SANCTURA XR
Clinical safety rating: caution
Comprehensive clinical and safety monograph for SANCTURA XR (SANCTURA XR).
Trospium is an antimuscarinic agent that competitively inhibits acetylcholine at muscarinic receptors, reducing bladder detrusor muscle contractions.
| Metabolism | Minimally metabolized via ester hydrolysis and conjugation; hepatic CYP450 enzymes are not significantly involved. |
| Excretion | Primarily renal excretion (70-80% as unchanged drug and active metabolite); approximately 10% fecal; 5-10% biliary. |
| Half-life | Terminal elimination half-life is approximately 7-10 hours in patients with normal renal function; prolonged to 20-30 hours in moderate to severe renal impairment. |
| Protein binding | Approximately 20-30% bound to plasma proteins, primarily albumin. |
| Volume of Distribution | Approximately 1.5-2.5 L/kg, indicating extensive tissue distribution. |
| Bioavailability | Oral extended-release: approximately 25-30% due to first-pass metabolism. |
| Onset of Action | Oral: 1-2 hours for antimuscarinic effects. |
| Duration of Action | 12-24 hours based on extended-release formulation; clinical effects may persist up to 24 hours with regular dosing. |
60 mg orally once daily, taken with a full glass of water at least 1 hour before meals. Extended-release capsule.
| Dosage form | CAPSULE, EXTENDED RELEASE |
| Renal impairment | Creatinine clearance 30-60 mL/min: 60 mg orally once daily. Creatinine clearance <30 mL/min: not recommended. |
| Liver impairment | Child-Pugh class A: 60 mg orally once daily. Child-Pugh class B or C: not recommended; no dosage adjustment data available. |
| Pediatric use | Not approved for use in pediatric patients; safety and efficacy not established. |
| Geriatric use | In elderly patients (≥65 years), start at 60 mg orally once daily; monitor for anticholinergic effects and renal function due to age-related decline. |
| 1st trimester | Consult provider |
| 2nd trimester | Consult provider |
| 3rd trimester | Consult provider |
Clinical note
Comprehensive clinical and safety monograph for SANCTURA XR (SANCTURA XR).
| Breastfeeding | Not recommended. Trospium is excreted in rat milk; no human data. M/P ratio unknown. Potential for anticholinergic adverse effects in infant. |
| Teratogenic Risk | Pregnancy Category C. No adequate and well-controlled studies in pregnant women. In animal studies, trospium chloride administered to pregnant rats during organogenesis at doses up to 200 mg/kg/day (approximately 10 times the maximum recommended human dose based on AUC) resulted in decreased fetal weight and increased incidence of skeletal variations. In rabbits, doses up to 200 mg/kg/day (approximately 50 times the MRHD) caused maternal toxicity and increased resorptions. Potential fetal risks are unknown; use only if clearly needed. |
■ FDA Black Box Warning
None.
| Serious Effects |
["Urinary retention, gastric retention, uncontrolled narrow-angle glaucoma, hypersensitivity to trospium or any component of the formulation."]
| Precautions | ["Angioedema, anaphylactic reactions, urinary retention, decreased GI motility, CNS effects (e.g., dizziness, confusion), exacerbation of narrow-angle glaucoma, heat prostration in hot environments."] |
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| Fetal Monitoring | Monitor maternal blood pressure, heart rate, and urinary retention due to anticholinergic effects. Assess fetal well-being via ultrasound if used during pregnancy. Monitor for signs of anticholinergic toxicity (e.g., constipation, blurred vision) in the mother. |
| Fertility Effects | In animal studies, trospium chloride administered to male and female rats at doses up to 200 mg/kg/day (approximately 10 times MRHD) did not impair fertility. No human data available. |