Trospium Chloride ER 60 mg Capsule, Extended Release, 30-count — NDC 0574-0118-30 (Billing 00574-0118-30)
This is a package of 30 capsules of Trospium Chloride ER 60 mg Capsule, Extended Release from Padagis US LLC, marketed since Jun 2013 and currently FDA-listed; retail pharmacies pay about $1.64 per capsule (NADAC). It is this product's only package size.
Identity & classification
Regulatory identifiers FDA, NLM and CMS codes for this package
Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification
- 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
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
- RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
- Medi-Span GPI (licensed)
- First Databank (licensed) · refreshed Oct 1, 2026
RxNorm drug class
This medicine belongs to the Cholinergic Muscarinic Antagonist class.
Where does this data come from?
- RxClass (NLM) · catalog refreshed Oct 1, 2026
Clinical
- 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,...
Patient education
Supplement & herbal interactions
Where does this data come from?
- MedlinePlus (NLM) · refreshed Oct 1, 2026
- FDA label on DailyMed · label index refreshed Oct 1, 2026
Ask a licensed pharmacist directly — free, answered by our team.
Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per ea | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | $1.643 | $49.29 / 30 capsules |
| Medicaid paysCMS SDUD · 12 mo | $1.96 | $58.81 / 30 capsules |
| Medicare drug plans payPart D · Q2 2026 | $3.32 | $99.68 / 30 capsules |
Where does this data come from?
- CMS NADAC weekly file · file of Sep 30, 2026
- CMS ASP pricing files · refreshed Sep 20, 2026
- CMS Medicaid State Drug Utilization Data · through Q1 2026
- CMS Part D plan pricing files · refreshed Sep 24, 2026
- VA National Acquisition Center price file
Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Marketing end | Status |
|---|---|---|---|---|
| 00574-0118-30 You're viewing this Main listing | 30 CAPSULE, EXTENDED RELEASE in 1 BOTTLE | 2013-06-07 | — | Active |
Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Trospium Chloride ER 60 mgthis 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 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 | — |
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- FDA Orange Book · refreshed Sep 3, 2026
- CMS NADAC weekly file · file of Sep 30, 2026
Availability & generic status
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?
- FDA Orange Book · refreshed Sep 3, 2026
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.
Where does this data come from?
IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.- FDA label on DailyMed · label index refreshed Oct 1, 2026
- FDA openFDA NDC Directory · synced Oct 1, 2026
Inactive ingredient FAQ
Are inactive ingredients the same for every manufacturer?
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Can inactive ingredients matter?
Manufacturer & labeler
Where does this data come from?
- FDA openFDA NDC Directory · synced Oct 1, 2026
- Drugs@FDA
Full prescribing information FDA SPL
🎯 Indications and Usage ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 ▾
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 Padagis 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 ▾
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 ▾
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 ▾
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 ▾
8.4Pediatric Use The safety and effectiveness of Trospium Chloride Extended-Release Capsules in pediatric patients have not been established.
🧓 Geriatric Use ▾
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 ▾
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 ▾
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 a (h) t ½ b (h) Trospium Chloride Extended-Release Capsules 60 mg 18.0 ± 13.4 2.0 ±… [Excerpted — this section continues on DailyMed.]
🧬 Mechanism of Action ▾
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 ▾
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 0574-0118-30 Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Dispense in a tight container.
📦 Storage and Handling ▾
Store at 20° to 25°C (68° to 77°F) [See USP controlled room temperature]. Dispense in a tight container.
📋 Description ▾
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. Chemical Structure
💬 Information for Patients ▾
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 ▾
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 ▾
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 a (h) t ½ b (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 a Tmax expressed as median (range). b t½ 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 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.
Figure 1 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 : Conc… [Excerpted — this section continues on DailyMed.]
🧬 Pharmacodynamics ▾
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 ▾
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 (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 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 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 (0.1) -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)… [Excerpted — this section continues on DailyMed.]
🧪 Nonclinical Toxicology ▾
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 ▾
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 ▾
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 ▾
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label NDC 0574-0118-30 Rx Only Once-Daily Trospium Chloride Extended-Release Capsules 60 mg Pharmacist: Dispense in this unit-of-use child resistant container with the patient information leaflet provided. 30 Capsules Unit-of-Use The following image is a placeholder representing the product identifier that is either affixed or imprinted on the drug package label during the packaging operation label serialization-template.jpg