Overview
11 DESCRIPTION Trospium chloride tablets USP (trospium chloride) is a quaternary ammonium compound with the chemical name of Spiro[8azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3-[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5 α). The empirical formula of trospium chloride USP is C25H30ClNO3 and its molecular weight is 427.97.
Mechanism of Action
12 CLINICAL PHARMACOLOGY 12.1 Mechanism of Action Trospium chloride tablets is a muscarinic antagonist. Trospium chloride antagonizes the effect of acetylcholine on muscarinic receptors in cholinergically innervated organs including the bladder. Its parasympatholytic action reduces the tonus of smooth muscle in the bladder. Receptor assays showed that trospium chloride has negligible affinity for nicotinic receptors as compared to muscarinic receptors at concentrations obtained from therapeutic doses. 12.2 Pharmacodynamics Placebo-controlled studies employing urodynamic variables were conducted in patients with conditions characterized by involuntary detrusor contractions.
Indications
- 1 INDICATIONS & USAGE Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency. Trospium chloride tablets is a muscarinic antagonist indicated for the treatment of overactive bladder (OAB) with symptoms of urge urinary incontinence, urgency, and urinary frequency.
Common Doses
- 20 mg
- 30 mL
Dosage
2 DOSAGE & 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) ].
Contraindications
- 4 CONTRAINDICATIONS Trospium chloride tablets 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 tablets is 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 )
Side Effects
- 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 Zameer Pharmaceuticals LLC at 1-888-851-7033 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...
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 [ see Clinical Pharmacology (12.3) ]. 7.