Sanctura

Sanctura (trospium chloride) is a muscarinic antagonist, which relieves spasms of the bladder, used to treat overactive bladder and symptoms of urinary incontinence, frequency, and urgency. Sanctura is available in generic form. Common side effects of Sanctura include:

• dry mouth or throat,
• constipation,
• stomach upset,
• gas,
• headache,
• dry eyes,
• dizziness,
• blurred vision, or
• drowsiness.

Tell your doctor if you have unlikely but serious side effects of Sanctura including:

• eye pain,
• difficulty urinating,
• fast heartbeat, or
• mental/mood changes (such as hallucinations, confusion).

The recommended dose of Sanctura is 20 mg twice daily, taken at least one hour before meals or on an empty stomach. Sanctura may interact with atropine, dicyclomine, glycopyrrolate, hyoscyamine, mepenzolate, metformin, methscopolamine, morphine, procainamide, propantheline, scopolamine, tenofovir, or vancomycin. Tell your doctor all medications you use. During pregnancy, Sanctura should be used only when prescribed. It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

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

 

Sanctura Consumer Information

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 (Trospium Chloride Tablets)

 

Sanctura Professional Information

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 safety of SANCTURA® was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with SANCTURA® (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, 12-week, U.S., efficacy and safety studies and a 9-month open-label extension. Of this total, 591 patients received SANCTURA® 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with SANCTURA® for at least 24 and 52 weeks, respectively.

In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving SANCTURA® 20 mg twice daily and 1.5% among patients receiving placebo. Table 1 lists adverse reactions from the combined 12-week U.S. safety and efficacy trials were reported by at least 1% of patients, and were reported more frequently in the SANCTURA® group than in the placebo group.

The two most common adverse reactions reported by patients receiving SANCTURA® 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse reaction for SANCTURA®, dry mouth, occurred in 20.1% of SANCTURA® treated patients and 5.8% of patients receiving placebo. In the two U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with SANCTURA® 20 mg twice daily. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

Table 1: Incidence (%) of adverse reactions with SANCTURA®, reported in greater than or equal to 1% of all patients treated with SANCTURA® and more frequent with SANCTURA® (20 mg twice daily) than placebo in Studies 1 and 2 combined

Adverse Reaction	Placebo (N=590)	SANCTURA® 20 mg twice daily (N=591)
Gastrointestinal Disorders
Dry mouth	34 ( 5.8)	119 (20.1)
Constipation	27 (4.6)	57 (9.6)
Abdominal pain upper	7 (1.2)	9 (1.5)
Constipation aggravated	5 (0.8)	8 (1.4)
Dyspepsia	2 (0.3)	7 (1.2)
Flatulence	5 (0.8)	7 (1.2)
Nervous System Disorders
Headache	12 (2.0)	25 (4.2)
General Disorders
Fatigue	8 (1.4)	11 (1.9)
Renal and Urinary Disorders
Urinary retention	2 (0.3)	7 (1.2)
Eye Disorders
Dry eyes	2 (0.3)	7 (1.2)

Other adverse reactions from the U.S., placebo-controlled trials , occurring in greater than or equal to 0.5% and less than 1.0% of SANCTURA® treated patients, and more common with SANCTURA® than placebo are: tachycardia , vision blurred, abdominal distension, vomiting, dysgeusia, dry throat, and dry skin.

During controlled clinical studies, one adverse reaction of angioneurotic edema was reported.

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 (Trospium Chloride Tablets)