Home › NDC Lookup › Ingredients › Solifenacin Succinate › 46708-0192-30
Solifenacin Succinate 5 mg Tablet, Coated, 30-count — NDC 46708-0192-30 package photo

Solifenacin Succinate 5 mg Tablet, Coated, 30-count

by Alembic Pharmaceuticals Limited · 30 TABLET, COATED in 1 BOTTLE (46708-192-30)
NDC 46708-0192-30
🏷️ FDA NDC (as labeled) 46708-192-30 billing pads the product segment with a zero
This package
Contains30-count Pack sizes4 compare ↓
Also priced by: Part D plans $0.3747/unit — full pricing hub ↓
Also comes in: 80 tablets 46708-0192-08 90 tablets 46708-0192-90 1000 tablets 46708-0192-91
Rx only Generic On market Non-controlled
🗂️ Data synced Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

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

⚠️
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 ↗

🆔 Identity & classification

FDA NDC (as labeled) 46708-192-30
Product NDC 46708-192
11-digit billing NDC 46708019230
RxCUI 477367, 477372
UNII KKA5DLD701
UPC 0346708193300
Application # ANDA205575
SPL Set ID aea71cde-6d62-4f8d-b813-47064cb213d9
Established class (EPC) Cholinergic Muscarinic Antagonist
Mechanism of action Cholinergic Muscarinic Antagonists
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2019-05-20
Route ORAL
Dosage form TABLET, COATED
Substance SOLIFENACIN SUCCINATE
TE code (Orange Book) AB · RLD · RS
Why two NDCs? The FDA registers this code as 46708-192-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 46708-0192-30. 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 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

LabelerAlembic Pharmaceuticals Limited
Application holderALEMBIC PHARMACEUTICALS LTD
FDA applicationANDA205575 (ANDA)
Labeler code46708
First marketedMay 2019
Product typeHuman Prescription Drug
Portfolio502 products on file
The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

🩺 Clinical

📖 What it is MedlinePlus · NLM

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.

💊 What it looks like

Color Yellow / Pink
ShapeRound
ImprintL;432
Size7 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 35SW5USQ3G
    A synthetic yellow dye used to color medicines. It helps make tablets, capsules, and liquids visually distinct so patients can easily identify their medication.
  • UNII EX438O2MRT
    Ferric oxide yellow is a naturally occurring iron compound used as a colorant in medications. It gives tablets, capsules, and other forms a yellow or golden hue for identification and appearance.
  • UNII 3NXW29V3WO
    Hypromellose is a plant-based thickener made from cellulose. It's used in medicines as a binder to hold ingredients together, a coating for tablets, and a thickener for liquids.
  • UNII EWQ57Q8I5X
    Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
  • UNII 70097M6I30
    Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
  • UNII Q662QK8M3B
    Polyethylene glycol 8000 is a synthetic polymer made from ethylene oxide. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and add bulk to the medicine.
  • UNII O8232NY3SJ
    A plant-based carbohydrate derived from corn kernels. It acts as a filler to add bulk, a binder to hold ingredients together, and a disintegrant to help the tablet break apart in your stomach for absorption.
  • 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.

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

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

Inactive ingredient FAQ

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

💲 Pricing

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

Price systemPer eachPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026 $0.3747 $11.24 / 30 tablets
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

🔁 Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Solifenacin succinate 5 mg 00591-3795-19 Actavis 90 tablets $0.155 AB Availability likely —
solifenacin succinate 5 mg 31722-0027-30 Camber 30 tablets $0.155 AB Availability likely —
Solifenacin Succinate 5 mg 60505-4702-03 Apotex 30 tablets $0.155 AB Availability likely —
Solifenacin Succinate 5 mg 67877-0527-30 Ascend 30 tablets $0.155 AB Availability likely —
Solifenacin Succinate 5 mg 72205-0020-30 Novadoz 30 tablets $0.155 AB Availability likely —
solifenacin succinate 5 mg 27241-0037-03 Ajanta 30 tablets $0.217 — FDA listed —
VESIcare 5 mg 51248-0150-01 Astellas 30 tablets $12.267 — Discontinued —
Solifenacin Succinate 5 mg 29300-0328-05 Unichem 500 tablets — AB FDA listed —
solifenacin succinate 5 mg 33342-0148-07 Macleods 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 35561-0285-10 Bostal 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 42291-0739-30 AvKARE 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mgthis 46708-0192-30 Alembic 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 50228-0427-05 ScieGen 500 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 51407-0471-30 Golden 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 62332-0192-08 Alembic 80 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 63629-8532-01 Bryant 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 63629-8867-01 Bryant 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 63629-8868-01 Bryant 90 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 65862-0878-03 Aurobindo 10 tablets — AB FDA listed —
solifenacin succinate 5 mg 68462-0386-14 Glenmark 10 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 71205-0559-30 Proficient 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 71205-0561-30 Proficient 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 71335-1729-01 Bryant 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 71335-2423-01 Bryant 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 72162-1848-03 Bryant 30 tablets — AB FDA listed —
Solifenacin Succinate 5 mg 82804-0044-30 Proficient 30 tablets — AB FDA listed —
Solifenacin succinate 5 mg 72303-0831-01 HEC 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

🏛️
2019
On the market since
May 2019
📍
2026
Currently FDA-listed
7 years listed
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

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

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

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

Medicare Part D (outpatient prescription) spending for Solifenacin Succinate — the program that covers self-administered drugs. 11 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 Solifenacin Succinate. 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
$16.12M
Claims incl. refills
445.4K
Beneficiaries
302.9K
Spend / beneficiary
$53.24
Spend / claim
$36.20
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.

📦 Packaging — all sizes for this product

Package NDCDescription Marketing startStatus
46708-0192-08 80 TABLET, COATED in 1 CARTON (46708-192-08) 2019-05-20 Active
46708-0192-30 You're viewing this 30 TABLET, COATED in 1 BOTTLE (46708-192-30) 2019-05-20 Active
46708-0192-90 90 TABLET, COATED in 1 BOTTLE (46708-192-90) 2019-05-20 Active
46708-0192-91 1000 TABLET, COATED in 1 BOTTLE (46708-192-91) 2019-05-20 Active

You're viewing the smallest of 4 pack sizes for this product.

Pack size FAQ

What quantity is in NDC 46708-0192-30?
NDC 46708-0192-30 is a 30-count package — 30 tablet, coated in 1 bottle.
What is the difference between NDC 46708-0192-30 and NDC 46708-0192-08?
Both are Solifenacin Succinate 5 mg Tablet, Coated — the drug itself is identical. NDC 46708-0192-30 is the 30-count package, while NDC 46708-0192-08 is the 80 tablets package.
What NDC number is used to bill for this package of Solifenacin Succinate 5 mg Tablet, Coated?
Bill NDC 46708-0192-30 — the 11-digit billing format is 46708019230. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

🧭 About this NDC listing & data coverage

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

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The FDA registers it as 46708-192-30, which is what is printed on the packaging and shown on DailyMed. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero: 46708-0192-30, written without dashes as 46708019230. The Identity section at the top of this page lists every form of this code.
What do the three segments of this NDC mean?
In 46708-0192-30, the first segment (46708) is the labeler code FDA assigned to Alembic Pharmaceuticals Limited; the middle segment (0192) identifies this specific product — its ingredient, strength, and dosage form; and the last segment (30) identifies this exact package size and type. Together they name one specific package of one specific product.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Alembic Pharmaceuticals Limited. Listing status can change — the directory data on this page refreshes weekly.
Does this product come in other package sizes?
Yes — the FDA directory lists 3 other package presentations of this same product, including 80 tablets (46708-0192-08), 90 tablets (46708-0192-90), 1000 tablets (46708-0192-91). Each has its own NDC and its own page — see the package list near the top of this page.
Who lists this product with the FDA?
Alembic Pharmaceuticals Limited is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.

📄 Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.
🎯 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 52 words ▾

1 INDICATIONS AND USAGE Solifenacin succinate tablet is a muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency. Solifenacin succinate tablets are muscarinic antagonist indicated for the treatment of overactive bladder with symptoms of urge urinary incontinence, urgency, and urinary frequency (1).

⏱️ Dosage and Administration ~1 min read ▾

2 DOSAGE AND ADMINISTRATION 5 mg tablet taken once daily, and if well tolerated may be increased to 10 mg once daily (2.1). Do not exceed 5 mg tablet once daily in patients with: severe renal impairment [Creatinine Clearance] (CL cr <30 mL/min) (2.2). moderate hepatic impairment (Child-Pugh B) (2.3). concomitant use of potent CYP3A4 inhibitors (2.4). Use of solifenacin succinate tablet is not recommended in patients with severe hepatic impairment (Child-Pugh C) (2.3).

2.1Dosing Information The recommended dose of solifenacin succinate tablet is 5 mg once daily. If the 5 mg dose is well tolerated, the dose may be increased to 10 mg once daily. Solifenacin succinate tablets should be taken with water and swallowed whole. Solifenacin succinate tablets can be administered with or without food.

2.2Dose Adjustment in Patients with Renal Impairment For patients with severe renal impairment (CL cr <30 mL/min), a daily dose of solifenacin succinate tablets greater than 5 mg is not recommended [see Warnings and Precautions (5.7) and Use in Specific Populations (8.6)] .

2.3Dose Adjustment in Patients with Hepatic Impairment For patients with moderate hepatic impairment (Child-Pugh B), a daily dose of solifenacin succinate tablets greater than 5 mg is not recommended. Use of solifenacin succinate tablets in patients with severe hepatic impairment (Child-Pugh C) is not recommended [see Warnings and Precautions (5.6) and Use in Specific Populations (8.7)] .

2.4Dose Adjustment in Patients Taking CYP3A4 Inhibitors When administered with potent CYP3A4 inhibitors such as ketoconazole, a daily dose of solifenacin succinate tablets greater than 5 mg is not recommended [see Drug Interactions (7.1)] .

💊 Dosage Forms and Strengths 56 words ▾

3 DOSAGE FORMS AND STRENGTHS The 5 mg tablets are creamish to light yellow, round, film-coated tablets, debossed with “L” on one side and “431” on other side. The 10 mg tablets are light pink, round, film-coated tablets, debossed with “L” on one side and “432” on other side. Tablets: 5 mg and 10 mg (3).

⛔ Contraindications 73 words ▾

4 CONTRAINDICATIONS Solifenacin succinate tablets are contraindicated in patients with: urinary retention [see Warnings and Precautions (5.2)] , gastric retention [see Warnings and Precautions (5.3)] , uncontrolled narrow-angle glaucoma [see Warnings and Precautions (5.5)] , and in patients who have demonstrated hypersensitivity to the drug [see Adverse Reactions(6.2)] . Urinary retention (4, 5.2). Gastric retention (4, 5.3).

Uncontrolled narrow-angle glaucoma (4, 5.5). In patients who have demonstrated hypersensitivity to the drug (4, 6.2).

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS Angioedema and anaphylactic reactions: Reports of angioedema of the face, lips and/or larynx, in some cases occurring after the first dose, have been described. Anaphylactic reactions have been reported rarely (5.1). Urinary Retention: Administer with caution to patients with clinically significant bladder outflow obstruction (5.2).

Gastrointestinal Disorders: Use with caution in patients with decreased gastrointestinal motility (5.3). Central Nervous System Effects: Somnolence has been reported with solifenacin succinate tablets. Advise patients not to drive or operate heavy machinery until they know how solifenacin succinate tablets affects them (5.4).

Controlled Narrow-Angle Glaucoma: Use with caution in patients being treated for narrow-angle glaucoma (5.5). QT Prolongation: Use with caution in patients with a known history of QT prolongation or patients who are taking medications known to prolong the QT interval (5.8).

5.1Angioedema and Anaphylactic Reactions Angioedema of the face, lips, tongue, and/or larynx have been reported with solifenacin. In some cases angioedema occurred after the first dose. Cases of angioedema have been reported to occur hours after the first dose or after multiple doses.

Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, solifenacin should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided. Anaphylactic reactions have been reported rarely in patients treated with solifenacin succinate.

Solifenacin succinate should not be used in patients with a known or suspected hypersensitivity to solifenacin succinate. In patients who develop anaphylactic reactions, solifenacin succinate should be discontinued and appropriate therapy and/or measures should be taken.

5.2Urinary Retention Solifenacin succinate tablets, like other anticholinergic drugs, should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see Contraindications (4)].

5.3Gastrointestinal Disorders Solifenacin succinate tablets, like other anticholinergics, should be used with caution in patients with decreased gastrointestinal motility [see Contraindications (4)].

5.4Central Nervous System Effects Solifenacin succinate tablets are associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.2)]. A variety of CNS anticholinergic effects have been reported, including headache, confusion, hallucinations 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 solifenacin succinate tablets affect them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

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

5.6Hepatic Impairment Solifenacin succinate tablets should be used with caution in patients with hepatic impairment. Doses of solifenacin succinate tablets greater than 5 mg are not recommended in patients with moderate hepatic impairment (Child-Pugh B). Solifenacin succinate tablets are not recommended for patients with severe hepatic impairment (Child-Pugh C) [see Dosage and Administration (2.3) and Use in Specific Populations (8.7)].

5.7Renal Impairment Solifenacin succinate tablets should be used with caution in patients with renal impairment. Doses of solifenacin succinate tablets greater than 5 mg are not recommended in patients with severe renal impairment (CL cr <30 mL/min) [see Dosage and Administration (2.2) and Use in Specific Populations (8.6)].

5.8 Patients with Congenita…

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (>4% and >placebo) were dry mouth, and constipation at both 5 mg and 10 mg doses; and urinary tract infection, and blurred vision at the 10 mg dose (6.1). To report SUSPECTED ADVERSE REACTIONS, contact 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. Solifenacin succinate tablets have been evaluated for safety in 1811 patients in randomized, placebo-controlled trials. Expected adverse reactions of antimuscarinic agents are dry mouth, constipation, blurred vision (accommodation abnormalities), urinary retention, and dry eyes.

The incidence of dry mouth and constipation in patients treated with solifenacin succinate tablets was higher in the 10 mg compared to the 5 mg dose group. In the four 12-week double-blind clinical trials, severe fecal impaction, colonic obstruction, and intestinal obstruction were reported in one patient each, all in the solifenacin succinate tablets 10 mg group. Angioneurotic edema has been reported in one patient taking solifenacin succinate tablets 5 mg.

Compared to 12 weeks of treatment with solifenacin succinate tablets, the incidence and severity of adverse reactions were similar in patients who remained on drug for up to 12 months. The most frequent adverse reaction leading to study discontinuation was dry mouth (1.5%). Table 1 lists the rates of identified adverse reactions, derived from all reported adverse events, in randomized, placebo-controlled trials at an incidence greater than placebo and in 1% or more of patients treated with solifenacin succinate tablets 5 or 10 mg once daily for up to 12 weeks.

Table 1: Percentages of Patients with Identified Adverse Reactions, Derived from All Adverse Events Exceeding Placebo Rate and Reported by 1% or More Patients for Combined Pivotal Studies Placebo (%) Solifenacin Succinate Tablets 5 mg (%) Solifenacin Succinate Tablets 10 mg (%) Number of Patients 1216 578 1233 GASTROINTESTINAL DISORDERS Dry Mouth 4.2 10.9

27.6Constipation 2.9 5.4

13.4Nausea 2 1.7

3.3Dyspepsia 1 1.4

3.9Abdominal Pain Upper 1 1.9

1.2Vomiting NOS 0.9 0.2

1.1INFECTIONS AND INFESTATIONS Urinary Tract Infection NOS 2.8 2.8

4.8Influenza 1.3 2.2

0.9Pharyngitis NOS 1 0.3

1.1NERVOUS SYSTEM DISORDERS Dizziness 1.8 1.9

1.8EYE DISORDERS Vision Blurred 1.8 3.8

4.8Dry Eyes NOS 0.6 0.3

1.6RENAL AND URINARY DISORDERS Urinary Retention 0.6 0

1.4GENERAL DISORDERS AND ADMINISTRATION SITE CONDITIONS Edema Lower Limb 0.7 0.3

1.1Fatigue 1.1 1

2.1PSYCHIATRIC DISORDERS Depression NOS 0.8 1.2

0.8RESPIRATORY, THORACIC AND MEDIASTINAL DISORDERS Cough 0.2 0.2

1.1VASCULAR DISORDERS Hypertension NOS 0.6 1.4 0.5

6.2Post-Marketing Experience Because these spontaneously reported events are from the worldwide postmarketing experience, the frequency of events and the role of solifenacin in their causation cannot be reliably determined. The following events have been reported in association with solifenacin use in worldwide postmarketing experience: General : peripheral edema, hypersensitivity reactions, including angioedema with airway obstruction, rash, pruritus, urticaria, and anaphylactic reaction; Central Nervous : headache, confusion, hallucinations, delirium, and somnolence; Cardiovascular : QT prolongation, Torsade de Pointes, atrial fibrillation, tachycardia, and palpitations; Hepatic : liver disorders mostly characterized by abnormal liver function tests, AST (aspartate aminotransferase), ALT (alanine aminotransferase), and GGT (gamma-glutamyl transferase); Renal : renal impairment; Metabolism and nutrition disorders : decreased appetite and hyperkalemia; Dermatologic : exfoliative dermatitis, erythema multiforme, and dry skin; Eye disorders : glauc…

🔄 Drug Interactions ~1 min read ▾

7 DRUG INTERACTIONS Inhibitors of CYP3A4 may increase the concentration of solifenacin succinate tablets (7.1). Inducers of CYP3A4 may decrease the concentration of solifenacin succinate tablets (7.2).

7.1Potent CYP3A4 Inhibitors Following the administration of 10 mg of solifenacin succinate tablets in the presence of 400 mg of ketoconazole, a potent inhibitor of CYP3A4, the mean C max and AUC of solifenacin increased by 1.5 and 2.7-fold, respectively. Therefore, it is recommended not to exceed a 5 mg daily dose of solifenacin succinate tablets when administered with therapeutic doses of ketoconazole or other potent CYP3A4 inhibitors [see Dosage and Administration (2.4) and Clinical Pharmacology (12.3)]. The effects of weak or moderate CYP3A4 inhibitors were not examined.

7.2CYP3A4 Inducers There were no in vivo studies conducted to evaluate the effect of CYP3A4 inducers on solifenacin succinate tablets. In vitro drug metabolism studies have shown that solifenacin is a substrate of CYP3A4. Therefore, inducers of CYP3A4 may decrease the concentration of solifenacin.

7.3Drugs Metabolized by Cytochrome P450 At therapeutic concentrations, solifenacin does not inhibit CYP1A1/2, 2C9, 2C19, 2D6, or 3A4 derived from human liver microsomes.

7.4Warfarin Solifenacin has no significant effect on the pharmacokinetics of R -warfarin or S -warfarin [see Clinical Pharmacology (12.3)].

7.5Oral Contraceptives In the presence of solifenacin there are no significant changes in the plasma concentrations of combined oral contraceptives (ethinyl estradiol/levonorgestrel) [see Clinical Pharmacology (12.3)].

7.6Digoxin Solifenacin had no significant effect on the pharmacokinetics of digoxin (0.125 mg/day) in healthy subjects [see Clinical Pharmacology (12.3)].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS Pregnancy and Nursing Mothers : Solifenacin succinate tablets should be used during pregnancy only if the potential benefit for the mother justifies the potential risk to the fetus. Solifenacin succinate tablets should not be administered during nursing (8.1, 8.3). Pediatric Use : The safety and effectiveness of solifenacin succinate tablets in pediatric patients have not been established (8.4).

8.1Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Reproduction studies have been performed in mice, rats and rabbits. After oral administration of 14 C-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier.

No embryotoxicity or teratogenicity was observed in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD] of 10 mg. Administration of solifenacin succinate to pregnant mice at 3.6 times and greater (100 mg/kg/day and greater) the exposure at the MRHD, during the major period of organ development resulted in reduced fetal body weights. Administration of 7.9 times (250 mg/kg/day) the MRHD to pregnant mice resulted in an increased incidence of cleft palate.

In utero and lactational exposures to maternal doses of solifenacin succinate of 3.6 times (100 mg/kg/day) the MRHD resulted in reduced peripartum and postnatal survival, reductions in body weight gain, and delayed physical development (eye opening and vaginal patency). An increase in the percentage of male offspring was also observed in litters from offspring exposed to maternal doses of 250 mg/kg/day. No embryotoxic effects were observed in rats at up to 50 mg/kg/day (<1 times the exposure at the MRHD) or in rabbits at up to 1.8 times (50 mg/kg/day) the exposure at the MRHD.

Because animal reproduction studies are not always predictive of human response, solifenacin succinate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

8.2Labor and Delivery The effect of solifenacin succinate tablets on labor and delivery in humans has not been studied. There were no effects on natural delivery in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD] of 10 mg. Administration of solifenacin succinate at 3.6 times (100 mg/kg/day) the exposure at the MRHD or greater increased peripartum pup mortality.

8.3Nursing Mothers After oral administration of 14 C-solifenacin succinate to lactating mice, radioactivity was detected in maternal milk. There were no adverse observations in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD]. Pups of female mice treated with 3.6 times (100 mg/kg/day) the exposure at the MRHD or greater revealed reduced body weights, postpartum pup mortality or delays in the onset of reflex and physical development during the lactation period.

It is not known whether solifenacin is excreted in human milk. Because many drugs are excreted in human milk, solifenacin succinate tablets should not be administered during nursing. A decision should be made whether to discontinue nursing or to discontinue solifenacin succinate tablets in nursing mothers.

8.4Pediatric Use The safety and effectiveness of solifenacin succinate tablets in pediatric patients have not been established.

8.5Geriatric Use In placebo-controlled clinical studies, similar safety and effectiveness were observed between older (623 patients ≥65 years and 189 patients ≥75 years) and younger patients (1188 patients <65 years) treated with solifenacin succinate tablets. Multiple dose studies of solifenacin succinate tablets in elderly volunteers (65 to 80 years) showed that C max , AUC and t 1/2 values were 20 to 25% higher as compared to the younger volunteers (18 to 55 years).

8.6 Renal Impairment Solifenacin succinate tablets should be used with caution i…

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Pregnancy Category C There are no adequate and well-controlled studies in pregnant women. Reproduction studies have been performed in mice, rats and rabbits. After oral administration of 14 C-solifenacin succinate to pregnant mice, drug-related material was shown to cross the placental barrier.

No embryotoxicity or teratogenicity was observed in mice treated with 1.2 times (30 mg/kg/day) the expected exposure at the maximum recommended human dose [MRHD] of 10 mg. Administration of solifenacin succinate to pregnant mice at 3.6 times and greater (100 mg/kg/day and greater) the exposure at the MRHD, during the major period of organ development resulted in reduced fetal body weights. Administration of 7.9 times (250 mg/kg/day) the MRHD to pregnant mice resulted in an increased incidence of cleft palate.

In utero and lactational exposures to maternal doses of solifenacin succinate of 3.6 times (100 mg/kg/day) the MRHD resulted in reduced peripartum and postnatal survival, reductions in body weight gain, and delayed physical development (eye opening and vaginal patency). An increase in the percentage of male offspring was also observed in litters from offspring exposed to maternal doses of 250 mg/kg/day. No embryotoxic effects were observed in rats at up to 50 mg/kg/day (<1 times the exposure at the MRHD) or in rabbits at up to 1.8 times (50 mg/kg/day) the exposure at the MRHD.

Because animal reproduction studies are not always predictive of human response, solifenacin succinate tablets should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

🧒 Pediatric Use 18 words ▾

8.4Pediatric Use The safety and effectiveness of solifenacin succinate tablets in pediatric patients have not been established.

🧓 Geriatric Use 75 words ▾

8.5Geriatric Use In placebo-controlled clinical studies, similar safety and effectiveness were observed between older (623 patients ≥65 years and 189 patients ≥75 years) and younger patients (1188 patients <65 years) treated with solifenacin succinate tablets. Multiple dose studies of solifenacin succinate tablets in elderly volunteers (65 to 80 years) showed that C max , AUC and t 1/2 values were 20 to 25% higher as compared to the younger volunteers (18 to 55 years).

🆘 Overdosage 122 words ▾

10 OVERDOSAGE Overdosage with solifenacin succinate tablets can potentially result in severe anticholinergic effects and should be treated accordingly. The highest dose ingested in an accidental overdose of solifenacin succinate was 280 mg in a 5-hour period. This case was associated with mental status changes.

Some cases reported a decrease in the level of consciousness. Intolerable anticholinergic side effects (fixed and dilated pupils, blurred vision, failure of heel-to-toe exam, tremors and dry skin) occurred on day 3 in normal volunteers taking 50 mg daily (5 times the maximum recommended therapeutic dose) and resolved within 7 days following discontinuation of drug. In the event of overdose with solifenacin succinate tablets, 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 and stimulation of salivary secretion.

12.2Pharmacodynamics Cardiac Electrophysiology The effect of 10 mg and 30 mg solifenacin succinate on the QT interval was evaluated at the time of peak plasma concentration of solifenacin in a multi-dose, randomized, double-blind, placebo and positive-controlled (moxifloxacin 400 mg) trial. Subjects were randomized to one of two treatment groups after receiving placebo and moxifloxacin sequentially. One group (n=51) went on to complete 3 additional sequential periods of dosing with solifenacin 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 co-administration of 10 mg solifenacin succinate tablets with potent CYP3A4 inhibitors (e.g. ketoconazole, 400 mg). Due to the sequential dose escalating nature of the study, baseline EKG 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 2.

Table 2: QTc changes in msec (90%CI) from baseline at T max (relative to placebo) * Drug/Dose Fridericia method (using mean difference) Solifenacin 10 mg 2 (-3, 6) Solifenacin 30 mg 8 (4, 13) *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 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 appeared greater for the 30 mg compared to the 10 mg dose of solifenacin. Although the effect of the highest solifenacin dose (three times the maximum therapeutic dose) studied did not appear as large as that of the positive control moxifloxacin at its therapeutic dose, the confidence intervals overlapped.

This study was not designed to draw direct statistical conclusions between the drugs or the dose levels.

12.3Pharmacokinetics Absorption After oral administration of solifenacin succinate tablets to healthy volunteers, peak plasma levels (C max ) of solifenacin are reached within 3 to 8 hours after administration, and at steady state ranged from 32.3 to 62.9 ng/mL for the 5 and 10 mg solifenacin succinate tablets, respectively. The absolute bioavailability of solifenacin is approximately 90%, and plasma concentrations of solifenacin are proportional to the dose administered. Effect of Food Solifenacin succinate tablets may be administered without regard to meals.

A single 10 mg dose administration of solifenacin succinate tablets with food increased C max and AUC by 4% and 3%, respectively. Distribution Solifenacin is approximately 98% ( in vivo ) bound to human plasma proteins, principally to µ 1 -acid glycoprotein. Solifenacin is highly distributed to non-CNS tissues, having a mean steady-state volume of distribution of 600L.

Metabolism Solifenacin is extensively metabolized in the liver. The primary p…

🧬 Mechanism of Action 35 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 and stimulation of salivary secretion.

📦 How Supplied / Storage and Handling 130 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Solifenacin succinate tablets 5 mg are creamish to light yellow, round, film-coated tablets, debossed with “L” on one side and “431” on other side. They are supplied as follows: NDC 46708-192-30 Bottle of 30 NDC 46708-192-90 Bottle of 90 NDC 46708-192-91 Bottle of 1000 NDC 46708-192-08 Carton of 80 (10 x 8) unit-dose tablets Solifenacin succinate tablets 10 mg are light pink, round, film-coated tablets, debossed with “L” on one side and “432” on other side. They are supplied as follows: NDC 46708-193-30 Bottle of 30 NDC 46708-193-90 Bottle of 90 NDC 46708-193-91 Bottle of 1000 NDC 46708-193-08 Carton of 80 (10 x 8) unit-dose tablets Store at 25ºC (77ºF) with excursions permitted from 15ºC to 30ºC (59°F to 86ºF) [see USP Controlled Room Temperature].

📋 Description 153 words ▾

11 DESCRIPTION Solifenacin succinate tablets are a muscarinic receptor antagonist. Chemically, solifenacin succinate is butanedioic acid, compounded 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 off white powder.

It is freely soluble in water, methanol, acetic acid and dimethyl sulfoxide. Each solifenacin succinate tablet contains 5 mg or 10 mg of solifenacin succinate and is formulated for oral administration. In addition to the active ingredient solifenacin succinate, each solifenacin succinate tablet also contains the following inert ingredients: lactose monohydrate, hypromellose, corn starch, magnesium stearate,titanium dioxide, polyethylene glycol, talc, iron oxide yellow with D&C Yellow #10 Aluminum Lake (5 mg solifenacin succinate tablet) or iron oxide red (10 mg solifenacin succinate tablet).

Structure

💬 Information for Patients 173 words ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Patients should be informed that antimuscarinic agents such as solifenacin succinate tablets have been associated with constipation and blurred vision. Patients should be advised to contact their physician if they experience severe abdominal pain or become constipated for 3 or more days.

Because solifenacin succinate tablets may cause blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug’s effect on the patient’s vision has been determined. Heat prostration (due to decreased sweating) can occur when anticholinergic drugs, such as solifenacin succinate tablets, are used in a hot environment. Patients should read the patient leaflet entitled “Patient Information solifenacin succinate tablets” before starting therapy with solifenacin succinate tablets.

Patients should be informed that solifenacin may produce angioedema, which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue solifenacin therapy and seek immediate attention if they experience edema of the tongue or laryngopharynx, or difficulty breathing.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗
← 46708-0191-06 · Alembic 46708-0193-08 · Alembic →
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.