TROSPIUM CHLORIDE

TROSPIUM CHLORIDE- trospium chloride tablet, film coated
Bryant Ranch Prepack

Chemical StructureFigure 1Figure 2Figure 3Figure 4Figure 5

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 following patient populations:

For patients with severe renal impairment (creatinine clearance < 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 ≥ 75 years of age, dose may be titrated down to 20 mg once daily based upon tolerability [see USE IN SPECIFIC POPULATIONS (8.5)].

3 DOSAGE FORMS AND STRENGTHS

Trospium Chloride Tablets are supplied as 20 mg tablets (white, round, standard cup film coated tablet, debossed with ‘PAD’ on one side and ‘145’ on the other side).

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.

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Urinary Retention

Trospium Chloride Tablets should be administered with caution to patients with clinically significant bladder outflow obstruction because of the risk of urinary retention [see CONTRAINDICATIONS (4)].

5.2 Angioedema

Angioedema of the face, lips, tongue, and/or larynx has been reported with trospium chloride, the active ingredient in Trospium Chloride Tablets. In one case, angioedema occurred after the first dose of trospium chloride. Angioedema associated with upper airway swelling may be life threatening. If involvement of the tongue, hypopharynx, or larynx occurs, Trospium Chloride Tablets should be promptly discontinued and appropriate therapy and/or measures necessary to ensure a patent airway should be promptly provided.

5.3 Decreased Gastrointestinal Motility

Trospium Chloride Tablets should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention (see CONTRAINDICATIONS (4)). Trospium Chloride Tablets, like other antimuscarinic agents, may decrease gastrointestinal motility and should be used with caution in patients with conditions such as ulcerative colitis, intestinal atony and myasthenia gravis.

5.4 Controlled Narrow-angle Glaucoma

In patients being treated for narrow-angle glaucoma, Trospium Chloride Tablets should only be used if the potential benefits outweigh the risks and in that circumstance only with careful monitoring [see CONTRAINDICATIONS (4)].

5.5 Central Nervous System Effects

Trospium Chloride Tablets are associated with anticholinergic central nervous system (CNS) effects [see ADVERSE REACTIONS (6.2) ]. A variety of CNS anticholinergic effects have been reported, including dizziness, confusion, hallucinations and somnolence. Patients should be monitored for signs of anticholinergic CNS effects, particularly after beginning treatment or increasing the dose. Advise patients not to drive or operate heavy machinery until they know how Trospium Chloride Tablets affect them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

5.6 Anticholinergic Adverse Reactions in Patients with Moderate Renal Impairment

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, anticholinergic adverse reactions (including dry mouth, constipation, dyspepsia, urinary tract infection, and urinary retention) are expected to be greater in patients with moderate renal impairment [see DOSAGE AND ADMINISTRATION (2), and USE IN SPECIFIC POPULATIONS (8.6)].

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 compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice.

The safety of Trospium Chloride Tablets was evaluated in controlled clinical trials in a total of 2975 patients, who were treated with Trospium Chloride Tablets (N=1673), placebo (N=1056) or active control medications (N=246). Of this total, 1181 patients participated in two, 12-week, U.S., efficacy and safety studies and a 9-month open-label extension. Of this total, 591 patients received Trospium Chloride Tablets 20 mg twice daily. In all controlled trials combined, 232 and 208 patients received treatment with Trospium Chloride Tablets for at least 24 and 52 weeks, respectively.

In all placebo-controlled trials combined, the incidence of serious adverse events was 2.9% among patients receiving Trospium Chloride Tablets 20 mg twice daily and 1.5% among patients receiving placebo. Table 1 lists adverse reactions from the combined 12-week U.S. safety and efficacy trials were reported by at least 1% of patients, and were reported more frequently in the Trospium Chloride Tablets group than in the placebo group.

The two most common adverse reactions reported by patients receiving Trospium Chloride Tablets 20 mg twice daily were dry mouth and constipation. The single most frequently reported adverse reaction for Trospium Chloride Tablets, dry mouth, occurred in 20.1% of Trospium Chloride Tablets treated patients and 5.8% of patients receiving placebo. In the two U.S. studies, dry mouth led to discontinuation in 1.9% of patients treated with Trospium Chloride Tablets 20 mg twice daily. For the patients who reported dry mouth, most had their first occurrence of the event within the first month of treatment.

Table 1. Incidence (%) of adverse reactions with Trospium Chloride Tablets, reported in ≥ 1% of all patients treated with Trospium Chloride Tablets and more frequent with Trospium Chloride Tablets (20 mg twice daily) than placebo in Studies 1 and 2 combined
Adverse Reaction Placebo
(N=590)
Trospium Chloride Tablets
20 mg twice daily
(N=591)

Gastrointestinal Disorders

Dry mouth

34 (5.8)

119 (20.1)

Constipation

27 (4.6)

57 (9.6)

Abdominal pain upper

7 (1.2)

9 (1.5)

Constipation aggravated

5 (0.8)

8 (1.4)

Dyspepsia

2 (0.3)

7 (1.2)

Flatulence

5 (0.8)

7 (1.2)

Nervous System Disorders

Headache

12 (2.0)

25 (4.2)

General Disorders

Fatigue

8 (1.4)

11 (1.9)

Renal and Urinary Disorders

Urinary retention

2 (0.3)

7 (1.2)

Eye Disorders

Dry eyes

2 (0.3)

7 (1.2)

Other adverse reactions from the U.S., placebo-controlled trials , occurring in ≥ 0.5% and < 1.0% of Trospium Chloride Tablets treated patients, and more common with Trospium Chloride Tablets than placebo are: tachycardia, vision blurred, abdominal distension, vomiting, dysgeusia, dry throat, and dry skin.

During controlled clinical studies, one adverse reaction of angioneurotic edema was reported.

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