These highlights do not include all the information needed to use SANCTURA XR® safely and effectively. See full prescribing information for SANCTURA XR®.
SANCTURA XR® is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)
DOSAGE AND ADMINISTRATION
The recommended dosage of SANCTURA XR® is one 60 mg capsule daily in the morning. SANCTURA XR® should be dosed with water on an empty stomach, at least one hour before a meal (2)
SANCTURA XR® is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute) (2)
DOSAGE FORMS AND STRENGTHS
60 mg capsules (white opaque body and orange opaque cap, printed with SAN 60) (3)
CONTRAINDICATIONS
SANCTURA XR® is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma, and in patients who are at risk for these conditions. (4)
WARNINGS AND PRECAUTIONS
SANCTURA XR® should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention (5.1, 5.3)
Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride (5.2)
In patients with narrow angle glaucoma SANCTURA XR® should be used only with careful monitoring (5.4)
SANCTURA XR® is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute) (5.5)
Alcohol should not be consumed within 2 hours of SANCTURA XR® administration (5.6)
ADVERSE REACTIONS
The most common adverse reactions with SANCTURA XR® were dry mouth (10.7%) and constipation (8.5%) (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Allergan, Inc. at 1-800-433-8871 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
DRUG INTERACTIONS
Trospium is metabolized by ester hydrolysis and excreted by the kidneys through a combination of tubular secretion and glomerular filtration (7)
Some drugs which are actively secreted by the kidney may interact with SANCTURA XR® by competing for renal tubular secretion(7)
Concomitant use with digoxin did not affect the pharmacokinetics of either drug (7.1)
Exposure to trospium on average was comparable in the presence of and without antacid, however, some individuals demonstrated increases or decreases in trospium exposure in the presence of antacid. The clinical relevance of these findings is not known. (7.2)
Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium (7.3)
USE IN SPECIFIC POPULATIONS
PREGNANCY CATEGORY C
In post-parturition animal studies trospium chloride was excreted to a limited extent into the milk (8.3)
The safety and effectiveness of SANCTURA XR® in pediatric patients have not been established (8.4)
Caution is advised when SANCTURA XR® is used in patients with moderate to severe hepatic impairment (8.7)
See 17 for PATIENT COUNSELING INFORMATION and FDA-approved patient labeling
Revised: 09/2011
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FULL PRESCRIBING INFORMATION: CONTENTS*
* Sections or subsections omitted from the full prescribing information are not listed
1 INDICATIONS AND USAGE
2 DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Urinary Retention
5.2 Angioedema
5.3 Decreased Gastrointestinal Motility
5.4 Controlled Narrow-angle Glaucoma
5.5 Patients with Severe Renal Impairment
5.6 Alcohol Interaction
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
6.2 Post-marketing Experience
7 DRUG INTERACTIONS
7.1 Digoxin
7.2 Antacid
7.3 Metformin
8 USE IN SPECIFIC POPULATIONS
8.1 Pregnancy
8.2 Labor and Delivery
8.3 Nursing Mothers
8.4 Pediatric Use
8.5 Geriatric Use
8.6 Renal Impairment
8.7 Hepatic Impairment
10 OVERDOSAGE
11 DESCRIPTION
12 CLINICAL PHARMACOLOGY
12.1 Mechanism of Action
12.2 Pharmacodynamics
12.3 Pharmacokinetics
13 NONCLINICAL TOXICOLOGY
13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility
14 CLINICAL STUDIES
16 HOW SUPPLIED/STORAGE AND HANDLING
17 PATIENT COUNSELING INFORMATION
FULL PRESCRIBING INFORMATION
1 INDICATIONS AND USAGE
SANCTURA XR® is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
2 DOSAGE AND ADMINISTRATION
The recommended dosage of SANCTURA XR® is one 60 mg capsule daily in the morning. SANCTURA XR® capsules should be dosed with water on an empty stomach, at least one hour before a meal.
SANCTURA XR® is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute) (see Warnings and Precautions (5), Use in Specific Populations (8), and Clinical Pharmacology (12)).
3 DOSAGE FORMS AND STRENGTHS
SANCTURA XR® is supplied as 60 mg capsules (white opaque body and orange opaque cap, printed with SAN 60).
4 CONTRAINDICATIONS
SANCTURA XR® is contraindicated in patients with urinary retention, gastric retention, or uncontrolled narrow-angle glaucoma and in patients who are at risk for these conditions. SANCTURA XR® is also contraindicated in patients who have demonstrated hypersensitivity to the drug or any of its ingredients.
5 WARNINGS AND PRECAUTIONS
5.1 Risk of Urinary Retention
SANCTURA XR® capsules should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention (see Contraindications (4)).
5.2 Angioedema
Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, trospium chloride should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.
5.3 Decreased Gastrointestinal Motility
SANCTURA XR® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention. SANCTURA XR®, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis (see Contraindications (4)).
5.4 Controlled Narrow-angle Glaucoma
In patients being treated for narrow-angle glaucoma, SANCTURA XR® should only be used if the potential benefits outweigh the risks, and in that circumstance only with careful monitoring (see Contraindications (4)).
5.5 Patients with Severe Renal Impairment
SANCTURA XR® is not recommended for use in patients with severe renal impairment (creatinine clearance < 30 mL/minute) (see Dosage and Administration (2), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)).
5.6 Alcohol Interaction
Alcohol should not be consumed within 2 hours of SANCTURA XR® administration. In addition, patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.
6 ADVERSE REACTIONS
6.1 Clinical Trials Experience
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=1165). These studies included overactive bladder patients of ages 21 to 90 years, of which 86% were female and 85% were Caucasian. Patients received 60mg 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
