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Trospium

AEMPS

Quaternary ammonium muscarinic blocker for overactive bladder

ATC code: G04BD09

Brand names: Sanctura XR, Sanctura

Updated · Methodology

Indications

B

Overactive bladder

Second line

Trospium is a second-line muscarinic blocker for overactive bladder and a preferred choice in older patients. NG123 (2024) explicitly notes: the quaternary amine does not cross the blood-brain barrier and is less likely to cause confusion, memory impairment and somnolence than tertiary antimuscarinics (solifenacin, tolterodine, oxybutynin). AEMPS approves 20 mg twice daily on an empty stomach (or 60 mg SR once daily). With renal impairment (CrCl <30 mL/min) the dose is halved.

Sources

  1. AEMPS: Ficha técnica de Trospio (Uraplex) (2023)
  2. NICE: Urinary incontinence and pelvic organ prolapse in women: management (NG123) (2024)
  3. EAU: Non-neurogenic Female LUTS Guidelines (2024)

ICD-10: N32.8 · ICD-11: GC50.0

B

Urge urinary incontinence

Second line

AEMPS approves trospium for urge urinary incontinence in adults after behavioural therapy fails. The Madhuvrata meta-analysis (Cochrane 2012) showed trospium efficacy comparable to tertiary antimuscarinics with fewer cognitive side effects. In older patients with cognitive impairment (mild cognitive impairment, early dementia), AEU 2023 and AGS Beers 2023 position trospium as the muscarinic blocker of choice due to minimal blood-brain barrier penetration.

Sources

  1. AEMPS: Ficha técnica de Trospio (Uraplex) (2023)
  2. Cochrane: Anticholinergic drugs versus placebo for overactive bladder syndrome in adults (2012)
  3. AGS: American Geriatrics Society 2023 Updated AGS Beers Criteria (2023)

ICD-10: N39.4 · ICD-11: MF50.21

Marketing claims without evidence base

The drug is promoted for these uses outside international guidelines. Each entry below is analyzed against AEMPS, FDA, EMA, Cochrane and major RCTs.

F

Frequent urination without prior evaluation

Not recommended

Trospium is prescribed for «frequent toilet visits» without proper diagnostic workup, especially in Russia under the Spasmex brand. Increased urinary frequency is a symptom that may mean UTI, diabetes mellitus, BPH, neurological disease, or excess caffeine and fluid intake. Before any muscarinic blocker, the patient needs a bladder ultrasound with post-void residual, urinalysis and a 3-day voiding diary. In men over 50 with untreated BPH, trospium raises the risk of acute urinary retention. If trospium was prescribed without a bladder ultrasound or urinalysis, consider seeking a second opinion.

Sources

  1. AEMPS: Ficha técnica de Trospio (Uraplex) (2023)
  2. NICE: Urinary incontinence and pelvic organ prolapse in women: management (NG123) (2024)
  3. AGS: American Geriatrics Society 2023 Updated AGS Beers Criteria (2023)

ICD-10: R35 · ICD-11: MF50.0

How to read tiers A–F
  • AStrong evidence – first or second line in international guidelines
  • BRecommended in selected cases
  • CStudy data contradict each other
  • DBenefit not proven, no documented harm
  • FDocumented harm, or risk without benefit

Mechanism of action

Quaternary amine: the molecule carries a permanent positive charge and barely crosses the blood-brain barrier. This distinguishes it from tertiary amines (solifenacin, tolterodine, fesoterodine, oxybutynin) and almost eliminates central side effects: confusion, memory impairment, somnolence. Competitive antagonist of M1–M5 muscarinic receptors without marked selectivity. Low bioavailability (around 10%), not CYP-metabolised, minimal drug interactions. Take on an empty stomach an hour before food or two hours after: food halves the bioavailability.

Safety

Contraindications

  • Hypersensitivity to trospium
  • Urinary retention
  • Gastric retention
  • Uncontrolled narrow-angle glaucoma
  • Myasthenia gravis
  • Severe ulcerative colitis and toxic megacolon
  • Tachyarrhythmias

Serious adverse effects

  • Acute urinary retention
  • Tachycardia
  • Acute angle-closure glaucoma
  • Angio-oedema

Common adverse effects

  • Dry mouth (10–22%)
  • Constipation (7–10%)
  • Dyspepsia
  • Headache
  • Dry eyes

Pregnancy: can you take Trospium?

AEMPS summary of product characteristics (section 4.6): animal studies showed no direct or indirect harmful effects on pregnancy, embryo-fetal development, parturition or postnatal development of the offspring; in rats, trospium chloride crosses the placenta. There are no clinical data on its effects during pregnancy, so it is used with caution in pregnant women.

Breastfeeding: can you take Trospium?

Use with caution. Hale L3. The quaternary structure minimises milk transfer: e-Lactancia rates the risk as low for short-term use. Monitor infant sucking and tolerance.

Calculate RID

Reference information, not a clinical decision. Discuss feeding pauses or changes with your physician or an IBCLC.

Label mentions5 mentions

Verbatim lines from the interaction sections, in the language of the label

From this drug’s label

  • ModerateMorphine
    «Drugs 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…»

    FDA, section 7 · Open on DailyMed

  • antidepresivos tricíclicosclass named in the label
    «Potenciación del efecto de los fármacos con acción anticolinérgica (tales como amantadina, antidepresivos tricíclicos), intensificación de la acción taquicárdica de los β-simpaticomiméticos…»

    AEMPS, section 4.5 · Open on CIMA

  • Metformin
    «DRUG INTERACTIONS: Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. ( 7.4 )»

    FDA, section 7 · Open on DailyMed

  • Metoclopramide
    «Potenciación del efecto de los fármacos con acción anticolinérgica (tales como amantadina, antidepresivos tricíclicos), intensificación de la acción taquicárdica de los β-simpaticomiméticos…»

    AEMPS, section 4.5 · Open on CIMA

  • simpaticomiméticosclass named in the label
    «Potenciación del efecto de los fármacos con acción anticolinérgica (tales como amantadina, antidepresivos tricíclicos), intensificación de la acción taquicárdica de los β-simpaticomiméticos…»

    AEMPS, section 4.5 · Open on CIMA

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Frequently asked

What is Trospium used for?

Trospium is evaluated for the following indications with varying evidence strength: Overactive bladder (evidence tier B), Urge urinary incontinence (evidence tier B), Frequent urination without prior evaluation (evidence tier F). See the full indication matrix with dosing and citations above on this page.

What are the side effects of Trospium?

Common side effects of Trospium (≥ 1 in 100): Dry mouth (10–22%), Constipation (7–10%), Dyspepsia, Headache, Dry eyes. See the Safety section for uncommon and serious reactions.

Is Trospium safe during pregnancy?

AEMPS summary of product characteristics (section 4.6): animal studies showed no direct or indirect harmful effects on pregnancy, embryo-fetal development, parturition or postnatal development of the offspring; in rats, trospium chloride crosses the placenta. There are no clinical data on its effects during pregnancy, so it is used with caution in pregnant women.

Is Trospium compatible with breastfeeding?

Use with caution. Hale L3. The quaternary structure minimises milk transfer: e-Lactancia rates the risk as low for short-term use. Monitor infant sucking and tolerance.

Who should not take Trospium?

Trospium is contraindicated in: Hypersensitivity to trospium; Urinary retention; Gastric retention; Uncontrolled narrow-angle glaucoma; Myasthenia gravis. Full list in the Safety section.

Official sources

Direct links to regulator labels. Open in a new tab.

Other drugs in this group

Vardenafil, Dutasteride, Dutasteride + Tamsulosin, Fesoterodine, Mirabegron, Pygeum africanum, Solifenacin, Finasteride