Trospium Chloride is a cholinergic muscarinic antagonist sold in the U.S. under 3 brand and generic names, for overactive urinary bladder and urge urinary incontinence. Below: what the FDA label says, every product that contains it, what the pills look like, and its recall record.
From the FDA label for Trospium Chloride (application ANDA213185). Other trospium chloride products — different forms, different strengths — are dosed differently. Follow the label for the one you were prescribed.
The recommended dosage of Trospium Chloride Extended-Release Capsules is one 60 mg capsule daily in the morning. Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal. Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Warnings and Precautions (5.6) , Use in Specific Populations (8.6) , and Clinical Pharmacology (12.3) ]. • The recommended dosage of Trospium Chloride Extended-Release Capsules is one 60 mg capsule daily in the morning. Trospium Chloride Extended-Release Capsules should be dosed with water on an empty stomach, at least one hour before a meal. (2) •Trospium Chloride Extended-Release Capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). (2)
The most common adverse reactions (greater than or equal to 1%) with Trospium Chloride Extended-Release Capsules are dry mouth (10.7%) and constipation (8.5%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Granules Pharmaceuticals Inc., at 1-877-770-3183 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 data described below reflect exposure to Trospium Chloride Extended-Release Capsules in 578 patients for 12 weeks in two Phase 3 double-blind, placebo controlled trials (n=1,165). These studies included overactive bladder patients of ages 21 to 90 years, of which 86% were female and 85% were Caucasian. Patients received 60 mg daily doses of Trospium Chloride Extended-Release Capsules. Patients in these studies were eligible to continue treatment with Trospium Chloride Extended-Release Capsules 60 mg for up to one year. From both these controlled trials combined, 769 and 238 patients received treatment with Trospium Chloride Extended-Release Capsules for at least 24 and 52 weeks, respectively. There were 157 (27.2%) Trospium Chloride Extended-Release Capsules…
Same active ingredient — different manufacturer, form, price and FDA recall record. That last one is what our independent score measures.
| # | Drug | Rating | Type | Form | Generic? | Typical price | |
|---|---|---|---|---|---|---|---|
| 1 | 72/100 | Prescription | Capsule | Generic | $7 | View → | |
| 2 | 70/100 | Prescription | Tablet | Generic |
Imprint codes, colour and shape from the FDA’s labelling data. Match the imprint on your pill — or search any imprint.
| Imprint | Strength | Colour | Shape | Maker |
|---|---|---|---|---|
| Karuna;50;20 | 50 mg / 20 mg | white | capsule | — |
| Karuna;100;20 | 100 mg / 20 mg | brown | capsule | — |
| Karuna;125;30 | 125 mg / 30 mg | orange | capsule | — |
| A;126 | 60 mg | orange, white | capsule | — |
| HP530 | 20 mg | white | round | — |
| PAD;145 |
A combination is a different drug — different dosing, different warnings. It is listed here so you can find it, not so you can substitute it.
Sources: FDA openFDA drug label, National Drug Code Directory, and Enforcement (recall) database. This page reproduces public FDA data and is not medical advice. Dosing is set by your prescriber.
Trospium Chloride Extended-Release Capsules 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 Extended-Release Capsules are 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)
Trospium is metabolized by ester hydrolysis and excreted by the kidneys through a combination of tubular secretion and glomerular filtration. Based on in vitro data, no clinically relevant metabolic drug-drug interactions are anticipated with Trospium Chloride Extended-Release Capsules. However, some drugs which are actively secreted by the kidney may interact with Trospium Chloride Extended-Release Capsules by competing for renal tubular secretion. The concomitant use of Trospium Chloride Extended-Release Capsules with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic effects may increase the frequency and/or severity of such effects. Trospium Chloride Extended-Release Capsules may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. • Some drugs which are actively secreted by the kidney may interact with Trospium Chloride Extended-Release Capsules by competing for renal tubular secretion.( 7 ) • Concomitant use with digoxin did not affect the pharmacokinetics of either drug. ( 7.1 ) • Exposure to trospium on average was comparable in the presence of and without antacid, however, some individuals demonstrated increases or decreases in trospium exposure in the presence of antacid. The clinical relevance of these findings is not known. ( 7.2 ) •…
| $7 |
| View → |
| 3 | 70/100 | Prescription | Capsule | Generic | $7 | View → |
| 20 mg |
| white |
| round |
| — |
| WPI;3636 | 60 mg | orange, white | capsule | — |
|---|