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Sanctura XR

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Sanctura XR

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

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].

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.

Decreased Gastrointestinal Motility

SANCTURA XR® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see CONTRAINDICATIONS]. 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 .

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].

Central Nervous System Effects

SANCTURA XR® and SANCTURA® are associated with anticholinergic central nervous system (CNS) effects [see ADVERSE REACTIONS]. A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how SANCTURA XR ® affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

Patients with Severe Renal Impairment

SANCTURA XR® is not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see DOSAGE AND ADMINISTRATION, Use in Specific Populations, and CLINICAL PHARMACOLOGY].

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.

Patient Counseling Information

"See FDA-approved Patient Labeling (PATIENT INFORMATION) "

Angioedema

Patients should be informed that SANCTURA XR® may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue SANCTURA XR® therapy and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing.

When Not to Use

Prior to treatment, patients should fully understand the risks and benefits of SANCTURA XR®. In particular, patients should be informed not to take SANCTURA XR® capsules if they:

  • have urinary retention;
  • gastric retention;
  • uncontrolled narrow-angle glaucoma;
  • are allergic to any component of SANCTURA XR®.

Administration

Patients should be instructed regarding the recommended dosing and administration of SANCTURA XR®:

  • Take one SANCTURA XR® capsule daily in the morning with water.
  • Take SANCTURA XR® on an empty stomach or at least 1 hour before a meal.
  • Use of alcoholic beverages within 2 hours of dosing with SANCTURA XR® is not recommended.

Adverse Reactions

Patients should be informed that the most common side effects with SANCTURA XR® are dry mouth and constipation and that other less common side effects include trouble emptying the bladder, blurred vision, and heat prostration. Because anticholinergics, such as SANCTURA XR®, may produce dizziness or blurred vision, patients should be advised to exercise caution in decisions to engage in potentially dangerous activities until the drug's effects have been determined. Patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.

Nonclinical Toxicology

Carcinogenesis, Mutagenesis, Impairment of Fertility

Carcinogenesis: Carcinogenicity studies with trospium chloride were conducted in mice and rats for 78 weeks and 104 weeks, respectively, at maximally tolerated doses. No evidence of a carcinogenic effect was found in either mice or rats administered up to 200 mg/kg/day (approximately 1 and 16 times, respectively (based on AUC), the expected clinical exposure levels at the maximum recommended human dose (MRHD) of 60 mg.

Mutagenesis: Trospium chloride was not mutagenic nor genotoxic in tests in vitro in bacteria (Ames test) and mammalian cells (L5178Y mouse lymphoma and CHO cells) or in vivo in the mouse micronucleus test.

Impairment of Fertility: No evidence of impaired fertility was observed in rats administered doses up to 200 mg/kg/day (about 16 times the expected clinical exposure at the MRHD, based on AUC).

Use In Specific Populations

Pregnancy

Teratogenic Effects

Pregnancy Category C: There are no adequate and well-controlled studies of SANCTURA XR® in pregnant women. SANCTURA XR® should be used during pregnancy only if the potential benefit to the patient outweighs the risk to the patient and fetus. Women who become pregnant during SANCTURA XR® treatment are encouraged to contact their physician.

Trospium chloride was not teratogenic at statistically significant levels in rats or rabbits administered doses up to 200 mg/kg/day. This corresponds to systemic exposures up to approximately 16 and 32 times, respectively (based on AUC), the clinical exposure at the maximum recommended human dose (MRHD) of 60 mg. However, in rabbits, one fetus in each of the three treated dose groups (1, 1, and 32 times the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A no effect level for maternal and fetal toxicity was observed at levels approximately equivalent to the clinical exposure at the MRHD (20 mg/kg/day in rats and rabbits). No developmental toxicity was observed in the offspring of female rats exposed pre- and post-natally to up to 200 mg/kg/day.

Labor and Delivery

The effect of SANCTURA XR capsules on labor and delivery is unknown.

Nursing Mothers

Trospium chloride (2 mg/kg orally and 50 mcg/kg intravenously) was excreted, to a limited extent (less than 1%), into the milk of lactating rats (primarily as parent compound). It is not known whether this drug is excreted into human milk. Because many drugs are excreted into human milk, SANCTURA XR® should be used during lactation only if the potential benefit justifies the potential risk.

Pediatric Use

The safety and effectiveness of SANCTURA XR® in pediatric patients have not been established.

Geriatric Use

Of 1165 patients in Phase 3 clinical studies of SANCTURA XR®, 37% (n=428) were ages 65 and over, while 12% (n=143) were ages 75 and over.

No overall differences in effectiveness were observed between those subjects aged 65 and over and younger subjects. In SANCTURA XR® subjects ages 65 and over compared to younger subjects, the following adverse reactions were reported at a higher incidence: dry mouth, constipation, abdominal pain, dyspepsia, urinary tract infection and urinary retention. In subjects ages 75 and over, three reported a fall and in one of them a relationship to the event could not be excluded.

Renal Impairment

Severe renal impairment (creatinine clearance less than 30 mL/minute) may significantly alter the disposition of SANCTURA XR®. In a study of immediate-release trospium chloride, 4.2-fold and 1.8-fold increases in mean AUC(0-∞) and Cmax, respectively, were detected in patients with severe renal impairment. Use of SANCTURA XR® is not recommended in patients with severe renal impairment [see WARNINGS AND PRECAUTIONS and CLINICAL PHARMACOLOGY]. The pharmacokinetics of trospium chloride have not been studied in patients with creatinine clearance ranging from 30-80 mL/min.

Trospium is known to be substantially excreted by the kidney, and the risk of adverse reactions may be greater in patients with impaired renal function.

Hepatic Impairment

There is no information regarding the effect of severe hepatic impairment on exposure to SANCTURA XR®. In a study of patients with mild and with moderate hepatic impairment, given 40 mg of immediate-release trospium chloride, mean Cmax increased 12% and 63%, respectively, and mean AUQo-oo) decreased 5% and 15%, respectively, compared to healthy subjects. The clinical significance of these findings is unknown. Caution is advised, however, when administering SANCTURA XR® to patients with moderate to severe hepatic impairment.

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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