Trospium Chloride 20 mg/1
Trospium Chloride · TABLET, FILM COATED · REMEDYREPACK INC.
Trospium chloride is an oral medication used to treat overactive bladder symptoms such as urge incontinence, urgency, and frequent urination. It works by relaxing bladder muscles to help improve bladder control.
Key Facts
- Brand Name
- Trospium Chloride
- Generic Name
- Trospium Chloride
- NDC Code (Product)
70518-4593- Manufacturer
- REMEDYREPACK INC.
- Strength
- 20 mg/1
- Dosage Form
- TABLET, FILM COATED
- Route
- ORAL
- Marketing Status
- Application #
- ANDA204945
- Marketing Start
- 03/23/2026
Recall History
Padagis US LLC
Failed Tablets/Capsules specifications; missing/broken/extra tablets within the capsules
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
1 INDICATIONS & USAGE Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Dosage & Administration
2 DOSAGE & ADMINISTRATION The recommended dose is 20 mg twice daily. Trospium chloride tablets 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 [ see Use in Specific Populations (8.5) ]. The recommended dose of trospium chloride tablets is one 20 mg tablet twice daily. Trospium chloride tablets should be dosed with water on an empty stomach, at least one hour before a meal. ( 2 ) For patients with severe renal impairment (creatinine clearance less than 30 mL/min), the recommended dose is 20 mg once daily at bedtime. ( 2 ) 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. ( 2 )
Contraindications
4 CONTRAINDICATIONS Trospium chloride tablets are 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. Trospium chloride tablets 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 ) patients with known hypersensitivity ( 4 )
Drug Interactions
7 DRUG INTERACTIONS Concomitant use with digoxin did not affect the pharmacokinetics of either drug. ( 7.1 ) Some drugs which are actively secreted by the kidney may interact with trospium chloride tablets by competing for renal tubular secretion. ( 7.2 ) Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. ( 7.4 ) 7.1 Digoxin Concomitant use of trospium chloride tablets 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, trospium chloride tablets 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 trospium chloride tablets with these drugs may increase the serum concentration of trospium chloride tablets and/or the coadministered drug due to competition for this elimination pathway. Careful patient monitoring is recommended in patients receiving such drugs [ see Clinical Phar…
Adverse Reactions
6 ADVERSE REACTIONS The most common adverse reactions (greater than or equal to 1%) with trospium chloride tablets are dry mouth (20.1%), constipation (9.6%), and headache (4.2%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Zameer Pharmaceuticals LLC at 1-888-851-7033 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 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 trospium chloride tablets was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with trospium chloride tablets (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 trospium chloride tablets 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with trospium chloride tablets for at least 24 an…
Frequently Asked Questions
What is Trospium Chloride used for?
Trospium chloride is an oral medication used to treat overactive bladder symptoms such as urge incontinence, urgency, and frequent urination. It works by relaxing bladder muscles to help improve bladder control.
Is Trospium Chloride a controlled substance?
Trospium Chloride is not classified as a controlled substance by the DEA.
What is the generic name for Trospium Chloride?
The generic name for Trospium Chloride is Trospium Chloride. There are 7 other brand versions of Trospium Chloride.
What is the NDC code for Trospium Chloride 20 mg/1?
The NDC (National Drug Code) for Trospium Chloride 20 mg/1 is 70518-4593, listed by REMEDYREPACK INC..