DailyMed Label: TROSPIUM CHLORIDE

DailyMed Label: Trospium Chloride

2024

DailyMed Prescription

Trospium Chloride

Trospium Chloride

Zameer Pharmaceuticals LLC

NDC: 90096-141

NDC: 90096-141

NDC: 90096-141

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. The structural formula of trospium chloride USP is represented below: Trospium chloride USP is colorless or white to slightly yellow, crystalline powder. It is very soluble in water and freely soluble in methanol. Each trospium chloride tablet USP contains 20 mg of trospium chloride USP, a muscarinic antagonist, for oral administration. Each tablet also contains the following inactive ingredients: colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, maize starch, microcrystalline cellulose, polyethylene glycol, povidone, red iron oxide, sucralose, titanium dioxide and yellow iron oxide. FDA approved dissolution specification differs from the USP dissolution specification.

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.

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) ]. In geriatric patients greater than or equal to 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability [ see  Use in Specific Populations (8.5) ].

Trospium chloride tablets USP are supplied as 20 mg tablets (brownish yellow, round, biconvex, film coated tablets, debossed with ‘E’ on one side and plain on other).

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 should be administered with caution to patients with clinically significant bladder outflow obstruction or gastrointestinal obstructive disorders due to risk of urinary or gastric retention. ( 5.1 , 5.3 ) Angioedema of the face, lips, tongue and/or larynx has been reported with trospium chloride. ( 5.2 ) In patients with controlled narrow angle glaucoma trospium chloride tablets should be used only with careful monitoring. ( 5.4 ) Central Nervous System Effects: Somnolence has been reported with trospium chloride tablets. Advise patients not to drive or operate heavy machinery until they know how trospium chloride tablets affects them ( 5.5 ). Trospium is substantially excreted by the kidney. The effects of moderate renal impairment on systemic exposure are not known but systemic exposure is likely increased. Therefore, the risk of anticholinergic adverse reactions is expected to be greater in patients with moderate renal impairment. ( 5.6 )

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%). (

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 )

The safety and effectiveness of trospium chloride tablets in pediatric patients have not been established. ( 8.4 )

Trospium chloride tablets USP 20 mg (brownish yellow, round, biconvex, film coated tablets, debossed with ‘E’ on one side and plain on other) are supplied as follows: 60 count HDPE bottle - NDC 90096-141-60 Store at 20 - 25°C (68 - 77°F). Excursion permitted at 15-30°C [see USP for controlled temperature].

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.

Carcinogenesis : Carcinogenicity studies with trospium chloride were conducted in mice and rats for 78 weeks and 104 weeks, respectively, at maximally tolerated doses. No evidence of a carcinogenic effect was found in either mice or rats administered up to 200 mg/kg/day, approximately 9 times the expected clinical exposure levels at the maximum recommended human dose (MRHD) of 40 mg. Mutagenesis : Trospium chloride was not mutagenic nor genotoxic in tests in vitro in bacteria (Ames test) and mammalian cells (L5178Y mouse lymphoma and CHO cells) or in vivo in the rat micronucleus test. Impairment of Fertility : No evidence of impaired fertility was observed in rats administered doses up to 200 mg/kg/day (about 16 times the expected clinical exposure at the MRHD, based on AUC).

Trospium chloride tablets 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 studies and one 9-month open label extension. Study 1 was a randomized, double-blind, placebo-controlled, parallel-group study in 523 patients. A total of 262 patients received trospium chloride tablets 20 mg twice daily and 261 patients received placebo. The majority of patients were Caucasian (85%) and female (74%) with a mean age of 61 years (range: 21 to 90 years). Entry criteria required that patients have urge or mixed incontinence (with a predominance of urge), urge incontinence episodes of at least 7 per week, and greater than 70 micturitions per week. The patient’s medical history and urinary diary during the treatment-free baseline confirmed the diagnosis. Reductions in urinary frequency, urge incontinence episodes and urinary void volume for placebo and trospium chloride tablets treatment groups are summarized in Table 3 and Figures 2 and 3. Study 2 was nearly identical in design to Study 1. A total of 329 patients received trospium chloride tablets 20 mg twice daily and 329 patients received placebo. The majority of patients were Caucasian (88%) and female (82%) with a mean age of 61 years (range: 19 to 94 years). Entry criteria were identical to Study 1. Reductions in urinary frequency, urge incontinence episodes, and urinary void volume for placebo and trospium chloride tablets treatment groups are summarized in Table 4 and Figures 4 and 5.

NDC 90096-141-60 Trospium Chloride Tablets, USP 20 mg 60 Tablets Rx only Zameer Pharmaceuticals LLC