Trospium Chloride 20 mg Tablet, Film Coated, 60-count
Other active recalls for Trospium Chloride (different manufacturers) — 1 · tap to view
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Cholinergic Muscarinic Antagonist class.
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🏭 Manufacturer & labeler
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🩺 Clinical
- Trospium works by calming the bladder muscle so it doesn't squeeze so often or urgently. In clinical trials, it helped reduce the number of times people needed to rush to the bathr...
- What exactly does trospium do, and will it really help my bladder symptoms?
- Yes — timing really matters with trospium. You need to take it on an empty stomach, at least one hour before you eat, with a full glass of water. A high-fat meal can cut the amount...
- Does it matter when I take it or whether I eat first?
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💊 What it looks like
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🧪 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.
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IACT rows and label-wide narrative are kept separate; availability and product-level specificity depend on the submitted label.Inactive ingredient FAQ
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💲 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 | $0.212 | $12.73 / 60 tablets |
| Medicaid paysCMS SDUD · 12 mo | $0.4236 | $25.42 / 60 tablets |
| Medicare drug plans payPart D · Q2 2026 | $0.4656 | $27.94 / 60 tablets |
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Trospium Chloride 20 mg 00574-0145-60 | Padagis | 60 tablets | $0.212 | AB | Availability likely | — |
| Trospium Chloride 20 mg 00904-7059-52 | Major | 60 tablets | $0.212 | AB | Availability likely | — |
| Trospium Chloride 20 mg 33342-0554-09 | Macleods | 60 tablets | $0.212 | AB | Availability likely | — |
| Trospium Chloride 20 mg 62135-0742-60 | Chartwell | 60 tablets | $0.212 | AB | Availability likely | — |
| Trospium Chloride 20 mgthis 68462-0461-60 | Glenmark | 60 tablets | $0.212 | AB | Availability likely | — |
| Trospium Chloride 20 mg 76282-0336-60 | Exelan | 60 tablets | $0.212 | AB | Availability likely | — |
| Trospium Chloride 20 mg 90096-0141-60 | Zameer | 60 tablets | $0.212 | AB | Availability likely | — |
| Trospium Chloride 20 mg 23155-0530-02 | Heritage | 200 tablets | — | AB | FDA listed | — |
| Trospium Chloride 20 mg 63629-8457-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Trospium Chloride 20 mg 63629-9279-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Trospium Chloride 20 mg 69097-0912-02 | CIPLA | 30 tablets | — | AB | FDA listed | — |
| Trospium Chloride 20 mg 70518-4593-00 | REMEDYREPACK | 1 tablet | — | AB | FDA listed | — |
| Trospium Chloride 20 mg 71335-2961-01 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Trospium Chloride 20 mg 71610-0812-87 | Aphena | 2400 tablets | — | AB | FDA listed | — |
| Trospium Chloride 20 mg 72162-1108-06 | Bryant | 60 tablets | — | AB | FDA listed | — |
| Trospium Chloride 20 mg 72789-0348-60 | PD-Rx | 60 tablets | — | AB | FDA listed | — |
| Trospium Chloride 20 mg 00904-7619-40 | MAJOR | 500 tablets | — | AB | FDA listed | — |
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⏳ Availability & generic status
This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.
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🗺️ Medicaid utilization & spend
💊 Medicaid utilization by pack size
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
Top reported reactions
Reporter sex
Serious outcomes
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📦 Packaging — all sizes for this product
| Package NDC | Description | Per unit | Per pack | Marketing start | Status |
|---|---|---|---|---|---|
| 68462-0461-05 | 500 TABLET, FILM COATED in 1 BOTTLE (68462-461-05) | — | — | 2010-08-13 | Active |
| 68462-0461-30 | 30 TABLET, FILM COATED in 1 BOTTLE (68462-461-30) | — | — | 2010-08-13 | Active |
| 68462-0461-60 You're viewing this | 60 TABLET, FILM COATED in 1 BOTTLE (68462-461-60) | $0.2121 / ea | $12.73 | 2010-08-13 | Active |
| 68462-0461-10 | 1000 TABLET, FILM COATED in 1 BOTTLE (68462-461-10) | $0.2121 / ea | $212.14 | 2023-06-30 | Active |
You're viewing one of 4 pack sizes for this product.
This pack has the lowest per-ea cost of the 2 priced pack sizes ($0.2121 NADAC).
In Medicaid, this is the most-dispensed pack of this product — about 94% of fills over the last four reported quarters. See all packs ↓
Pack size FAQ
What quantity is in NDC 68462-0461-60?
What is the difference between NDC 68462-0461-60 and NDC 68462-0461-30?
What NDC number is used to bill for this package of Trospium Chloride 20 mg Tablet, Film Coated?
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.
📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets 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 dose is 20 mg twice daily. Trospium chloride tablets should be dosed at least one hour before meals or given on an empty stomach. Dosage modification is recommended in the following patient populations: • For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime [ see Warnings and Precautions ( 5.5 ), Use in Specific Populations ( 8.6 ), and Clinical Pharmacology ( 12.3 ) ]. • In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability [ see Use in Specific Populations ( 8.5 ) ]. • The recommended dose of trospium chloride tablets is one 20 mg tablet twice daily.
Trospium chloride tablets should be dosed with water on an empty stomach, at least one hour before a meal. ( 2 ) • For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime. ( 2 ) • In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability.
( 2 )
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS Trospium Chloride Tablets, USP are supplied as 20 mg tablets (brownish yellow, round, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘1’ on the other side). 20 mg tablets. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Trospium chloride is 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 is 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 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 controlled narrow angle glaucoma trospium chloride should be used only with careful monitoring.
( 5.4 ) • Central Nervous System Effects: Somnolence has been reported with trospium chloride. Advise patients not to drive or operate heavy machinery until they know how trospium chloride affects them ( 5.5 ). • Trospium is substantially excreted by the kidney. The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased.
Therefore, the risk of anticholinergic adverse reactions is expected to be greater in patients with moderate renal impairment. ( 5.6 )
5.1Risk of Urinary Retention Trospium chloride 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, the active ingredient in 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 should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [ see Contraindications ( 4 ) ]. Trospium chloride, 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 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 is 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 affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.
5.6Anticholinergic Adverse Reactions in Patients with Moderate Renal Impairment Trospium is substantially excreted by the kidney. The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate renal impairment [ see Dosage and Administration ( 2 ), and Use in Specific Populations ( 8.6 ) ].
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The most common adverse reactions (greater than or equal to 1%) with trospium chloride are dry mouth (20.1%), constipation (9.6%), and headache (4.2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 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 safety of trospium chloride was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with trospium chloride (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, 12-week, U.S., efficacy and safety studies and a 9-month open-label extension.
Of this total, 591 patients received trospium chloride 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with trospium chloride for at least 24 and 52 weeks, respectively. In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving trospium chloride 20 mg twice daily and 1.5% among patients receiving placebo.
Table 1 lists adverse reactions from the combined 12-week U.S. safety and efficacy trials were reported by at least 1% of patients, and were reported more frequently in the trospium chloride group than in the placebo group. The two most common adverse reactions reported by patients receiving trospium chloride 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse reaction for trospium chloride, dry mouth, occurred in 20.1% of trospium chloride treated patients and 5.8% of patients receiving placebo.
In the two U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with trospium chloride 20 mg twice daily. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment. Table 1.
Incidence (%) of adverse reactions with trospium chloride, reported in greater than or equal to 1% of all patients treated with trospium chloride and more frequent with trospium chloride (20 mg twice daily) than placebo in Studies 1 and 2 combined Adverse Reaction Placebo (N=590) Trospium Chloride 20 mg twice daily (N=591) Gastrointestinal Disorders Dry mouth 34 (5.8) 119 (20.1) Constipation 27 (4.6) 57 (9.6) Abdominal pain upper 7 (1.2) 9 (1.5) Constipation aggravated 5 (0.8) 8 (1.4) Dyspepsia 2 (0.3) 7 (1.2) Flatulence 5 (0.8) 7 (1.2) Nervous System Disorders Headache 12 (2) 25 (4.2) General Disorders Fatigue 8 (1.4) 11 (1.9) Renal and Urinary Disorders Urinary retention 2 (0.3) 7 (1.2) Eye Disorders Dry eyes 2 (0.3) 7 (1.2) Other adverse reactions from the U.S., placebo-controlled trials, occurring in greater than or equal to 0.5% and less than 1% of trospium chloride treated patients, and more common with trospium chloride than placebo are: tachycardia, vision blurred, abdominal distension, vomiting, dysgeusia, dry throat, and dry skin.
During controlled clinical studies, one adverse reaction of angioneurotic edema was reported.
6.2Post-marketing Experience The following adverse reactions have been identified during post-approval use of trospium chloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Gastrointestinal – gastritis; Cardiovascular – palpitations, supraventricular tachycardia, chest pain, syncope, “hypertensive crisis”; Immunological – Stevens-Johnson syndrome, anaphylactic reaction, angioedema; Nervous System – dizziness, confusion, vision abnormal, hallucinations, somnolence and delirium; Musculoskel…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS • Concomitant use with digoxin did not affect the pharmacokinetics of either drug. ( 7.1 ) • Some drugs which are actively secreted by the kidney may interact with trospium chloride by competing for renal tubular secretion. ( 7.2 ) • Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. ( 7.4 )
7.1Digoxin Concomitant use of trospium chloride and digoxin did not affect the pharmacokinetics of either drug [ see Clinical Pharmacology ( 12.3 ) ].
7.2Drugs Eliminated by Active Tubular Secretion Although demonstrated in a drug-drug interaction study not to affect the pharmacokinetics of digoxin, trospium chloride has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). Coadministration of trospium chloride with these drugs may increase the serum concentration of trospium chloride and/or the coadministered drug due to competition for this elimination pathway.
Careful patient monitoring is recommended in patients receiving such drugs [ see Clinical Pharmacology ( 12.3 ) ].
7.3Antimuscarinic Agents The concomitant use of trospium chloride with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. Trospium chloride may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
7.4Metformin Co-administration of 500 mg metformin immediate release tablets twice daily with trospium chloride 60 mg extended release reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC 0 to 24 and by 34% for mean C max [ see Clinical Pharmacology ( 12.3 ) ].
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS • The safety and effectiveness of trospium chloride 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 in pregnant women. Trospium chloride 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 treatment are encouraged to contact their physician.
Risk Summary Based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. Adverse developmental findings were not observed to correlate with dose in rats or in rabbits. No increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg.
Animal Data In a rat embryo/fetal development study, pregnant rats received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate, with maternal systemic exposures corresponding to approximately nine times the exposure of women treated at the MRHD of 40 mg, based on AUC. No malformations or fetal toxicity were observed. The offspring of female rats exposed orally, pre- and post-natally, to trospium chloride up to 200 mg/kg/day showed no increased developmental toxicity over background in surviving pups.
However, maternal toxicity (death, irregular breathing, increased excitability) was observed at 200 mg/kg/day. A no-effect level for maternal and pup toxicity (survival to Day 4) was 20 mg/kg/day, an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg. In a rabbit embryo/fetal development study, pregnant rabbits received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate.
At 200 mg/kg/day, maternal systemic exposures corresponded to approximately 16 times the exposure of women treated at the MRHD of 40 mg, based on AUC. However, one fetus in each of the three treated dose groups (0.3 to 16 times exposures at the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A maternal no-effect level was set at 20 mg/kg/day, at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg, due to clinical signs (reduced feces, hunched posture, diarrhea) observed in a pharmacokinetic study at 200 mg/kg/day.
8.2Labor and Delivery The effect of trospium chloride tablets 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 in human milk. Because many drugs are excreted in human milk, trospium chloride should be used during lactation only if the potential benefit justifies the potential risk to the newborn.
8.4Pediatric Use The safety and effectiveness of trospium chloride in pediatric patients have not been established.
8.5Geriatric Use Of the 591 patients with overactive bladder who received treatment with trospium chloride in the two U.S., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. Eighty-eight trospium chloride treated patients (15%) were greater than or equal to 75 years of age. In these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with trospium chloride (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) was higher in patients 75 years of age and older as compared to younger patients.
This effect may be related to an enhanced sensitivity to anticholinergic agents in this patient population [ see Clinical Pharmaco…
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of trospium chloride in pregnant women. Trospium chloride 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 treatment are encouraged to contact their physician.
Risk Summary Based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. Adverse developmental findings were not observed to correlate with dose in rats or in rabbits. No increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg.
Animal Data In a rat embryo/fetal development study, pregnant rats received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate, with maternal systemic exposures corresponding to approximately nine times the exposure of women treated at the MRHD of 40 mg, based on AUC. No malformations or fetal toxicity were observed. The offspring of female rats exposed orally, pre- and post-natally, to trospium chloride up to 200 mg/kg/day showed no increased developmental toxicity over background in surviving pups.
However, maternal toxicity (death, irregular breathing, increased excitability) was observed at 200 mg/kg/day. A no-effect level for maternal and pup toxicity (survival to Day 4) was 20 mg/kg/day, an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg. In a rabbit embryo/fetal development study, pregnant rabbits received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate.
At 200 mg/kg/day, maternal systemic exposures corresponded to approximately 16 times the exposure of women treated at the MRHD of 40 mg, based on AUC. However, one fetus in each of the three treated dose groups (0.3 to 16 times exposures at the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A maternal no-effect level was set at 20 mg/kg/day, at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg, due to clinical signs (reduced feces, hunched posture, diarrhea) observed in a pharmacokinetic study at 200 mg/kg/day.
🧒 Pediatric Use ▾
8.4Pediatric Use The safety and effectiveness of trospium chloride in pediatric patients have not been established.
🧓 Geriatric Use ▾
8.5Geriatric Use Of the 591 patients with overactive bladder who received treatment with trospium chloride in the two U.S., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. Eighty-eight trospium chloride treated patients (15%) were greater than or equal to 75 years of age. In these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with trospium chloride (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) was higher in patients 75 years of age and older as compared to younger patients.
This effect may be related to an enhanced sensitivity to anticholinergic agents in this patient population [ see Clinical Pharmacology ( 12.3 ) ]. Therefore, based upon tolerability, the dose frequency of trospium chloride may be reduced to 20 mg once daily in patients 75 years of age and older.
🆘 Overdosage ▾
10 OVERDOSAGE Overdosage with antimuscarinic agents, including trospium chloride, can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of overdosage, electrocardiographic monitoring is recommended.
A 7-month-old baby experienced tachycardia and mydriasis after administration of a single dose of trospium 10 mg given by a sibling. The baby’s weight was reported as 5 kg. Following admission into the hospital and about 1 hour after ingestion of the trospium, medicinal charcoal was administered for detoxification.
While hospitalized, the baby experienced mydriasis and tachycardia up to 230 beats per minute. Therapeutic intervention was not deemed necessary. The baby was discharged as completely recovered the following day.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action Trospium chloride is a muscarinic antagonist. 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.
Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.
12.2Pharmacodynamics Placebo-controlled studies employing urodynamic variables were conducted in patients with conditions characterized by involuntary detrusor contractions. The results demonstrate that trospium chlorideincreases 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 trospium chloride on QT interval was evaluated in a single-blind, randomized, placebo and active (moxifloxacin 400 mg once 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. The 100 mg twice daily dose of trospium chloride was chosen because this achieves the C max expected in severe renal impairment. 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. This finding was not observed during routine safety monitoring in 2 other placebo-controlled clinical trials in 591 trospium chloride treated overactive bladder patients [ see Clinical Studies ( 14 ) ]. The clinical significance of T wave inversion in this study is unknown.
Trospium chloride is associated with an increase in heart rate that correlates with increasing plasma concentrations. In the study described above, trospium chloride demonstrated a mean increase in heart rate compared to placebo of 9.1 bpm for the 20 mg dose and of 18 bpm for the 100 mg dose. In the two U.S. placebo-controlled trials in patients with overactive bladder, the mean increase in heart rate compared to placebo in Study 1 was observed to be 3 bpm and in Study 2 was 4 bpm.
12.3Pharmacokinetics Absorption: After oral administration, less than 10% of the dose is absorbed. Mean absolute bioavailability of a 20 mg dose is 9.6% (range: 4 to 16.1%). Peak plasma concentrations (C max ) occur between 5 to 6 hours post-dose.
Mean C max increases greater than dose-proportionally; a 3-fold and 4-fold increase in C max was observed for dose increases from 20 mg to 40 mg and from 20 mg to 60 mg, respectively. AUC exhibits dose linearity for single doses up to 60 mg. Trospium chloride exhibits diurnal variability in exposure with a decrease in C max and AUC of up to 59% and 33%, respectively, for evening relative to morning doses.
Effect of Food: Administration with a high (50%) fat-content meal resulted in reduced absorption, with AUC and C max values 70 to 80% lower than those obtained when trospium chloride was administered while fasting. Therefore, it is recommended that trospium chloride should be taken at least one hour prior to meals or on an empty stomach [ see Dosage and Administration ( 2 ) ]. A summary of mean (± standard deviation) pharmacokinetic parameters for a single 20 mg dose of trospium chloride is provided in Table 2.
Table 2. Mean (± SD) Pharmacokinetic Parameter Estimates for a Single 20 mg Trospium Chloride Tablet Dose in Healthy Volunteers C max AUC 0 to ∞ T max t ½ (ng/mL) (ng/mL•hr) (hr) (hr) 3.5 ± 4 36.4 ± 21.8 5.3 ± 1.2 18.3 ±
3.2 The mean plasma concentration-time (+SD) profile for trospium chlorid…
🧬 Mechanism of Action ▾
12.1Mechanism of Action Trospium chloride is a muscarinic antagonist. 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.
Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Trospium Chloride Tablets, USP, 20 mg (brownish yellow, round, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘1’ on the other side) are supplied as follows: Bottles of 30 NDC 68462-461-30 Bottles of 60 NDC 68462-461-60 Bottles of 500 NDC 68462-461-05 Bottles of 1,000 NDC 68462-461-10 Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
📦 Storage and Handling ▾
Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature].
📋 Description ▾
11 DESCRIPTION Trospium chloride, USP is a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1 R , 3 r , 5 S ). The empirical formula of trospium chloride, USP is C 25 H 30 ClNO 3 and its molecular weight is 427.96 g/mol. The structural formula of trospium chloride, USP is represented below: Trospium chloride, USP is a white or almost white, crystalline powder.
It is very soluble in water, freely soluble in methanol, practically insoluble in methylene chloride. Each Trospium Chloride Tablet, USP contains 20 mg of trospium chloride, USP, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, corn starch, povidone, croscarmellose sodium, colloidal silicon dioxide, magnesium stearate, titanium dioxide, polyethylene glycol 400, hypromellose, yellow iron oxide and red iron oxide. structure
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION “See FDA-approved Patient Labeling (Patient Information)”
17.1Angioedema Patients should be informed that trospium chloride, the active ingredient in trospium chloride tablets, may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue trospium chloride tablets 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 tablets. In particular, patients should be informed not to take trospium chloride tablets if they: • have urinary retention; • gastric retention; • uncontrolled narrow-angle glaucoma; • are allergic to any component of trospium chloride tablets.
17.3Administration Patients should be instructed regarding the recommended dosing and administration of trospium chloride tablets: • Take one trospium chloride tablet twice daily with water. • Take trospium chloride tablets on an empty stomach or at least 1 hour before a meal.
17.4Adverse Reactions Patients should be informed that the most common side effects with trospium chloride 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, 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.
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