TROSPIUM CHLORIDE

TROSPIUM CHLORIDE- trospium chloride capsule, extended release
A-S Medication Solutions

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.

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 less than 30 mL/minute) [see Warnings and Precautions ( 5.6), Use in Specific Populations ( 8.6), and Clinical Pharmacology ( 12.3)].

3 DOSAGE FORMS AND STRENGTHS

Trospium Chloride Extended-Release Capsules are supplied as 60 mg capsules (opaque medium orange cap printed with” image-A” and opaque white body printed with “126” in black ink).

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.

5 WARNINGS AND PRECAUTIONS

5.1 Risk of Urinary Retention

Trospium chloride extended-release capsules 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. 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 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 extended-release capsules should be administered with caution to patients with gastrointestinal obstructive disorders because of the risk of gastric retention [see Contraindications ( 4)] . Trospium chloride extended-release capsules, 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 extended-release capsules 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 extended-release capsules and trospium chloride immediate release 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 extended-release capsules affect them. If a patient experiences anticholinergic CNS effects, dose reduction or drug discontinuation should be considered.

5.6 Patients with Severe Renal Impairment

Trospium chloride extended-release capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute) [see Dosage and Administration ( 2), Use in Specific Populations ( 8.6), and Clinical Pharmacology ( 12.3)].

5.7 Alcohol Interaction

Alcohol should not be consumed within 2 hours of trospium chloride extended-release capsules administration. In addition, patients should be informed that alcohol may enhance the drowsiness caused by anticholinergic agents.

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 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=1,165). 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 treatment with trospium chloride extended-release capsules for at least 24 and 52 weeks, respectively.

There were 157 (27.2%) trospium chloride extended-release capsules patients and 98 (16.7%) placebo patients who experienced one or more double-blind treatment-emergent adverse events (TEAEs) that were assessed by the investigator as at least possibly related to study medication. The most common TEAEs were dry mouth and constipation which, when reported, commonly occurred early in treatment (often within the first week). In the two Phase 3 studies, constipation, dry mouth, and urinary retention led to discontinuation in 1%, 0.7%, and 0.5% of patients treated with trospium chloride extended-release capsules 60 mg daily, respectively. In the placebo group, there were no discontinuations due to dry mouth or urinary retention and one due to constipation.

The incidence of serious adverse events was similar among patients receiving trospium chloride extended-release capsules and patients receiving placebo. No treatment-emergent serious adverse events in either treatment group were judged by the investigators as being possibly related to the study medication.

Table 1 lists those treatment emergent adverse events from the trials that were assessed by the investigator as possibly related to study medication, reported in at least 1% of trospium chloride extended-release capsules patients, and were more common for the trospium chloride extended-release capsules group than for placebo.

Table 1: Incidence of treatment-emergent adverse events reported in at least 1% of patients judged by the investigator as at least possibly related to treatment and more common for the Trospium Chloride Extended-Release Capsules group than for placebo

MedDRA Preferred term Number of patients (%)
Placebo N=587 Trospium Chloride Extended-Release Capsules N=578
Dry mouth 22 (3.7) 62 (10.7)
Constipation 9 (1.5) 49 (8.5)
Dry eye 1 (0.2) 9 (1.6)
Flatulence 3 (0.5) 9 (1.6)
Nausea 2 (0.3) 8 (1.4)
Abdominal pain 2 (0.3) 8 (1.4)
Dyspepsia 4 (0.7) 7 (1.2)
Urinary tract infection 5 (0.9) 7 (1.2)
Constipation aggravated 3 (0.5) 7 (1.2)
Abdominal distension 2 (0.3) 6 (1.0)
Nasal dryness 0 (0.0) 6 (1.0)

Additional adverse events reported in less than 1% of trospium chloride extended-release capsules treated patients and more common for trospium chloride extended-release capsules than placebo, judged by the investigator at least possibly related to treatment were: vision blurred, feces hard, back pain, somnolence, urinary retention, and dry skin.

Table 2 lists all treatment-emergent adverse events for the trials reported in at least 2% of all trospium chloride extended-release capsules patients and more common for the trospium chloride extended-release capsules group than for placebo without regard to the investigator’s judgment on drug relatedness.

Table 2: Incidence of treatment-emergent adverse events reported in at least 2% of patients regardless of reported relationship to treatment and more common for the Trospium Chloride Extended-Release Capsules group than for placebo

MedDRA Preferred term Number of patients (%)
Placebo N=587 Trospium Chloride Extended-Release Capsules N=578
Dry mouth 22 (3.7) 64 (11.1)
Constipation 10 (1.7) 52 (9.0)
Urinary tract infection 29 (4.9) 42 (7.3)
Nasopharyngitis 10 (1.7) 17 (2.9)
Influenza 9 (1.5) 13 (2.2)

Additional adverse events reported in less than 2% of trospium chloride extended-release capsules treated patients and twice as frequent for trospium chloride extended-release capsules compared to placebo, regardless of reported relationship to treatment were: tachycardia, dry eyes, abdominal pain, dyspepsia, abdominal distension, constipation aggravated, nasal dryness, and rash.

In the open-label treatment phase, the most common TEAEs reported in the 769 patients with at least 6 months exposure to trospium chloride extended-release capsules were: constipation, and dry mouth. Urinary tract infection and rash was also reported in several patients, including one of each judged by the investigator to be possibly related to treatment. Several adverse events were reported as severe in the open-label treatment phase, including one urinary tract infection, two urinary retention events, and one aggravated constipation.

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