 785 received fesoterodine fumarate extended-release tablets 8 mg/day with treatment periods of 8- or 12- weeks. Approximately 80% of these patients had greater than 10-weeks of exposure to fesoterodine fumarate extended-release tablets in these trials. A total of 1,964 patients participated in two 12-week, Phase 3 efficacy and safety studies and subsequent open-label extension studies.

In these two studies combined, 554 patients received fesoterodine fumarate extended-release tablets 4 mg/day and 566 patients received fesoterodine fumarate extended-release tablets 8 mg/day. In Phase 2 and 3 placebo-controlled trials combined, the incidences of serious adverse events in patients receiving placebo, fesoterodine fumarate extended-release tablets 4 mg, and fesoterodine fumarate extended-release tablets 8 mg were 1.9%, 3.5%, and 2.9%, respectively. All serious adverse events were judged to be not related or unlikely to be related to study medication by the investigator, except for four patients receiving fesoterodine fumarate who reported one serious adverse reaction each: angina, chest pain, gastroenteritis, and QT prolongation on ECG.

The most commonly reported adverse event in patients treated with fesoterodine fumarate was dry mouth. The incidence of dry mouth was higher in those taking 8 mg/day (35%) and in those taking 4 mg/day (19%), as compared to placebo (7%). Dry mouth led to discontinuation in 0.4%, 0.4%, and 0.8% of patients receiving placebo, fesoterodine fumarate extended-release tablets 4 mg, and fesoterodine fumarate extended-release tablets 8 mg, respectively.

For those patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment. The second most commonly reported adverse event was constipation. The incidence of constipation was 2% in those taking placebo, 4% in those taking 4 mg/day, and 6% in those taking 8 mg/day.

Table 4 lists adverse events, regardless of causality, that were reported in the combined Phase 3, randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with fesoterodine fumarate 4mg or 8 mg once daily for up to 12 weeks. Table 4: Adverse Events With an…

🔄 Drug Interactions ~3 min read ▾

7 DRUG INTERACTIONS

7.1Antimuscarinic Drugs Coadministration of fesoterodine fumarate with other antimuscarinic agents that produce dry mouth, constipation, urinary retention, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Anticholinergic agents may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.

7.2CYP3A4 Inhibitors Doses of fesoterodine fumarate extended-release tablets greater than 4 mg are not recommended in adult patients taking strong CYP3A4 inhibitors, such as ketoconazole, itraconazole, and clarithromycin [see Dosage and Administration (2.5)]. The fesoterodine fumarate extended-release dose in pediatric patients taking strong CYP3A4 inhibitors is recommended to be reduced to 4 mg once daily in patients >35 kg and is not recommended in patients weighing greater than 25 kg and up to 35 kg [see Dosage and Administration ( 2.5 )].

In a study in adults, coadministration of the strong CYP3A4 inhibitor ketoconazole with fesoterodine led to approximately a doubling of the maximum concentration (C max ) and area under the concentration versus time curve (AUC) of 5-hydroxymethyl tolterodine (5-HMT), the active metabolite of fesoterodine. Compared with CYP2D6 extensive metabolizers not taking ketoconazole, further increases in the exposure to 5-HMT were observed in subjects who were CYP2D6 poor metabolizers taking ketoconazole [ see Clinical Pharmacology ( 12.3 ) ].

There is no clinically relevant effect of moderate CYP3A4 inhibitors on the pharmacokinetics of fesoterodine. Following blockade of CYP3A4 by coadministration of the moderate CYP3A4 inhibitor fluconazole 200 mg twice a day for 2 days, the average (90% confidence interval) increase in C max and AUC of the active metabolite of fesoterodine was approximately 19% (11% to 28%) and 27% (18% to 36%) respectively. No dosing adjustments are recommended in the presence of moderate CYP3A4 inhibitors (e.g., erythromycin, fluconazole, diltiazem, verapamil and grapefruit juice).

The effect of weak CYP3A4 inhibitors (e.g. cimetidine) was not examined; it is not expected to be in excess of the effect of moderate inhibitors [ see Clinical Pharmacology ( 12.3 ) ].

7.3CYP3A4 Inducers No dosing adjustments are recommended in the presence of CYP3A4 inducers, such as rifampin and carbamazepine. Following induction of CYP3A4 by coadministration of rifampin 600 mg once a day, C max and AUC of the active metabolite of fesoterodine decreased by approximately 70% and 75%, respectively, after oral administration of fesoterodine fumarate extended-release tablets 8 mg. The terminal half-life of the active metabolite was not changed.

7.4CYP2D6 Inhibitors The interaction with CYP2D6 inhibitors was not tested clinically. In poor metabolizers for CYP2D6, representing a maximum CYP2D6 inhibition, C max and AUC of the active metabolite are increased 1.7- and 2-fold, respectively. No dosing adjustments are recommended in the presence of CYP2D6 inhibitors.

7.5Drugs Metabolized by Cytochrome P450 In vitro data indicate that at therapeutic concentrations, the active metabolite of fesoterodine does not have the potential to inhibit or induce Cytochrome P450 enzyme systems [ see Clinical Pharmacology ( 12.3 ) ].

7.6Oral Contraceptives In the presence of fesoterodine, there are no clinically significant changes in the plasma concentrations of combined oral contraceptives containing ethinyl estradiol and levonorgestrel [ see Clinical Pharmacology ( 12.3 ) ].

7.7Warfarin A clinical study has shown that fesoterodine extended-release tablets 8 mg once daily has no significant effect on the pharmacokinetics or the anticoagulant activity (PT/INR) of warfarin 25 mg. Standard therapeutic monitoring for warfarin should be continued [see Clinical Pharmacology ( 12.3 )].

7.8Drug-Laboratory Test Interactions Interactions between fesoterodine fumarate and laboratory t…

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no available data with the use of fesoterodine fumarate extended-release tablets in pregnant women and adolescents to evaluate for a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively the maximum recommended human dose (MRHD) of 8 mg/day based on AUC (see Data) .

The background risk of major birth defects and miscarriage for the indicated population are unknown. However, in the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data No dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits.

In mice at 6 to 27 times the expected exposure at the maximum recommended human dose (MRHD) of 8 mg based on AUC (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. One fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. In rabbits treated at 3 to 11 times the MRHD (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses.

In rabbits at 9 to 11 times the MRHD (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). In rabbits at 3 times the MRHD (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. Oral administration of 30 mg/kg/day fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups.

No effects were noted on mating and reproduction of the F 1 dams or on the F 2 offspring.

8.2Lactation Risk Summary There is no information on the presence of fesoterodine fumarate in human milk, the effects on the breastfed child, or the effects on milk production. The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for fesoterodine fumarate and any potential adverse effects on the breastfed child from fesoterodine fumarate or from the underlying maternal condition.

8.4Pediatric Use The safety and effectiveness of fesoterodine fumarate extended-release tablets have been established for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older and weighing greater than 25 kg. The information on this use is discussed throughout labeling. Use of fesoterodine fumarate extended-release tablets for treatment of NDO is supported by evidence from a randomized, open-label trial with an initial 12-week efficacy phase followed by a 12-week safety extension phase in pediatric patients from 6 years to 17 years of age (Study 3) [see Adverse Reactions (6.1) and Clinical Studies (14.2)].

Study results demonstrated that treatment with fesoterodine fumarate extended-release tablets 4 mg and 8 mg daily resulted in improvements from baseline to Week 12 in maximum cystometric bladder capacity (MCBC) for patients weighing greater than 25 kg [see Clinical Studies (14.2) and Clinical Pharmacology (12.3)]. The most commonly reported adverse reactions in patients who received fesoterodine fumarate extended-release tablets 4 mg or 8 mg in Study 3 (≥2%) were diarrhea, UTI, dry mouth, constipation, abdominal pain, nausea, weight increase and headache [see Adverse Reactions (6.1)].

Mean increases from baseline in heart rate were reported with both the 4 mg and 8 mg daily doses of fesoterodine fumarate extended-release tablets, with larger mean increase…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary There are no available data with the use of fesoterodine fumarate extended-release tablets in pregnant women and adolescents to evaluate for a drug associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. In animal reproduction studies, oral administration of fesoterodine to pregnant mice and rabbits during organogenesis resulted in fetotoxicity at maternal exposures that were 6 and 3 times, respectively the maximum recommended human dose (MRHD) of 8 mg/day based on AUC (see Data) .

The background risk of major birth defects and miscarriage for the indicated population are unknown. However, in the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Data Animal Data No dose-related teratogenicity was observed in reproduction studies performed in mice and rabbits.

In mice at 6 to 27 times the expected exposure at the maximum recommended human dose (MRHD) of 8 mg based on AUC (75 mg/kg/day, oral), increased resorptions and decreased live fetuses were observed. One fetus with cleft palate was observed at each dose (15, 45, and 75 mg/kg/day), at an incidence within the background historical range. In rabbits treated at 3 to 11 times the MRHD (27 mg/kg/day, oral), incompletely ossified sternebrae (retardation of bone development) and reduced survival were observed in fetuses.

In rabbits at 9 to 11 times the MRHD (4.5 mg/kg/day, subcutaneous), maternal toxicity and incompletely ossified sternebrae were observed in fetuses (at an incidence within the background historical range). In rabbits at 3 times the MRHD (1.5 mg/kg/day, subcutaneous), decreased maternal food consumption in the absence of any fetal effects was observed. Oral administration of 30 mg/kg/day fesoterodine to mice in a pre- and post-natal development study resulted in decreased body weight of the dams and delayed ear opening of the pups.

No effects were noted on mating and reproduction of the F 1 dams or on the F 2 offspring.

🧒 Pediatric Use ~1 min read ▾

8.4Pediatric Use The safety and effectiveness of fesoterodine fumarate extended-release tablets have been established for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 6 years and older and weighing greater than 25 kg. The information on this use is discussed throughout labeling. Use of fesoterodine fumarate extended-release tablets for treatment of NDO is supported by evidence from a randomized, open-label trial with an initial 12-week efficacy phase followed by a 12-week safety extension phase in pediatric patients from 6 years to 17 years of age (Study 3) [see Adverse Reactions (6.1) and Clinical Studies (14.2)].

Study results demonstrated that treatment with fesoterodine fumarate extended-release tablets 4 mg and 8 mg daily resulted in improvements from baseline to Week 12 in maximum cystometric bladder capacity (MCBC) for patients weighing greater than 25 kg [see Clinical Studies (14.2) and Clinical Pharmacology (12.3)]. The most commonly reported adverse reactions in patients who received fesoterodine fumarate extended-release tablets 4 mg or 8 mg in Study 3 (≥2%) were diarrhea, UTI, dry mouth, constipation, abdominal pain, nausea, weight increase and headache [see Adverse Reactions (6.1)].

Mean increases from baseline in heart rate were reported with both the 4 mg and 8 mg daily doses of fesoterodine fumarate extended-release tablets, with larger mean increases reported in pediatric patients who received the 8 mg daily dose [see Adverse Reactions (6.1)]. The safety and effectiveness of fesoterodine fumarate extended-release have not been established in pediatric patients younger than 6 years of age or weighing 25 kg or less.

🧓 Geriatric Use 144 words ▾

8.5Geriatric Use No dose adjustment is recommended for the elderly. The pharmacokinetics of fesoterodine are not significantly influenced by age. Of the 1,567 patients who received fesoterodine fumarate 4 mg or 8 mg orally once daily in Phase 2 and 3, placebo-controlled, efficacy and safety studies for OAB, 515 (33%) were 65 years of age or older, and 140 (9%) were 75 years of age or older.

No overall difference in effectiveness was observed between patients younger than 65 years of age and those 65 years of age or older in these studies; However, the incidence of antimuscarinic adverse reactions, including dry mouth, constipation, dyspepsia, increase in residual urine, dizziness ( 8 mg only) and urinary tract infection, was higher in patients 75 years of age and older as compared to younger patients [see Clinical Studies (14.1) and Adverse Reactions ( 6 )].

🆘 Overdosage 27 words ▾

10 OVERDOSAGE Overdosage with fesoterodine fumarate can result in severe anticholinergic effects. Treatment should be symptomatic and supportive. In the event of overdosage, ECG monitoring is recommended.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Fesoterodine is a competitive muscarinic receptor antagonist. After oral administration, fesoterodine is rapidly and extensively hydrolyzed by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for the antimuscarinic activity of fesoterodine. Muscarinic receptors play a role in contractions of urinary bladder smooth muscle.

Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.

12.2Pharmacodynamics In a urodynamic study involving patients with involuntary detrusor contractions, the effects after the administration of fesoterodine on the volume at first detrusor contraction and bladder capacity were assessed. Administration of fesoterodine increased the volume at first detrusor contraction and bladder capacity in a dose-dependent manner. These findings are consistent with an antimuscarinic effect on the bladder.

Cardiac Electrophysiology The effect of fesoterodine 4 mg and 28 mg on the QT interval was evaluated in a double-blind, randomized, placebo- and positive-controlled (moxifloxacin 400 mg once a day) parallel trial with once-daily treatment over a period of 3 days in 261 male and female subjects aged 44 to 65 years. Electrocardiographic parameters were measured over a 24-hour period at pre-dose, after the first administration, and after the third administration of study medication. Fesoterodine 28 mg was chosen because this dose, when administered to CYP2D6 extensive metabolizers, results in an exposure to the active metabolite that is similar to the exposure in a CYP2D6 poor metabolizer receiving fesoterodine 8 mg together with CYP3A4 blockade.

Corrected QT intervals (QTc) were calculated using Fridericia’s correction and a linear individual correction method. Analyses of 24-hour average QTc, time-matched baseline-corrected QTc, and time-matched placebo-subtracted QTc intervals indicate that fesoterodine at doses of 4 and 28 mg/day did not prolong the QT interval. The sensitivity of the study was confirmed by positive QTc prolongation by moxifloxacin.

In this study, conducted in subjects aged 44 to 65 years, fesoterodine fumarate was associated with an increase in heart rate that correlates with increasing dose. When compared to placebo, the mean increase in heart rate associated with fesoterodine 4 mg/day and fesoterodine 28 mg/day was 3 beats/minute and 11 beats/minute, respectively. In the two, phase 3, placebo-controlled studies in adult in patients with overactive bladder, the mean increases in heart rate compared to placebo were 3 to 4 beats/minute in the fesoterodine 4 mg/day group and 3 to 5 beats/minute in the fesoterodine 8 mg/day group.

12.3Pharmacokinetics Absorption After oral administration, fesoterodine is well absorbed. Due to rapid and extensive hydrolysis by nonspecific esterases to its active metabolite 5-hydroxymethyl tolterodine, fesoterodine cannot be detected in plasma. Bioavailability of the active metabolite is 52%.

After single or multiple-dose oral administration of fesoterodine in doses from 4 mg to 28 mg, plasma concentrations of the active metabolite are proportional to the dose. Maximum plasma levels are reached after approximately 5 hours. No accumulation occurs after multiple-dose administration.

A Summary of pharmacokinetic parameters for the active metabolite after a single dose of fesoterodine fumarate 4 mg and 8 mg in extensive and poor metabolizers of CYP2D6 is provided in Table 8. Table 8: Summary of Geometric Mean [CV] Pharmacokinetic Parameters for the Active Metabolite After a Single Dose of fesoterodine fumarate 4 mg and 8 mg in Extensive and Poor CYP2D6 Metabolizers Parameter Fesoterodine fumarate 4 mg Fesoterodine fumarate 8 mg EM (N=16) PM (N=8) EM (N=16) PM (N=8) C max (ng/mL) 1.89 [43%] 3.45 [54%] 3.98 [28%] 6.90 [39%] AUC 0-tz (ng*h/mL) 21.2 [38%] 40.5 [31%] 45.3 [32%] 88.7 [36%] t max (h) a 5 [2 to 6] 5 [5 to…

🧬 Mechanism of Action 69 words ▾

12.1Mechanism of Action Fesoterodine is a competitive muscarinic receptor antagonist. After oral administration, fesoterodine is rapidly and extensively hydrolyzed by nonspecific esterases to its active metabolite, 5-hydroxymethyl tolterodine, which is responsible for the antimuscarinic activity of fesoterodine. Muscarinic receptors play a role in contractions of urinary bladder smooth muscle.

Inhibition of these receptors in the bladder is presumed to be the mechanism by which fesoterodine produces its effects.

📦 How Supplied / Storage and Handling 116 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Fesoterodine fumarate extended-release tablets, 4 mg are light blue colored, oval shaped, biconvex, film-coated, debossed with ‘ ’ on one side and 'FS' on the other side and are supplied in bottles of 30's, and 90’s. Bottles of 30 NDC 43598-247-30 Bottles of 90 NDC 43598-247-90 Fesoterodine fumarate extended-release tablets, 8 mg are blue colored, oval shaped, biconvex, film-coated, debossed with ‘ ’ on one side and ‘FT’ on the other side and are supplied in bottles of 30's, and 90’s.

Bottles of 30 NDC 43598-248-30 Bottles of 90 NDC 43598-248-90 Store fesoterodine fumarate extended-release tablets, at 20º to 25°C (68º to 77°F) [see USP Controlled Room Temperature]. Protect from moisture.

📋 Description 121 words ▾

11 DESCRIPTION Fesoterodine fumarate extended-release tablets contains fesoterodine fumarate. Fesoterodine is rapidly de-esterified to its active metabolite (R)-2-(3-diisopropylamino-1-phenylpropyl)-4-hydroxymethyl-phenol, or 5-hydroxymethyl tolterodine, which is a muscarinic receptor antagonist. Chemically, fesoterodine fumarate is designated as isobutyric acid 2-((R)-3-diisopropylammonium-1-phenylpropyl)-4-(hydroxymethyl) phenyl ester hydrogen fumarate.

The molecular formula is C 30 H 41 NO 7 and its molecular weight is 527.4. The structural formula is: The asterisk (*) indicates the chiral carbon. Fesoterodine fumarate is a white crystalline powder, which is freely soluble in water.

Each Fesoterodine fumarate extended-release tablet contains either 4 mg or 8 mg of fesoterodine fumarate and the following inactive ingredients: FD&C Blue #2, fructose, glyceryl behenate, hypromellose, lactose anhydrous, lecithin soya, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, talc and titanium dioxide.

💬 Information for Patients 187 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-Approved Patient Labeling (Patient Information) Angioedema Inform patients and/or their caregivers that fesoterodine fumarate extended-release tablets may cause angioedema, which could result in life-threatening airway obstruction. Advise patients and/or their caregivers to promptly discontinue fesoterodine fumarate extended-release tablets and seek immediate medical attention if they experience edema of the lips, tongue or laryngopharynx, or difficulty breathing.

Antimuscarinic Effects Inform patients that fesoterodine fumarate, like other antimuscarinic agents, may produce clinically significant adverse effects related to antimuscarinic pharmacological activity including constipation and urinary retention. Fesoterodine fumarate, like other antimuscarinics, may be associated with blurred vision, therefore, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effects on the patient have been determined. Heat prostration (due to decreased sweating) can occur when fesoterodine fumarate, like other antimuscarinic drugs, is used in a hot environment.

Alcohol Patients should also be informed that alcohol may enhance the drowsiness caused by fesoterodine fumarate, like other anticholinergic agents. R X only Distributor: Dr. Reddy’s Laboratories Inc., Princeton, NJ 08540 Made in India Revised: 09/2025

Glossary — plain-language definitions of medical terms used in this label:

anticoagulant: A medicine that slows down blood clotting; often called a blood thinner.

contraindicated: Should not be used in that situation, because the risk is considered too high.

in vitro: In a laboratory dish or test tube rather than in a living person or animal; results may not carry over to people.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

Absorption: How a medicine moves from where it is taken, such as the stomach or gut, into the bloodstream.

accumulation: A buildup of a medicine in the body when new doses are taken before earlier ones are fully removed.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse event: Any unwanted medical problem that happens during treatment, whether or not the medicine actually caused it.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

antagonist: A substance that blocks a target in the body so a natural signal or another medicine cannot produce its usual effect.

AUC: A measure of total drug exposure over time, showing how much medicine the blood is exposed to overall.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

Bioavailability: The share of a dose that actually reaches the bloodstream and is able to have an effect.

clearance: How quickly the body removes a medicine from the blood, usually through the liver and kidneys.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

confidence interval: A range of numbers that likely contains the true result, showing how sure researchers can be about a study's finding.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

creatinine clearance: An estimate of how fast the kidneys filter waste from the blood, often used to choose the right medicine dose.

CYP2D6: A liver enzyme that breaks down many medicines; people inherit different versions, so it works faster in some and slower in others.

CYP3A4: One of the most important liver and gut enzymes, responsible for breaking down a large share of all medicines.

cytochrome P450: A large family of enzymes, mostly in the liver, that break down many medicines so the body can remove them.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

dose reduction: Lowering the amount of a medicine, often to ease side effects or fit a person's needs.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

dyspepsia: Discomfort, fullness, or a burning feeling in the upper belly, commonly called indigestion.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

eGFR: Estimated glomerular filtration rate, a blood-test-based estimate of how well the kidneys filter; lower numbers mean weaker function.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

extended-release: A pill or capsule made to release its medicine slowly over many hours, so it can be taken less often; often labeled ER or XR.

Full Prescribing Information: The complete, detailed label for a prescription medicine that follows the summary highlights.

GFR: A measure (glomerular filtration rate) of how well the kidneys filter the blood; lower numbers mean weaker kidney function.

glaucoma: An eye condition, often linked to high pressure inside the eye, that can slowly damage vision.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

How Supplied/Storage and Handling: The label section describing the forms and strengths a medicine comes in and how to store it properly.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

Indications and Usage: The label section stating which medical conditions the FDA has officially approved the medicine to treat, prevent, or manage.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

lactation: The making and release of milk from a mother's breasts after giving birth.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

metabolite: A new substance formed when the body breaks a medicine down.

myasthenia gravis: A long-term condition where muscles tire and grow weak easily, often affecting the eyes, face, and swallowing.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

Patient Counseling Information: The label section telling health professionals what to explain to patients about using a medicine safely.

Pharmacokinetics: The study of how the body takes in a medicine, spreads it around, breaks it down, and removes it over time.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

placebo-controlled: Describes a study that compares people taking the real medicine against people taking a dummy pill with no active ingredient.

poor metabolizer: A person whose inherited enzymes break down certain drugs slowly, so those drugs can build up higher than usual.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

QTc: A number from a heart tracing (ECG) that measures the heart's electrical recovery time, adjusted for the heart rate.

randomized: Assigned to a treatment group purely by chance, like a coin flip, so the groups being compared start out fair and similar.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

renal impairment: Reduced kidney function, meaning the kidneys do not filter waste and fluid from the blood as well as normal.

somnolence: Feeling very sleepy or drowsy, with trouble staying awake during the day.

subcutaneous: An injection placed into the fatty layer just under the skin; often written as subcut or SC.

terminal half-life: The time it takes blood levels to fall by half during the final, slowest stage of removal.

urinary retention: Being unable to empty the bladder fully or at all.

Use in Specific Populations: The label section describing how a medicine affects particular groups, such as pregnant people, children, or older adults.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

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

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🧪 All Fesoterodine Fumarate NDCsSame ingredient 🏭 All Dr.Reddy's labeler NDCsLabeler code 43598

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Other drugs sharing this product’s First Databank therapeutic class (HIC3). Each links to that NDC’s page in our directory.

Fesoterodine fumarate 8 mg Tablet, Extended Release, 30-count

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7 DRUG INTERACTIONS

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12 CLINICAL PHARMACOLOGY

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