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Trospium Chloride ER 60 mg Capsule, Extended Release, 30-count — NDC 63629-8458-1 (Billing 63629-8458-01)

by Bryant Ranch Prepack · 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

This is a package of 30 capsules of Trospium Chloride ER 60 mg Capsule, Extended Release from Bryant Ranch Prepack, marketed since Jun 2013 and currently FDA-listed. It is this product's only package size.

NDC 63629-8458-01
🏷️ FDA NDC (as labeled) 63629-8458-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed 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 Trospium Chloride (different manufacturers) — 1 · tap to view
These affect other manufacturers’ products for the same ingredient — not necessarily the exact NDC on this page.
Class II · Nov 1, 2023 — Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules (Padagis US LLC) · FDA recall D-0139-2024
Each entry is an official FDA enforcement report — look up any recall number in the FDA recall database ↗

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 63629-8458-1
Product NDC 63629-8458
11-digit billing NDC 63629845801
NCPDP billing unit EA — each (per item)
RxCUI 857564
UNII 1E6682427E
Application # ANDA201291
SPL Set ID 2f431dd1-e130-45e5-a796-1662f498585e
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 2013-06-07
Route ORAL
Dosage form CAPSULE, EXTENDED RELEASE
Substance TROSPIUM CHLORIDE
TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GPI-14 54100065207020
GPI class Trospium Chloride ER
GCN Seq No 063466
GCN 99193
HICL code 017498
Ingredient (HICL) Trospium Chloride
HIC1 code R
Therapeutic class — broad (HIC1) Kidney/Urinary Tract
HIC2 code R1
Therapeutic class — intermediate (HIC2) Affect Primarily Kidneys/Urinary Tract
HIC3 code R1A
Therapeutic class — specific (HIC3) Urinary Tract Antispasmodic/Antiincontinence Agent
AHFS code 86:12.04.00
AHFS class Antimuscarinics
FDB label name TROSPIUM CHLORIDE ER 60 MG CAP
FDB brand name Trospium Chloride Er
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 063466
  • GCN: 99193
  • GPI-14 (Medi-Span): 54100065207020
  • HICL (First Databank): 017498
  • AHFS class code: 86:12.04.00
  • RxCUI (RxNorm): 857564
Why two NDCs? The FDA registers this code as 63629-8458-1 — a 5-4-1 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 package segment → 63629-8458-01. 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, Other antipsychotics
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.

Clinical

Label name TROSPIUM CHLORIDE ER 60 MG CAP Ingredient Trospium Chloride
📖 What it is MedlinePlus · NLM

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

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • Trospium treats overactive bladder. That means sudden urges to urinate, leaking with those urges, and going often. It calms the bladder muscle to help with those symptoms.
  • Take it with water on an empty stomach, at least an hour before a meal. The tablets are usually taken twice a day, and the extended-release capsules once in the morning. Follow the...
  • Dry mouth and constipation are the most common, and they often show up in the first week. Dry eyes, gas, nausea, and stomach upset can also happen. Tell me or your doctor if they b...
  • Get emergency help right away if your face, lips, tongue, or throat swells. Call your doctor if you can't urinate, can't pass stool, or feel confused, see things that aren't there,...
📖 Read our full Trospium guide →

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

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 $3.32 $99.68 / 30 capsules
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.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
63629-8458-01 You're viewing this Main listing 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE 2022-02-09 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Trospium Chloride ER 60 mg 00574-0118-30 Padagis 30 capsules $1.643 AB Availability likely —
Trospium Chloride 60 mg 68001-0427-04 Bluepoint 30 capsules $1.643 AB Availability likely —
Trospium Chloride 60 mg 70010-0027-03 Granules 30 capsules $1.643 AB Availability likely —
Trospium Chloride 60 mg 70436-0174-04 Slate 30 capsules $1.643 AB Availability likely —
Trospium Chloride 60 mg 00591-3636-05 Actavis 500 capsules — AB FDA listed —
Trospium Chloride 60 mg 60429-0098-30 Golden 30 capsules — AB FDA listed —
Trospium Chloride ER 60 mgthis 63629-8458-01 Bryant 30 capsules — AB FDA listed —
Trospium Chloride 60 mg 71205-0917-00 Proficient 100 capsules — AB FDA listed —
Trospium Chloride ER 60 mg 71335-2931-01 Bryant 30 capsules — AB FDA listed —
Trospium Chloride ER 60 mg 72162-1106-03 Bryant 30 capsules — 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

🏛️
2013
On the market since
Jun 2013
📍
2026
Currently FDA-listed
13 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.

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 H77VEI93A8
    A synthetic yellow dye used to color medications. It helps identify the drug and make it visually distinctive, with no effect on how the medicine works.
  • UNII XM0M87F357
    A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
  • UNII 2G86QN327L
    Gelatin is a protein derived from animal collagen, commonly used in medicines as a gelling agent and capsule material. It helps create soft or hard capsule shells that hold and release medication, and can also thicken liquid formulations.
  • UNII 6M3P64V0NC
    A fine powder made from magnesium, aluminum, and silicon compounds. It absorbs moisture and helps keep medicine ingredients from clumping or separating, so the product stays stable and flows smoothly during manufacturing.
  • 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 NX76LV5T8J
    A synthetic plastic polymer made from methacrylic acid and ethyl acrylate. It's used as a coating or binder to control how and where the medicine dissolves in your digestive system.
  • UNII B697894SGQ
    Polyethylene glycol 400 is a clear, thick liquid made from petroleum-derived polymers. It acts as a solvent and humectant in medicines, helping dissolve active ingredients and retain moisture in the formulation.
  • UNII WZH3C48M4T
    Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
  • UNII FZ989GH94E
    Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
  • UNII 46N107B71O
    Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
  • UNII ETJ7Z6XBU4
    Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
  • UNII 451W47IQ8X
    Sodium chloride is common table salt. It's used in medicines as a buffer to maintain proper pH, as a filler to add bulk, or to adjust the osmotic balance in liquid formulations.
  • UNII 368GB5141J
    A detergent and foaming agent derived from coconut or palm oil. In medications, it helps break down and mix oil and water-based ingredients, aids in tablet disintegration, and improves how the drug dissolves and spreads in the mouth or digestive system.
  • UNII 4ELV7Z65AP
    Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
  • 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.

17 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.

Manufacturer & labeler

LabelerBryant Ranch Prepack
Application holderPADAGIS US LLC
FDA applicationANDA201291 (ANDA)
Labeler code63629
First marketedJun 2013
Product typeHuman Prescription Drug
Portfolio4,436 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.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). 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 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 57 words ▾

1 INDICATIONS AND USAGE Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)

⏱️ Dosage and Administration 141 words ▾

2 DOSAGE AND ADMINISTRATION The recommended dosage of Trospium Chloride Extended-Release Capsules is one 60 mg capsule daily in the morning. Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal. Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute) [ see WARNINGS AND PRECAUTIONS (5.6) , USE IN SPECIFIC POPULATIONS (8.6) , and CLINICAL PHARMACOLOGY (12.3) ]. • The recommended dosage of Trospium Chloride Extended- Release Capsules is one 60 mg capsule daily in the morning.

Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal. (2) • Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute). (2)

💊 Dosage Forms and Strengths 29 words ▾

3 DOSAGE FORMS AND STRENGTHS Trospium Chloride Extended-Release Capsules are supplied as 60 mg capsules (white opaque capsule printed with PAD 0118). • 60 mg capsules ( 3 )

⛔ Contraindications 77 words ▾

4 CONTRAINDICATIONS Trospium Chloride Extended-Release Capsules are contraindicated in patients with: • urinary retention • gastric retention • uncontrolled narrow-angle glaucoma • known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported. Trospium Chloride Extended-Release Capsules are contraindicated in • patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions ( 4 ) • patients with known hypersensitivity ( 4 )

⚠️ Warnings and Cautions ~2 min read ▾

5 WARNINGS AND PRECAUTIONS • Trospium Chloride Extended-Release Capsules should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention. ( 5.1 , 5.3 ) • Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. ( 5.2 ) • In patients with narrow-angle glaucoma, Trospium Chloride Extended-Release Capsules should be used only with careful monitoring.

( 5.4 ) • Central Nervous System Effects: Somnolence has been reported with Trospium Chloride Extended-Release Capsules. Advise patients not to drive or operate heavy machinery until they know how Trospium Chloride Extended-Release Capsules affect them. ( 5.5 ) • Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute).

( 5.6 ) • Alcohol should not be consumed within 2 hours of Trospium Chloride Extended-Release Capsules administration. ( 5.7 )

5.1Risk of Urinary Retention Trospium Chloride Extended-Release Capsules should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [s ee CONTRAINDICATIONS (4) ].

5.2Angioedema Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life threatening.

If involvement of the tongue, hypopharynx, or larynx occurs, trospium chloride should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

5.3Decreased Gastrointestinal Motility Trospium Chloride Extended-Release Capsules should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [s ee CONTRAINDICATIONS (4) ]. Trospium Chloride Extended-Release Capsules, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis.

5.4Controlled Narrow-angle Glaucoma In patients being treated for narrow-angle glaucoma, Trospium Chloride Extended-Release Capsules should only be used if the potential benefits outweigh the risks, and in that circumstance only with careful monitoring [ see CONTRAINDICATIONS (4) ] .

5.5Central Nervous System Effects Trospium Chloride Extended-Release Capsules and Trospium Chloride Immediate-Release 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 dizziness, 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 Trospium Chloride Extended-Release Capsules affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

5.6Patients with Severe Renal Impairment Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute) [ see DOSAGE AND ADMINISTRATION (2) , USE IN SPECIFIC POPULATIONS (8.6) , and CLINICAL PHARMACOLOGY (12.3) ] .

5.7Alcohol Interaction Alcohol should not be consumed within 2 hours of Trospium Chloride Extended-Release Capsules administration. In addition, patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (≥ 1%) with Trospium Chloride Extended-Release Capsules are dry mouth (10.7%) and constipation (8.5%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 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, the 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 clinical practice. The data described below reflect exposure to Trospium Chloride Extended-Release Capsules in 578 patients for 12 weeks in two Phase 3 double-blind, placebo controlled trials (n = 1165). These studies included overactive bladder patients of ages 21 to 90 years, of which 86% were female and 85% were Caucasian.

Patients received 60 mg daily doses of Trospium Chloride Extended-Release Capsules. Patients in these studies were eligible to continue treatment with Trospium Chloride Extended-Release Capsules 60 mg for up to one year. From both these controlled trials combined, 769 and 238 patients received treatment with Trospium Chloride Extended-Release Capsules for at least 24 and 52 weeks, respectively.

There were 157 (27.2%) Trospium Chloride Extended-Release Capsules patients and 98 (16.7%) placebo patients who experienced one or more double-blind treatment-emergent adverse events (TEAEs) that were assessed by the investigator as at least possibly related to study medication. The most common TEAEs were dry mouth and constipation which, when reported, commonly occurred early in treatment (often within the first week). In the two Phase 3 studies, constipation, dry mouth, and urinary retention led to discontinuation in 1%, 0.7%, and 0.5% of patients treated with Trospium Chloride Extended-Release Capsules 60 mg daily, respectively.

In the placebo group, there were no discontinuations due to dry mouth or urinary retention and one due to constipation. The incidence of serious adverse events was similar among patients receiving Trospium Chloride Extended-Release Capsules and patients receiving placebo. No treatment-emergent serious adverse events in either treatment group were judged by the investigators as being possibly related to the study medication.

Table 1 lists those treatment emergent adverse events from the trials that were assessed by the investigator as possibly related to study medication, reported in at least 1% of Trospium Chloride Extended-Release Capsules patients, and were more common for the Trospium Chloride Extended-Release Capsules group than for placebo. Table 1: Incidence of treatment-emergent adverse events reported in at least 1% of patients judged by the investigator as at least possibly related to treatment and more common for the Trospium Chloride Extended-Release Capsules group than for placebo Number of patients (%) Placebo Trospium Chloride Extended-Release Capsules MedDRA Preferred term N=587 N=578 Dry mouth 22 (3.7) 62 (10.7) Constipation 9 (1.5) 49 (8.5) Dry eye 1 (0.2) 9 (1.6) Flatulence 3 (0.5) 9 (1.6) Nausea 2 (0.3) 8 (1.4) Abdominal pain 2 (0.3) 8 (1.4) Dyspepsia 4 (0.7) 7 (1.2) Urinary tract infection 5 (0.9) 7 (1.2) Constipation aggravated 3 (0.5) 7 (1.2) Abdominal distension 2 (0.3) 6 (1.0) Nasal dryness 0 (0.0) 6 (1.0) Additional adverse events reported in < 1% of Trospium Chloride Extended-Release Capsules treated patients and more common for Trospium Chloride Extended-Release Capsules than placebo, judged by the investigator at least possibly related to treatment were: vision blurred, feces hard, back pain, somnolence, urinary retention, and dry skin.

Table 2 lists all treatment-emergent adverse events for the trials reported in at least 2% of all Trospium Chloride Extended-Release Capsules patients and more common for the Trospium Chloride Extended-Release Capsules group than for placebo without regard to the… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions ~2 min read ▾

7 DRUG INTERACTIONS Trospium is metabolized by ester hydrolysis and excreted by the kidneys through a combination of tubular secretion and glomerular filtration. Based on in vitro data, no clinically relevant metabolic drug-drug interactions are anticipated with Trospium Chloride Extended-Release Capsules. However, some drugs which are actively secreted by the kidney may interact with Trospium Chloride Extended-Release Capsules by competing for renal tubular secretion.

The concomitant use of Trospium Chloride Extended-Release Capsules with other antimuscarinic agents that produce dry mouth and constipation and other anticholinergic effects may increase the frequency and/or severity of such effects. Trospium Chloride Extended-Release Capsules may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. • Some drugs which are actively secreted by the kidney may interact with Trospium Chloride Extended-Release Capsules by competing for renal tubular secretion.

( 7 ) • Concomitant use with digoxin did not affect the pharmacokinetics of either drug. ( 7.1 ) • Exposure to trospium on average was comparable in the presence of and without antacid, however, some individuals demonstrated increases or decreases in trospium exposure in the presence of antacid. The clinical relevance of these findings is not known.

( 7.2 ) • Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. ( 7.3 )

7.1Digoxin Concomitant use of trospium chloride 20 mg twice daily and digoxin did not affect the pharmacokinetics of either drug [ see CLINICAL PHARMACOLOGY (12.3) ].

7.2Antacid While the systemic exposure of trospium on average was comparable with and without antacid containing aluminum hydroxide and magnesium carbonate, 5 out of 11 individuals in a drug interaction study demonstrated either an increase or decrease in trospium exposure, in presence of antacid. The clinical relevance of these findings is not known [ see CLINICAL PHARMACOLOGY (12.3) ].

7.3Metformin Co-administration of 500 mg metformin immediate-release tablets twice daily reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC 0-24 and by 34% for mean C max . The effect of a decrease in trospium exposure on the efficacy of Trospium Chloride Extended-Release Capsules is unknown. The steady-state pharmacokinetics of metformin were comparable when administered with or without 60 mg Trospium Chloride Extended-Release Capsules once daily under fasted condition.

The effect of metformin at higher doses on trospium PK is unknown [ see CLINICAL PHARMACOLOGY (12.3) ].

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • The safety and effectiveness of Trospium Chloride Extended-Release Capsules in pediatric patients have not been established. ( 8.4 )

8.1Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of Trospium Chloride Extended-Release Capsules in pregnant women. Trospium Chloride Extended-Release Capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Trospium Chloride Extended-Release Capsules treatment are encouraged to contact their physician.

Trospium chloride was not teratogenic at statistically significant levels in rats or rabbits administered doses up to 200 mg/kg/day. This corresponds to systemic exposures up to approximately 16 and 32 times, respectively (based on AUC), the clinical exposure at the maximum recommended human dose (MRHD) of 60 mg. However, in rabbits, one fetus in each of the three treated dose groups (1, 1, and 32 times the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations.

A no effect level for maternal and fetal toxicity was observed at levels approximately equivalent to the clinical exposure at the MRHD (20 mg/kg/day in rats and rabbits). No developmental toxicity was observed in the offspring of female rats exposed pre- and post-natally to up to 200 mg/kg/day.

8.2Labor and Delivery The effect of Trospium Chloride Extended-Release Capsules on labor and delivery is unknown.

8.3Nursing Mothers Trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (< 1%), into the milk of lactating rats (primarily as parent compound). It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, Trospium Chloride Extended-Release Capsules should be used during lactation only if the potential benefit justifies the potential risk.

8.4Pediatric Use The safety and effectiveness of Trospium Chloride Extended-Release Capsules in pediatric patients have not been established.

8.5Geriatric Use Of 1165 patients in Phase 3 clinical studies of Trospium Chloride Extended-Release Capsules, 37% (n=428) were ages 65 and over, while 12% (n=143) were ages 75 and over. No overall differences in effectiveness were observed between those subjects aged 65 and over and younger subjects. In Trospium Chloride Extended-Release Capsules subjects ages 65 and over compared to younger subjects, the following adverse reactions were reported at a higher incidence: dry mouth, constipation, abdominal pain, dyspepsia, urinary tract infection and urinary retention.

In subjects ages 75 and over, three reported a fall and in one of them a relationship to the event could not be excluded.

8.6Renal Impairment Severe renal impairment (creatinine clearance < 30 mL/minute) may significantly alter the disposition of Trospium Chloride Extended-Release Capsules. In a study of immediate-release trospium chloride, 4.2-fold and 1.8-fold increases in mean AUC (0– ∞) and C max , respectively, were detected in patients with severe renal impairment. Use of Trospium Chloride Extended-Release Capsules is not recommended in patients with severe renal impairment [ see WARNINGS AND PRECAUTIONS (5.4) and CLINICAL PHARMACOLOGY (12.3) ].

The pharmacokinetics of trospium chloride have not been studied in patients with creatinine clearance ranging from 30 to 80 mL/min. Trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.

8.7Hepatic Impairment There is no information regarding the effect of severe hepatic impairment on exposure to Trospium Chloride Extended-Release Capsules. In a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release trospium chloride, mean C max increased 12% and 63%, respectively, and mean AUC (0– ∞)… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy 188 words ▾

8.1Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of Trospium Chloride Extended-Release Capsules in pregnant women. Trospium Chloride Extended-Release Capsules should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during Trospium Chloride Extended-Release Capsules treatment are encouraged to contact their physician.

Trospium chloride was not teratogenic at statistically significant levels in rats or rabbits administered doses up to 200 mg/kg/day. This corresponds to systemic exposures up to approximately 16 and 32 times, respectively (based on AUC), the clinical exposure at the maximum recommended human dose (MRHD) of 60 mg. However, in rabbits, one fetus in each of the three treated dose groups (1, 1, and 32 times the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations.

A no effect level for maternal and fetal toxicity was observed at levels approximately equivalent to the clinical exposure at the MRHD (20 mg/kg/day in rats and rabbits). No developmental toxicity was observed in the offspring of female rats exposed pre- and post-natally to up to 200 mg/kg/day.

🧒 Pediatric Use 19 words ▾

8.4Pediatric Use The safety and effectiveness of Trospium Chloride Extended-Release Capsules in pediatric patients have not been established.

🧓 Geriatric Use 108 words ▾

8.5Geriatric Use Of 1165 patients in Phase 3 clinical studies of Trospium Chloride Extended-Release Capsules, 37% (n=428) were ages 65 and over, while 12% (n=143) were ages 75 and over. No overall differences in effectiveness were observed between those subjects aged 65 and over and younger subjects. In Trospium Chloride Extended-Release Capsules subjects ages 65 and over compared to younger subjects, the following adverse reactions were reported at a higher incidence: dry mouth, constipation, abdominal pain, dyspepsia, urinary tract infection and urinary retention.

In subjects ages 75 and over, three reported a fall and in one of them a relationship to the event could not be excluded.

🆘 Overdosage 34 words ▾

10 OVERDOSAGE Overdosage with antimuscarinic agents, including Trospium Chloride Extended-Release Capsules, can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of overdosage, ECG monitoring is recommended.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Trospium chloride is an antispasmodic, antimuscarinic agent. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.

In vitro receptor binding studies have demonstrated the selectivity of trospium chloride for muscarinic over nicotinic receptors, and similar affinity for the M 2 and M 3 muscarinic receptor subtypes. M 2 and M 3 receptors are found in the bladder and may play a role in the pathogenesis of overactive bladder.

12.2Pharmacodynamics Placebo-controlled studies assessing the impact on urodynamic variables of an immediate-release formulation of trospium chloride were conducted in patients with conditions characterized by involuntary detrusor contractions. The results demonstrated that trospium chloride increases maximum cystometric bladder capacity and volume at first detrusor contraction. Electrophysiology The effect of 20 mg twice daily and up to 100 mg twice daily of an immediate-release formulation of trospium chloride on QT interval was evaluated in a single-blind, randomized, placebo and active (moxifloxacin 400 mg daily) controlled, 5-day parallel trial in 170 male and female healthy volunteer subjects aged 18 to 45 years.

The QT interval was measured over a 24-hour period at steady state. Trospium chloride was not associated with an increase in individual corrected (QTcI) or Fridericia corrected (QTcF) QT interval at any time during steady state measurement, while moxifloxacin was associated with a 6.4 msec increase in QTcF. In this study, asymptomatic, non-specific T-wave inversions were observed more often in subjects receiving trospium chloride than in subjects receiving moxifloxacin or placebo following five days of treatment.

The clinical significance of T-wave inversion in this study is unknown. This finding was not observed during routine safety monitoring in overactive bladder patients from 2 placebo-controlled clinical trials in 591 patients treated with 20 mg twice daily of immediate-release trospium chloride, nor was it observed in 2 placebo-controlled clinical trials in 578 patients treated with Trospium Chloride Extended-Release Capsules. Also in this study, the immediate-release formulation of trospium chloride was associated with an increase in heart rate that correlated with increasing plasma concentration, with a mean elevation in heart rate compared to placebo of 9 beats per minute for the 20 mg dose and of 18 beats per minute for the 100 mg dose.

In the two Phase 3 Trospium Chloride Extended-Release Capsules trials the mean increase in heart rate compared to placebo was approximately 3 beats per minute in both studies.

12.3Pharmacokinetics Absorption : Mean absolute bioavailability of a 20 mg immediate-release dose is 9.6% (range 4.0 to 16.1%). Following a single 60 mg dose of Trospium Chloride Extended-Release Capsules, peak plasma concentration (C max ) of 2.0 ng/mL occurred 5.0 hours post dose. By contrast, following a single 20 mg dose of an immediate-release formulation of trospium chloride, C max was 2.7 ng/mL.

Effect of Food: Administration of Trospium Chloride Extended-Release Capsules immediately after a high (50%) fat-content meal reduced the oral bioavailability of trospium chloride by 35% for AUC (0-Tlast) and by 60% for C max . Other pharmacokinetic parameters such as T max and t ½ were unchanged in the presence of food. A summary of mean (± standard deviation) pharmacokinetic parameters for a single dose of 60 mg Trospium Chloride Extended-Release Capsules is provided in Table 3 .

Table 3: Mean (±SD) Pharmacokinetic Parameter Estimates for a Single 60 mg Oral Dose of Trospium Chloride Extended-Release Capsules in Healthy Volunteers Treatment AUC (0-24) (ng•h/mL) C max (ng/mL) T max T max expressed as median (range). (h) t ½ t ½ was determined following multiple (1… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 92 words ▾

12.1Mechanism of Action Trospium chloride is an antispasmodic, antimuscarinic agent. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder.

In vitro receptor binding studies have demonstrated the selectivity of trospium chloride for muscarinic over nicotinic receptors, and similar affinity for the M 2 and M 3 muscarinic receptor subtypes. M 2 and M 3 receptors are found in the bladder and may play a role in the pathogenesis of overactive bladder.

📦 How Supplied / Storage and Handling 58 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Trospium Chloride Extended-Release Capsules are supplied as 60 mg capsules (white opaque capsule, printed with PAD 0118): 60 mg capsule, 30 count, HDPE bottle: NDC 63629-8458-1 Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Dispense in a tight container. Repackaged/Relabeled by: Bryant Ranch Prepack, Inc. Burbank, CA 91504

📋 Description 146 words ▾

11 DESCRIPTION Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25 H 30 ClNO 3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below: Trospium chloride is a fine, colorless to slightly yellow, crystalline solid.

The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: colloidal silicon dioxide, magnesium aluminum silicate, magnesium stearate, methacrylic acid copolymer dispersion, polyethylene glycol 400, povidone, sodium chloride, stearic acid, talc, FD&C yellow no.

6. The capsule shell contains: black iron oxide, gelatin, potassium hydroxide, propylene glycol, shellac, sodium lauryl sulfate and titanium dioxide.

💬 Information for Patients ~1 min read ▾

17 PATIENT COUNSELING INFORMATION "See FDA-approved Patient Labeling ( Patient Information )"

17.1Angioedema Patients should be informed that Trospium Chloride Extended-Release Capsules may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue Trospium Chloride Extended-Release Capsules therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.

17.2When Not to Use Prior to treatment, patients should fully understand the risks and benefits of Trospium Chloride Extended-Release Capsules. In particular, patients should be informed not to take Trospium Chloride Extended-Release Capsules if they: • have urinary retention; • gastric retention; • uncontrolled narrow-angle glaucoma; • are allergic to any component of Trospium Chloride Extended-Release Capsules.

17.3Administration Patients should be instructed regarding the recommended dosing and administration of Trospium Chloride Extended-Release Capsules: • Take one Trospium Chloride Extended-Release Capsule daily in the morning with water. • Take Trospium Chloride Extended-Release Capsules on an empty stomach or at least 1 hour before a meal. • Use of alcoholic beverages within 2 hours of dosing with Trospium Chloride Extended-Release Capsules is not recommended.

17.4Adverse Reactions Patients should be informed that the most common side effects with Trospium Chloride Extended-Release Capsules are dry mouth and constipation and that other less common side effects include trouble emptying the bladder, blurred vision, and heat prostration. Because anticholinergics, such as Trospium Chloride Extended-Release Capsules, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug's effects have been determined.

Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.

🍼 Nursing Mothers 68 words ▾

8.3Nursing Mothers Trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (< 1%), into the milk of lactating rats (primarily as parent compound). It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, Trospium Chloride Extended-Release Capsules should be used during lactation only if the potential benefit justifies the potential risk.

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics Absorption : Mean absolute bioavailability of a 20 mg immediate-release dose is 9.6% (range 4.0 to 16.1%). Following a single 60 mg dose of Trospium Chloride Extended-Release Capsules, peak plasma concentration (C max ) of 2.0 ng/mL occurred 5.0 hours post dose. By contrast, following a single 20 mg dose of an immediate-release formulation of trospium chloride, C max was 2.7 ng/mL.

Effect of Food: Administration of Trospium Chloride Extended-Release Capsules immediately after a high (50%) fat-content meal reduced the oral bioavailability of trospium chloride by 35% for AUC (0-Tlast) and by 60% for C max . Other pharmacokinetic parameters such as T max and t ½ were unchanged in the presence of food. A summary of mean (± standard deviation) pharmacokinetic parameters for a single dose of 60 mg Trospium Chloride Extended-Release Capsules is provided in Table 3 .

Table 3: Mean (±SD) Pharmacokinetic Parameter Estimates for a Single 60 mg Oral Dose of Trospium Chloride Extended-Release Capsules in Healthy Volunteers Treatment AUC (0-24) (ng•h/mL) C max (ng/mL) T max T max expressed as median (range). (h) t ½ t ½ was determined following multiple (10) doses. (h) Trospium Chloride Extended-Release Capsules 60 mg 18.0 ± 13.4 2.0 ± 1.5 5.0 (3.0 to 7.5) 36 ± 22 The mean sample concentration-time (+ standard deviation) profile for Trospium Chloride Extended-Release Capsules is shown in Figure 1 .

Figure 1: Mean (+SD) Concentration-Time Profile for a Single 60 mg Oral Dose of Trospium Chloride Extended-Release Capsules in Healthy Volunteers Administration of Trospium Chloride Extended-Release Capsules immediately after a high (50%) fat-content meal reduced the oral bioavailability of trospium chloride by 35% for AUC (0-Tlast) and by 60% for C max . Other pharmacokinetic parameters such as T max and t ½ were unchanged in the presence of food. Co-administration with antacid had inconsistent effects on the oral bioavailability of Trospium Chloride Extended-Release Capsules.

Distribution : Protein binding ranged from 50 to 85%, depending upon the assessment method used, when a range of concentration levels of trospium chloride (0.5 to 50 mcg/L) were incubated in vitro with human serum. The ratio of 3 H-trospium chloride in plasma to whole blood was 1.6:1. This ratio indicates that the majority of 3 H-trospium chloride is distributed in plasma.

Trospium chloride is widely distributed, with an apparent volume of distribution > 600 L. Metabolism : The metabolic pathway of trospium in humans has not been fully defined. Of the dose absorbed following oral administration, metabolites account for approximately 40% of the excreted dose.

The major metabolic pathway of trospium is hypothesized as ester hydrolysis with subsequent conjugation of benzylic acid to form azoniaspironortropanol with glucuronic acid. Cytochrome P450 does not contribute significantly to the elimination of trospium. Data taken from in vitro studies of human liver microsomes, investigating the inhibitory effect of trospium on seven cytochrome P450 isoenzyme substrates (CYP1A2, 2A6, 2C9, 2C19, 2D6, 2E1, and 3A4), suggest a lack of inhibition at clinically relevant concentrations.

Excretion : The plasma half-life for trospium following oral administration of Trospium Chloride Extended-Release Capsules is approximately 35 hours. After oral administration of an immediate-release formulation of 14 C-labeled trospium chloride, a majority of the dose (85.2%) was recovered in feces and a smaller amount (5.8% of the dose) was recovered in urine. Of the radioactivity excreted into the urine, 60% was unchanged trospium.

The mean renal clearance for trospium (29.07 L/hour) is 4-fold higher than average glomerular filtration rate, indicating that active tubular secretion is a major route of elimination. There may be competition for elimination with other compounds that are also renally eliminated [ see DRUG INTERACTIONS (7) ]. Drug Interactions Digoxin : Concomitant use o… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics ~1 min read ▾

12.2Pharmacodynamics Placebo-controlled studies assessing the impact on urodynamic variables of an immediate-release formulation of trospium chloride were conducted in patients with conditions characterized by involuntary detrusor contractions. The results demonstrated that trospium chloride increases maximum cystometric bladder capacity and volume at first detrusor contraction. Electrophysiology The effect of 20 mg twice daily and up to 100 mg twice daily of an immediate-release formulation of trospium chloride on QT interval was evaluated in a single-blind, randomized, placebo and active (moxifloxacin 400 mg daily) controlled, 5-day parallel trial in 170 male and female healthy volunteer subjects aged 18 to 45 years.

The QT interval was measured over a 24-hour period at steady state. Trospium chloride was not associated with an increase in individual corrected (QTcI) or Fridericia corrected (QTcF) QT interval at any time during steady state measurement, while moxifloxacin was associated with a 6.4 msec increase in QTcF. In this study, asymptomatic, non-specific T-wave inversions were observed more often in subjects receiving trospium chloride than in subjects receiving moxifloxacin or placebo following five days of treatment.

The clinical significance of T-wave inversion in this study is unknown. This finding was not observed during routine safety monitoring in overactive bladder patients from 2 placebo-controlled clinical trials in 591 patients treated with 20 mg twice daily of immediate-release trospium chloride, nor was it observed in 2 placebo-controlled clinical trials in 578 patients treated with Trospium Chloride Extended-Release Capsules. Also in this study, the immediate-release formulation of trospium chloride was associated with an increase in heart rate that correlated with increasing plasma concentration, with a mean elevation in heart rate compared to placebo of 9 beats per minute for the 20 mg dose and of 18 beats per minute for the 100 mg dose.

In the two Phase 3 Trospium Chloride Extended-Release Capsules trials the mean increase in heart rate compared to placebo was approximately 3 beats per minute in both studies.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES Trospium Chloride Extended-Release Capsules were evaluated for the treatment of patients with overactive bladder who had symptoms of urinary frequency, urgency and urge urinary incontinence in two 12-week, randomized, double-blind, placebo-controlled studies. For both studies, entry criteria required the presence of urge incontinence (predominance of urge), at least one incontinence episode per day, and 10 or more micturitions (voids) per day (assessed by 3-day urinary diary). Medical history and data from the baseline urinary diary confirmed the diagnosis.

Approximately 88% of the patients enrolled completed the 12-week studies. The mean age was 60 years, and the majority of patients were female (84%) and Caucasian (86%). The co-primary endpoints in the trials were the mean change from baseline to Week 12 in number of voids/24 hours (reductions in urinary frequency) and the mean change from baseline to Week 12 in number of incontinence episodes/24 hours.

Secondary endpoints included mean change from baseline to Week 12 in volume per void. Study 1 included 592 patients in both Trospium Chloride Extended-Release Capsules 60 mg and placebo groups. As illustrated in Table 4 and Figures 2 and 3 , Trospium Chloride Extended-Release Capsules demonstrated statistically significantly (p<0.01) greater reductions in the urinary frequency and incontinence episodes, and increases in void volume when compared to placebo starting at Week 1 and maintained through Weeks 4 and 12.

Table 4: Mean (SE) Change from Baseline in Urinary Frequency, Urge Incontinence Episodes and Void Volume in Study 1 Efficacy Endpoint treatment differences assessed by rank ANOVA for intent-to-treat population, last observation carried forward (ITT:LOCF) data set Week Placebo Trospium Chloride Extended-Release Capsules P-Value Urinary frequency / 24 hours (N=300) (N=292) Mean Baseline 0 12.7 (0.2) 12.8 (0.2) Mean Change from Baseline 1 -1.2 (0.1) -1.7 (0.1) 0.0092 4 -1.6 (0.2) -2.4 (0.2) <0.0001 12 -2.0 (0.2) -2.8 (0.2) <0.0001 Urge incontinence episodes / week (N=300) (N=292) Mean Baseline 0 29.0 (1.3) 28.8 (1.3) Mean Change from Baseline 1 -8.7 (1.0) -13.0 (0.9) 0.0003 4 -12.2 (1.1) -16.5 (1.2) 0.0054 12 -13.5 (1.1) -17.3 (1.2) 0.0024 Urinary volume / void (mL) (N=300) (N=290) Mean Baseline 0 155.9 (3.0) 151.0 (2.9) Mean Change from Baseline 1 12.1 (2.1) 21.6 (2.8) 0.0036 4 17.2 (2.5) 30.0 (3.1) 0.0007 12 18.9 (2.8) 29.8 (3.2) 0.0039 Figure 2: Mean Change from Baseline in Urinary Frequency/24 hours by Visit: Study 1 WEEK OF TREATMENT Figure 3: Mean Change from Baseline in Incontinence Episodes/Week by Visit: Study 1 WEEK OF TREATMENT Study 2 included 543 patients in both Trospium Chloride Extended-Release Capsules 60 mg and placebo groups and was identical in design to Study 1.

As illustrated in Table 5 and Figures 4 and 5 , Trospium Chloride Extended-Release Capsules demonstrated statistically significantly (p<0.01) greater reductions in urinary frequency and incontinence episodes, and increases in void volume when compared to placebo at Weeks 4 and 12. However, at Week 1, statistically significant reductions were seen in urinary incontinence episodes and volume void only. Table 5: Mean (SE) Change from Baseline in Urinary Frequency, Urge Incontinence Episodes and Void Volume in Study 2 Efficacy Endpoint Week Placebo Trospium Chloride Extended-Release Capsules P-Value Urinary frequency / 24 hours (N=276) (N=267) Mean Baseline 0 12.9 (0.2) 12.8 (0.2) Mean Change from Baseline 1 -1.2 (0.2) -1.4 (0.2) 0.0759 4 -1.7 (0.2) -2.3 (0.2) 0.0047 12 -1.8 (0.2) -2.5 (0.2) 0.0009 Urge incontinence episodes / week (N=276) (N=267) Mean Baseline 0 28.3 (1.4) 28.2 (1.2) Mean Change from Baseline 1 -7.3 (1.0) -11.9 (1.0) <0.0001 4 -10.6 (1.1) -15.8 (1.1) <0.0001 12 -11.3 (1.2) -16.4 (1.3) <0.0001 Urinary volume / void (mL) (N=276) (N=266) Mean Baseline 0 151.8 (2.8) 149.6 (2.9) Mean Change from Baseline 1 11.9 (2.5) 24.1 (2.4) <0.0001 4 19.6 (3.1) 29.3 (3.0) 0.0… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 140 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis : Carcinogenicity studies with trospium chloride were conducted in mice and rats for 78 weeks and 104 weeks, respectively, at maximally tolerated doses. No evidence of a carcinogenic effect was found in either mice or rats administered up to 200 mg/kg/day (approximately 1 and 16 times, respectively (based on AUC), the expected clinical exposure levels at the maximum recommended human dose (MRHD) of 60 mg. Mutagenesis : Trospium chloride was not mutagenic nor genotoxic in tests in vitro in bacteria (Ames test) and mammalian cells (L5178Y mouse lymphoma and CHO cells) or in vivo in the mouse micronucleus test.

Impairment of Fertility: No evidence of impaired fertility was observed in rats administered doses up to 200 mg/kg/day (about 16 times the expected clinical exposure at the MRHD, based on AUC).

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 137 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenesis : Carcinogenicity studies with trospium chloride were conducted in mice and rats for 78 weeks and 104 weeks, respectively, at maximally tolerated doses. No evidence of a carcinogenic effect was found in either mice or rats administered up to 200 mg/kg/day (approximately 1 and 16 times, respectively (based on AUC), the expected clinical exposure levels at the maximum recommended human dose (MRHD) of 60 mg. Mutagenesis : Trospium chloride was not mutagenic nor genotoxic in tests in vitro in bacteria (Ames test) and mammalian cells (L5178Y mouse lymphoma and CHO cells) or in vivo in the mouse micronucleus test.

Impairment of Fertility: No evidence of impaired fertility was observed in rats administered doses up to 200 mg/kg/day (about 16 times the expected clinical exposure at the MRHD, based on AUC).

📄 Patient Package Insert ~3 min read ▾

Patient Information Trospium (TROSE-pee-um) Chloride Extended-Release Capsules Read the Patient Information that comes with Trospium Chloride Extended-Release Capsules before you start taking it and each time you get a refill. There may be new information. This leaflet does not take the place of talking with your doctor about your medical condition or your treatment.

What are Trospium Chloride Extended-Release Capsules? Trospium Chloride Extended-Release Capsules are a prescription medicine used to treat adults with overactive bladder who have the following symptoms: • a strong need to urinate right away; • leaking or wetting accidents due to a strong need to urinate right away; • a need to urinate often. Who should not take Trospium Chloride Extended-Release Capsules?

Do not take Trospium Chloride Extended-Release Capsules if you: • have trouble emptying your bladder; • have delayed or slow emptying of your stomach; • have an eye problem called “uncontrolled narrow-angle glaucoma”; • are allergic to Trospium Chloride Extended-Release Capsules or any of its ingredients. See the end of this leaflet for a complete list of ingredients. Trospium Chloride Extended-Release Capsules have not been studied in children under the age of 18 years.

What should I tell my doctor before starting Trospium Chloride Extended-Release Capsules? Tell your doctor about all of your medical conditions including if you: • have any stomach or intestinal problems or problems with constipation; • have trouble emptying your bladder or have a weak urine stream; • have an eye problem called narrow-angle glaucoma; • have kidney problems; • have liver problems; • are pregnant or planning to become pregnant. It is not known if Trospium Chloride Extended-Release Capsules can harm your unborn baby. • are breastfeeding.

It is not known if Trospium Chloride Extended-Release Capsules pass into breast milk and if it can harm your baby. You should talk to your doctor about the best way to feed your baby if you are taking Trospium Chloride Extended-Release Capsules. Tell your doctor about all the medicines you take including prescription and nonprescription medicines, vitamins and herbal supplements.

Trospium Chloride Extended-Release Capsules and certain other medicines can interact and make some side effects worse. Trospium Chloride Extended-Release Capsules can affect how other medicines are handled by the body. Know all the medicines you take.

Keep a list of them with you to show your doctor and pharmacist each time you get a new medicine. How should I take Trospium Chloride Extended-Release Capsules? Take Trospium Chloride Extended-Release Capsules exactly as prescribed. • Take one Trospium Chloride Extended-Release Capsule daily in the morning with water. • Take Trospium Chloride Extended-Release Capsules on an empty stomach or at least 1 hour before a meal. • Do not take alcohol within 2 hours of taking Trospium Chloride Extended-Release Capsules. • If you take too much Trospium Chloride Extended-Release Capsules, call your local Poison Control Center or go to an emergency room right away.

What are the possible side effects of Trospium Chloride Extended-Release Capsules? Trospium Chloride Extended-Release Capsules may cause allergic reactions that may be serious. Symptoms of a serious allergic reaction may include swelling of the face, lips, throat or tongue.

If you experience these symptoms, you should stop taking Trospium Chloride Extended-Release Capsules and get emergency medical help right away. The most common side effects with Trospium Chloride Extended-Release Capsules are: • dry mouth; • constipation. Trospium Chloride Extended-Release Capsules may cause other less common side effects, including: • trouble emptying the bladder; • blurred vision and drowsiness.

Do not drive or operate heavy machinery until you know how Trospium Chloride Extended-Release Capsules affects you. • heat prostration. Due to decreased sweating, heat prostration can occur when d… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 8 words ▾

Trospium Chloride ER 60 mg Capsule, #30 Label

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

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

Medicare Part D (outpatient prescription) spending for Trospium Chloride ER — the program that covers self-administered drugs. 5 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 Trospium Chloride ER. 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
$5.38M
Claims incl. refills
35.3K
Beneficiaries
24.2K
Spend / beneficiary
$222.36
Spend / claim
$152.56
Trend by period
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

Reported adverse events (FAERS)

Read carefully: FAERS reports are voluntary and unverified. Counts are not incidence, do not establish causation, are subject to reporting bias, and cannot be used to compare one drug to another. Shown for signal context only. Reports for Trospium Chloride ER (this brand).

Top reported reactions

Fall178
Fatigue163
Urinary Tract Infection137
Asthenia112
Dyspnoea112
Headache110
Nausea105

Age at onset

Neonate1
Child3
Adolescent2
Adult159
Elderly211

Reporter sex

2,273 reports
Male · 35%
Female · 65%
Unknown · 0%

Serious outcomes

Hospitalization901
Life-threatening122
Disabling71
Reports over time (by year) — tap or hover for the count & year
2019 2021 2023 2026 254 114
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.

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 — Not published for this NDC No photo available yet for this listing.
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 form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
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 Bryant Ranch Prepack. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Bryant Ranch Prepack 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.
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For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.