Drugplain

Trospium Chloride ER 60 mg/1

Trospium Chloride · CAPSULE, EXTENDED RELEASE · Bryant Ranch Prepack

No Recall History
Plain English

Trospium Chloride ER is a capsule, extended release containing trospium chloride at 60 mg/1, taken oral. Manufactured by Bryant Ranch Prepack.

Key Facts

Brand Name
Trospium Chloride ER
Generic Name
Trospium Chloride
NDC Code (Product)
71335-2931
Manufacturer
Bryant Ranch Prepack
Strength
60 mg/1
Dosage Form
CAPSULE, EXTENDED RELEASE
Route
ORAL
Marketing Status
Application #
ANDA201291
Marketing Start
06/07/2013

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

fall171 reports
fatigue158 reports
urinary tract infection133 reports
drug ineffective127 reports
asthenia110 reports
dyspnoea110 reports
headache106 reports
nausea98 reports
gait disturbance96 reports
dizziness93 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

1 INDICATIONS AND USAGE Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium Chloride Extended-Release Capsules are a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. (1)

Dosage & Administration

2 DOSAGE AND ADMINISTRATION 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 < 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 < 30 mL/minute). (2)

Contraindications

4 CONTRAINDICATIONS 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 )

Drug Interactions

7 DRUG INTERACTIONS 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 and 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 t…

Adverse Reactions

6 ADVERSE REACTIONS The most common adverse reactions (≥ 1%) with Trospium Chloride Extended-Release Capsules are dry mouth (10.7%) and constipation (8.5%). (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Perrigo at 1-866-634-9120 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 = 1165). 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 t…

Frequently Asked Questions

What is Trospium Chloride ER used for?

Trospium Chloride ER contains Trospium Chloride. It is a capsule, extended release taken oral. Consult your doctor for specific uses.

Is Trospium Chloride ER a controlled substance?

Trospium Chloride ER is not classified as a controlled substance by the DEA.

What is the generic name for Trospium Chloride ER?

The generic name for Trospium Chloride ER is Trospium Chloride. There are 11 other brand versions of Trospium Chloride.

What is the NDC code for Trospium Chloride ER 60 mg/1?

The NDC (National Drug Code) for Trospium Chloride ER 60 mg/1 is 71335-2931, listed by Bryant Ranch Prepack.

Product NDC

71335-2931

Package NDC

71335-2931-1

Other Trospium Chloride ER Dosages

Other Trospium Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)