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 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 ↗- 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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🧪 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.
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UNII H0G9379FGK
Calcium carbonate is a white mineral powder used as a filler and buffering agent in medicines. It helps give tablets their bulk and size while neutralizing stomach acid in some formulations.
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UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
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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.
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UNII EWQ57Q8I5X
Lactose monohydrate is a natural sugar derived from milk. It serves as a filler and binder in tablets and capsules, helping create the proper size, texture, and consistency of the medicine.
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UNII 70097M6I30
Magnesium stearate is a salt made from magnesium and stearic acid, a fatty substance. It's used in tablets and capsules as a lubricant and glidant to help ingredients flow smoothly during manufacturing and prevent sticking.
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UNII OP1R32D61U
Microcrystalline cellulose is a purified form of cellulose, a natural fiber from plant sources. It acts as a binder and filler in tablets and capsules, helping hold ingredients together and give the medicine its shape and size.
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UNII G2M7P15E5P
Polyethylene glycol 3350 is a synthetic polymer used as a solvent, humectant, and thickening agent in medicines. It helps dissolve other ingredients, retain moisture in the product, and achieve the desired consistency.
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UNII FZ989GH94E
Povidone is a synthetic polymer made from a plastic-like material. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in your stomach so the medicine can be absorbed.
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UNII ETJ7Z6XBU4
Silicon dioxide is a naturally occurring mineral used as a glidant and anti-caking agent. It helps powder ingredients flow smoothly and prevents clumping during manufacturing and storage.
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UNII 4ELV7Z65AP
Stearic acid is a fatty acid derived from plant or animal sources. It acts as a binder and lubricant in tablets and capsules, helping them hold together and flow smoothly during manufacturing.
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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.
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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.
12 inactive ingredients listed in the exact product block matched to this NDC.
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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
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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 each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data. | |
| Medicare drug plans payPart D · Q2 2026 | $0.4656 | $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 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 68462-0461-05 | Glenmark | 500 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 mgthis 72162-1108-02 | 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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📊 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 | Marketing start | Status |
|---|---|---|---|
| 72162-1108-06 | 60 TABLET, FILM COATED in 1 BOTTLE (72162-1108-6) | 2023-10-09 | Active |
| 72162-1108-02 You're viewing this | 60 TABLET, FILM COATED in 1 BOTTLE (72162-1108-2) | 2023-10-09 | Active |
Pack size FAQ
What quantity is in NDC 72162-1108-02?
What is the difference between NDC 72162-1108-02 and NDC 72162-1108-06?
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🧭 About this NDC listing & data coverage
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | ✓ Available |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | ✓ Available |
| HCPCS J-code billing crosswalk | — Not published for this NDC Most self-administered / retail products have no J-code — that is normal. |
| Medicaid utilization (CMS SDUD) | — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold. |
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📄 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 < 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 ≥ 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 are 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 < 30 mL/min), the recommended dose is 20 mg once daily at bedtime. ( 2 ) • In geriatric patients ≥ 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 are supplied as 20 mg tablets (white, round, standard cup film coated tablet, debossed with 'PAD' on one side and '145' on the other side). • 20 mg tablets. ( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS Trospium Chloride Tablets 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 Tablets 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 Tablets 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 Tablets should be used only with careful monitoring.
( 5.4 ) • Central Nervous System Effects: Somnolence has been reported with Trospium Chloride Tablets. Advise patients not to drive or operate heavy machinery until they know how Trospium Chloride Tablets affect 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 Tablets 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 Tablets. 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 Tablets 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 Tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention ( see CONTRAINDICATIONS (4) ). Trospium Chloride Tablets, 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 Tablets 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 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 Tablets affect 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 (≥ 1%) with Trospium Chloride Tablets are dry mouth (20.1%), constipation (9.6%), and headache (4.2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-800-328-5113 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 Tablets was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with Trospium Chloride Tablets (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 Tablets 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with Trospium Chloride Tablets 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 Tablets 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 Tablets group than in the placebo group. The two most common adverse reactions reported by patients receiving Trospium Chloride Tablets 20 mg twice daily were dry mouth and constipation.
The single most frequently reported adverse reaction for Trospium Chloride Tablets, dry mouth, occurred in 20.1% of Trospium Chloride Tablets 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 Tablets 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 Tablets, reported in ≥ 1% of all patients treated with Trospium Chloride Tablets and more frequent with Trospium Chloride Tablets (20 mg twice daily) than placebo in Studies 1 and 2 combined Adverse Reaction Placebo (N=590) Trospium Chloride Tablets 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 (2.0) 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 ≥ 0.5% and < 1.0% of Trospium Chloride Tablets treated patients, and more common with Trospium Chloride Tablets 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, s…
🔄 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 Tablets 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 Tablets 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 Tablets have 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 Tablets with these drugs may increase the serum concentration of Trospium Chloride Tablets 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 Tablets 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 Tablets may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
7.4Metformin Coadministration of 500 mg metformin immediate release tablets twice daily with Trospium Chloride 60 mg Extended Release Capsules reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC 0-24 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 Tablets 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 Tablets in pregnant women. Trospium Chloride Tablets 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 Tablets 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 (< 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 Tablets 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 Tablets in pediatric patients have not been established.
8.5Geriatric Use Of the 591 patients with overactive bladder who received treatment with Trospium Chloride Tablets 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 Tablet treated patients (15%) were ≥ 75 years of age. In these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with Trospium Chloride Tablets (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 pa…
🤰 Pregnancy ▾
8.1Pregnancy Teratogenic Effects Pregnancy Category C: There are no adequate and well-controlled studies of Trospium Chloride Tablets in pregnant women. Trospium Chloride Tablets 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 Tablets 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 Tablets 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 Tablets 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 Tablet treated patients (15%) were ≥ 75 years of age. In these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with Trospium Chloride Tablets (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 Tablets 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 Tablets, 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 Chloride Tablets increase 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 Tablets 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 Tablets was chosen because this achieves the C max expected in severe renal impairment. Trospium Chloride Tablets were 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 Tablets 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 Tablets treated overactive bladder patients [ see CLINICAL STUDIES (14) ]. The clinical significance of T wave inversion in this study is unknown.
Trospium Chloride Tablets are associated with an increase in heart rate that correlates with increasing plasma concentrations. In the study described above, Trospium Chloride Tablets 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, < 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 Tablets exhibit 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 Tablets were administered while fasting. Therefore, it is recommended that Trospium Chloride Tablets 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 Tablets 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 (ng/mL) AUC 0-∞ (ng/mL∙hr) T max (hr) t 1/2 (hr) 3.5 ± 4.0 36.4 ± 21.8 5…
🧬 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 20 mg (white, round, standard cup film coated tablet, debossed with 'PAD' on one side and '145' on the other side) are supplied as follows: 60 count bottle - NDC 72162-1108-2 60 count bottle - NDC 72162-1108-6 Store at 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature]. Repackaged/Relabeled by: Bryant Ranch Prepack Burbank, CA 91504
📋 Description ▾
11 DESCRIPTION Trospium chloride is 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 per 2 mL. Each Trospium Chloride Tablet contains 20 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: microcrystalline cellulose, lactose monohydrate, calcium carbonate, croscarmellose sodium, povidone, hypromellose, talc, stearic acid, titanium dioxide, colloidal silicon dioxide, magnesium stearate and polyethylene glycol 3350.
💬 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 Tablets 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 Tablets, 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.