TM Owner Allergan / AbbVie
Sanctura XR 60mg Capsule
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Indications & Clinical Uses
- The Sanctura XR brand of trospium chloride 60 mg extended-release capsules has been discontinued in the United States (per Drugs.com; generic trospium chloride extended-release capsules remain FDA-approved and available).
- Trospium chloride is an anticholinergic (antimuscarinic) medicine approved for the treatment of overactive bladder in adults, to reduce urge urinary incontinence, urgency and urinary frequency, by relaxing the bladder muscle and reducing involuntary contractions.
- It was taken by mouth once daily and was not approved for children.
- It should not be used by anyone with urinary retention, gastric retention or uncontrolled narrow-angle glaucoma.
- The related immediate-release trospium chloride tablet (Sanctura), taken twice daily, is a separate, distinct product and the two are not interchangeable dose-for-dose.
Side Effects
- The most common side effects reported with trospium chloride extended-release capsules were dry mouth (about 1 in 10 people) and constipation (under 1 in 10); dry eyes, gas, stomach upset, dizziness, blurred vision, drowsiness and headache were also reported.
- There is no boxed warning on the trospium chloride label.
- It can rarely cause angioedema — swelling of the face, lips, tongue or throat that can become life-threatening — needing emergency care and permanent discontinuation.
- It can also cause urinary retention, particularly in men with bladder outlet obstruction, and may slow bowel movement in people with reduced gut motility.
- Because it can cause dizziness or blurred vision, avoid driving until you know how it affects you.
- Seek urgent help for facial or throat swelling, or inability to pass urine.
Precautions & Warnings
- Trospium chloride extended-release capsules should not be used by anyone with urinary retention, gastric retention or delayed gastric emptying, or uncontrolled narrow-angle glaucoma, and should be used cautiously with controlled narrow-angle glaucoma, reduced gastrointestinal motility, or significant bladder outlet obstruction.
- It is not recommended in severe renal impairment (creatinine clearance below 30 mL/minute) or severe hepatic impairment, and a lower dose is advised in moderate renal impairment.
- Being an anticholinergic, it may reduce sweating and cause heat prostration in hot environments, and can impair the ability to drive or operate machinery until its effects are known.
- Safety in pregnancy and breastfeeding has not been established.
- The capsule must be swallowed whole on an empty stomach, at least one hour before a meal, and must not be crushed, split or chewed.
Avoid Interactions
- Trospium should not be combined with other anticholinergic medicines, since this increases the risk of dry mouth, constipation, blurred vision and urinary retention.
- Alcohol should not be taken within two hours of a dose, as it can add to central nervous system effects such as drowsiness.
- Because trospium is cleared largely unchanged by the kidneys, it can compete with other drugs eliminated by active renal tubular secretion, including metformin, digoxin, procainamide, pancuronium and vancomycin, so levels of these may need monitoring.
- Taking a dose with a high-fat meal cuts absorption significantly, so it should always be taken on an empty stomach.
- Tell your healthcare provider about every prescription medicine, over-the-counter product and herbal supplement you use before starting trospium chloride.
References
Frequently Asked Questions
Sanctura XR (trospium chloride) is an anticholinergic medicine approved for overactive bladder in adults, reducing urgency, frequency and urge incontinence. Note: the Sanctura XR brand has been discontinued in the US, though generic trospium chloride extended-release capsules remain available. It works by relaxing the bladder muscle to calm involuntary contractions.
Sanctura XR is one 60 mg capsule swallowed whole, once daily in the morning, on an empty stomach at least one hour before food. Do not crush or chew it. It should not be combined with other anticholinergic bladder medicines without medical advice.
The most common side effects are dry mouth and constipation, along with dry eyes, gas, dizziness and headache. Rarely, trospium can cause angioedema — sudden swelling of the face, lips, tongue or throat — a medical emergency requiring immediate care and stopping the drug.
Avoid alcohol within two hours of a dose, since it can add to drowsiness. Avoid combining Sanctura XR with other anticholinergic medicines, which raises the risk of dry mouth, constipation and urinary retention. Take it on an empty stomach, since fatty food reduces absorption.
Skip a missed dose of Sanctura XR and take the next one at your usual time the next day; do not take two capsules together. Sanctura XR (trospium chloride) is meant for once-daily dosing, always on an empty stomach in the morning.
Sanctura XR can be used long term for chronic overactive bladder under medical supervision, but it is not approved for children. Safety in pregnancy and breastfeeding has not been established, so tell your healthcare provider if you are pregnant, planning pregnancy, or breastfeeding.
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