Trospium

Trospium
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Rabin Bista, M.B.B.S. [2]

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Overview

Trospium is a muscarinic antagonist that is FDA approved for the treatment of overactive bladder. Common adverse reactions include dry mouth, constipation, and headache.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Indications

• SANCTURA® is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.

Dosage

• The recommended dose is 20 mg twice daily. SANCTURA® should be dosed at least one hour before meals or given on an empty stomach.

Dosage modification is recommended in the following patient populations:

For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime [see Warnings and Precautions (5.5), Use in Specific Populations (8.6), and Clinical Pharmacology (12.3)]. In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability

DOSAGE FORMS AND STRENGTHS

• SANCTURA® is supplied as 20 mg tablets (brownish yellow, biconvex, glossy coated tablets printed with S in black ink)

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Trospium in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Trospium in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding FDA-Labeled Use of Trospium in pediatric patients.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Trospium in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Trospium in pediatric patients.

Contraindications

• SANCTURA® is contraindicated in patients with:

urinary retention gastric retention uncontrolled narrow-angle glaucoma. known hypersensitivity to the drug or its ingredients. Angioedema, rash and anaphylactic reaction have been reported.

Warnings

• 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 (4)].

5.2 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.

5.3 Decreased Gastrointestinal Motility SANCTURA® should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications (4)]. 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.

5.4 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 (4)].

5.5 Central Nervous System Effects SANCTURA® is associated with anticholinergic central nervous system (CNS) effects [see Adverse Reactions (6.2)]. 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.

5.6 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

Adverse Reactions

Clinical Trials Experience

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 safety of SANCTURA® was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with SANCTURA® (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, 12-week, U.S., efficacy and safety studies and a 9-month open-label extension. Of this total, 591 patients received SANCTURA® 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with SANCTURA® for at least 24 and 52 weeks, respectively.

In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving SANCTURA® 20 mg twice daily and 1.5% among patients receiving placebo. TABLE 1 lists adverse reactions from the combined 12-week U.S. safety and efficacy trials were reported by at least 1% of patients, and were reported more frequently in the SANCTURA® group than in the placebo group.

The two most common adverse reactions reported by patients receiving SANCTURA® 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse reaction for SANCTURA®, dry mouth, occurred in 20.1% of SANCTURA® treated patients and 5.8% of patients receiving placebo. In the two U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with SANCTURA® 20 mg twice daily. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

• Other adverse reactions from the U.S., placebo-controlled trials , occurring in greater than or equal to 0.5% and less than 1.0% of SANCTURA® treated patients, and more common with SANCTURA® than placebo are: tachycardia, vision blurred, abdominal distension, vomiting, dysgeusia, dry throat, and dry skin.

During controlled clinical studies, one adverse reaction of angioneurotic edema was reported.

Postmarketing Experience

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.

Drug Interactions

• Digoxin

Concomitant use of SANCTURA® and digoxin did not affect the pharmacokinetics of either drug [see Clinical Pharmacology (12.3)].

7.2 Drugs Eliminated by Active Tubular Secretion Although demonstrated in a drug-drug interaction study not to affect the pharmacokinetics of digoxin, SANCTURA® has the potential for pharmacokinetic interactions with other drugs that are eliminated by active tubular secretion (e.g., procainamide, pancuronium, morphine, vancomycin, and tenofovir). Coadministration of SANCTURA® with these drugs may increase the serum concentration of SANCTURA® and/or the coadministered drug due to competition for this elimination pathway. Careful patient monitoring is recommended in patients receiving such drugs [see Clinical Pharmacology (12.3)].

7.3 Antimuscarinic Agents The concomitant use of SANCTURA® with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic pharmacological effects may increase the frequency and/or severity of such effects. SANCTURA® may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility.

7.4 Metformin Co-administration of 500 mg metformin immediate release tablets twice daily with SANCTURA XR® (trospium chloride 60 mg extended release) reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC0-24 and by 34% for mean Cmax

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA):

• Pregnancy Category

Pregnancy Category (AUS):

• Australian Drug Evaluation Committee (ADEC) Pregnancy Category

There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Trospium in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Trospium during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Trospium with respect to nursing mothers.

Pediatric Use

There is no FDA guidance on the use of Trospium with respect to pediatric patients.

Geriatic Use

There is no FDA guidance on the use of Trospium with respect to geriatric patients.

Gender

There is no FDA guidance on the use of Trospium with respect to specific gender populations.

Race

There is no FDA guidance on the use of Trospium with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Trospium in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Trospium in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Trospium in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Trospium in patients who are immunocompromised.

Administration and Monitoring

Administration

• Oral

• Intravenous

Monitoring

There is limited information regarding Monitoring of Trospium in the drug label.

• Description

IV Compatibility

There is limited information regarding IV Compatibility of Trospium in the drug label.

Overdosage

Acute Overdose

Signs and Symptoms

• Description

Management

• Description

Chronic Overdose

There is limited information regarding Chronic Overdose of Trospium in the drug label.

Pharmacology

There is limited information regarding Trospium Pharmacology in the drug label.

Mechanism of Action

Structure

File:Trospium01.png

This image is provided by the National Library of Medicine.

Pharmacodynamics

There is limited information regarding Pharmacodynamics of Trospium in the drug label.

Pharmacokinetics

There is limited information regarding Pharmacokinetics of Trospium in the drug label.

Nonclinical Toxicology

There is limited information regarding Nonclinical Toxicology of Trospium in the drug label.

Clinical Studies

There is limited information regarding Clinical Studies of Trospium in the drug label.

How Supplied

Storage

There is limited information regarding Trospium Storage in the drug label.

Images

Drug Images

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Package and Label Display Panel

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Patient Counseling Information

There is limited information regarding Patient Counseling Information of Trospium in the drug label.

Precautions with Alcohol

• Alcohol-Trospium interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

• ®

Look-Alike Drug Names

• A® — B®

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.

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