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Sanctura XR

"April 9, 2012 -- Drugs that treat incontinence caused by an overactive bladder offer modest benefits to some women, and they often come with significant side effects, a new review of research shows.

The government-funded review compar"...

Sanctura XR

Sanctura XR Side Effects Center

Medical Editor: John P. Cunha, DO, FACOEP

Sanctura XR (trospium chloride) is used to treat overactive bladder and symptoms of urinary incontinence, frequency, and urgency. It is a muscarinic antagonist that relieves spasms of the bladder. Common side effects include dry mouth, constipation, stomach upset, dry eyes, dry nose, dizziness, blurred vision, or drowsiness.

The recommended dosage of Sanctura XR is one 60 mg capsule daily in the morning, taken with water on an empty stomach, at least one hour before a meal. Sanctura XR may interact with atropine, dicyclomine, glycopyrrolate, hyoscyamine, mepenzolate, metformin, methscopolamine, morphine, procainamide, propantheline, scopolamine, tenofovir, or vancomycin. Tell your doctor all medications and supplements you use. During pregnancy, Sanctura XR should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Our Sanctura XR (trospium chloride) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is Patient Information in Detail?

Easy-to-read and understand detailed drug information and pill images for the patient or caregiver from Cerner Multum.

Sanctura XR in Detail - Patient Information: Side Effects

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using trospium and call your doctor at once if you have a serious side effect such as:

  • severe stomach pain or bloating;
  • severe constipation;
  • urinating less than usual or not at all; or
  • confusion, hallucinations.

Less serious side effects may include:

  • dry mouth or throat;
  • headache;
  • mild constipation;
  • upset stomach, gas;
  • dizziness, drowsiness, or
  • dry eyes.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the entire detailed patient monograph for Sanctura XR (Trospium Chloride Extended Release Capsule) »

What is Patient Information Overview?

A concise overview of the drug for the patient or caregiver from First DataBank.

Sanctura XR Overview - Patient Information: Side Effects

SIDE EFFECTS: Dry mouth, constipation, stomach upset, dry eyes, dry nose, dizziness, blurred vision, or drowsiness may occur. If any of these effects persist or worsen, tell your doctor or pharmacist promptly.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor immediately if any of these unlikely but serious side effects occur: eye pain, difficulty urinating, fast heartbeat, mental/mood changes (such as hallucinations, confusion).

A very serious allergic reaction to this drug is rare. However, seek immediate medical attention if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Read the entire patient information overview for Sanctura XR (Trospium Chloride Extended Release Capsule)»

What is Prescribing information?

The FDA package insert formatted in easy-to-find categories for health professionals and clinicians.

Sanctura XR FDA Prescribing Information: Side Effects
(Adverse Reactions)

SIDE EFFECTS

Clinical Trials Experience

Because clinical trials are conducted under widely varying conditions, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The data described below reflect exposure to SANCTURA XR® capsules in 578 patients for 12 weeks in two Phase 3 double-blind, placebo controlled trials (n=l 165). These studies included overactive bladder patients of ages 21 to 90 years, of which 86% were female and 85% were Caucasian. Patients received 60 mg daily doses of SANCTURA XR®. Patients in these studies were eligible to continue treatment with SANCTURA XR® 60 mg for up to one year. From both these controlled trials combined, 769 and 238 patients received treatment with SANCTURA XR® for at least 24 and 52 weeks, respectively.

There were 157 (27.2%) SANCTURA XR® patients and 98 (16.7%) placebo patients who experienced one or more double-blind treatment-emergent adverse events (TEAEs) that were assessed by the investigator as at least possibly related to study medication. The most common TEAEs were dry mouth and constipation which, when reported, commonly occurred early in treatment (often within the first week). In the two Phase 3 studies, constipation, dry mouth, and urinary retention led to discontinuation in 1%, 0.7%, and 0.5% of patients treated with SANCTURA XR® 60 mg daily, respectively. In the placebo group, there were no discontinuations due to dry mouth or urinary retention and one due to constipation.

The incidence of serious adverse events was similar among patients receiving SANCTURA XR® and patients receiving placebo. No treatment-emergent serious adverse events in either treatment group were judged by the investigators as being possibly related to the study medication.

Table 1 lists those treatment emergent adverse events from the trials that were assessed by the investigator as possibly related to study medication, reported in at least 1% of SANCTURA XR® patients, and were more common for the SANCTURA XR® group than for placebo.

Table 1: Incidence of treatment-emergent adverse events reported in at least 1% of patients judged by the investigator as at least possibly related to treatment and more common for the SANCTURA XR® group than for placebo

MedDRA Preferred term Number of patients (%)
Placebo
N=587
SANCTURA XR®
N=578
Dry mouth 22 (3.7) 62 (10.7)
Constipation 9(1.5) 49 (8.5)
Dry eye 1 (0.2) 9(1.6)
Flatulence 3 (0.5) 9(1.6)
Nausea 2 (0.3) 8(1.4)
Abdominal pain 2 (0.3) 8(1.4)
Dyspepsia 4(0.7) 7(1.2)
Urinary tract infection 5 (0.9) 7(1.2)
Constipation aggravated 3 (0.5) 7(1.2)
Abdominal distension 2 (0.3) 6(1.0)
Nasal dryness 0 (0.0) 6(1.0)

Additional adverse events reported in less than 1% of SANCTURA XR® treated patients and more common for SANCTURA XR® than placebo, judged by the investigator at least possibly related to treatment were: vision blurred, feces hard, back pain, somnolence, urinary retention, and dry skin.

Table 2 lists all treatment-emergent adverse events for the trials reported in at least 2% of all SANCTURA XR® patients and more common for the SANCTURA XR® group than for placebo without regard to the investigator's judgment on drug relatedness.

Table 2: Incidence of treatment-emergent adverse events reported in at least 2% of patients regardless of reported relationship to treatment and more common for the SANCTURA XR® group than for placebo

MedDRA Preferred term Number of patients (%)
Placebo
N=587
SANCTURA XR®
N=578
Dry mouth 22 (3.7) 64(11.1)
Constipation 10(1.7) 52 (9.0)
Urinary tract infection 29 (4.9) 42 (7.3)
Nasopharyngitis 10(1.7) 17 (2.9)
Influenza 9(1.5) 13 (2.2)

Additional adverse events reported in less than 2% of SANCTURA XR® treated patients and twice as frequent for SANCTURA XR® compared to placebo, regardless of reported relationship to treatment were: tachycardia, dry eyes, abdominal pain, dyspepsia, abdominal distension, constipation aggravated, nasal dryness, and rash.

In the open-label treatment phase, the most common TEAEs reported in the 769 patients with at least 6 months exposure to SANCTURA XR® were: constipation, and dry mouth. Urinary tract infection and rash was also reported in several patients, including one of each judged by the investigator to be possibly related to treatment. Several adverse events were reported as severe in the open-label treatment phase, including one urinary tract infection, two urinary retention events, and one aggravated constipation.

Post-marketing Experience

The following adverse reactions have been identified during post-approval use of trospium chloride. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

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; Musculoskeletal - rhabdomyolysis; General - rash.

Read the entire FDA prescribing information for Sanctura XR (Trospium Chloride Extended Release Capsule) »

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Sanctura XR - User Reviews

Sanctura XR User Reviews

Now you can gain knowledge and insight about a drug treatment with Patient Discussions.

Here is a collection of user reviews for the medication Sanctura XR sorted by most helpful. Patient Discussions FAQs

Report Problems to the Food and Drug Administration

 

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.


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