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Trospium Chloride 60 mg Capsule, Extended Release, 30-count — NDC 70010-027-03 (Billing 70010-0027-03)

by Granules Pharmaceuticals Inc. · 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE

This is a package of 30 capsules of Trospium Chloride 60 mg Capsule, Extended Release from Granules Pharmaceuticals Inc., marketed since Aug 2020 and currently FDA-listed; retail pharmacies pay about $1.64 per capsule (NADAC). It is the main listing for this product, which comes in 2 package sizes.

NDC 70010-0027-03
🏷️ FDA NDC (as labeled) 70010-027-03 billing pads the product segment with a zero
This package
Contains30-count Cost per ea$1.64 NADAC Per package$49.29 / 30 capsules Pack sizes2 compare ↓
Also priced by: Medicaid pays $1.99/unit · Part D plans $3.32/unit — full pricing hub ↓
Main listing for product 70010-027 · Also comes in: 500 capsules 70010-027-05
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) 70010-027-03
Product NDC 70010-027
11-digit billing NDC 70010002703
NCPDP billing unit EA — each (per item)
RxCUI 857564
UNII 1E6682427E
Application # ANDA213185
SPL Set ID 5c088397-f407-4606-95a0-d9fe619888c3
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 2020-08-19
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 70010-027-03 — 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 → 70010-0027-03. 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 eaPer package
Retail pharmacies payNADAC · weekly $1.643 $49.29 / 30 capsules
Medicaid paysCMS SDUD · 12 mo $1.99 $59.76 / 30 capsules
Medicare drug plans payPart D · Q2 2026 $3.32 $99.68 / 30 capsules
NADAC price history (per ea) — tap or hover for the price & month
Jan 2022 Aug 2022 Jan 2026 Sep 2026 $3.475 $1.643
▼ Down 50% over the last 24 months.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Per unit Per pack Marketing startMarketing endStatus
70010-0027-03 You're viewing this Main listing 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE $1.64 / ea $49.29 2020-08-19 — Active
70010-0027-05 70010-027-05 500 CAPSULE, EXTENDED RELEASE in 1 BOTTLE — — 2020-08-19 — Active

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

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

Pack size FAQ

What quantity is in this package?
This is a 30-count package — 30 capsule, extended release in 1 bottle.
How does this package differ from NDC 70010-0027-05?
Both are Trospium Chloride 60 mg Capsule, Extended Release — the drug itself is identical. This page's package is the 30-count one, while NDC 70010-0027-05 is the 500 capsules package.
What NDC number is used to bill for this package of Trospium Chloride 60 mg Capsule, Extended Release?
Use the 11-digit billing form listed in the identifiers section of this page. Pharmacy and medical claims use the 11-digit form; the FDA label may print a shorter form of the same code.

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

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 mgthis 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 mg 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

🏛️
2020
On the market since
Aug 2020
📍
2026
Currently FDA-listed
6 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.

What it looks like

Color orange
ShapeCapsule
ImprintG60;027
Size22 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 5138Q19F1X
    Ammonia is a colorless gas made from nitrogen and hydrogen. It's used in medicines as a pH buffer to maintain the correct acidity level and help keep the product stable.
  • UNII 7Z8S9VYZ4B
    Ethylcellulose is a plant-derived thickener and film-former made by chemically modifying cellulose. It's used as a binder to hold tablet ingredients together, a coating to control how quickly medicine is released, or a thickener in liquid formulations.
  • UNII H3R47K3TBD
    FD&C Blue No. 1 is a synthetic blue dye approved for use in foods and medicines. It serves as a colorant to give the medication its distinctive appearance and help with product identification.
  • UNII WZB9127XOA
    A synthetic red dye used to color medications and make them easier to identify. It serves as a colorant in tablets, capsules, and liquid formulations.
  • 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 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 99Q3C7L77T
    A synthetic polymer made from acrylic compounds. It acts as a film-former and pH-dependent release agent in tablets and capsules, helping control how and where the active drug dissolves in the digestive system.
  • UNII 3WJQ0SDW1A
    Polyethylene glycol is a synthetic liquid or solid polymer used in medicines as a solvent, lubricant, and humectant. It helps dissolve active ingredients, reduces friction during manufacturing, and retains moisture in the final product.
  • UNII 6OZP39ZG8H
    Polysorbate 80 is a synthetic emulsifier derived from sorbitol and oleic acid. It helps mix oil and water-based ingredients together in medications and improves how the product disperses in the body.
  • 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 MB5IUD6JUA
    Shellac is a natural resin secreted by lac beetles, purified and processed into a coating material. It seals and protects tablets and capsules, controls how quickly the medicine dissolves, and gives pills their glossy finish.
  • 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 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 C151H8M554
    A natural sugar derived from sugar cane or sugar beets. It's used as a sweetener, filler, and binder to improve taste, add bulk, and help hold tablet or capsule ingredients together.
  • 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.
  • UNII XHX3C3X673
    Triacetin is a clear, oily liquid made from glycerin and acetic acid. It works as a plasticizer and solvent in medicines, helping soften coatings and improve how liquids mix together in formulations.
  • UNII 8Z96QXD6UM
    Triethyl citrate is a clear liquid derived from citric acid. It acts as a plasticizer and solvent in tablet coatings and film formulations, helping the coating remain flexible and adhere properly to the medicine.

20 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

LabelerGranules Pharmaceuticals Inc.
Application holderGRANULES PHARMACEUTICALS INC
FDA applicationANDA213185 (ANDA)
Labeler code70010
First marketedAug 2020
Product typeHuman Prescription Drug
Portfolio136 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 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 59 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 140 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 less than 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 less than 30 mL/minute). (2)

💊 Dosage Forms and Strengths 34 words ▾

3 DOSAGE FORMS AND STRENGTHS Trospium Chloride Extended-Release Capsules are supplied as 60 mg capsules (white opaque body and orange opaque cap, printed with “027” and “G60”). • 60 mg capsules ( 3 )

⛔ Contraindications 76 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 affects them. ( 5.5 ) • Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 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 [ see 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 [ see 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 Capsules 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 less than 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 (greater than or equal to 1%) with Trospium Chloride Extended-Release Capsules are dry mouth (10.7%) and constipation (8.5%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 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=1,165). 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 MedDRA Preferred term Number of patients (%) Placebo N=587 Trospium Chloride Extended-Release Capsules 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) Nasal dryness 0 (0) 6 (1) Additional adverse events reported in less than 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 Capsul… [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, 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 20mg 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 (less than 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 1,165 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 less than 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… [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 1,165 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 Following a single 60 mg dose of Trospium Chloride Extended-Release Capsules, peak plasma concentration (Cmax) of 2 ng/mL occurred 5 hours post dose. By contrast, following a single 20 mg dose of an immediate-release formulation of trospium chloride, Cmax 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 Cmax.

Other pharmacokinetic parameters such as Tmax and t1/2 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 Treaetment AUC (0 -24 ).

(ng•h/mL) C max. (ng/mL) T max a (h) t 1/2 b. (h) Trospium Chloride Extended-Release Capsules 60 mg 18 ± 13.4 2 ± 1.5 5 (3 to 7.5) 36 ± 22 a T max expressed as median (range). b t 1/2 was determined following multiple (10) d… [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 83 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING Trospium Chloride Extended-Release Capsules are supplied as 60 mg capsules (white opaque body and orange opaque cap, printed with “027” and “G60”). 60 mg capsule, 30 count, HDPE bottle: NDC 70010- 027-03 60 mg capsule, 500 count, HDPE bottle: NDC 70010-027-05 Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.

📋 Description 152 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 428. 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: corn starch, ethylcellulose, FD&C Blue# 1, FD&C Red# 40, FD&C Yellow# 6, gelatin, hypromellose, methacrylic acid copolymer, polyethylene glycol, polysorbate 80, sodium lauryl sulfate, sucrose, talc, titanium dioxide, triacetin and triethyl citrate.

In addition, capsule printing ink contains ammonium hydroxide, black iron oxide, propylene glycol and shellac glaze. trospium-structure

💬 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. Print Patient Information Leaflet at: https://granulespharma.com/product/trospium-er-cap/ Manufactured By: Granules Pharmaceuticals Inc. Chantilly, VA 20151 Rev.

12/2022

🍼 Nursing Mothers 69 words ▾

8.3Nursing Mothers Trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 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 Following a single 60 mg dose of Trospium Chloride Extended-Release Capsules, peak plasma concentration (Cmax) of 2 ng/mL occurred 5 hours post dose. By contrast, following a single 20 mg dose of an immediate-release formulation of trospium chloride, Cmax 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 Cmax.

Other pharmacokinetic parameters such as Tmax and t1/2 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 Treaetment AUC (0 -24 ).

(ng•h/mL) C max. (ng/mL) T max a (h) t 1/2 b. (h) Trospium Chloride Extended-Release Capsules 60 mg 18 ± 13.4 2 ± 1.5 5 (3 to 7.5) 36 ± 22 a T max expressed as median (range). b t 1/2 was determined following multiple (10) doses.

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 1/2 were unchanged in the presence of food.

Coadministration 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. CYP 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 CYP 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 of 20 mg Trospium Chloride Immediate Release twice daily at steady state and a single dose of 0.5 mg digoxin in a crossover st… [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 a 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 (0.2) - 2.8 (0.2) <0.0001 Urge incontinence episodes / week (N=300) (N=292) Mean Baseline 0 29 (1.3) 28.8 (1.3) Mean Change from Baseline 1 - 8.7 (1) - 13 (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) 151 (2.9) Mean Change from Baseline 1 12.1 (2.1) 21.6 (2.8) 0.0036 4 17.2 (2.5) 30 (3.1) 0.0007 12 18.9 (2.8) 29.8 (3.2) 0.0039 a treatment differences assessed by rank ANOVA for intent-to-treat population, last observation carried forward (ITT:LOCF) data set Figure 2: Mean Change from Baseline in Urinary Frequency/24 hours by Visit: Study 1 Figure 3: Mean Change from Baseline in Incontinence Episodes/Week by Visit: Study 1 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 a 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) - 11.9 (1) <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) 0.0020 12 17.8 (3.3) 31.5 (3.4… [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).

📄 Package Label / Principal Display Panel 5 words ▾

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL trospium-60mg-30

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

Medicaid utilization & spend

📍 This exact package only: Medicaid data is reported per full 11-digit NDC — labeler, product and pack size — so every number here is for this package alone, not the drug overall. Other pack sizes report separately.
💊 Pharmacy benefit only: These are Medicaid outpatient pharmacy claims, billed by NDC. They exclude the medical benefit — clinic- or hospital-administered drugs billed under HCPCS J-codes — so drugs used mostly that way (e.g. Avastin, Lucentis, Keytruda) can look low or missing here. That’s expected, not an error.
📅 Q1 2025 – Q1 2026 · 5 quarters of data
ⓘ The newest quarter is usually incomplete when first published; states restate recent quarters in later CMS releases, so the latest figures typically revise upward. State coverage-policy changes can also shift quarter-to-quarter totals.
Prescriptions last 4 qtrs
3.9K
Units reimbursed last 4 qtrs
150.3K
Gross reimbursed last 4 qtrs
$299.4K
Avg / prescription
$77.07
Avg / unit
$1.9921
Latest quarter Q1 2026
932Rx
Medicaid pays / ea
$1.9921
gross reimbursed
vs
NADAC / ea
$1.6430
acquisition cost
=
Spread
+$0.3491
+21% vs cost
What Medicaid paid per ea (before rebates; includes the pharmacy’s dispensing fee) compared with NADAC — the average price pharmacies pay to buy the drug. A positive spread means Medicaid reimbursed more than the purchase price, before manufacturer rebates.
Fee-for-service vs managed care ⓘ
42% FFS 58% MCO
Fee-for-service · 1,631 Rx Managed care · 2,254 Rx
State Medicaid map
Alaska: no data reported AK Maine: no data reported ME Washington: 1,218 units · 15.6 per 100k residents WA Idaho: 1,137 units · 57.9 per 100k residents ID Montana: no data reported MT North Dakota: no data reported ND Minnesota: 3,168 units · 55.2 per 100k residents MN Wisconsin: 414 units · 7.0 per 100k residents WI Michigan: 5,714 units · 56.9 per 100k residents MI New York: 27,502 units · 141 per 100k residents NY Vermont: no data reported VT New Hampshire: 380 units · 27.1 per 100k residents NH Oregon: 10,432 units · 246 per 100k residents OR Nevada: no data reported NV Wyoming: no data reported WY South Dakota: no data reported SD Iowa: 780 units · 24.3 per 100k residents IA Illinois: no data reported IL Indiana: 3,596 units · 52.4 per 100k residents IN Ohio: 11,347 units · 96.3 per 100k residents OH Pennsylvania: 4,766 units · 36.8 per 100k residents PA New Jersey: 352 units · 3.8 per 100k residents NJ Massachusetts: 1,948 units · 27.8 per 100k residents MA California: 39,213 units · 101 per 100k residents CA Utah: 5,355 units · 157 per 100k residents UT Colorado: no data reported CO Nebraska: no data reported NE Missouri: 870 units · 14.0 per 100k residents MO Kentucky: 6,493 units · 143 per 100k residents KY West Virginia: no data reported WV Virginia: 4,503 units · 51.7 per 100k residents VA Maryland: 8,946 units · 145 per 100k residents MD Connecticut: no data reported CT Rhode Island: no data reported RI Arizona: no data reported AZ New Mexico: 1,812 units · 85.7 per 100k residents NM Kansas: no data reported KS Arkansas: no data reported AR Tennessee: 900 units · 12.6 per 100k residents TN North Carolina: 1,800 units · 16.6 per 100k residents NC South Carolina: no data reported SC Delaware: no data reported DE Oklahoma: no data reported OK Louisiana: no data reported LA Mississippi: no data reported MS Alabama: 1,200 units · 23.5 per 100k residents AL Georgia: 1,323 units · 12.0 per 100k residents GA D.C.: 2,940 units · 433 per 100k residents DC Hawaii: no data reported HI Texas: 1,489 units · 4.9 per 100k residents TX Florida: 708 units · 3.1 per 100k residents FL
Units reimbursed · per 100k residents
3.1433
gray = no data reported ⓘ
Colors are per 100,000 residents, so big states don’t automatically dominate. Tap or hover a state for its actual totals.
Tap or hover a state
…for its Medicaid breakdown
🏆 Top states by units · per 100k residents
1 D.C. 433 /100k
2 Oregon 246 /100k
3 Utah 157 /100k
4 Maryland 145 /100k
5 Kentucky 143 /100k
6 New York 141 /100k
7 California 101 /100k
8 Ohio 96.3 /100k
National units — by quarter
💵 About the dollar figures: “reimbursed” is what Medicaid paid pharmacies before confidential manufacturer rebates, so the program’s real net cost is lower than these numbers. Fee-for-service and managed-care claims are combined unless split above. Source: CMS State Drug Utilization Data; per-100k rates use 2023 Census population estimates.

Medicaid utilization by pack size

Medicaid (SDUD) totals over the four most recent reported quarters for every package size of this drug — handy when a specific package (e.g. a starter/titration pack) carries little or no Medicaid volume on its own.
30 capsules this page70010-0027-03 3,885 Rx · $299,419
500 capsules70010-0027-05 No Medicaid data
Drug total (last 4 qtrs): 3,885 Rx · 150,306 units · $299,419 gross reimbursed
Tap a pack size to open its page. Source: CMS State Drug Utilization Data, last 4 quarters.

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

Medicare Part D (outpatient prescription) spending for Trospium Chloride — the program that covers self-administered drugs. 9 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. 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
$7.67M
Claims incl. refills
162.7K
Beneficiaries
109.3K
Spend / beneficiary
$70.19
Spend / claim
$47.14
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.
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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.