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Sanctura

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Sanctura

WARNINGS

Included as part of the PRECAUTIONS section.

PRECAUTIONS

Risk of Urinary Retention

SANCTURA® 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, the active ingredient in SANCTURA®. 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, SANCTURA® should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

Decreased Gastrointestinal Motility

SANCTURA® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see CONTRAINDICATIONS]. SANCTURA®, 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® 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® is 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® affects them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

Anticholinergic Adverse Reactions in Patients with Moderate Renal Impairment

Trospium is substantially excreted by the kidney. The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased. Therefore, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate renal impairment [see DOSAGE AND ADMINISTRATION, and Use in Specific Populations].

Patient Counseling Information

“See FDA-approved Patient Labeling (PATIENT INFORMATION)

Angioedema

Patients should be informed that trospium chloride, the active ingredient in SANCTURA®, may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue SANCTURA® 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®. In particular, patients should be informed not to take SANCTURA® tablets if they:

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

Administration

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

  • Take one SANCTURA® tablet twice daily with water.
  • Take SANCTURA® on an empty stomach or at least 1 hour before a meal.

Adverse Reactions

Patients should be informed that the most common side effects with SANCTURA® 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®, 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 9 times the expected clinical exposure levels at the maximum recommended human dose (MRHD) of 40 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 rat 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® in pregnant women. SANCTURA® 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® treatment are encouraged to contact their physician.

Risk Summary

Based on animal data, trospium chloride is predicted to have a low probability of increased risk of adverse developmental outcomes, above background risk. Adverse developmental findings were not observed to correlate with dose in rats or in rabbits. No increased risk above background was observed in rats and rabbits treated at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg.

Animal Data

In a rat embryo/fetal development study, pregnant rats received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate, with maternal systemic exposures corresponding to approximately nine times the exposure of women treated at the MRHD of 40 mg, based on AUC. No malformations or fetal toxicity were observed.

The offspring of female rats exposed orally, pre-and post-natally, to trospium chloride up to 200 mg/kg/day showed no increased developmental toxicity over background in surviving pups. However, maternal toxicity (death, irregular breathing, increased excitability) was observed at 200 mg/kg/day. A no-effect level for maternal and pup toxicity (survival to Day 4) was 20 mg/kg/day, an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg.

In a rabbit embryo/fetal development study, pregnant rabbits received doses of trospium chloride up to 200 mg/kg/day, from implantation to closure of the fetal hard palate. At 200 mg/kg/day, maternal systemic exposures corresponded to approximately 16 times the exposure of women treated at the MRHD of 40 mg, based on AUC. However, one fetus in each of the three treated dose groups (0.3 to 16 times exposures at the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A maternal no-effect level was set at 20 mg/kg/day, at an exposure approximately equivalent to the maximal recommended human dose (MRHD) of 40 mg, due to clinical signs (reduced feces, hunched posture, diarrhea) observed in a pharmacokinetic study at 200 mg/kg/day.

Labor and Delivery

The effect of SANCTURA® tablets 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 in human milk. Because many drugs are excreted in human milk, SANCTURA® should be used during lactation only if the potential benefit justifies the potential risk to the newborn.

Pediatric Use

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

Geriatric Use

Of the 591 patients with overactive bladder who received treatment with SANCTURA® in the two U.S., placebo-controlled, efficacy and safety studies, 249 patients (42%) were 65 years of age and older. Eighty-eight SANCTURA® treated patients (15%) were greater than or equal to 75 years of age.

In these 2 studies, the incidence of commonly reported anticholinergic adverse reactions in patients treated with SANCTURA® (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) was higher in patients 75 years of age and older as compared to younger patients. This effect may be related to an enhanced sensitivity to anticholinergic agents in this patient population [see CLINICAL PHARMACOLOGY]. Therefore, based upon tolerability, the dose frequency of SANCTURA® may be reduced to 20 mg once daily in patients 75 years of age and older.

Renal Impairment

Severe renal impairment (creatinine clearance less than 30 mL/minute) significantly altered the disposition of SANCTURA®. A 4.2-fold and 1.8-fold increase in mean AUC(0-∞) and Cmax, respectively, and the appearance of an additional elimination phase with a long half-life (~33 hr) were detected in patients with severe renal impairment compared with nearly age-matched subjects with creatinine clearance equal to or higher than 80 mL/min. The different pharmacokinetic behavior of SANCTURA® in patients with severe renal impairment necessitates adjustment of dosage frequency [see DOSAGE AND ADMINISTRATION]. The pharmacokinetics of trospium 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®. 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 AUC(0-∞) decreased 5% and 15%, respectively, compared to healthy subjects. The clinical significance of these findings is unknown. Caution should be used when administering SANCTURA® to patients with moderate and severe hepatic impairment.

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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