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Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. In one case, angioedema occurred after the first dose. 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.

General

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.

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 anticholinergic drugs, 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.

Patients with Renal Impairment

Dose modification is recommended in patients with severe renal impairment (creatinine clearance < 30 mL/min). In such patients, SANCTURA® should be administered as 20 mg once a day at bedtime (See DOSAGE AND ADMINISTRATION).

Patients with Hepatic Impairment

Caution should be used when administering SANCTURA® in patients with moderate or severe hepatic impairment (See CLINICAL PHARMACOLOGY: Pharmacokinetics in Specific Populations).

Carcinogenesis, Mutagenesis, Impairment of Fertility

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.

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.

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)

Pregnancy

Teratogenic Effects

Pregnancy Category C: There are no adequate and well-controlled studies of SANCTURA® in pregnant women.

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 9 and 16 times, respectively (based on AUC), the clinical exposure at the maximum recommended human dose (MRHD) of 40 mg. However, in rabbits, one fetus in each of the three treated dose groups (0.5, 0.3, and 16 times the exposures at the MRHD) demonstrated multiple malformations, including umbilical hernia and skeletal malformations. A no effect level (20 mg/kg/day in rats and rabbits) for maternal and fetal toxicity was observed at levels approximately equivalent to the clinical exposure at the MRHD. No developmental toxicity was observed in the offspring of female rats exposed pre- and post-natally to up to 200 mg/kg/day. SANCTURA® should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

Trospium chloride (2 mg/kg PO and 50 μg/kg IV) was excreted, to a limited extent ( < 1%), into the milk of lactating rats (primarily parent compound). It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when SANCTURA® is administered to a nursing woman. 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 ≥ 75 years of age.

In these 2 studies, the incidence of commonly reported anticholinergic adverse events in patients treated with SANCTURA® (including dry mouth, constipation, dyspepsia, UTI, 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: Pharmacokinetics in Special Populations and DOSAGE AND ADMINISTRATION). 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.

Last reviewed on RxList: 9/30/2011
This monograph has been modified to include the generic and brand name in many instances.