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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 (%)|
| SANCTURA XR®
|Dry mouth||22 (3.7)||62 (10.7)|
|Dry eye||1 (0.2)||9(1.6)|
|Abdominal pain||2 (0.3)||8(1.4)|
|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 (%)|
| SANCTURA XR®
|Dry mouth||22 (3.7)||64(11.1)|
|Urinary tract infection||29 (4.9)||42 (7.3)|
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.
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 XR (trospium chloride extended release capsule) Side Effects Center for a complete guide to possible side effects
Trospium is metabolized by ester hydrolysis and excreted by the kidneys through a combination of tubular secretion and glomerular filtration. Based on in vitro data, no clinically relevant metabolic drug-drug interactions are anticipated with SANCTURA XR®. However, some drugs which are actively secreted by the kidney may interact with SANCTURA XR® by competing for renal tubular secretion.
The concomitant use of SANCTURA XR® with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic effects may increase the frequency and/or severity of such effects. SANCTURA XR® may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.
Concomitant use of trospium chloride 20mg twice daily and digoxin did not affect the pharmacokinetics of either drug [see CLINICAL PHARMACOLOGY].
While the systemic exposure of trospium on average was comparable with and without antacid containing aluminum hydroxide and magnesium carbonate, 5 out of 11 individuals in a drug interaction study demonstrated either an increase or decrease in trospium exposure, in presence of antacid. The clinical relevance of these findings is not known [see CLINICAL PHARMACOLOGY].
Co-administration of 500 mg metformin immediate release tablets twice daily reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC(0-24) and by 34% for mean Cmax. The effect of a decrease in trospium exposure on the efficacy of SANCTURA XR® is unknown. The steady-state pharmacokinetics of metformin were comparable when administered with or without 60 mg SANCTURA XR® once daily under fasted condition. The effect of metformin at higher doses on trospium PK is unknown [see CLINICAL PHARMACOLOGY].
Read the Sanctura XR Drug Interactions Center for a complete guide to possible interactions
Last reviewed on RxList: 9/27/2012
This monograph has been modified to include the generic and brand name in many instances.
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