Trospium

Trospium chloride tablets is a muscarinic antagonist. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder.

• & USAGE Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.ICD-10: N32.81

• Trospium chloride tablets are contraindicated in patients with: urinary retention gastric retention uncontrolled narrow-angle glaucoma. known hypersensitivity to the drug or its ingredients.contraindicated

DOSAGE & 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 )

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 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 ) 5.1 Risk 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) ]. 5.2 Angioedema 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.

The most common adverse reactions (greater than or equal to 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 Zameer Pharmaceuticals LLC at 1-888-851-7033 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical 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.

The safety and effectiveness of trospium chloride tablets in pediatric patients have not been established. ( 8.4 ) 8.1 Pregnancy 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.

Metabolism

Absorption: After oral administration, less than 10% of the dose is absorbed. Mean absolute bioavailability of a 20 mg dose is 9.6% (range: 4-16.1%).

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.

• Aug 13, 2010ANDAANDA091575Glenmark Pharms Ltd
• Nov 17, 2010ANDAANDA091573Padagis Us
• Oct 12, 2012ANDAANDA091289Actavis Labs Fl Inc
• May 24, 2013ANDAANDA201291Padagis Us
• Aug 23, 2016ANDAANDA091688Invagen Pharms
• Aug 30, 2016ANDAANDA204945Heritage Pharms Inc
• Apr 23, 2020ANDAANDA213185Granules
• Sep 26, 2024NDANDA216158Bristol-myers

1. 1Nausea45612%
2. 2Vomiting3699.4%
3. 3Constipation2045.2%
4. 4Off Label Use2005.1%
5. 5Fatigue1914.8%
6. 6Fall1734.4%
7. 7Drug Ineffective1704.3%
8. 8Dizziness1694.3%
9. 9Urinary Retention1634.1%
10. 10Urinary Tract Infection1453.7%
11. 11Headache1413.6%
12. 12Diarrhoea1253.2%
13. 13Asthenia1223.1%
14. 14Dyspnoea1183.0%
15. 15Dyspepsia1082.7%

The 10 most recently updated of 68 ClinicalTrials.gov registrations naming Trospium as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• A Study to Evaluate the Effects of KarXT on the Drug Levels of Midazolam, Fexofenadine, and Digoxin
  Recruiting · Phase 1 · Interventional · 60 enrolled · Karuna Therapeutics, Inc., a Bristol Myers Squibb company
  NCT07118215updated 2026-06-11
• A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-1)
  Recruiting · Phase 3 · Interventional · 352 enrolled · Bristol-Myers Squibb
  NCT07011732updated 2026-06-10
• A Study to Evaluate the Efficacy and Safety of Adjunctive KarXT for the Treatment of Mania, With or Without Mixed Features, in Participants With Bipolar-I Disorder Taking Lithium, Valproate, or Lamotrigine
  Recruiting · Phase 3 · Interventional · 424 enrolled · Bristol-Myers Squibb
  NCT07140913updated 2026-06-10
• A Phase 3 Study to Evaluate the Safety and Efficacy of KarXT + KarX-EC for the Treatment of Agitation Associated With Alzheimer's Disease (ADAGIO-2)
  Recruiting · Phase 3 · Interventional · 352 enrolled · Bristol-Myers Squibb
  NCT07011745updated 2026-06-10
• A Study to Evaluate the Efficacy and Safety of KarXT for the Treatment of Manic Episodes in Bipolar-I Disorder (BALSAM-2)
  Recruiting · Phase 3 · Interventional · 274 enrolled · Bristol-Myers Squibb
  NCT06951711updated 2026-06-04
• A Study to Evaluate the Effect of KarXT on Urological Safety
  Recruiting · Phase 4 · Interventional · 60 enrolled · Bristol-Myers Squibb
  NCT07221877updated 2026-06-03
• The Impact of Cobenfy Maintenance on Cocaine's Effects
  Not yet recruiting · Phase 1 · Phase 2 · Interventional · 32 enrolled · Joshua A. Lile, Ph.D.
  NCT07624227updated 2026-06-03
• Open-Label Extension Study to Assess the Long-Term Safety and Tolerability of KarXT in Subjects With Psychosis Associated With Alzheimer's Disease (ADEPT-3)
  Recruiting · Phase 3 · Interventional · 800 enrolled · Karuna Therapeutics, Inc., a Bristol Myers Squibb company
  NCT05980949updated 2026-06-02
• A Study to Assess Efficacy and Safety of KarXT for the Treatment of Psychosis Associated With Alzheimer's Disease (ADEPT-2)
  Recruiting · Phase 3 · Interventional · 500 enrolled · Karuna Therapeutics, Inc., a Bristol Myers Squibb company
  NCT06126224updated 2026-06-02
• A Study to Evaluate Safety and Efficacy of KarXT + KarX-EC as a Treatment for Psychosis Associated With Alzheimer's Disease (ADEPT-5)
  Recruiting · Phase 3 · Interventional · 325 enrolled · Bristol-Myers Squibb
  NCT06947941updated 2026-06-02

Frequently asked questions

How does Trospium work?

Trospium chloride tablets is a muscarinic antagonist. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder.

What is Trospium used for?

According to FDA labeling, Trospium carries indications including: & USAGE Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Trospium?

Trospium is classified as Drugs for urinary frequency and incontinence, Cholinergic Muscarinic Antagonist, Cholinergic Muscarinic Antagonists, Decreased Bladder Contractility.

What are the brand names for Trospium?

Trospium is marketed under brand names including Cobenfy.

What are the contraindications for Trospium?

Trospium labeling lists contraindications including: Trospium chloride tablets are contraindicated in patients with: urinary retention gastric retention uncontrolled narrow-angle glaucoma. known hypersensitivity to the drug or its ingredients.. Always consult the full prescribing information and a clinician.