Trospium Chloride
FDA Drug Information • Also known as: Trospium Chloride, Trospium Chloride Er
- Brand Names
- Trospium Chloride, Trospium Chloride Er
- Dosage Form
- POWDER
- Product Type
- BULK INGREDIENT
Description
11 DESCRIPTION Trospium Chloride Extended-Release Capsules are an extended-release formulation of trospium chloride, a quaternary ammonium compound with the chemical name of Spiro [8-azoniabicyclo[3.2.1]octane-8,1'-pyrrolidinium], 3[(hydroxydiphenylacetyl)oxy]-, chloride, (1α, 3β, 5α). The empirical formula of trospium chloride is C 25 H 30 ClNO 3 and its molecular weight is 427.97. The structural formula of trospium chloride is represented below: Trospium chloride is a fine, colorless to slightly yellow, crystalline solid. The compound’s solubility in water is approximately 1 g/2 mL. Trospium Chloride Extended-Release Capsules contain 60 mg of trospium chloride, a muscarinic antagonist, for oral administration. Each capsule also contains the following inactive ingredients: ethylcellulose, FD&C Yellow 6, gelatin, hypromellose, methacrylic acid, methyl acrylate, methyl methacrylate, polyethylene glycol 3350, polysorbate 80, polyvinyl alcohol, sodium lauryl sulfate, sugar spheres, talc, titanium dioxide, and triethyl citrate. The imprinting ink have the following ingredients: ferrosoferric oxide, potassium hydroxide and shellac. api-structure
What Is Trospium Chloride Used For?
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. 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. ( 1 )
Dosage and Administration
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 )]. 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. ( 2 ) Trospium chloride extended-release capsules are not recommended for use in patients with severe renal impairment (creatinine clearance less than 30 mL/minute). ( 2 )
Side Effects (Adverse Reactions)
6 ADVERSE REACTIONS The most common adverse reactions (greater than or equal to 1%) with trospium chloride extended-release capsules are dry mouth (10.7%) and constipation (8.5%). ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Slate Run Pharmaceuticals, LLC at 1-888-341-9214 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 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...
Drug Interactions
7 DRUG INTERACTIONS Trospium is metabolized by ester hydrolysis and excreted by the kidneys through a combination of tubular secretion and glomerular filtration. Based on in vitro data, no clinically relevant metabolic drug-drug interactions are anticipated with trospium chloride extended-release capsules. However, some drugs which are actively secreted by the kidney may interact with trospium chloride extended-release capsules by competing for renal tubular secretion. The concomitant use of trospium chloride extended-release capsules with other antimuscarinic agents that produce dry mouth, constipation, and other anticholinergic effects may increase the frequency and/or severity of such effects. Trospium chloride extended-release capsules may potentially alter the absorption of some concomitantly administered drugs due to anticholinergic effects on gastrointestinal motility. Some drugs which are actively secreted by the kidney may interact with trospium chloride extended-release capsules by competing for renal tubular secretion. ( 7 ) Concomitant use with digoxin did not affect the pharmacokinetics of either drug. ( 7.1 ) Exposure to trospium on average was comparable in the presence of and without antacid, however, some individuals demonstrated increases or decreases in trospium exposure in the presence of antacid. The clinical relevance of these findings is not known. ( 7.2 ) Concomitant use with metformin immediate release tablets reduced exposure and peak concentration of trospium. ( 7.3 ) 7.1 Digoxin Concomitant use of trospium chloride 20 mg twice daily and digoxin did not affect the pharmacokinetics of either drug [see Clinical Pharmacology ( 12.3 )]. 7.2 Antacid While the systemic exposure of trospium on average was comparable with and without antacid containing aluminum hydroxide and magnesium carbonate, 5 out of 11 individuals in a drug interaction study demonstrated either an increase or decrease in trospium exposure, in presence of antacid. The clinical relevance of these findings is not known [see Clinical Pharmacology ( 12.3 )]. 7.3 Metformin Co-administration of 500 mg metformin immediate release tablets twice daily reduced the steady-state systemic exposure of trospium by approximately 29% for mean AUC (0-24) and by 34% for mean C max . The effect of a decrease in trospium exposure on the efficacy of trospium chloride extended-release capsules is unknown. The steady-state pharmacokinetics of metformin were comparable when administered with or without 60 mg trospium chloride extended-release capsules once daily under fasted condition. The effect of metformin at higher doses on trospium PK is unknown [see Clinical Pharmacology ( 12.3 )].
Contraindications
4 CONTRAINDICATIONS Trospium Chloride Extended-Release Capsules are contraindicated in patients with:
Overdosage
10 OVERDOSAGE Overdosage with antimuscarinic agents, including trospium chloride extended-release capsules, can result in severe antimuscarinic effects. Supportive treatment should be provided according to symptoms. In the event of overdosage, ECG monitoring is recommended.
How Supplied
16 HOW SUPPLIED/STORAGE AND HANDLING Trospium Chloride Extended-Release Capsules are supplied as follows: 60 mg capsules, opaque medium orange cap printed with" ” and opaque white body printed with “126” in black ink. NDC 70436-174-04, bottle of 30 capsules with child-resistant closure. Store at 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature] Keep this and all drugs out of the reach of children. image-A-2
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.