Label: TROSPIUM CHLORIDE tablet, film coated

  • NDC Code(s): 68462-461-05, 68462-461-10, 68462-461-30, 68462-461-60
  • Packager: Glenmark Pharmaceuticals Inc., USA
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 28, 2023

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  • HIGHLIGHTS OF PRESCRIBING INFORMATION
    These highlights do not include all the information needed to use TROSPIUM CHLORIDE TABLETS safely and effectively. See full prescribing information for TROSPIUM CHLORIDE TABLETS. TROSPIUM ...
  • Table of Contents
    Table of Contents
  • 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.
  • 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 ...
  • 3 DOSAGE FORMS AND STRENGTHS
    Trospium Chloride Tablets, USP are supplied as 20 mg tablets (brownish yellow, round, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘1’ on the other side).
  • 4 CONTRAINDICATIONS
    Trospium chloride is contraindicated in patients with: • urinary retention - • gastric retention - • uncontrolled narrow-angle glaucoma. • known hypersensitivity to the drug or its ingredients ...
  • 5 WARNINGS AND PRECAUTIONS
    5.1 Risk of Urinary Retention - Trospium chloride should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention ...
  • 6 ADVERSE REACTIONS
    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 ...
  • 7 DRUG INTERACTIONS
    7.1 Digoxin - Concomitant use of trospium chloride and digoxin did not affect the pharmacokinetics of either drug [see Clinical Pharmacology (12.3)]. 7.2 Drugs Eliminated by Active Tubular ...
  • 8 USE IN SPECIFIC POPULATIONS
    8.1 Pregnancy - Teratogenic Effects - There are no adequate and well-controlled studies of trospium chloride in pregnant women. Trospium chloride should be used during pregnancy only if the ...
  • 10 Overdosage
    Overdosage with antimuscarinic agents, including trospium chloride, can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of ...
  • 11 DESCRIPTION
    Trospium chloride, USP is a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1R, 3r, 5S) ...
  • 12 CLINICAL PHARMACOLOGY
    12.1 Mechanism of Action - Trospium chloride is a muscarinic antagonist. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs ...
  • 13 NONCLINICAL TOXICOLOGY
    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility - Carcinogenesis: Carcinogenicity studies with trospium chloride were conducted in mice and rats for 78 weeks and 104 weeks ...
  • 14 CLINICAL STUDIES
    Trospium chloride was evaluated for the treatment of patients with overactive bladder who had symptoms of urinary frequency, urgency, and urge incontinence in two U.S. 12-week, placebo-controlled ...
  • 16 HOW SUPPLIED/STORAGE AND HANDLING
    Trospium Chloride Tablets, USP, 20 mg (brownish yellow, round, biconvex film-coated tablets, debossed with ‘L’ on one side and ‘1’ on the other side) are supplied as follows: Bottles of 30 NDC ...
  • 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 ...
  • PATIENT INFORMATION
    Trospium Chloride (trose’ pee um klor’ ide) Tablets - Read the Patient Information that comes with trospium chloride tablets before you start taking it and each time you get a refill. There may ...
  • PACKAGE/LABEL PRINCIPAL DISPLAY PANEL
    NDC 68462-461-60 - TROSPIUM CHLORIDE TABLETS USP - 20 mg - Pharmacist: Dispense the patient information sheet provided separately to each patient.
  • INGREDIENTS AND APPEARANCE
    Product Information