Trospium chloride is the generic equivalent of the brand-name drug Trospium Chloride. Licensed pharmacies, clinics, doctor's offices, and veterinary practices can source wholesale Trospium chloride through Premier Pharma with same-day fulfillment on in-stock SKUs.
FDA Drug Information
Indications & Usage
1 INDICATIONS AND USAGE Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. ( 1 )
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 Cipla Ltd. at 1-866-604-3268 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 direc…
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…
Dosage & Administration
2 DOSAGE AND 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 ) ]…
Patient Counseling Information
17 PATIENT COUNSELING INFORMATION “See FDA-approved Patient Labeling (Patient Information)” 17.1 Angioedema Patients should be informed that trospium chloride, the active ingredient in trospium chloride tablets, may produce angioedema which could result in life-threatening airway obstruction. Patients should be advised to promptly discontinue trospium chloride tablets and seek immediate medical attention if they experience edema of the tongue, edema of the laryngopharynx, or difficulty breathing. 17.2 When Not to Use Prior to treatment, patients should fully understand the risks and benefits o…
Source: FDA. For professional use only. Not a substitute for prescribing information.
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