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Sanctura

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Sanctura

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 Sanctura (trospium chloride tablets) Side Effects Center for a complete guide to possible side effects

DRUG INTERACTIONS

Digoxin

Concomitant use of SANCTURA® and digoxin did not affect the pharmacokinetics of either drug [see CLINICAL PHARMACOLOGY].

Drugs Eliminated by Active Tubular Secretion

Although demonstrated in a drug-drug interaction study not to affect the pharmacokinetics of digoxin, SANCTURA® has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). Coadministration of SANCTURA® with these drugs may increase the serum concentration of SANCTURA® and/or the coadministered drug due to competition for this elimination pathway. Careful patient monitoring is recommended in patients receiving such drugs [see CLINICAL PHARMACOLOGY].

Antimuscarinic Agents

The concomitant use of SANCTURA® with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. SANCTURA® may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.

Metformin

Co-administration of 500 mg metformin immediate release tablets twice daily with SANCTURA XR® (trospium chloride 60 mg extended release) reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC0-24 and by 34% for mean Cmax [see CLINICAL PHARMACOLOGY].

Read the Sanctura Drug Interactions Center for a complete guide to possible interactions

Last reviewed on RxList: 8/6/2012
This monograph has been modified to include the generic and brand name in many instances.

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Sanctura - User Reviews

Sanctura User Reviews

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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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