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VESIcare LS solifenacin succinate 1 mg/mL Suspension

by Astellas Pharma US, Inc. · 1 BOTTLE, PLASTIC in 1 CARTON (51248-250-99) / 150 mL in 1 BOTTLE, PLASTIC
NDC 51248-0250-99
🏷️ FDA NDC (as labeled) 51248-250-99 billing pads the product segment with a zero
Rx only Brand Discontinued Non-controlled ⚠ Discontinued by firm
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
Other active recalls for Solifenacin Succinate (different manufacturers) — 2 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0333-2025
Class II · Mar 13, 2025 — CGMP Deviations (Glenmark Pharmaceuticals Inc., USA) · FDA recall D-0317-2025
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗
⚠️
Excluded from the active FDA NDC Directory. The labeler reported this product as discontinued, so it is excluded from the active NDC Directory. The listing was last certified through Jul 2026. A label may still appear on DailyMed, but the NDC is no longer in the current FDA NDC Directory. Search the FDA NDC Directory ↗

🆔 Identity & classification

FDA NDC (as labeled) 51248-250-99
Product NDC 51248-250
11-digit billing NDC 51248025099
NCPDP billing unit ML — per mL (volume)
RxCUI 2375321, 2375325
UNII KKA5DLD701
Application # NDA209529
SPL Set ID e0300384-e980-45d5-8ed4-48a2618671ae
Established class (EPC) Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category NDA
Marketing status Discontinued
FDA listing status Discontinued by firm (certified through Jul 2026)
Marketing start 2020-05-26
Marketing end 2026-07-31
Route ORAL
Dosage form SUSPENSION
Substance SOLIFENACIN SUCCINATE
GPI-14 54100055201820
GPI class VESIcare LS
GCN Seq No 080587
GCN 47476
HICL code 026595
Ingredient (HICL) Solifenacin Succinate
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1I
Therapeutic class — specific (HIC3) Urinary Tract Antispasmodic, M(3) Selective Antag.
AHFS code 86:12.04.00
AHFS class Antimuscarinics
FDB label name VESICARE LS 5 MG/5 ML SUSP
FDB brand name Vesicare Ls
Legend status F — Federal legend — prescription drug or device
Why two NDCs? The FDA registers this code as 51248-250-99 — 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 → 51248-0250-99. 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 Cholinergic Muscarinic Antagonist class.

Pharmacologic class Cholinergic Muscarinic Antagonist
Drug family (ATC) Drugs for urinary frequency and incontinence
How it works Cholinergic Muscarinic Antagonists
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

LabelerAstellas Pharma US, Inc.
Application holderASTELLAS PHARMA US INC
FDA applicationNDA209529 (NDA)
Labeler code51248
First marketedMay 2020
Product typeHuman Prescription Drug
Portfolio35 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

Label name VESICARE LS 5 MG/5 ML SUSP Ingredient Solifenacin Succinate
📖 What it is MedlinePlus · NLM

Solifenacin is used to treat overactive bladder (a bladder condition that causes sudden urges to urinate that may be hard to control). Solifenacin is in a class of medications called antimuscarinics. It works by relaxing the bladder muscles.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It helps calm an overactive bladder. If you're rushing to the bathroom constantly, waking up at night to urinate, or sometimes not making it in time, solifenacin works by blocking...
  • What exactly is solifenacin supposed to do for me?
  • 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 a saliva substitute can all h...
  • The dry mouth is really bothering me — is there anything I can do?
📖 Read our full Solifenacin guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

🧪 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.

We could not link this NDC to a current FDA Structured Product Label. An inactive-ingredient list is therefore not available from this source.
Where does this data come from?
Source: official FDA Structured Product Labeling (SPL) via DailyMed and the openFDA label index. Structured IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly $1.638 $245.75 / 150 ml
Medicaid paysCMS SDUD · 12 mo $1.65 $247.34 / 150 ml
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
NADAC price history (per mL) — tap or hover for the price & month
Aug 2025 $1.638 $1.638
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
VESIcare LS 1 mg/mLthis 51248-0250-99 Astellas 1 bottle $1.638 — Discontinued —
About this product: this is the brand-name version. We did not find an FDA-approved generic match for this exact strength, form and route.
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

🏛️
2020
First FDA approval
May 2020
📍
2026
Currently FDA-listed
6 years listed
🛡️
2031
Latest patent/protection listed
not a guaranteed launch date
🔒No FDA-approved generic found

We did not find an FDA-approved generic match for this exact strength, form and route. Patent/protection dates below may affect future generic timing.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through May 2031. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved May 26, 2020 RLD RS ⏳ ~4.7 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
US 9918970 — drug product
2020 2022 2024 2026 2028 2030
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

Listed patents (1)
PatentTypeUse codeExpires
US 9918970 ↗ Drug product — May 18, 2031
Common questions
Is there a generic version of VESICARE LS 5 MG/5 ML SUSP?
No FDA-approved generic equivalent is currently listed in the FDA Orange Book for VESICARE LS 5 MG/5 ML SUSP. Based on the patents and exclusivity currently listed, the Orange Book estimate is that full-label generic entry may be delayed until May 2031 — an estimate, not a guaranteed launch date.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
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 51248-0250-99, 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 – Q1 2026 · 5 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
482
Units reimbursed last 4 qtrs
77.3K
Gross reimbursed last 4 qtrs
$127.5K
Avg / prescription
$264.49
Avg / unit
$1.6489
Latest quarter Q1 2026
0Rx
Medicaid pays / mL
$1.6489
gross reimbursed
vs
NADAC / mL
$1.6383
acquisition cost
=
Spread
+$0.0106
+1% vs cost
What Medicaid paid per mL (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 ⓘ
21% FFS 79% MCO
Fee-for-service · 101 Rx Managed care · 381 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: no data reported WA Idaho: no data reported ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: no data reported MN Wisconsin: no data reported WI Michigan: no data reported MI New York: 9,100 units · 46.5 per 100k residents NY Vermont: no data reported VT New Hampshire: no data reported NH Oregon: no data reported OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: no data reported IA Illinois: no data reported IL Indiana: no data reported IN Ohio: no data reported OH Pennsylvania: 27,590 units · 213 per 100k residents PA New Jersey: 12,150 units · 131 per 100k residents NJ Massachusetts: no data reported MA California: no data reported CA Utah: no data reported UT Colorado: no data reported CO Nebraska: 5,130 units · 259 per 100k residents NE Missouri: no data reported MO Kentucky: no data reported KY West Virginia: no data reported WV Virginia: 1,485 units · 17.0 per 100k residents VA Maryland: no data reported MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: no data reported NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 8,380 units · 118 per 100k residents TN North Carolina: no data reported NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: 4,560 units · 99.7 per 100k residents LA Mississippi: no data reported MS Alabama: no data reported AL Georgia: no data reported GA D.C.: no data reported DC Hawaii: no data reported HI Texas: 8,920 units · 29.2 per 100k residents TX Florida: no data reported FL
Units reimbursed · per 100k residents
17.0259
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 Nebraska 259 /100k
2 Pennsylvania 213 /100k
3 New Jersey 131 /100k
4 Tennessee 118 /100k
5 Louisiana 99.7 /100k
6 New York 46.5 /100k
7 Texas 29.2 /100k
8 Virginia 17.0 /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.

📊 Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Vesicare Ls — the program that covers self-administered drugs. 1 manufacturer.
⚠️ 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 Vesicare Ls. 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.
Total Part D spend
$31.6K
Claims incl. refills
96
Beneficiaries
38
Spend / beneficiary
$831.72
Spend / claim
$329.22
💵 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 Solifenacin succinate — the ingredient across all brands.

Top reported reactions

Constipation1,636
Dry Mouth1,630
Fatigue1,295
Fall1,239
Dizziness1,062
Nausea906
Headache871

Age at onset

Infant1
Child20
Adolescent6
Adult831
Elderly1,285

Reporter sex

26,018 reports
Male · 29%
Female · 70%
Unknown · 1%

Serious outcomes

Hospitalization5,872
Death1,364
Disabling587
Life-threatening584
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 1,629 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
51248-0250-99 You're viewing this 1 BOTTLE, PLASTIC in 1 CARTON (51248-250-99) / 150 mL in 1 BOTTLE, PLASTIC 2020-05-26 Discontinued by firm

🧭 About this NDC listing & data coverage

Finished prescription product No longer marketed (per FDA listing data)
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 — Not published for this NDC No photo available yet for this listing.
Inactive ingredients (structured) — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available.
NADAC pharmacy acquisition price (CMS) ✓ Available
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) ✓ Available
“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

What does the discontinued status mean for this NDC?
The labeler reported a marketing end date (or the listing was delisted), so this specific package is no longer actively marketed. Remaining stock may still be dispensed for a time, and the NDC stays valid for historical records and claims — but data feeds (pricing, labeling) typically stop updating for it. Other package sizes or other manufacturers' versions of the same medication may still be marketed — see the equivalents section where available.
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 51248-250-99, 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: 51248-0250-99, written without dashes as 51248025099. 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 51248-0250-99, the first segment (51248) is the labeler code FDA assigned to Astellas Pharma US, Inc.; the middle segment (0250) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (99) identifies this exact package size and type. Together they name one specific package of one specific product.
Who lists this product with the FDA?
Astellas Pharma US, Inc. 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.
🎯 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 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients
🎯 Indications and Usage 50 words ▾

1 INDICATIONS AND USAGE VESIcare LS ® is indicated for the treatment of neurogenic detrusor overactivity (NDO) in pediatric patients aged 2 years and older. VESIcare LS is a muscarinic antagonist indicated for the treatment of neurogenic detrusor overactivity in pediatric patients aged 2 years and older. ( 1 )

⏱️ Dosage and Administration ~2 min read ▾

2 DOSAGE AND ADMINISTRATION • The recommended once daily dose of VESIcare LS is based on patient weight, refer to Table 1. Dosing should be initiated at the recommended starting dose. Dosage may be titrated to the lowest effective dose but should not exceed the maximum recommended dose.

( 2.1 ) • Instruct patients or their caregivers that patients should take VESIcare LS orally followed by liquid (e.g., water or milk). • Do not exceed the recommended starting dose of VESIcare LS in patients with: • Severe renal impairment creatinine clearance < 30 mL/min/1.73 m 2 . ( 2.2 , 8.6 ) • Moderate hepatic impairment (Child-Pugh B). VESIcare LS is not recommended in patients with severe hepatic impairment (Child-Pugh C).

( 2.3 , 8.7 ) • Concomitant use of strong CYP3A4 inhibitors. ( 2.4 , 7.1 )

2.1Dosing Information Dosing Information in Pediatric Patients Aged 2 Years and Older The recommended starting and maximum VESIcare LS oral suspension doses are shown in mL in Table 1 . VESIcare LS oral suspension has a concentration of 1 mg/1 mL. The recommended doses are weight-based and are administered once daily.

After administration of the recommended starting dose, the dose may be increased to the lowest effective dose but should not exceed the maximum recommended dose. Table 1: Once Daily Recommended Dosage According to Patient Body Weight Weight range Starting dose Maximum dose 9 kg to 15 kg 2 mL 4 mL greater than 15 kg to 30 kg 3 mL 5 mL greater than 30 kg to 45 kg 3 mL 6 mL greater than 45 kg to 60 kg 4 mL 8 mL greater than 60 kg 5 mL 10 mL Evaluate patients periodically for potential dose adjustment. VESIcare LS oral suspension should be taken once daily.

Instruct patients or their caregivers that patients should take VESIcare LS orally followed by liquid (e.g., water or milk). Instruct patients to take any missed doses as soon as they remember, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped, and the next dose should be taken at the usual time.

2.2Dosing Recommendations in Patients with Renal Impairment Do not exceed the recommended VESIcare LS oral suspension starting dose in patients with severe renal impairment (CL cr < 30 mL/min/1.73 m 2 ) [see Use in Specific Populations ( 8.6 )] .

2.3Dosing Recommendations in Patients with Hepatic Impairment Do not exceed the recommended VESIcare LS oral suspension starting dose in patients with moderate hepatic impairment (Child-Pugh B). Do not use VESIcare LS in patients with severe hepatic impairment (Child-Pugh C) [see Use in Specific Populations ( 8.7 )] .

2.4Dosing Recommendations in Patients Taking CYP3A4 Inhibitors Do not exceed the recommended VESIcare LS oral suspension starting dose when VESIcare LS is administered with strong CYP3A4 inhibitors such as ketoconazole [see Drug Interactions ( 7.1 )] .

💊 Dosage Forms and Strengths 35 words ▾

3 DOSAGE FORMS AND STRENGTHS Oral Suspension: 5 mg/5 mL (1 mg/mL) of solifenacin succinate in a white to off-white colored suspension. Oral suspension: 5 mg/5 mL (1 mg/mL) of solifenacin succinate. ( 3 )

⛔ Contraindications 100 words ▾

4 CONTRAINDICATIONS VESIcare LS is contraindicated in patients: • With gastric retention [see Warnings and Precautions ( 5.3 )] , • With uncontrolled narrow-angle glaucoma [see Warnings and Precautions ( 5.5 )] , and • Who have demonstrated hypersensitivity to solifenacin succinate or the inactive ingredients in VESIcare LS oral suspension. Reported adverse reactions have included anaphylaxis and angioedema [see Adverse Reactions ( 6.2 )] . • Gastric retention. ( 4 , 5.3 ) • Uncontrolled narrow-angle glaucoma.

( 4 , 5.5 ) • Hypersensitivity to this product or any of its components. ( 4 , 5.1 , 6.2 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Angioedema and Anaphylactic Reactions : Promptly discontinue VESIcare LS and provide appropriate therapy. ( 5.1 ) • Urinary Retention : VESIcare LS is not recommended for use in patients with clinically significant bladder outlet obstruction in the absence of clean intermittent catherization. ( 5.2 ) • Gastrointestinal Disorders : VESIcare LS is not recommended for use in patients with decreased gastrointestinal motility.

( 5.3 ) • Central Nervous System Effects : Somnolence has been reported with solifenacin succinate. Advise patients not to drive or operate heavy machinery until they know how VESIcare LS affects them. ( 5.4 ) • Controlled Narrow-Angle Glaucoma : Use VESIcare LS with caution in patients being treated for narrow-angle glaucoma.

( 5.5 ) • QT Prolongation in Patients at High Risk of QT Prolongation : VESIcare LS is not recommended for use in patients at high risk of QT prolongation, including patients with a known history of QT prolongation and patients taking medications known to prolong the QT interval. ( 5.6 )

5.1Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin succinate. 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. Anaphylactic reactions have also been reported in patients treated with solifenacin succinate.

Angioedema associated with upper airway swelling and anaphylactic reactions may be life-threatening. VESIcare LS oral suspension is contraindicated in patients with a known or suspected hypersensitivity to solifenacin succinate [see Contraindications ( 4 )] . If involvement of the tongue, hypopharynx, or larynx occurs, promptly discontinue VESIcare LS oral suspension and provide appropriate therapy and/or measures necessary to ensure a patent airway.

5.2Urinary Retention The use of VESIcare LS oral suspension, like other antimuscarinic drugs, in patients with clinically significant bladder outlet obstruction may result in urinary retention. The use of VESIcare LS oral suspension is not recommended in patients with clinically significant bladder outflow obstruction in the absence of clean intermittent catheterization because of the risk of urinary retention.

5.3Gastrointestinal Disorders The use of VESIcare LS oral suspension, like other antimuscarinic drugs, in patients with conditions associated with decreased gastrointestinal motility may result in further decreased gastrointestinal motility. VESIcare LS oral suspension is contraindicated in patients with gastric retention [see Contraindications ( 4 )] . The use of VESIcare LS oral suspension is not recommended in patients with conditions associated with decreased gastrointestinal motility.

5.4Central Nervous System Effects Solifenacin succinate is associated with antimuscarinic central nervous system (CNS) adverse reactions [see Adverse Reactions ( 6.2 )] . A variety of CNS antimuscarinic adverse reactions have been reported, including headache, confusion, hallucinations, and somnolence. Monitor patients for signs of antimuscarinic CNS adverse reactions, particularly after beginning treatment or increasing the dose.

Advise patients not to drive or operate heavy machinery until they know how VESIcare LS affects them. If a patient experiences antimuscarinic CNS adverse reactions, consider dose reduction or drug discontinuation.

5.5Controlled Narrow-Angle Glaucoma VESIcare LS should be used with caution in patients being treated for narrow-angle glaucoma [see Contraindications ( 4 )] .

5.6QT Prolongation in Patients at High Risk of QT Prolongation In a study of the effect of solifenacin succinate on the QT interval conducted in 76 healthy adult women [see Clinical Pharmacology ( 12.2 )] , solifenacin succinate 30 mg (three times the largest maximum recommended dose in pediatric patients) was associated with a mean increase in the Friderici…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS • Angioedema and Anaphylactic Reactions [see Warnings and Precautions ( 5.1 )] • Urinary Retention [see Warnings and Precautions ( 5.2 )] • Gastrointestinal Disorders [see Warnings and Precautions ( 5.3 )] • Central Nervous System Effects [see Warnings and Precautions ( 5.4 )] • QT Prolongation in Patients at High Risk of QT Prolongation [see Warnings and Precautions ( 5.6 )] The most common adverse reactions (> 2%) were constipation, dry mouth and urinary tract infection. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Astellas Pharma US, Inc. at 1-800-727-7003 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. The safety of VESIcare LS oral suspension was evaluated in two open-label trials (Studies 1 and 2) [see Clinical Studies ( 14 )] . The two studies included 95 pediatric patients aged 2 to 17 years with neurogenic detrusor overactivity (NDO) who were 53% female, 58% White, 34% Asian and 2% Black.

Treatment was initiated at the weight-based starting recommended dose and was titrated up or down in 2.5 mg increments over 12 weeks to the lowest effective dose (not to exceed the maximum recommended dose). Subsequent to the dose titration period, patients continued their optimized dose for a 40-week maintenance period (mean exposure duration 301 days, range 1 to 413 days). The most commonly reported adverse reactions were constipation, dry mouth, urinary tract infection, abdominal pain, urinalysis bacterial test positive, and somnolence.

The incidence of adverse reactions was similar between patients taking the starting recommended dose and patients taking the maximum recommended dose with the exception of constipation, which was reported, in 8.5% of patients taking the maximum recommended dose compared to 0% of patients taking the starting recommended dose. Table 2 lists the adverse reactions reported in Studies 1 and 2 at an incidence equal to or greater than 1%. Table 2: Adverse Reactions Reported in ≥ 1% of Neurogenic Detrusor Overactivity (NDO) Patients Aged 2 to 17 Years Taking VESIcare LS Oral Suspension in Studies 1 and 2 Adverse Reaction Percentage (%) of Patients Reporting Adverse Reactions N=95 Constipation

7.4 Dry mouth

3.2 Urinary tract infection

2.1 Abdominal pain

1.1 Urinalysis bacterial test positive

1.1 Somnolence

1.1Adverse reactions reported in ≥ 1% of solifenacin succinate-treated adult patients and at an incidence greater than in placebo-treated adult patients in clinical adult trials were: Gastrointestinal disorders : dry mouth, constipation, nausea, dyspepsia, upper abdominal pain, vomiting Infections and infestations : urinary tract infection, influenza, pharyngitis Nervous system disorders : dizziness Eye disorders : blurred vision, dry eyes Renal and urinary disorders : urinary retention General disorders and administration site conditions : lower limb edema, fatigue Psychiatric disorders : depression Respiratory, thoracic and mediastinal disorders : cough Vascular disorders : hypertension

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of solifenacin succinate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. General disorders and administration site conditions : peripheral edema, hypersensitivity reactions (including angioedema with airway obstruction, rash, pruritus, urticaria, anaphylactic reaction); Nervous system disorders : dizziness, headache, confusion, hallucinations, delirium, somnolence; Cardiac disorders : QT prolongation, Torsade de Pointes, atrial fibrillation,…

🔄 Drug Interactions 85 words ▾

7 DRUG INTERACTIONS CYP3A4 Inhibitors : Do not exceed the recommended starting dose of VESIcare LS with concomitant use of strong CYP3A4 inhibitors. ( 7.1 )

7.1Strong CYP3A4 Inhibitors Solifenacin is a substrate of CYP3A4. Concomitant use of ketoconazole, a strong CYP3A4 inhibitor, significantly increased the exposure of solifenacin [see Clinical Pharmacology ( 12.3 )] . The dosage of VESIcare LS greater than the starting dose is not recommended when concomitantly used with strong CYP3A4 inhibitors [see Dosage and Administration ( 2.4 )] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary There are no studies with the use of solifenacin succinate in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day.

However, administration of doses 3.6 times and greater than the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see Data ] . In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Oral administration of 14 C-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier.

In pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the MRHD of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality. Administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the MRHD, resulted in reduced fetal body weights and reduced maternal body weight gain. No embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD).

Administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (< 1 times and 1.8 times the systemic exposure at the MRHD, respectively), resulted in no findings of embryo-fetal toxicity. Oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency).

An increase in the percentage of male offspring was also observed in litters from offspring (F2 generation) exposed to maternal doses of 250 mg/kg/day. There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the MRHD.

8.2Lactation Risk Summary There is no information on the presence of solifenacin in human milk, the effects on the breastfed child, or the effects on milk production. Solifenacin is present in mouse milk [see Data ] . When a drug is present in animal milk, it is likely that the drug will be present in human milk.

The developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for VESIcare LS and any potential adverse effects on the breastfed child from VESIcare LS or from the underlying maternal condition. Data Animal Data Oral administration of 14 C-solifenacin succinate to lactating mice resulted in the recovery of radioactivity in maternal milk. Lactating female mice orally administered solifenacin succinate at a maternally toxic dose of 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) had increased postpartum pup mortality, pups with reduced body weights, or delays in the onset of reflex and physical development.

Pups from lactating dams orally administered solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD) had no discernible adverse findings. The concentrations of solifenacin in animal milk does not necessarily predict the concentration of drug in human milk.

8.4 Pediatric Use…

🤰 Pregnancy ~2 min read ▾

8.1Pregnancy Risk Summary There are no studies with the use of solifenacin succinate in pregnant women or adolescents to inform a drug-associated risk of major birth defects, miscarriages, or adverse maternal or fetal outcomes. No adverse developmental outcomes were observed in animal reproduction studies with oral administration of solifenacin succinate to pregnant mice during the period of organogenesis at a dose resulting in 1.2 times the systemic exposure at the maximum recommended human dose (MRHD) of 10 mg/day.

However, administration of doses 3.6 times and greater than the MRHD during organogenesis produced maternal toxicity in the pregnant mice and resulted in developmental toxicity and reduced fetal body weights in offspring [see Data ] . In the U.S. general population, the estimated background risk of major birth defects or miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Oral administration of 14 C-solifenacin succinate to pregnant mice resulted in the recovery of radiolabel in the fetus indicating that solifenacin-related product can cross the placental barrier.

In pregnant mice, administration of solifenacin succinate at a dose of 250 mg/kg/day (7.9 times the systemic exposure at the MRHD of 10 mg), resulted in an increased incidence of cleft palate and increased maternal lethality. Administration of solifenacin succinate to pregnant mice during organogenesis at greater than or equal to 3.6 times (100 mg/kg/day and greater) the systemic exposure at the MRHD, resulted in reduced fetal body weights and reduced maternal body weight gain. No embryo-fetal toxicity or teratogenicity was observed in fetuses from pregnant mice treated with solifenacin succinate at a dose of 30 mg/kg/day (1.2 times the systemic exposure at the MRHD).

Administration of solifenacin succinate to pregnant rats and rabbits at a dose of 50 mg/kg/day (< 1 times and 1.8 times the systemic exposure at the MRHD, respectively), resulted in no findings of embryo-fetal toxicity. Oral pre- and post-natal administration of solifenacin succinate at 100 mg/kg/day (3.6 times the systemic exposure at the MRHD) during the period of organogenesis through weaning, resulted in reduced peripartum and postnatal survival, reduced body weight gain by the pups, and delayed physical development (eye opening and vaginal patency).

An increase in the percentage of male offspring was also observed in litters from offspring (F2 generation) exposed to maternal doses of 250 mg/kg/day. There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected systemic exposure at the MRHD.

🧒 Pediatric Use 60 words ▾

8.4Pediatric Use The safety and effectiveness of VESIcare LS have been established in pediatric patients aged 2 years and older for the treatment of neurogenic detrusor overactivity (NDO) and the information on this use is discussed throughout the labeling. The safety and effectiveness of VESIcare LS have not been established in pediatric patients less than 2 years of age.

🆘 Overdosage 178 words ▾

10 OVERDOSAGE Overdosage with VESIcare LS oral suspension can potentially result in severe antimuscarinic effects and should be treated accordingly. The highest dose ingested in an accidental overdose of solifenacin succinate was 280 mg (28 times the maximum dosage) in a 5-hour period in adults. This case was associated with mental status changes.

Some cases reported a decrease in the level of consciousness. Intolerable antimuscarinic adverse reactions (fixed and dilated pupils, blurred vision, failure of heel-to-toe exam, tremors, and dry skin) occurred on day 3 in normal adult volunteers taking 50 mg daily (5 times the maximum recommended dosage) and resolved within 7 days following discontinuation of drug. The highest overdose reported in a pediatric patient was the accidental ingestion of 95 mg of solifenacin succinate (9.5 times the maximum recommended dosage).

The child experienced severe antimuscarinic adverse reactions and was treated with gastric lavage and supportive measures until all antimuscarinic signs and symptoms reversed. In the event of overdose with VESIcare LS oral suspension, treat with gastric lavage and appropriate supportive measures. ECG monitoring is also recommended.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.

12.2Pharmacodynamics Cardiac Electrophysiology The effect of 10 mg and 30 mg solifenacin succinate (three times the maximum recommended dose) on the QT interval was evaluated in adults at the time of peak plasma concentration of solifenacin in a multi-dose, randomized, double-blind, placebo and positive-controlled (moxifloxacin 400 mg) trial [see Warnings and Precautions ( 5.6 )]. After receiving placebo and moxifloxacin sequentially, adult subjects were randomized to one of two treatment groups. One group (n=51) completed 3 additional sequential periods of dosing with solifenacin succinate 10, 20, and 30 mg while the second group (n=25) in parallel completed a sequence of placebo and moxifloxacin.

Study subjects were female volunteers aged 19 to 79 years. The 30 mg dose of solifenacin succinate (three times the highest recommended dose) was chosen for use in this study because this dose results in a solifenacin exposure that covers those observed upon coadministration of 10 mg solifenacin succinate with strong CYP3A4 inhibitors (e.g., ketoconazole, 400 mg). Due to the sequential dose escalating nature of the study, baseline ECG measurements were separated from the final QT assessment (of the 30 mg dose level) by 33 days.

The median difference from baseline in heart rate associated with the 10 and 30 mg doses of solifenacin succinate compared to placebo was -2 and 0 beats/minute, respectively. Because a significant period effect on QTc was observed, the QTc effects were analyzed utilizing the parallel placebo control arm rather than the pre-specified intra-patient analysis. Representative results are shown in Table 3 .

Table 3: QTc changes in msec (90% CI) from baseline at T max (relative to placebo) in adults Results displayed are those derived from the parallel design portion of the study and represent the comparison of Group 1 to time-matched placebo effects in Group 2. Drug/Dose Fridericia Method (using mean difference) Solifenacin succinate 10 mg 2 (-3, 6) Solifenacin succinate 30 mg 8 (4, 13) Moxifloxacin was included as a positive control in this study and, given the length of the study, its effect on the QT interval was evaluated in 3 different sessions.

The placebo-subtracted mean changes (90% CI) in QTcF for moxifloxacin in the three sessions were 11 (7, 14), 12 (8, 17), and 16 (12, 21), respectively. The QT interval prolonging effect of the highest solifenacin succinate dose (three times the maximum therapeutic dose) studied was not as large as that of the positive control moxifloxacin at its recommended dose. However, the confidence intervals overlapped, and this study was not designed to draw direct statistical conclusions between the drugs or the dose levels.

12.3Pharmacokinetics Absorption After oral administration of VESIcare LS in pediatric patients with neurogenic detrusor overactivity (NDO) aged 2 to 17 years, peak plasma concentrations (C max ) of solifenacin were reached within 2 to 6 hours after administration (t max ) and, at steady-state, the dose-normalized C max ranged from 2.5 - 29 ng/mL/mg. The absolute bioavailability of solifenacin in adults is approximately 90%, with plasma concentrations of solifenacin proportional to the dose administered. Effect of Food Food intake did not significantly affect the C max and AUC of solifenacin following oral administration of VESIcare LS.

Distribution Solifenacin is approximately 98% ( in vivo ) bound to human plasma proteins, principally to α 1 -acid glycoprotein. Solifenacin is highly distributed to non-CNS tissues, having a median steady-state volume of distribution of 211 L in pediatric neurogenic detrusor overactivity (NDO) patients from 2 to 17 years old. Elimination The median elimination hal…

🧬 Mechanism of Action 30 words ▾

12.1Mechanism of Action Solifenacin is a competitive muscarinic receptor antagonist. Muscarinic receptors play an important role in several major cholinergically mediated functions, including contractions of urinary bladder smooth muscle.

📦 How Supplied / Storage and Handling 104 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING VESIcare LS is supplied as a white to off-white colored 5 mg/5 mL (1 mg/mL) aqueous oral suspension of solifenacin succinate, packaged in 150 mL amber polyethylene terephthalate (PET) bottles, which are capped with child-resistant high-density polyethylene-polypropylene caps with a pulp and vinyl seal liner. Carton contains one bottle (NDC 51248-250-99) Store at 20°C to 25°C (68°F to 77°F) with excursions permitted from 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].

Store in original bottle to protect from degradation. Dispense in a tight, light-resistant container. Discard any unused product 28 days after opening the original bottle.

📋 Description 161 words ▾

11 DESCRIPTION VESIcare LS (solifenacin succinate) oral suspension is a muscarinic receptor antagonist. Chemically, solifenacin succinate is a butanedioic acid compound with (1 S )-(3 R )-1-azabicyclo[2.2.2]oct-3-yl 3,4-dihydro-1-phenyl-2(1 H )-iso-quinolinecarboxylate (1:1) having an empirical formula of C 23 H 26 N 2 O 2 •C 4 H 6 O 4 , and a molecular weight of 480.55. The structural formula of solifenacin succinate is: Solifenacin succinate is a white to pale-yellowish-white crystal or crystalline powder.

It is freely soluble at room temperature in water, glacial acetic acid, dimethyl sulfoxide, and methanol. VESIcare LS contains 1 mg/mL of solifenacin succinate as an oral suspension (1 mg solifenacin succinate is equivalent to 0.75 mg solifenacin). The inactive ingredients are polacrilin potassium, methylparaben, propylparaben, propylene glycol, simethicone emulsion 30%, carbomer homopolymer Type B, xylitol, acesulfame potassium, natural orange flavor, sodium hydroxide, and purified water.

VESIcare LS is a white to off-white color aqueous homogenous oral suspension with an orange flavor. structure of Solifenacin succinate

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient and/or caregiver to read the FDA-approved patient labeling (Patient Information). Angioedema and Anaphylactic Reactions Inform patients and/or their caregivers that angioedema and anaphylactic reactions have been reported in patients treated with solifenacin succinate. Angioedema and anaphylactic reactions may be life-threatening.

Advise patients to promptly discontinue VESIcare LS therapy and seek immediate attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing [see Contraindications ( 4 ) and Warnings and Precautions ( 5.1 )] . Urinary Retention Inform patients and/or their caregivers that VESIcare LS may cause urinary retention in patients with conditions associated with bladder outlet obstruction [see Warnings and Precautions ( 5.2 )] . Gastrointestinal Disorders Inform patients and/or their caregivers that VESIcare LS oral suspension may cause further decrease in gastrointestinal motility in patients with conditions associated with decreased gastrointestinal motility.

VESIcare LS oral suspension has been associated with constipation and dry mouth. Advise patients and/or their caregivers to contact their health care providers if they experience severe abdominal pain or become constipated for 3 or more days [see Warnings and Precautions ( 5.3 )] . Central Nervous System Effects Because VESIcare LS oral suspension, like other antimuscarinic agents, may cause central nervous system effects or blurred vision, advise patients and/or caregivers to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effect on the patient has been determined [see Warnings and Precautions ( 5.4 )] .

Narrow-Angle Glaucoma Inform patients and/or caregivers that VESIcare LS, like other antimuscarinics, may cause worsening of the glaucoma condition in patients with narrow-angle glaucoma [see Warnings and Precautions ( 5.5 )] . Dry Skin Inform patients and/or caregivers that VESIcare LS, like other antimuscarinics, may cause dry skin due to decreased sweating. Heat prostration due to decreased sweating can occur when antimuscarinic drugs are used in a hot environment [see Adverse Reactions ( 6.2 )] .

Administration Instructions Ensure that the patient has an appropriate measuring device and instructions for measuring the correct dose. Instruct patients or their caregivers to use an oral dosing syringe to correctly measure the prescribed amount of VESIcare LS oral suspension. Inform patients that oral dosing syringes may be obtained from their pharmacy.

Instruct patients or their caregivers to shake the bottle well prior to administration of each dose and that patients should take VESIcare LS orally followed by liquid (e.g., water or milk) 1 time a day. Inform patients or their caregivers that simultaneous use of VESIcare LS oral suspension with food and/or other liquids may result in a bitter taste. • Clean the measuring device and allow to dry after each use. • Discard VESIcare LS 28 days (4 weeks) after first opening the bottle. Instruct patients or their caregivers that patients should take VESIcare LS orally followed by liquid (e.g., water or milk).

Instruct patients to take any missed doses as soon as they remember, unless more than 12 hours have passed since the missed dose. If more than 12 hours have passed, the missed dose can be skipped and the next dose should be taken at the usual time. Marketed and Distributed by: Astellas Pharma US, Inc.

Northbrook, IL 60062 VESIcare LS is a registered trademark of Astellas US LLC. © 2004 – 2022 Astellas Pharma US, Inc. 366572-VES

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 51248-0151-01 · Astellas 51265-0363-01 · Kaken →
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.