Dosing and uses of Sanctura (trospium chloride)
Adult dosage forms and strengths
tablet
- 20mg
capsule, extended release
- 60mg
Overactive Bladder
Immediate release: 20 mg PO twice daily
Extended Release: 60 mg PO qDay
Renal Impairment
CrCl <30 mL/min: 20 mg immediate release PO qHS; extended release not recommended
Pediatric dosage forms and strengths
Safety and efficacy not established
Geriatric dosage forms and strengths
>75 years
Immediate release: May titrate down to 20 mg immediated release qDay based on tolerability
Extended release: 60 mg PO qDay
Sanctura (trospium chloride) adverse (side) effects
>10%
Dry mouth (20.1%)
1-10%
Constipation (9.6%)
Tachycardia (<2%)
Headache (4.2%)
Fatigue (1.9%)
Rash (<2%)
Dyspepsia (1-2%)
Abdominal pain (1-3%)
Abdominal distention (<2%)
Constipation (9-10%)
Dry eyes (1-2%)
Dyspepsia (1-2%)
Flatulence (1-2%)
Urinary retention (<1%)
Urinary tract infection (1-7%)
Nasopharyngitis (3%)
Nasal dryness (1%)
Postmarketing Reports
Gastrointestinal: Gastritis
Cardiovascular: Palpitations, supraventricular tachycardia, chest pain, syncope, hypertensive crisis
Immunological: Stevens-Johnson syndrome, anaphylactic reaction, angioedema
Nervous system: Dizziness, confusion, vision abnormal, hallucinations, somnolence and delirium
Skeletal system: Musculoskeletal: Rhabdomyolysis
Dermatology: Rash
Warnings
Contraindications
Urinary/gastric retention
Uncontrolled narrow-angle glaucoma
Hypersensitivity
Cautions
Controlled narrow-angle glaucoma
Renal impairment
Decreased GI motility
CNS anticholinergic effects reported including dizziness, confusion, hallucinations and somnolence
Geriatric patients
Pregnancy/lactation
Caution with moderate or severe hepatic dysfunction
Angioedema of the face, lips, tongue and/or larynx reported (including with 1st dose)
Pregnancy and lactation
Pregnancy category: C
Lactation: Excretion in mikl unknown; use with caution
Pregnancy categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.
C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.
D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.
X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.
NA: Information not available.
Pharmacology of Sanctura (trospium chloride)
Mechanism of action
Reduces the smooth muscle tone of the bladder by antagonizing the effects of acetyl choline on muscarinic receptors.
Pharmacokinetics
Absorption: <10%; reduced when administered with high-fat meaL
Half-life: 20 hr (immediate release)
Peak plasma time: 5-6 hr
Protein bound: 45-85%
Metabolism: Not fully elucidated; major pathway is thought to be ester hydrolysis followed by glucuronide conjugation of benzylic acid
Renal clearance: 29.07 L/hr
Excretion: Feces (85.2%); urine (5.8% with 60% unchanged drug)