SANCTURA
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SANCTURA (SANCTURA).
Trospium chloride is an antimuscarinic agent that competitively inhibits acetylcholine at muscarinic receptors, thereby reducing detrusor muscle contractions and increasing bladder capacity.
| Metabolism | Trospium undergoes minimal hepatic metabolism via ester hydrolysis and conjugation; less than 10% is metabolized. It is primarily excreted unchanged in urine (60%) and feces (40%). CYP450 enzymes are not significantly involved. |
| Excretion | Primarily renal (approximately 60% as unchanged drug and metabolites); biliary/fecal elimination accounts for ~30%. |
| Half-life | Terminal elimination half-life is approximately 12–20 hours in healthy adults, allowing twice-daily dosing. |
| Protein binding | ~80% bound primarily to albumin. |
| Volume of Distribution | Approximately 2 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral: ~30% due to first-pass metabolism. |
| Onset of Action | Oral: Onset of anticholinergic effect occurs within 1 hour. |
| Duration of Action | Duration of action is 8–12 hours, supporting twice-daily administration for overactive bladder symptoms. |
20 mg orally twice daily, with or without food. Maximum dose 20 mg twice daily.
| Dosage form | TABLET |
| Renal impairment | Contraindicated in patients with GFR <30 mL/min/1.73 m² (severe renal impairment). No dose adjustment recommended for mild-to-moderate renal impairment (GFR 30-89 mL/min/1.73 m²). |
| Liver impairment | Contraindicated in patients with Child-Pugh class C (severe hepatic impairment). For Child-Pugh class A or B, no dose adjustment recommended due to limited data; use with caution. |
| Pediatric use | Not approved for pediatric use; safety and efficacy not established. |
| Geriatric use | Elderly patients may be more sensitive to anticholinergic effects. No specific dose adjustment recommended, but initiate at lowest effective dose and monitor closely. Avoid in patients with significant impairment of renal or hepatic function. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SANCTURA (SANCTURA).
| Breastfeeding | Not recommended during breastfeeding. No data on excretion in human milk; however, due to anticholinergic properties, may suppress lactation and cause adverse effects in infant. M/P ratio unknown. |
| Teratogenic Risk | Pregnancy Category C. Animal studies have shown adverse effects (fetal resorption, reduced fetal weight) at doses 1.6 times the maximum recommended human dose. No adequate human studies in pregnant women. Risk cannot be ruled out. First trimester: potential for teratogenicity, avoid unless clearly needed. Second and third trimesters: potential for fetal anticholinergic effects (tachycardia, constipation). |
■ FDA Black Box Warning
No FDA black box warning.
| Serious Effects |
["Urinary retention","Gastric retention","Uncontrolled narrow-angle glaucoma","Hypersensitivity to trospium or any component of the formulation"]
| Precautions | ["Angioedema has been reported with trospium; if occurs, discontinue and manage appropriately.","May cause urinary retention; use with caution in patients with bladder outflow obstruction.","May aggravate symptoms in patients with gastrointestinal obstructive disorders.","May decrease gastric motility; use with caution in patients with severe constipation or ulcerative colitis.","May cause blurred vision and dizziness; advise patients not to drive or operate machinery until effects are known.","Use with caution in patients with myasthenia gravis.","Use with caution in patients with moderate to severe renal impairment (dose adjustment required).","May cause heat prostration in hot environments due to decreased sweating."] |
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| Fetal Monitoring | Monitor for maternal anticholinergic side effects (dry mouth, constipation, blurred vision, tachycardia, urinary retention). Fetal monitoring: consider fetal heart rate monitoring if used near term due to potential for fetal tachycardia. |
| Fertility Effects | Reduced fertility observed in animal studies. In humans: no controlled studies; anticholinergic effects may theoretically affect reproductive function, but clinical significance unknown. |