Uses
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.
Source: US FDA prescribing information
- Presentations
- 2
- Brands
- 0
- Manufacturers
- 0
- Available from stock
- 0
Trospium is a cholinergic muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. It is available as tablets and extended-release capsules for oral use. MedsAcross supplies Trospium for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
Key facts
- Pharmacological class
- Cholinergic Muscarinic Antagonist, Cholinergic Muscarinic Antagonists
- ATC classification
- G04BD09 Trospium · Urology medicines, subgroup G04B, subgroup G04BD
- US FDA first approval
- 28 May 2004
- EU status
- Not recorded
- Orphan designation
- Not recorded
- WHO essential medicine
- Not recorded
- India (CDSCO)
- Not yet confirmed against CDSCO approval lists
- Routes
- Oral
- Dosage forms
- Tablet, Extended-release capsule
- Identifiers
- UNII T4Y8ORK057RxCUI 236778CAS 47608-32-2Q513396
Clinical information
From the regulator-approved product information. Each section names its source.
How it works
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.
Source: US FDA prescribing information
Dosing overview
The recommended dosage of Trospium Chloride Extended-Release Capsules is one 60 mg capsule daily in the morning. Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal. Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). • The recommended dosage of Trospium Chloride Extended-Release Capsules is one 60 mg capsule daily in the morning. Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal. • Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute).
Source: US FDA prescribing information
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. • Patients with known hypersensitivity
Source: US FDA prescribing information
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. • Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. • In patients with narrow angle glaucoma, Trospium Chloride Extended-Release Capsules should be used only with careful monitoring. • Central Nervous System Effects: Somnolence has been reported with Trospium Chloride Extended-Release Capsules. Advise patients not to drive or operate heavy machinery until they know how Trospium Chloride Extended-Release Capsules affects them. • Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute).
Source: US FDA prescribing information
Side effects
The most common adverse reactions (greater than or equal to 1%) with Trospium Chloride Extended-Release Capsules are dry mouth (10.7%) and constipation (8.5%).
Source: US FDA prescribing information
Interactions
Trospium is metabolized by ester hydrolysis and excreted by the kidneys through a combination of tubular secretion and glomerular filtration. Based on in vitro data, no clinically relevant metabolic drug-drug interactions are anticipated with Trospium Chloride Extended-Release Capsules. However, some drugs which are actively secreted by the kidney may interact with Trospium Chloride Extended-Release Capsules by competing for renal tubular secretion. The concomitant use of Trospium Chloride Extended-Release Capsules with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic effects may increase the frequency and/or severity of such effects. Trospium Chloride Extended-Release Capsules may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Source: US FDA prescribing information
Storage
Store at 20° to 25°C (68° to 77°F), excursions permitted between 15° to 30°C (59° to 86°F) Dispense in a tight, light-resistant container as defined in the USP, with a child-resistant closure.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
All presentations
2 presentations of Trospium, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Trospium 20 mg tabletOralGeneric name | — | US FDA | Available on request |
| Trospium 60 mg extended-release capsuleOralGeneric name | — | US FDA | Available on request |
Regulatory status
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 28 May 2004 | Drugs@FDA |
| EU (EMA) | Not recorded | — |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Questions and answers
Is Trospium available for export from India?
Yes, on request. MedsAcross lists 2 presentations of Trospium and sources them for licensed hospitals, importers and physicians against valid import documents.
Is Trospium approved by the US FDA?
Yes. The US FDA first approved Trospium on 28 May 2004, according to Drugs@FDA.
Does Trospium need cold chain shipping?
No listed presentation of Trospium is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Which ATC class is Trospium in?
Trospium is classified under ATC code G04BD09 (Trospium).
References
- TROSPIUM CHLORIDE prescribing information (Granules India). U.S. National Library of Medicine, DailyMed. Retrieved 8 October 2026
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