Trospium Chloride
Generic: TROSPIUM CHLORIDE
Basic Information
Manufacturer
REMEDYREPACK INC.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
ORAL
FDA Set ID
48d1b484-ee0a-4d66-9b45-4ba34e65ed13
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 )
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 are dry mouth (20.1%), constipation (9.6%), and headache (4.2%).
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc.
at 1-866-901-DRUG (3784) 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 was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with trospium chloride (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 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 trospium chloride tablets 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 trospium chloride group than in the placebo group.
The two most common adverse reactions reported by patients receiving trospium chloride tablets 20 mg twice daily were dry mouth and constipation.
The single most frequently reported adverse reaction for trospium chloride tablets, dry mouth, occurred in 20.1% of trospium chloride 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 trospium chloride tablets 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.
Table 1.
Incidence (%) of adverse reactions with trospium chloride, reported in greater than or equal to 1% of all patients treated with trospium chloride tablets and more frequent with trospium chloride tablets (20 mg twice daily) than placebo in Studies 1 and 2 combined Adverse Reaction Placebo (N=590) Trospium Chloride Tablets 20 mg twice daily (N=591) Gastrointestinal Disorders Dry mouth 34 (5.8) 119 (20.1) Constipation 27 (4.6) 57 (9.6) Abdominal pain upper 7 (1.2) 9 (1.5) Constipation aggravated 5 (0.8) 8 (1.4) Dyspepsia 2 (0.3) 7 (1.2) Flatulence 5 (0.8) 7 (1.2) Nervous System Disorders Headache 12 (2.0) 25 (4.2) General Disorders Fatigue 8 (1.4) 11 (1.9) Renal and Urinary Disorders Urinary retention 2 (0.3) 7 (1.2) Eye Disorders Dry eyes 2 (0.3) 7 (1.2) 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 patients treated with trospium chloride, and more common with trospium chloride 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.
6.2 Post-marketing 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.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Avet Pharmaceuticals Inc.
at 1-866-901-DRUG (3784) 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 was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with trospium chloride (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 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 trospium chloride tablets 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 trospium chloride group than in the placebo group.
The two most common adverse reactions reported by patients receiving trospium chloride tablets 20 mg twice daily were dry mouth and constipation.
The single most frequently reported adverse reaction for trospium chloride tablets, dry mouth, occurred in 20.1% of trospium chloride 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 trospium chloride tablets 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.
Table 1.
Incidence (%) of adverse reactions with trospium chloride, reported in greater than or equal to 1% of all patients treated with trospium chloride tablets and more frequent with trospium chloride tablets (20 mg twice daily) than placebo in Studies 1 and 2 combined Adverse Reaction Placebo (N=590) Trospium Chloride Tablets 20 mg twice daily (N=591) Gastrointestinal Disorders Dry mouth 34 (5.8) 119 (20.1) Constipation 27 (4.6) 57 (9.6) Abdominal pain upper 7 (1.2) 9 (1.5) Constipation aggravated 5 (0.8) 8 (1.4) Dyspepsia 2 (0.3) 7 (1.2) Flatulence 5 (0.8) 7 (1.2) Nervous System Disorders Headache 12 (2.0) 25 (4.2) General Disorders Fatigue 8 (1.4) 11 (1.9) Renal and Urinary Disorders Urinary retention 2 (0.3) 7 (1.2) Eye Disorders Dry eyes 2 (0.3) 7 (1.2) 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 patients treated with trospium chloride, and more common with trospium chloride 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.
6.2 Post-marketing 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.